[Rev. 2/11/2014 12:56:02 PM]

[NAC-639 Revised Date: 1-14]

CHAPTER 639 - PHARMACISTS AND PHARMACY

GENERAL PROVISIONS

639.010            Definitions.

639.030            “Date” interpreted.

639.032            “Facsimile machine” interpreted.

639.040            “File” interpreted.

639.050            Storage and destruction of certain controlled substances.

639.060            Marketing codes of conduct: Adoption of certain codes by reference.

639.065            Marketing codes of conduct: Periodic review of adopted codes.

STATE BOARD OF PHARMACY

639.100            Seal of Board.

639.110            Inactive regulations: Duties of Executive Secretary.

639.120            Conduct of disciplinary hearings.

639.130            Representation by counsel at disciplinary hearings.

639.140            Petitions to adopt, amend or repeal regulations.

639.150            Declaratory orders and advisory opinions.

639.160            Required time for receipt of application.

639.170            Waiver of regulation upon declaration of emergency: Authority; required notices.

CERTIFICATES, LICENSES AND PERMITS

639.200            Temporary certificates, licenses and permits.

639.205            Application to register as pharmacist: Completion required within 1 year.

639.210            Educational qualifications: Approval of accredited programs of education in pharmacy.

639.212            Educational qualifications: Advanced degree in pharmacy.

639.214            Application for license to operate pharmacy: Information required.

639.215            Application for license to operate pharmacy: Appearance of applicant before Board; execution on behalf of partnership or corporation; payment of expenses for special meeting of Board.

639.218            Application for inactive status.

639.219            Application for return to active status.

639.220            Schedule of fees; penalty for late renewal; exemptions from certain fees.

639.225            Notice to Executive Secretary of change of address.

639.226            Notice to Board by certain licensees of change of address.

639.227            Application or written notice to Board concerning change in ownership of pharmacy required under certain circumstances; suspension of license.

639.230            Voluntary surrender of certificate, license or registration to practice pharmacy in another state pursuant to agreement relating to disciplinary matter.

PHARMACEUTICAL TECHNICIANS

639.240            Requirements for registration of pharmaceutical technicians.

639.242            Registration of pharmaceutical technician in training; affidavit of managing pharmacist.

639.245            Maintenance and availability of records regarding certain pharmaceutical personnel on duty; activities of pharmaceutical technicians.

639.247            Establishment and maintenance of policies and procedures for personnel; maintenance and availability of personnel records.

639.250            Restrictions on supervision.

639.252            Initialing of prescriptions, records and reports; responsibility for filled prescriptions.

639.254            Initial and biennial in-service training of pharmaceutical technicians working in or for pharmacy; substitution of continuing education for in-service training.

639.256            Program of training: Approval by Board; testing of pharmaceutical technician in training for presence of alcohol or drug.

639.258            Participation in program of training for pharmaceutical technicians.

639.260            Disciplinary action against pharmacy.

INTERN PHARMACISTS

639.262            Application for registration; issuance of certificate of registration; maintenance of records relating to internship.

639.264            Employment at pharmacy as part of internship.

639.266            Supervision and training: Service as preceptor; duties; evaluation of internship.

639.268            Supervision and training: Responsibilities of registered pharmacist.

PHYSICIAN ASSISTANTS

639.269            “Physician assistant” defined.

639.270            Scope.

639.272            Requirements for registration certificate.

639.277            Change in location of practice or supervising physician.

639.280            Scope of authority to prescribe and dispense.

639.283            Prescriptions: Orders on charts of hospitalized patients.

639.285            Security and storage of controlled substances and drugs.

639.290            Substitution in case of illness or absence.

639.295            Grounds for denial of application or suspension or revocation of registration.

IMMUNIZATION BY PHARMACISTS AND INTERN PHARMACISTS

639.297            “Immunization” defined.

639.2971          Authorization; contents of and deviation from written protocol.

639.2972          Duties of authorizing physician.

639.2973          Training and certification to administer immunizations.

639.2974          Certification in basic cardiac life support; continuing education.

639.2975          Legal possession and control of drugs administered as immunizations; drugs to counteract adverse reactions.

639.2976          Reporting of certain information concerning immunizations.

639.2977          Maintenance of records.

639.2978          Confidentiality of records.

CONTINUING PROFESSIONAL EDUCATION

639.300            Definitions.

639.305            “Acceptable materials” defined.

639.310            “Accredited material” defined.

639.315            “Continuing education unit” defined.

639.320            “Provider” defined.

639.330            Registration and reregistration: Continuing education required; submission of proof.

639.333            Registration and reregistration: Acceptance of certificate issued by another state as proof of compliance with requirements for continuing education.

639.335            Registration and reregistration: Exceptions to requirement of continuing education.

639.340            Providers of continuing education: Request for recognition; grant, denial or withdrawal of recognition.

639.345            Providers of continuing education: Records required; issuance of certificates of completion.

639.350            Providers of continuing education: List of participants; reference to accreditation; information to be transmitted to Board.

639.360            Accreditation of material, course or program.

639.365            Advertising, announcements and other promotional material.

639.370            Materials for continuing education: Formats of programs; subject matter.

639.380            Advisory Committee on Continuing Education: Creation; number of members.

639.385            Advisory Committee on Continuing Education: Composition; powers and duties; quorum; review of materials for continuing education.

639.390            Certificate of completion: Retention by pharmacist; copy to be submitted to Board upon request.

REMOTE SITES AND TELEPHARMACIES

639.391            Pharmacist or dispensing practitioner required to obtain certificate of registration to dispense controlled substances or dangerous drugs at remote site.

639.392            Telepharmacies and associated remote sites required to be located within State; requirements concerning accessibility of pharmacist or dispensing practitioner; procedure during interruption of communicative access between telepharmacy and remote site.

639.393            Requirements for pharmaceutical technicians and dispensing technicians.

639.394            Supervision of pharmaceutical technicians and dispensing technicians.

639.395            Transmission of new prescription to telepharmacy; consultation with pharmacist or dispensing practitioner required before accessing controlled substances or dangerous drugs at remote site; prerequisites for dispensing at remote site.

639.396            Requirements for maintenance of records.

639.397            Requirements for labeling.

639.398            Establishment of policies and procedures for operation of remote site; monthly inspections.

639.399            Responsibility of pharmacist or dispensing practitioner concerning dispensing of controlled substances or dangerous drugs at remote site.

OFF-SITE PHARMACY PRACTICE

639.401            Pharmacist authorized to engage in practice of pharmacy only at licensed pharmacy; exceptions.

639.403            Application required for pharmacist to engage in practice of pharmacy at site other than licensed pharmacy; exemption for pharmacists who administer immunizations.

639.406            Hearing to approve or deny application from pharmacist.

639.409            Grounds for revocation, suspension or placement of restrictions on approval granted to pharmacist to practice pharmacy at site other than licensed pharmacy.

639.412            Application for licensed pharmacy to use services of one or more pharmacists at site other than licensed pharmacy.

639.415            Hearing to approve or deny application from licensed pharmacy.

639.418            Grounds for revocation, suspension or placement of restrictions on approval granted to licensed pharmacy to use services of one or more pharmacists at site other than licensed pharmacy.

INTERNET PHARMACIES

General Provisions

639.420            Definitions.

639.422            “Certified Internet pharmacy” defined.

639.424            “Internet pharmacy” defined.

Certification

639.426            Requirements for approval of application.

639.428            Access to premises and records; suspension for noncompliance.

CANADIAN PHARMACIES

639.430            Licensure: Requirement; application.

639.432            Restrictions on dispensing drugs.

639.434            Standards of practice.

639.436            Dissemination of certain contact information; printing of certain information on label of prescription.

MEDICAL FACILITIES AND CORRECTIONAL INSTITUTIONS

General Provisions

639.440            Definitions.

639.441            “Administer” defined.

639.442            “Chart order” defined.

639.445            “Compound” and “compounding” defined.

639.446            “Consultant pharmacist” defined.

639.4465          “Correctional institution” defined.

639.447            “Deliver” and “delivery” defined.

639.448            “Device” defined.

639.449            “Direct copy” defined.

639.450            “Dispense” defined.

639.451            “Distribute” defined.

639.452            “Floor stock” defined.

639.453            “Formulary” defined.

639.455            “Investigational drug” defined.

639.456            “IV admixture” defined.

639.457            “Medical facility” defined.

639.4575          “Pharmacy” defined.

639.458            “Prescription” defined.

639.459            “Unit dose” defined.

639.460            “Unit of use” defined.

639.461            Licensing.

639.462            Biennial registration.

639.463            Change of ownership.

Standards of Operation

639.464            Scope of services in hospital or correctional institution.

639.4645          Maintenance of registration certificates required.

639.465            Managing pharmacist.

639.466            Consultant pharmacist.

639.467            Staff pharmacists.

639.468            Establishment of policies, procedures and systems.

639.4685          Handling of medications in correctional institutions without pharmacies.

639.469            Standards for premises.

639.470            Security of premises.

639.472            Maintenance of reference library.

639.473            Procurement and storage of drugs.

639.474            Development and use of formulary.

639.475            Preparation and labeling of admixtures.

639.476            Prepackaging of drugs.

639.477            Policies and procedures for distribution of drugs.

639.478            Limitations on distribution of drugs.

639.479            Withdrawal of drugs when full-time pharmacist is absent.

639.480            Withdrawal of drugs when part-time or consultant pharmacist is absent.

639.481            Withdrawal of drugs when facility uses floor stock and pharmacy is closed.

Records

639.482            Maintenance and availability of records.

639.483            Statutes applicable to maintenance of records.

639.484            Contents and maintenance of chart orders.

639.485            Maintenance of records for controlled substances.

639.486            Maintenance of records of controlled substances administered from floor stock.

639.487            Maintenance of additional records.

639.488            Maintenance of records for distribution of controlled substances to another pharmacy or practitioner.

639.489            Separation of certain records.

639.490            Permission to use centralized system for keeping records.

Chart Order Processing Services

639.491            Definitions.

639.4911          “Chart order” defined.

639.49115        “Chart order processing services” defined.

639.4912          “Correctional institution” defined.

639.4913          “Off-site pharmaceutical service provider” defined.

639.4914          “Remote chart order processing services” defined.

639.4915          Provision of services by pharmacies within certain hospitals and correctional institutions.

639.4916          Provision of remote services by pharmacist employed by off-site pharmaceutical service provider.

639.4917          Policies and procedures of off-site pharmaceutical service providers.

FACILITIES FOR INTERMEDIATE CARE AND FACILITIES FOR SKILLED NURSING

639.492            Definitions.

639.494            Prescriptions for controlled substances: Accountability record; handling of unused portions.

639.496            Maintenance of accountability record; examination of chart orders; issuance of receipt for controlled substances delivered to coroner.

639.498            Destruction of certain controlled substances: Requirement; procedure.

SURGICAL CENTERS FOR AMBULATORY PATIENTS

639.4985          Definitions.

639.4987          “Compounding” defined.

639.4989          “Drug” defined.

639.4991          “Investigational drug” defined.

639.4992          Dispensing of controlled substances: Registration and licensing required.

639.4996          Establishment and review of policies and procedures by pharmacist.

639.4998          Duties of pharmacist who establishes policies and procedures.

PHARMACIES IN GENERAL

639.500            Ownership of pharmacies; application to conduct a pharmacy.

639.5005          Representative of pharmacy: General requirements; exceptions; approval; enforcement.

639.5007          Terms and conditions of license to conduct pharmacy for applicant required to designate representative.

639.501            Inspections; provision of self-assessment form.

639.5012          Confidentiality and use of self-assessment and accompanying documentation.

639.5014          Completion of self-assessment form before annual inspections; suggestions relating to compliance by or improvement of pharmacy.

639.5016          Annual inspections: Review of self-assessment form; notes regarding discrepancies or deficiencies; correction of discrepancies or deficiencies.

639.5018          Protection of employee providing answers, information or suggestions on self-assessment form or during inspections.

639.5019          Annual review by Board of provisions of NAC 639.501 to 639.5019, inclusive.

639.503            Maintenance in pharmacy of current statutes, regulations and reference material.

639.505            Maintenance in pharmacy of reports of inspection, warning notices and special bulletins.

639.510            Maintenance and storage of pharmaceutical stock.

639.512            Class A and B packaging: Label; expiration date; log.

639.513            Class C packaging: Expiration date.

639.515            Stock of drugs in facility for skilled nursing or intermediate care.

639.517            Nurse employed by medical facility or agency to provide nursing in the home may maintain stock of certain drugs.

639.520            Security of prescription departments.

639.523            Physical address for delivery of drugs.

639.525            Minimum requirements for work area and equipment.

639.526            Drive-through facilities.

639.527            Required temperature in refrigerator or freezer used to store medicine.

639.528            Preparation and storage of food in prescription department of pharmacy.

639.530            Sanitation; required washbasins; exception.

639.535            Remodeling or relocation of pharmacy or prescription department.

639.540            Notice of employment and termination of employment of certain pharmaceutical professionals.

639.542            Identification of persons employed by pharmacy.

639.556            Meal periods and rest periods for employees of pharmacy.

639.570            Involuntary closure of pharmacy.

639.575            Voluntary closure of pharmacy.

639.580            Permanent closure of pharmacy.

NUCLEAR PHARMACIES

639.5802          Definitions.

639.5804          “Agreement state” defined.

639.5806          “Authentication of product history” defined.

639.5808          “Procedures to assure the quality of radiopharmaceuticals” defined.

639.581            “Qualified nuclear pharmacist” defined.

639.5812          “Radiopharmaceutical services” defined.

639.5814          “Testing to control the quality of radiopharmaceutical” defined.

639.5816          “Radiopharmaceutical” interpreted.

639.5818          Nuclear pharmacist: Certification; training and instruction; affidavit of experience and training.

639.582            Permit to operate.

639.5822          Space and equipment requirements; floor plan.

639.5824          Security.

639.5826          Records.

639.5828          Quality assurance procedures for radiopharmaceuticals.

639.583            Dispensing or transferring radiopharmaceuticals.

639.5832          Oral order for radiopharmaceutical: Requirement to keep record; contents of record.

639.5834          Outer shield of radiopharmaceutical container: Label required; contents of label.

639.5836          Inner label of radiopharmaceutical container; contents.

639.5838          Records of nuclear pharmacy when radiopharmaceutical is dispensed pursuant to investigational new drug application: Contents.

639.584            Required equipment.

WHOLESALERS

639.585            Definitions.

639.587            “Facility” defined.

639.588            “Manufacturer” defined.

639.589            “Ongoing relationship” defined.

639.5895          “Purchaser” defined.

639.5897          “Purchasing wholesaler” defined.

639.5902          “Statement of prior sales” defined.

639.5905          “Supplier” defined.

639.592            “Wholesaler” defined.

639.593            Licensing requirements; consideration of transaction as wholesale transaction; transferability and renewal of license.

639.5931          Submission of fingerprints: Required method.

639.5932          Provisional license: Prerequisites for issuance.

639.5935          Representative of wholesaler: General requirements; exceptions; approval; enforcement.

639.5937          Bond or other security: Amount required from certain wholesalers; reduction of amount; substitution.

639.5938          Filing of single bond for multiple sites.

639.594            Establishment of ongoing relationship.

639.595            Qualifications of employees who engage in storage or distribution of drugs.

639.596            Facilities: General requirements; maintenance of stock.

639.597            Facilities: Security.

639.5975          Prescription drugs: Restrictions on purchase and receipt; disposal of certain drugs.

639.5977          Prescription drugs: Sale to purchasing wholesaler.

639.598            Prescription drugs: Storage.

639.599            Prescription drugs: Examination of shipments; actions upon determination of certain conditions.

639.601            Prescription drugs: Separation and disposal of certain drugs.

639.6015          Prescription drugs: Destruction.

639.602            Prescription drugs: Records.

639.603            Prescription drugs: Requirements regarding statements of prior sales.

639.6035          Prescription drugs: Exclusion of certain transactions from statements of prior sales.

639.604            Maintenance and availability of list of wholesalers with whom manufacturer has ongoing relationship.

639.605            Establishment and maintenance of policies and procedures regarding prescription drugs.

639.6053          Wholesaler who employs person to sell or market drug, medicine or chemical: Annual submission of certain information to Board; review and contents of marketing code of conduct; exemption.

639.6055          Submission of certain information regarding sales and marketing staff: Submission of form after initial submittal; method of submission.

639.6057          Submission of certain information regarding sales and marketing staff: Incomplete, improperly completed or noncompliant submittal; correction of deficiencies.

639.606            Establishment and maintenance of lists regarding certain personnel.

639.6065          Annual submission of certain reports or proof to Board.

639.607            Inspections; examination of records and procedures; copies of documents.

MANUFACTURERS

639.609            “Manufacturer” defined.

639.610            Minimum standards for premises.

639.615            Equipment and requirements for operation; employees.

639.616            Manufacturer who employs person to sell or market drug, medicine or chemical: Annual submission of certain information to Board; review and contents of marketing code of conduct.

639.617            Manufacturer who employs person to sell or market device or appliance: Annual submission of certain information to Board; review and contents of marketing code of conduct.

639.618            Submission of certain information regarding sales and marketing staff: Submission of form after initial submittal; method of submission.

639.619            Submission of certain information regarding sales and marketing staff: Incomplete, improperly completed or noncompliant submittal; correction of deficiencies.

WAREHOUSES

639.620            Definitions.

639.621            “Authorized person” defined.

639.622            “Authorized warehouse” defined.

639.623            “Chain warehouse” defined.

639.624            “Facility” defined.

639.625            “Goods” defined.

639.626            “Manufacturer” defined.

639.627            “Pharmacy” defined.

639.6282          “Third-party logistics provider” defined.

639.629            “Wholesaler” defined.

639.6305          Third-party logistics providers: General requirements.

639.631            Licensing: General requirements.

639.633            Contracts authorizing receipt, storage and shipment of prescription drugs and goods.

639.634            Enforcement of statutory liens.

639.635            Cessation of operation.

639.636            Change in legal ownership of facility resulting from legal proceeding.

639.637            Facilities: General requirements.

639.638            Facilities: Security.

639.639            Prescription drugs: Storage.

639.640            Prescription drugs: Shipment.

639.641            Prescription drugs: Records.

639.642            Establishment of policies and procedures regarding prescription drugs.

639.643            Inspections; examination of records and procedures.

639.644            Enforcement.

VETERINARY DRUGS

639.650            Fee for and scope of permit to sell; penalty for late registration; prohibited sales; refrigeration.

639.660            Restriction on use of rabies vaccine.

COMPOUNDING AND DISPENSING DRUG PRODUCTS

General Provisions

639.661            Definitions.

639.6611          “Active ingredient” defined.

639.6613          “Ante-area” defined.

639.6615          “Barrier isolator cabinet” defined.

639.6617          “Beyond-use date” defined.

639.6619          “Buffer area” defined.

639.6621          “Chart order” defined.

639.6623          “Component” defined.

639.6625          “Compound” and “compounding” defined.

639.6627          “Compounding aseptic containment isolator” defined.

639.6629          “Compounding aseptic isolator” defined.

639.663            “Cytotoxic” defined.

639.6631          “Drug product” defined.

639.6633          “Gloved fingertip sampling” defined.

639.6635          “Hazardous drug” defined.

639.6637          “High-risk sterile compounded drug product” defined.

639.6639          “Immediate-use sterile compounded drug product” defined.

639.6641          “ISO Class 5” defined.

639.6643          “ISO Class 7” defined.

639.6645          “ISO Class 8” defined.

639.6647          “Low-risk sterile compounded drug product” defined.

639.6649          “Media fill test” defined.

639.665            “Medical facility” defined.

639.6655          “Medium-risk sterile compounded drug product” defined.

639.6665          “Nonsterile compounded drug product” defined.

639.667            “Nursing personnel” defined.

639.6673          “Parenteral nutrition” defined.

639.6677          “Sterile compounded drug product” defined.

639.670            Adoption of certain publications by reference; revision of publication after adoption.

Standards for Compounding and Dispensing Generally

639.6701          Inspection of materials and equipment; recordkeeping.

639.67013        Competency and proficiency of certain pharmaceutical personnel.

639.67015        Establishment of policies and procedures.

639.67017        Use of automated compounding devices.

639.67019        Retention of records.

639.6702          Records concerning drug products compounded in excess and in bulk quantities.

Standards for Compounding and Dispensing Nonsterile Products

639.6703          Labeling.

639.67033        Environmental standards.

639.67035        Establishment of policies and procedures.

639.67037        Safety procedures for storage, handling, compounding and disposal; training required.

Standards for Compounding and Dispensing Sterile Products

639.6705          Environmental standards.

639.67051        Air quality testing and certification.

639.67053        Tests for competency and proficiency of certain pharmaceutical personnel.

639.67055        Record verifying accuracy required to be made.

639.67057        Procedures following breach of seal of single-dose and multi-dose containers.

639.67059        Exemptions for certain institutional pharmacies.

639.67061        Low-risk sterile compounding: Process and storage.

639.67063        Low-risk sterile compounding: Radiopharmaceutical drug products.

639.67065        Medium-risk sterile compounding: Process and storage.

639.67067        High-risk sterile compounding: Process and storage.

639.67069        High-risk sterile compounding: Sterilization.

639.67071        High-risk sterile compounding: Testing of certain drug products.

639.67073        Immediate-use sterile compounding: Preparation and labeling.

639.67075        Immediate-use sterile compounding: Compounding standards.

639.67077        Sterile hazardous drugs: Safety procedures for storage, handling, compounding and disposal.

639.67079        Sterile hazardous drugs: Required training for certain pharmaceutical personnel.

Standards for Compounding and Dispensing Parenteral Solutions

639.672            Reference materials required to be located in or immediately available to pharmacy.

639.680            Labeling.

639.682            Record for each patient.

639.683            Delivery, storage and recordation of delivery.

639.686            Written policies and procedures for disposal of infectious materials and materials containing cytotoxic residues.

639.688            Written policies and procedures regarding provision of services related to parenteral therapy.

639.690            Pharmacist: Consultation with patient; proper training in safe handling, compounding and therapy related to parenteral solutions.

PROVIDERS AND WHOLESALERS OF MEDICAL PRODUCTS

General Provisions

639.693            Definitions.

639.69305        “Accreditation and certification organization” defined.

639.6931          “Assistive equipment” defined.

639.6932          “Consumer” defined.

639.69325        “Customized orthotic or prosthetic device” defined.

639.6933          “Health professional” defined.

639.6934          “Life-sustaining equipment” defined.

639.6935          “Medical products” defined.

639.6936          “Medical products provider” defined.

639.6937          “Medical products wholesaler” defined.

639.6938          “Respiratory equipment” defined.

639.6939          Adoption by reference of code of ethics and code of professional conduct; revision of codes after adoption.

639.694            Administrator required.

639.6941          Unprofessional conduct; responsibility of owner for acts of others.

Licensing and Fees

639.6942          Application for license; license required for each location; notification of change in information; license nontransferable; expiration.

639.6943          Licensing of practicing health professionals.

639.6944          Licensing of applicants located outside of State.

639.6945          Waiver of license fee.

Medical Products Providers

639.6946          Duties of providers; repair and maintenance of medical products; hours of operation; consumer complaints.

639.6947          Change in controlling interest.

639.6948          Compliance with provisions by person or business who is not medical products provider.

639.6949          Provision of medical products to consumer with or without bona fide order or prescription; tracking requirements.

639.695            Maintenance of records.

639.6951          Communications and advisement of options and use of medical products; written record.

639.6952          Communications concerning use of medical products provided by written or oral order or prescription; written record.

639.6953          Assistive equipment.

639.69533        Customized orthotic or prosthetic devices: Approval by Board required.

639.69535        Customized orthotic or prosthetic devices: Accessibility of services and confidentiality.

639.69537        Customized orthotic or prosthetic devices: Practitioner’s order required.

639.6954          Medical gases and associated equipment or respiratory equipment.

639.69543        Insulin pumps.

639.69545        Pressurized stockings.

639.6955          Life-sustaining equipment.

639.6956          Parenteral and enteral services and equipment.

Medical Products Wholesalers

639.6957          Duties of wholesalers; repair and maintenance of medical products; hours of operation; consumer complaints.

639.69573        Wholesaler who employs person to sell or market device or appliance: Annual submission of certain information to Board; review and contents of marketing code of conduct.

639.69575        Submission of certain information regarding sales and marketing staff: Submission of form after initial submittal; method of submission.

639.69577        Submission of certain information regarding sales and marketing staff: Incomplete, improperly completed or noncompliant submittal; correction of deficiencies.

Disciplinary Action

639.6958          Summary suspension of license.

TRADE PRACTICES

639.700            Performance of certain acts by pharmacists and pharmaceutical interns only.

639.701            Acts not required to be performed by pharmaceutical professionals.

639.702            Responsibility for acts and omissions of personnel who are not pharmacists.

639.704            Check of license or certification required before employment by pharmacy or wholesaler.

639.706            Marking of prescriptions with serial numbers; maintenance of files of prescriptions.

639.707            Counseling of patients: Duties of pharmacist or intern pharmacist; documentation.

639.708            Counseling of patients: Duties of pharmacy.

639.709            Persons to whom pharmacy may furnish certain restricted products.

639.7102          Use of computer system for issuance and transmission of prescription.

639.7105          Electronic transmission of prescription.

639.711            Transmission of prescription by facsimile machine.

639.712            Transcribing prescription transmitted by oral order.

639.7125          Use of fulfillment pharmacy by dispensing pharmacy.

639.713            Transfer of information between pharmacies: Conditions; prohibitions.

639.714            Transfer of information between pharmacies: Procedure for oral transfers.

639.7145          Transfer of information between pharmacies: Requirements for transfer by facsimile machine.

639.715            Mechanical devices: Restrictions on use.

639.718            Mechanical devices: Use by pharmacy to furnish prescription drugs to patients.

639.720            Mechanical devices: Use to furnish drugs and medicines for administration to registered patients in medical facility and to patients receiving treatment in emergency room of hospital.

639.725            Use of mechanical counting device for dispensing medication to be taken orally.

639.730            Inspection of damaged pharmaceuticals.

639.740            Container for dispensing prescribed medicine.

639.742            Dispensing of controlled substances or dangerous drugs: Application by practitioner for certificate of registration; application by facility required under certain circumstances; duties of dispensing practitioner and facility relating to drugs; authority of dispensing practitioner and technician.

639.7425          Dispensing technician: Requirements; application and fee for registration; provisional registration; issuance of certificate of registration.

639.743            Dispensing technician: Access to drugs; performance of functions.

639.7435          Dispensing technician: Transferability, expiration and termination of registration; notice of change of address of employment; subsequent employment.

639.744            Dispensing practitioner: Fee for initial registration and renewal; registration of multiple dispensing technicians.

639.7445          Dispensing practitioner: Disciplinary action for violation of NAC 639.742 to 639.7445, inclusive.

639.745            Duties of certain practitioners concerning dispensing of controlled substances and dangerous drugs.

639.748            Identification of person to whom controlled substance is dispensed.

639.750            Dispensing of medication at certain locations when local retail pharmacy is closed.

639.751            Requirements concerning signatures or initials to be placed on prescription.

639.752            Restrictions on filling or dispensing certain prescriptions.

639.753            Declination of pharmacist to fill prescription.

639.754            Refilling prescriptions: Restrictions; authorization by patient without specific request for particular refill.

639.755            Sale of preparations for treatment of asthma.

639.757            Preparation and sale of compounded drugs by pharmacy or pharmacist: License as manufacturer not required under certain circumstances; unsafe or ineffective drug; restrictions on sale.

639.760            Return of unused drugs packaged in unit doses.

639.765            Disclosure by practitioner of certain ownership interests in pharmacy.

REPACKAGING OF PREVIOUSLY DISPENSED DRUGS

639.781            Definitions.

639.784            Duties of repackaging pharmacy.

639.788            Restrictions on repackaging pharmacy.

ADVANCED PRACTITIONERS OF NURSING

General Provisions

639.841            “Collaborating physician” defined.

639.846            Change in location of practice or collaborating physician.

Prescribing

639.850            Certificate of registration: Application; appearance before Board; collaborating physician.

639.854            Scope of authority to prescribe.

639.858            Authorization to write prescription in form of chart order or physician’s order.

Dispensing

639.870            Certificate of registration: Application; fee; period of validity; appearance before Board; collaborating physician; late renewal.

639.879            Scope of authority to dispense.

639.892            Use of child-proof container.

639.898            Security and storage of controlled substances and drugs.

Disciplinary Action

639.900            Grounds for denial of application or suspension or revocation of registration.

COMPUTERIZED SYSTEMS

Recording of Information

639.910            Information to be provided by system; procedure to ensure information not lost or destroyed.

639.912            Requirements for use of system; maintenance of physical records.

639.914            Maintenance and availability of information relating to operation; entrance of each prescription into system required; issuance of consecutive numbers for prescriptions.

639.918            Written record of refills; exception.

639.921            Sharing information between systems: Conditions and requirements.

639.924            Computerized system to record prescriptions required for pharmacies licensed on or after August 27, 1996.

639.926            Transmission of information regarding dispensing of controlled substances to certain persons.

639.930            Safeguards against access to and modification or manipulation of information.

639.935            Printed record of contents.

639.938            Auxiliary procedure to document prescriptions when system not functioning.

Automated Dispensing Systems

639.940            “Computerized system to fill prescriptions” defined.

639.9405          Authority to use system.

639.941            Written policies and procedures of operation.

639.9415          Written program for quality assurance.

639.942            Written plan for recovery.

639.9425          Written program for preventative maintenance of system.

639.943            Required security of drugs and records.

DISCIPLINARY ACTION

639.945            Unprofessional conduct; owner responsible for acts of employees.

639.951            Violations by employees of pharmacy concerning controlled substances or other drugs; screening tests.

639.955            Imposition of fines; authority to take disciplinary action.

 

 

 

GENERAL PROVISIONS

      NAC 639.010  Definitions. (NRS 639.070)  As used in this chapter, unless the context otherwise requires:

     1.  “Board” means the State Board of Pharmacy.

     2.  “Controlled substances” has the meaning ascribed to it in NRS 0.031.

     3.  “Dangerous drug” has the meaning ascribed to it in NRS 454.201.

     4.  “Direct supervision” means the direction given by a supervising pharmacist who is:

     (a) On the premises of the pharmacy at all times when the persons he or she is supervising are working at the pharmacy; and

     (b) Aware of the activities of those persons related to the preparation of medications, including the maintenance of appropriate records.

     5.  “Executive Secretary” means the Executive Secretary employed by the Board pursuant to NRS 639.040.

     6.  “Pharmaceutical technician” means a person who performs technical services in a pharmacy under the direct supervision of a pharmacist and is registered with the Board pursuant to NAC 639.240.

     7.  “Pharmaceutical technician in training” means a person who is registered with the Board pursuant to NAC 639.242 in order to obtain the training and experience required to be a pharmaceutical technician pursuant to subparagraph (3) of paragraph (e) of subsection 2 of NAC 639.240, or who is enrolled in a program of training for pharmaceutical technicians that is approved by the Board.

     8.  “Practitioner” has the meaning ascribed to it in NRS 639.0125.

     9.  “Prescription drug” means a drug or medicine as defined in NRS 639.007 which:

     (a) May be dispensed only upon a prescription order that is issued by a practitioner; and

     (b) Is labeled with the symbol “Rx only” pursuant to federal law or regulation.

     10.  “Public or nonprofit agency” means a health center as defined in 42 U.S.C. § 254b(a) which:

     (a) Provides health care primarily to medically underserved persons in a community;

     (b) Is receiving a grant issued pursuant to 42 U.S.C. § 254b or, although qualified to receive such a grant directly from the Federal Government, is receiving money from such a grant under a contract with the recipient of that grant; and

     (c) Is not a medical facility as defined in NRS 449.0151.

     11.  “Surgical center for ambulatory patients” has the meaning ascribed to it in NRS 449.019.

     [Bd. of Pharmacy, § 639.010, 6-26-80]—(NAC A 3-27-90; 6-14-90; 10-1-93; 11-15-93; 5-22-96; 10-24-97; R014-99, 11-3-99; R019-03, 10-21-2003; R041-04, 5-25-2004; R036-07, 1-30-2008)

      NAC 639.030  “Date” interpreted. (NRS 639.070, 639.2801)  The Board interprets the term “date” as used in subsection 1 of NRS 639.2801 to mean the most recent date on which the drug was dispensed or the prescription was refilled.

     (Added to NAC by Bd. of Pharmacy, eff. 6-16-86)

      NAC 639.032  “Facsimile machine” interpreted. (NRS 639.070, 639.0745, 639.2353)  As used in NRS 639.0745 and 639.2353, the Board will interpret the term “facsimile machine” to include, without limitation, a computer that has a facsimile modem through which documents can be sent and received.

     (Added to NAC by Bd. of Pharmacy by R112-99, eff. 11-3-99)

      NAC 639.040  “File” interpreted. (NRS 639.070)  The Board interprets the term “file” as used in subsection 1 of NRS 639.2392 to mean a file for:

     1.  Paper records; or

     2.  Records maintained in a computer system.

     (Added to NAC by Bd. of Pharmacy by R050-07, eff. 12-17-2008)

      NAC 639.050  Storage and destruction of certain controlled substances. (NRS 639.070)

     1.  Upon the discontinuance of a controlled substance, a controlled substance becoming outdated or the demise of a patient at a facility for skilled nursing or facility for intermediate care which is licensed by the Division of Public and Behavioral Health of the Department of Health and Human Services, any remaining controlled substance dispensed to the patient must be placed in a secured locked compartment. The controlled substance must be secured in the locked container until destroyed in the manner prescribed in NAC 639.498.

     2.  Each practitioner or pharmacy shall physically separate each controlled substance which is outdated, damaged, deteriorated, misbranded or adulterated from the balance of its stock medications. The practitioner or pharmacy shall destroy such controlled substances at least once each year. The practitioner or pharmacy shall complete Form DEA-41 of the Drug Enforcement Administration, “Registrants Inventory of Drugs Surrendered,” to acknowledge the destruction of the controlled substances.

     3.  This section does not apply to controlled substances packaged in manufacturer’s unit-dose packages which are governed by the provisions of NRS 639.267.

     (Added to NAC by Bd. of Pharmacy, eff. 12-3-84; A 7-1-92; R016-13, 12-23-2013)

      NAC 639.060  Marketing codes of conduct: Adoption of certain codes by reference. (NRS 639.070, 639.570)  The Board hereby adopts by reference:

     1.  The Code on Interactions with Healthcare Professionals developed by the Pharmaceutical Research and Manufacturers of America. A copy of this publication may be obtained, free of charge, from the Pharmaceutical Research and Manufacturers of America at the Internet address http://www.phrma.org/code_on_interactions_with_healthcare_professionals.

     2.  The Code of Ethics on Interactions with Health Care Professionals adopted by the Advanced Medical Technology Association. A copy of this publication may be obtained, free of charge, from the Advanced Medical Technology Association at the Internet address http://www.advamed.org/MemberPortal/About/code.

     (Added to NAC by Bd. of Pharmacy by R122-07, eff. 1-30-2008)

      NAC 639.065  Marketing codes of conduct: Periodic review of adopted codes. (NRS 639.070, 639.570)  The Board will periodically review:

     1.  The Code on Interactions with Healthcare Professionals, as adopted by reference in subsection 1 of NAC 639.060; and

     2.  The Code of Ethics on Interactions with Health Care Professionals, as adopted by reference in subsection 2 of NAC 639.060,

Ê and determine, within 30 days after the review, whether any change made to a publication listed in subsection 1 or 2 is appropriate for application in this State. If the Board does not disapprove a change to an adopted publication within 30 days after the review, the change is deemed to be approved by the Board.

     (Added to NAC by Bd. of Pharmacy by R122-07, eff. 1-30-2008)

STATE BOARD OF PHARMACY

      NAC 639.100  Seal of Board. (NRS 639.070)  The Board hereby adopts a seal for its own use. The seal has imprinted thereon the words and figures “Nevada State Board of Pharmacy-Organized May 6, 1901.” The care and custody of the seal is in the hands of the Executive Secretary.

     [Bd. of Pharmacy, § 639.015, eff. 6-26-80]

      NAC 639.110  Inactive regulations: Duties of Executive Secretary. (NRS 639.070)  When any regulation adopted by the Board and filed with the Secretary of State expires by its own terms, is repealed or is declared unconstitutional by a court of competent jurisdiction, the Executive Secretary shall so inform the Secretary of State and request that it be placed in an inactive file.

     [Bd. of Pharmacy, § 639.030, eff. 6-26-80]

      NAC 639.120  Conduct of disciplinary hearings. (NRS 639.070, 639.247)

     1.  The Board will convene a disciplinary hearing at the time and place specified in the notice of hearing. The person presiding at the hearing may grant a continuance only upon:

     (a) A joint stipulation of the parties;

     (b) The existence of an emergency condition; or

     (c) A written request by a party filed at least 5 days before the date of the hearing and actually served upon the other parties at least 1 day before the date of the hearing.

Ê A continuance based on a written request pursuant to paragraph (c) may be granted only upon a showing of good cause which term must be narrowly construed. A party requesting a continuance must appear on the date of the hearing and be prepared to proceed unless the request has been made pursuant to a joint stipulation.

     2.  The hearing must then proceed in the following manner unless the Board for good cause or to prevent manifest injustice orders otherwise:

     (a) An opening statement may be made on behalf of the Board or waived.

     (b) An opening statement on behalf of respondent may be made, reserved until the close of the Board’s case, or waived.

     (c) The presentation of the Board’s case is followed by cross-examination.

     (d) The presentation of the respondent’s case is followed by cross-examination.

     (e) Any rebuttal is limited to issues previously raised. No new matter may be presented upon rebuttal unless the Board for good cause so permits.

     (f) Argument on behalf of the Board is presented unless waived.

     (g) Argument on behalf of the respondent is presented unless waived.

     (h) The matter is submitted to the Board for decision.

     3.  After the matter is submitted, the Board will render a decision and its order.

     [Bd. of Pharmacy, § 639.065, eff. 6-26-80]—(NAC A 12-3-84)

      NAC 639.130  Representation by counsel at disciplinary hearings. (NRS 639.070, 639.247)  No respondent may be represented by counsel in a disciplinary hearing unless the counsel is admitted to practice before the highest court of:

     1.  The State of Nevada; or

     2.  Another state and appears in association with counsel who has been admitted to practice in this State and maintains an office in this State.

     [Bd. of Pharmacy, § 639.060, eff. 6-26-80]

      NAC 639.140  Petitions to adopt, amend or repeal regulations. (NRS 639.070)

     1.  A petition requesting the Board to adopt, file, amend or repeal any regulation must be in writing and signed by the petitioner. The petition must be accompanied by a draft of the proposed regulation in a form suitable for submission to the Legislative Counsel.

     2.  The original and six legible copies of the petition and the original and seven legible copies of the proposed regulation must be filed with the Executive Secretary.

     3.  A petition filed other than in conformity with this section will be rejected.

     [Bd. of Pharmacy, § 639.025, eff. 6-26-80]

      NAC 639.150  Declaratory orders and advisory opinions. (NRS 639.070)  A petition requesting a declaratory order or advisory opinion, pursuant to NRS 233B.120, must be in writing and signed by the petitioner. An original and six legible copies of the petition must be filed with the Executive Secretary. The petition will be considered by the Board at its next regularly scheduled meeting. Within 30 days thereafter the Board will issue the declaratory order or advisory opinion requested.

     [Bd. of Pharmacy, § 639.055, eff. 6-26-80]

      NAC 639.160  Required time for receipt of application. (NRS 639.070)  Any application required to be submitted to the Board must be received in one of the offices of the Board at least 15 days before the meeting of the Board at which action on the application will be taken. An application which is not submitted by the time required may still be considered by the Board for good cause.

     (Added to NAC by Bd. of Pharmacy, eff. 6-16-86; A 6-14-90)

      NAC 639.170  Waiver of regulation upon declaration of emergency: Authority; required notices. (NRS 639.070)

     1.  The President, Executive Secretary or General Counsel of the Board may waive any of the requirements set forth in any regulation adopted by the Board governing the practice of pharmacy if a federal, state or local official authorized to issue a declaration of emergency concerning the health and welfare of the general public submits a notice of such declaration of emergency to the Board.

     2.  If the President, Executive Secretary or General Counsel of the Board issues a waiver pursuant to subsection 1, he or she shall:

     (a) Provide written notification of the waiver, identifying the requirements of the applicable regulations that have been waived, any conditions of the waiver and the period of the waiver, to each pharmacy, pharmacist or other person to whom the Board deems necessary to effectuate the waiver; and

     (b) Provide written notification of the termination of the waiver, by the most accessible and efficient means, to the same persons that were provided a written notification of the waiver pursuant to paragraph (a).

     (Added to NAC by Bd. of Pharmacy by R189-01, eff. 3-4-2002)

CERTIFICATES, LICENSES AND PERMITS

      NAC 639.200  Temporary certificates, licenses and permits. (NRS 639.070)

     1.  Except as otherwise provided in subsection 2, the Executive Secretary may issue a temporary certificate, license or permit required by chapter 453, 454 or 639 of NRS to a qualified person for a period of effectiveness which ends not more than 6 months after the next regular meeting of the Board following issuance, except for a temporary certificate of reciprocal registration of a pharmacist, which may not be effective for a period of more than 6 months after issuance.

     2.  The Executive Secretary may issue a temporary license to operate a pharmacy to a licensed pharmacy which, because of a change of location of the pharmacy, requires a new license before the next meeting of the Board. Before such a temporary license is issued, a satisfactory examination of the premises of the pharmacy must be conducted by the staff of the Board. At the next regular meeting of the Board following the issuance of the temporary license, the Board will consider an application for a permanent license for that pharmacy.

     [Bd. of Pharmacy, § 639.020, eff. 6-26-80]—(NAC A 10-1-93; 11-9-95)

      NAC 639.205  Application to register as pharmacist: Completion required within 1 year. (NRS 639.070, 639.127)  An applicant for a certificate as a registered pharmacist must provide all information and make all appearances required by the Board within 1 year after having successfully passed the North American Pharmacist Licensure Examination prepared by the National Association of Boards of Pharmacy. An applicant who does not provide all information and make all appearances required by the Board within 1 year after having successfully passed the North American Pharmacist Licensure Examination must submit a new application.

     [Bd. of Pharmacy, § 639.040, eff. 6-26-80]—(NAC A by R115-98, 9-9-98)

      NAC 639.210  Educational qualifications: Approval of accredited programs of education in pharmacy. (NRS 639.070, 639.120)  For the purpose of determining the educational qualifications of applicants to become registered pharmacists, the Board hereby approves all colleges of pharmacy and departments of pharmacy of universities which are accredited by the Accreditation Council for Pharmacy Education.

     [Bd. of Pharmacy, § 639.035, eff. 6-26-80]

      NAC 639.212  Educational qualifications: Advanced degree in pharmacy. (NRS 639.070, 639.120)  In considering the educational qualifications of an applicant to become a registered pharmacist, the Board will not accept an advanced degree in pharmacy, gained through a university’s graduate program, as evidencing sufficient qualifications unless the applicant as an undergraduate earned all the required credits for a degree of bachelor of science in pharmacy or for a pharmaceutical doctorate at a college or department of pharmacy of a university accredited by the Accreditation Council for Pharmacy Education and was awarded the degree by that university.

     (Added to NAC by Bd. of Pharmacy, eff. 10-26-83)

      NAC 639.214  Application for license to operate pharmacy: Information required. (NRS 639.070, 639.231)  In addition to any information required by NRS 639.231, each application to conduct a pharmacy must, if the applicant or any person having an ownership interest in the applicant is:

     1.  A joint venture, identify each member of the joint venture.

     2.  A partnership other than a limited partnership, identify each partner.

     3.  A limited partnership, identify each:

     (a) General partner;

     (b) Limited partner who holds 10 percent or more of the interest in the profits of the limited partnership; and

     (c) General partner and limited partner who is a practitioner.

     4.  A corporation, none of whose shares are registered under the Securities Exchange Act of 1934, as amended (15 U.S.C. §§ 78a et seq.), identify each:

     (a) Officer of the corporation;

     (b) Shareholder who holds 10 percent or more of the shares of the corporation; and

     (c) Shareholder who is a practitioner.

     5.  A corporation, any of whose shares are registered under the Securities Exchange Act of 1934, as amended (15 U.S.C. §§ 78a et seq.), identify:

     (a) Each officer of the corporation; and

     (b) Regarding each class of its shares registered under the Securities Exchange Act of 1934, as amended:

          (1) The date of that registration;

          (2) The number assigned to that registration by the Securities and Exchange Commission; and

          (3) The securities exchange upon which those shares are listed.

     (Added to NAC by Bd. of Pharmacy, eff. 10-1-93)

      NAC 639.215  Application for license to operate pharmacy: Appearance of applicant before Board; execution on behalf of partnership or corporation; payment of expenses for special meeting of Board. (NRS 639.070, 639.231)

     1.  An applicant for a license to operate a pharmacy in the State of Nevada must appear before the Board in support of the application and must receive instructions relative to the pharmacy laws if the applicant:

     (a) Is applying for a license to operate a pharmacy in this State for the first time;

     (b) Responded affirmatively to any of the questions on the application regarding his or her character or competency;

     (c) Is applying for the licensure of a pharmacy located outside the State that will be shipping compounded parenteral products into this State; or

     (d) Is requested to do so by the Board.

     2.  If an applicant who is required to appear before the Board is:

     (a) A partnership, all partners must appear.

     (b) A corporation, a designated representative of the corporation must appear. If the designated representative is not an officer of the corporation, a letter authorizing him or her to appear on behalf of the corporation that is signed by an officer of the corporation must be submitted with the application. Documentation of the status of the person signing the letter of authorization must be submitted with the application.

     3.  If the applicant is a partnership or corporation, the application must be signed by a partner or by an officer of the corporation. Documentation of the status of the person signing the application must be submitted with the application.

     4.  A special meeting of the Board will not be called for the purpose of considering an application for a license to operate a pharmacy until the applicant has paid the Executive Secretary sufficient money to defray all expenses of the meeting.

     [Bd. of Pharmacy, § 639.045, eff. 6-26-80]—(NAC A 3-17-92; 10-1-93)

      NAC 639.218  Application for inactive status. (NRS 639.070, 639.2176)

     1.  A registered pharmacist may apply to the Board to have his or her certificate of registration placed on inactive status.

     2.  A registered pharmacist who wishes to have his or her certificate of registration placed on inactive status must submit to the Board:

     (a) A completed application on a form provided by the Board; and

     (b) A statement certifying that the pharmacist:

          (1) Is not engaged in the practice of pharmacy in this State; and

          (2) Will not engage in the practice of pharmacy in this State during the period that his or her certificate of registration is placed on inactive status.

     3.  If the Board places the certificate of registration of a registered pharmacist on inactive status, the pharmacist:

     (a) May not engage in the practice of pharmacy in this State during the period that his or her certificate of registration is placed on inactive status;

     (b) Must renew the certificate of registration biennially;

     (c) Is not required to complete continuing education during the period that his or her certificate of registration is placed on inactive status, except as otherwise required to return the certificate of registration to active status pursuant to subparagraph (1) of paragraph (b) of subsection 2 of NAC 639.219; and

     (d) May apply to the Board pursuant to NAC 639.219 to have his or her certificate of registration returned to active status.

     (Added to NAC by Bd. of Pharmacy by R050-08, eff. 6-17-2008)

      NAC 639.219  Application for return to active status. (NRS 639.070, 639.2176)

     1.  If a pharmacist whose certificate of registration has been placed on inactive status wishes to resume the practice of pharmacy in this State, the pharmacist must submit to the Board a completed application for return to active status on a form provided by the Board.

     2.  The Board will grant an application for return to active status if the applicant submits to the Board:

     (a) Evidence that the applicant holds an active certificate, license or registration to practice pharmacy in another state; or

     (b) Evidence that the applicant has:

          (1) Completed 30 units of continuing professional education within the 2 years immediately preceding the date on which the application for return to active status is filed; and

          (2) Passed the written continuing education examination on law provided by the Board.

     3.  In addition to the requirements set forth in subsection 2, an applicant who was granted inactive status because of a medical disability must submit proof satisfactory to the Board that he or she is physically capable of resuming the practice of pharmacy. Unless the proof submitted by the applicant is otherwise satisfactory, the Board will require the applicant to submit to a medical examination to be conducted by a physician chosen by the Board. The applicant shall pay for the cost of the examination.

     (Added to NAC by Bd. of Pharmacy, eff. 6-16-86; A by R050-08, 6-17-2008)

      NAC 639.220  Schedule of fees; penalty for late renewal; exemptions from certain fees. (NRS 639.070, 639.170)

     1.  The Board hereby adopts the following schedule of fees:

 

          For the examination of an applicant for registration as a pharmacist...........

           Actual cost

                    of the

          examination

          For the investigation or registration of an applicant as a registered pharmacist...............................................................................................

                     $180

          For the investigation, examination or registration of an applicant as a registered pharmacist by reciprocity........................................................

                       180

          For the investigation or issuance of an original license to conduct a retail pharmacy.................................................................................................

                       500

          For the biennial renewal of a license to conduct a retail pharmacy..............

                       500

          For the investigation or issuance of an original license to conduct an institutional pharmacy.............................................................................

                       500

          For the biennial renewal of a license to conduct an institutional pharmacy.

                       500

          For the investigation or issuance of an original license to conduct a pharmacy in a correctional institution.....................................................

                       500

          For the biennial renewal of a license to conduct a pharmacy in a correctional institution.............................................................................

                       500

          For the issuance of an original or duplicate certificate of registration as a registered pharmacist...............................................................................

                         50

          For the biennial renewal of registration as a registered pharmacist..............

                       180

          For the reinstatement of a lapsed registration (in addition to the fees for renewal for the period of lapse)..............................................................

                       100

          For the initial registration of a pharmaceutical technician or pharmaceutical technician in training......................................................

                         40

          For the biennial renewal of registration of a pharmaceutical technician or pharmaceutical technician in training......................................................

                         40

          For the investigation or registration of an intern pharmacist........................

                         40

          For the biennial renewal of registration as an intern pharmacist..................

                         40

          For the investigation or registration of an advanced practitioner of nursing or a physician assistant to prescribe drugs that are not controlled substances................................................................................................

                         80

          For the biennial renewal of registration of an advanced practitioner of nursing or a physician assistant to prescribe drugs that are not controlled substances..............................................................................

                         80

          For authorization of a physician, advanced practitioner of nursing, physician assistant, euthanasia technician, ambulatory surgical center, facility for treatment with narcotics, researcher, instructional user or any other authorized person to prescribe or possess controlled substances................................................................................................

                         80

          For the biennial renewal of authorization of a physician, advanced practitioner of nursing, physician assistant, euthanasia technician, ambulatory surgical center, facility for treatment with narcotics, researcher, instructional user or any other authorized person to prescribe or possess controlled substances..............................................

                         80

          For the investigation or issuance of an original license to engage in business as an authorized warehouse, medical products provider or medical products wholesaler...................................................................

                       500

          For the biennial renewal of a license to engage in business as an authorized warehouse, medical products provider or medical products wholesaler................................................................................................

                       500

          For the investigation or issuance of an original license to a manufacturer or wholesaler...........................................................................................

                       500

          For the biennial renewal of a license for a manufacturer or wholesaler.......

                       500

          For the reissuance of a license issued to a pharmacy, when no change of ownership is involved, but the license must be reissued because of a change in the information required thereon............................................

                         50

          For authorization of a practitioner to dispense controlled substances or dangerous drugs, or both, for each location where the practitioner will dispense controlled substances or dangerous drugs, or both..................

                       300

          For the biennial renewal of authorization of a practitioner to dispense controlled substances or dangerous drugs, or both, for each location where the practitioner will dispense controlled substances or dangerous drugs, or both..........................................................................................

                       300

 

     2.  The penalty for failure to pay the renewal fee for any license, permit or certificate within the statutory period, as provided in subsection 4 of NRS 639.170, is 50 percent of the renewal fee for each period of delinquency in addition to the renewal fee for each period of delinquency.

     3.  Any person who has been registered as a pharmacist in this State for at least 50 years is not required to pay the fee for the biennial renewal of a certificate of registration as a registered pharmacist.

     4.  The provisions of this section concerning the fee for the biennial renewal of the authorization to dispense controlled substances or dangerous drugs do not apply to an advanced practitioner of nursing who is required to pay a fee pursuant to NAC 639.870.

     5.  A health center:

     (a) Which is a federally qualified health center as defined in 42 U.S.C. § 1396d(l)(2)(B), as that section existed on March 1, 2000, that provides health care primarily to medically underserved persons in a community; and

     (b) Which is not a medical facility as defined in NRS 449.0151,

Ê is not required to pay the fee for the collective certification of advanced practitioners of nursing in the employ of a public or nonprofit agency as set forth in subsection 1.

     6.  A practitioner employed by or serving as an independent contractor of a health center:

     (a) Which is a federally qualified health center as defined in 42 U.S.C. § 1396d(l)(2)(B), as that section existed on March 1, 2000, that provides health care primarily to medically underserved persons in a community; and

     (b) Which is not a medical facility as defined in NRS 449.0151,

Ê is not required to pay a fee to the Board for a change of address or for an additional address at which the practitioner dispenses drugs.

     7.  A practitioner who is exempt from the payment of a fee pursuant to subsection 6 shall notify the Board in writing of each change of address or additional address, or both.

     [Bd. of Pharmacy, § 639.050, eff. 6-26-80]—(NAC A 6-25-82; 6-16-86; 2-18-88; 4-28-88; 8-10-89; 9-11-91; 10-17-91; 11-15-93; 1-10-94; 7-7-94; 11-9-95; 5-22-96; R155-99, 3-1-2000; R011-01, 11-1-2001; R012-02, 5-31-2002; R081-04, 8-25-2004; R217-05, 5-4-2006; R114-08, 9-18-2008; R119-09, 1-28-2010)

      NAC 639.225  Notice to Executive Secretary of change of address. (NRS 639.070)  Every registered pharmacist, pharmaceutical intern and pharmaceutical technician shall, within 10 days after changing his or her residence or place of practice, give written notice of the change to the Executive Secretary.

     [Bd. of Pharmacy, § 639.185, eff. 6-26-80]—(NAC A 11-15-93)

      NAC 639.226  Notice to Board by certain licensees of change of address. (NRS 639.070)  A pharmacy, wholesaler, authorized warehouse, medical products provider or medical products wholesaler shall notify the Board of a change of address on a form prescribed by the Board.

     (Added to NAC by Bd. of Pharmacy by R114-08, eff. 9-18-2008)

      NAC 639.227  Application or written notice to Board concerning change in ownership of pharmacy required under certain circumstances; suspension of license. (NRS 639.070, 639.230)

     1.  Not less than 15 business days before a change of 50 percent or more of the beneficial interest of a pharmacy as indicated on the application filed pursuant to NRS 639.231, the person to whom the license to operate the pharmacy was issued shall file with the Board an application for change of ownership.

     2.  If the person to whom the license to operate the pharmacy was issued is not a corporation whose securities are publicly traded, then not more than 5 calendar days after a change of less than 50 percent of the beneficial interest in a pharmacy as indicated on the application filed pursuant to NRS 639.231, the person to whom the license to operate the pharmacy was issued shall file with the Board written notice of the change.

     3.  If an application or notice required by this section is not filed, the Board may initiate proceedings, pursuant to NRS 639.241 to 639.2576, inclusive, to suspend the license to operate the pharmacy.

     (Added to NAC by Bd. of Pharmacy by R011-99, eff. 11-3-99)

      NAC 639.230  Voluntary surrender of certificate, license or registration to practice pharmacy in another state pursuant to agreement relating to disciplinary matter. (NRS 639.070)  If a pharmacist voluntarily surrenders his or her certificate, license or registration to practice pharmacy in another state pursuant to an agreement entered into by the pharmacist and the authorizing agency of that state relating to a disciplinary matter, the Board will initiate proceedings, pursuant to NRS 639.241 to 639.2576, inclusive, to revoke the certificate of registration of the pharmacist to practice pharmacy in the State of Nevada.

     (Added to NAC by Bd. of Pharmacy by R010-99, eff. 11-3-99)

PHARMACEUTICAL TECHNICIANS

      NAC 639.240  Requirements for registration of pharmaceutical technicians. (NRS 639.070, 639.1371)

     1.  No person may perform the duties of a pharmaceutical technician until the person has been issued a certificate of registration.

     2.  An applicant for registration as a pharmaceutical technician must:

     (a) Be 18 years of age or older;

     (b) Be a high school graduate or the equivalent;

     (c) Not have been convicted of any felony or a misdemeanor involving moral turpitude, dishonesty or the unlawful possession, sale or use of drugs;

     (d) Have no history of drug abuse; and

     (e) Have complied with one of the following requirements:

          (1) The successful completion of a program of training for pharmaceutical technicians, including, but not limited to, a program of training offered by a postsecondary school, that is approved by the Board pursuant to NAC 639.256.

          (2) Registration in another state as a pharmaceutical technician, if the requirements for registration in that state are equivalent to the requirements of this State, and the successful completion of at least 240 hours of employment as a pharmaceutical technician in a pharmacy in that state, which must be verified by the managing pharmacist of the pharmacy.

          (3) If the state in which the applicant has been employed does not offer registration, licensure or certification as a pharmaceutical technician:

               (I) The successful completion of at least 1,500 hours of experience in a pharmacy in that state performing the duties set forth in paragraph (c) of subsection 3 of NRS 639.1371 during the 3 years immediately preceding the date on which his or her application was submitted;

               (II) The successful completion of at least 350 hours of employment in a pharmacy in this State; and

               (III) The acquisition of a written statement to the Board from the managing pharmacist of the pharmacy referred to in sub-subparagraph (II) stating that the applicant, during his or her employment, demonstrated competence to perform the tasks assigned to him or her.

Ê Such an applicant must register as a pharmaceutical technician in training before he or she completes the requirements of sub-subparagraph (II).

          (4) The successful completion of at least 1,500 hours of training and experience as a pharmaceutical technician in training. A pharmaceutical technician in training may accumulate certified hours of training from each place of employment.

          (5) The successful completion of a program of training for pharmaceutical technicians conducted by a branch of the Armed Forces of the United States, the Indian Health Service of the United States Department of Health and Human Services or the United States Department of Veterans Affairs.

          (6) Certification by the Pharmacy Technician Certification Board or the National Healthcareer Association as a pharmacy technician if:

               (I) The applicant successfully completes a program of training for pharmaceutical technicians conducted by a postsecondary school in another state;

               (II) The program is accredited or otherwise approved by the appropriate regulatory authority in that state; and

               (III) The applicant successfully completes at least 240 hours of employment as a pharmaceutical technician in training in a pharmacy in another state, which must be verified by the managing pharmacist of the pharmacy.

     3.  An applicant who attended a school outside the United States must submit to an organization which evaluates educational credentials a copy of the transcript of his or her academic record from that school for a determination of whether the grades the applicant received are substantially equivalent to the grades required for an applicant who attended a school, or a program of training for pharmaceutical technicians that is accredited by the American Society of Health-System Pharmacists, in the United States. The applicant must ensure that a copy of the organization’s evaluation of the transcript is submitted to the Board.

     4.  Upon receipt of an application and the required fee, the Executive Secretary shall, unless he or she has good cause to deny the registration, issue a certificate of registration to the pharmaceutical technician.

     [Bd. of Pharmacy, § 639.200, eff. 6-26-80]—(NAC A 12-3-84; 3-27-90; 11-15-93; 11-9-95; 7-17-96; R012-01, 11-1-2001; R041-04, 5-25-2004; R036-07, 1-30-2008; R121-08, 9-18-2008; R175-12, 12-20-2012)

REVISER’S NOTE.

      The regulation of the State Board of Pharmacy filed with the Secretary of State on January 30, 2008 (LCB File No. R036-07), which amended this section, contains the following provisions not included in NAC:

      “Notwithstanding the provisions of NAC 639.256, if a program of training for pharmaceutical technicians has been approved by the State Board of Pharmacy before January 30, 2008:

      1.  The program is not required to be accredited by the American Society of Health-System Pharmacists until January 30, 2010; and

      2.  An applicant for registration as a pharmaceutical technician may satisfy the requirement set forth in subparagraph (1) of paragraph (e) of subsection 2 of NAC 639.240 if he successfully completes the program not later than January 30, 2010.”

 

      NAC 639.242  Registration of pharmaceutical technician in training; affidavit of managing pharmacist. (NRS 639.070, 639.1371)

     1.  An applicant for registration as a pharmaceutical technician in training must:

     (a) Be 18 years of age or older;

     (b) Be a high school graduate or the equivalent;

     (c) Not have been convicted of any felony or a misdemeanor involving moral turpitude, dishonesty or the unlawful possession, sale or use of drugs;

     (d) Have no history of drug abuse; and

     (e) Participate in training while on the job and acquire experience that is commensurate with the duties of his or her employment.

     2.  A person may perform the duties of a pharmaceutical technician while the person is receiving the training and experience required by paragraph (e) of subsection 1 if he or she is registered with the Board.

     3.  Upon receipt of an application and the required fee, the Executive Secretary shall, unless he or she has good cause to deny the registration, issue a registration certificate for a pharmaceutical technician in training to the managing pharmacist of the pharmacy where the trainee will be employed.

     4.  Registration as a pharmaceutical technician in training is effective for 24 months after the date of issuance unless an extension is granted by the Board.

     5.  The registration certificate of a pharmaceutical technician in training who is receiving the training and experience required by paragraph (e) of subsection 1 will specify the pharmacy where he or she will be employed. Termination of that employment voids the registration, and the trainee must reapply for registration before his or her services may be used by another pharmacy. This subsection does not prohibit a trainee from accumulating certified hours of training from each place of employment.

     6.  The managing pharmacist of the pharmacy where a pharmaceutical technician in training is employed to receive the training and experience required by paragraph (e) of subsection 1 shall file with the Board a signed affidavit certifying:

     (a) The number of hours of training and experience the trainee has successfully completed;

     (b) The specific training and experience the trainee has completed; and

     (c) That the trainee is competent to perform the duties of a pharmaceutical technician.

     (Added to NAC by Bd. of Pharmacy, eff. 11-15-93; A 11-9-95; 7-17-96)

      NAC 639.245  Maintenance and availability of records regarding certain pharmaceutical personnel on duty; activities of pharmaceutical technicians. (NRS 639.070, 639.1371)

     1.  A written record must be kept available for inspection showing the pharmacists, pharmaceutical technicians and pharmaceutical technicians in training on duty during the hours of business. This record must be:

     (a) Readily retrievable; and

     (b) Retained for 2 years.

     2.  A pharmaceutical technician under the direct supervision of a pharmacist may:

     (a) Prepackage and label unit dose and unit of use and repackage drugs if a pharmacist:

          (1) Inspects the final products; and

          (2) Affixes his or her initials to the appropriate records for controlling quality.

     (b) Prepare, package, compound and label prescription drugs pursuant to prescriptions or orders for medication if a pharmacist:

          (1) Inspects the final product; and

          (2) Affixes his or her initials to the appropriate records for controlling quality.

     (c) Prepare bulk compounds if a pharmacist:

          (1) Inspects the final product; and

          (2) Affixes his or her initials to the appropriate records for controlling quality.

     (d) Distribute routine orders and stock medications and supplies in the pharmacy or areas where care is provided to patients.

     (e) Maintain inventories of supplies of drugs.

     (f) Maintain pharmaceutical records.

     (g) Request authorization to refill a prescription from the prescribing practitioner.

     (h) Transfer a prescription through a computer network if the:

          (1) Pharmaceutical technician is employed by a pharmacy that:

               (I) Has more than one location; and

               (II) Maintains a computer network which provides information between its pharmacies; and

          (2) Prescription is transferred to one of the pharmacies within its computer network.

     (i) Enter information into the pharmacy’s computer system, including, without limitation, information contained in a new prescription concerning the prescription drug and the directions for its use.

     3.  A pharmaceutical technician may not:

     (a) Perform any action requiring a judgmental decision regarding a drug, the interpretation of a prescription or the instructions for the preparation of a prescription.

     (b) Take new prescription or chart orders by telephone.

     (c) Distribute medications pursuant to a chart order or dispense a prescription unless the order or prescription has been verified by a pharmacist.

     4.  A pharmaceutical technician shall prepare and distribute drugs only pursuant to written procedures and guidelines established by the pharmacy in which the pharmaceutical technician performs his or her duties.

     [Bd. of Pharmacy, § 639.205, eff. 6-26-80]—(NAC A 12-3-84; 6-16-86; 3-27-90; 11-15-93; R214-99, 3-13-2000; R037-07, 1-30-2008)

      NAC 639.247  Establishment and maintenance of policies and procedures for personnel; maintenance and availability of personnel records. (NRS 639.070, 639.1371)

     1.  A pharmacy that uses the services of a pharmaceutical technician shall:

     (a) Establish and maintain written policies and procedures that include:

          (1) Job descriptions for all personnel.

          (2) Procedures to ensure the quality and safety of pharmaceutical services.

          (3) The duties that may be performed only by registered pharmacists.

          (4) The minimum qualifications for supportive personnel, including the minimum educational and training requirements that must be completed by supportive personnel.

          (5) Procedures for processing prescriptions and compounding medications.

     (b) Maintain a written record that includes:

          (1) Documentation of the completion of the orientation and training required for each pharmaceutical technician that demonstrates the competency of the pharmaceutical technician to perform the tasks assigned to him or her.

          (2) Evidence that each pharmaceutical technician has read and is familiar with the written policies of the pharmacy and state and federal laws relating to the practice of pharmacy.

     2.  The written record maintained pursuant to paragraph (b) of subsection 1 must be available for inspection upon the request of any person authorized to inspect the record for a period of at least 2 years.

     (Added to NAC by Bd. of Pharmacy, eff. 11-15-93)

      NAC 639.250  Restrictions on supervision. (NRS 639.070, 639.0727, 639.1371)  Except as otherwise provided in NAC 639.258 and 639.394:

     1.  Except as otherwise provided in this section, in a hospital, a pharmacist who is dispensing prescriptions may not supervise more than three pharmaceutical technicians at one time. A pharmacist who is supervising distributive functions may not supervise more than two pharmaceutical technicians and one pharmaceutical technician in training while the trainee is performing technician functions in on-the-job training.

     2.  Except as otherwise provided in this section, in any pharmacy, other than a hospital pharmacy, a pharmacist may not supervise more than three pharmaceutical technicians or one pharmaceutical technician and two pharmaceutical technicians in training at one time.

     3.  A pharmacist may supervise more pharmaceutical technicians and pharmaceutical technicians in training at one time than are otherwise allowed pursuant to subsections 1 and 2 if:

     (a) Not more than three of the pharmaceutical technicians or pharmaceutical technicians in training are performing the duties of a pharmaceutical technician as set forth in NAC 639.245; and

     (b) The record kept by the pharmacy pursuant to NAC 639.245 identifies the pharmaceutical technicians and pharmaceutical technicians in training who are performing the duties of a pharmaceutical technician as set forth in NAC 639.245.

     [Bd. of Pharmacy, § 639.215, eff. 6-26-80]—(NAC A 12-3-84; 2-18-88; 3-27-90; 11-15-93; 12-13-96; R016-99, 11-3-99; R037-07, 1-30-2008)

REVISER’S NOTE.

      The provisions of subsection 3 of NAC 639.250 as added by LCB File No. R037-10 have been codified as NAC 639.394.

 

      NAC 639.252  Initialing of prescriptions, records and reports; responsibility for filled prescriptions. (NRS 639.070, 639.1371)

     1.  A prescription and any record or report prepared by a pharmaceutical technician must bear the legible initials of the pharmaceutical technician and the pharmacist who is supervising him or her.

     2.  If a pharmaceutical technician performs one or more of the functions necessary to prepare a prescription, the pharmacist supervising the pharmaceutical technician is responsible for the filled prescription, including, but not limited to, verifying:

     (a) The selection and strength of the drug;

     (b) The dosage form; and

     (c) The labeling of the prescription.

     (Added to NAC by Bd. of Pharmacy, eff. 11-15-93)

      NAC 639.254  Initial and biennial in-service training of pharmaceutical technicians working in or for pharmacy; substitution of continuing education for in-service training. (NRS 639.070, 639.1371)

     1.  The owner and managing pharmacist of a pharmacy shall provide training for pharmaceutical technicians working in or for the pharmacy that ensures the continuing competency of those technicians. Except as otherwise provided in this section, the training must consist of initial training upon employment and at least 12 hours of in-service training during the 2-year period immediately preceding the renewal of the registration of the pharmaceutical technician. One of the 12 hours of in-service training must be a jurisprudence program approved or presented by the Board that relates to the practice of pharmacy or the law concerning pharmacy in this State.

     2.  The managing pharmacist shall maintain a written record of the initial training and the annual training completed by each pharmaceutical technician working in or for the pharmacy that contains:

     (a) The name and signature of the person receiving the training;

     (b) The date or dates on which the training was received;

     (c) The number of hours of training received;

     (d) A general description of the topics covered; and

     (e) The name of the person or provider conducting the training.

     3.  A pharmaceutical technician may substitute the completion of the continuing education necessary for recertification by the Pharmacy Technician Certification Board or the National Healthcareer Association for the biennial in-service training required by subsection 1.

     (Added to NAC by Bd. of Pharmacy, eff. 11-15-93; A by R033-02, 5-31-2002; R121-08, 9-18-2008; R016-09, 10-27-2009; R175-12, 12-20-2012)

      NAC 639.256  Program of training: Approval by Board; testing of pharmaceutical technician in training for presence of alcohol or drug. (NRS 639.070, 639.1371)

     1.  A program of training for pharmaceutical technicians must be approved by the Board before it is provided in this State. A request for approval must be filed with the Board. The Board will approve a program only if the program:

     (a) Is accredited by the American Society of Health-System Pharmacists; and

     (b) Administers at least one random test for the presence of alcohol or a controlled substance or other drug to each pharmaceutical technician in training before the pharmaceutical technician in training is allowed to participate in any part of the program that involves employment or training in a pharmacy. If the pharmaceutical technician in training tests positive for the presence of alcohol or a controlled substance or other drug for which the pharmaceutical technician in training does not have a lawfully issued prescription or the pharmaceutical technician in training refuses to submit to such a test, the administrator of the program must:

          (1) Suspend the pharmaceutical technician in training from participating in any part of the program that involves employment or training in a pharmacy;

          (2) Notify the Board that the pharmaceutical technician in training has tested positive for the presence of alcohol or a controlled substance or other drug for which the pharmaceutical technician in training does not have a lawfully issued prescription or has refused to submit to such a test; and

          (3) Prevent the pharmaceutical technician in training from resuming participation in any part of the program that involves employment or training in a pharmacy without the approval of the Board.

     2.  The Board may refuse to approve a program of training for pharmaceutical technicians or may withdraw its approval of a program at any time for good cause shown.

     3.  A program of training for pharmaceutical technicians that is provided outside this State shall be deemed to be approved by the Board if the program is accredited by the American Society of Health-System Pharmacists.

     4.  For the purposes of this section, “program of training for pharmaceutical technicians” does not include on-the-job training that is provided to a pharmaceutical technician in training by his or her employer.

     (Added to NAC by Bd. of Pharmacy, eff. 11-15-93; A by R036-07, 1-30-2008)

REVISER’S NOTE.

      The regulation of the State Board of Pharmacy filed with the Secretary of State on January 30, 2008 (LCB File No. R036-07), which amended this section, contains the following provisions not included in NAC:

      “Notwithstanding the provisions of NAC 639.256, if a program of training for pharmaceutical technicians has been approved by the State Board of Pharmacy before January 30, 2008:

      1.  The program is not required to be accredited by the American Society of Health-System Pharmacists until January 30, 2010; and

      2.  An applicant for registration as a pharmaceutical technician may satisfy the requirement set forth in subparagraph (1) of paragraph (e) of subsection 2 of NAC 639.240 if he successfully completes the program not later than January 30, 2010.”

 

      NAC 639.258  Participation in program of training for pharmaceutical technicians. (NRS 639.070, 639.1371)

     1.  A pharmaceutical technician in training who is registered with the Board may perform the duties of a pharmaceutical technician while he or she is participating in a program of training for pharmaceutical technicians that is approved by the Board pursuant to NAC 639.256. The registration of such a pharmaceutical technician in training:

     (a) Will specify the program of training in which he or she is participating; and

     (b) Expires when the enrollment of the pharmaceutical technician in the program terminates.

     2.  A person who is participating in a program of training for pharmaceutical technicians that is approved by the Board pursuant to NAC 639.256 may be trained in more than one pharmacy as a part of the program.

     3.  A pharmacist who is acting as an instructor for a program of training for pharmaceutical technicians that is approved by the Board pursuant to NAC 639.256 may, while acting as an instructor, supervise one pharmaceutical technician in training, in addition to the persons that he or she may supervise pursuant to NAC 639.250, if the additional pharmaceutical technician in training:

     (a) Has completed at least 9 months of a program of training for pharmaceutical technicians that is approved by the Board pursuant to NAC 639.256; and

     (b) Has not yet successfully completed 240 hours of practical training.

     4.  A pharmacist shall not supervise an additional pharmaceutical technician in training pursuant to subsection 3 after that pharmaceutical technician in training has successfully completed 240 hours of practical training.

     (Added to NAC by Bd. of Pharmacy, eff. 11-15-93; A 12-13-96; R036-07, 1-30-2008)

REVISER’S NOTE.

      The regulation of the State Board of Pharmacy filed with the Secretary of State on January 30, 2008 (LCB File No. R036-07), which amended this section, contains the following provisions not included in NAC:

      “Notwithstanding the provisions of NAC 639.256, if a program of training for pharmaceutical technicians has been approved by the State Board of Pharmacy before January 30, 2008:

      1.  The program is not required to be accredited by the American Society of Health-System Pharmacists until January 30, 2010; and

      2.  An applicant for registration as a pharmaceutical technician may satisfy the requirement set forth in subparagraph (1) of paragraph (e) of subsection 2 of NAC 639.240 if he successfully completes the program not later than January 30, 2010.”

 

      NAC 639.260  Disciplinary action against pharmacy. (NRS 639.070, 639.1371, 639.210)  A pharmacy that requires or allows a pharmacist to use the services of a pharmaceutical technician in violation of any provision of this chapter or chapter 639 of NRS is subject to the disciplinary actions set forth in NRS 639.210.

     (Added to NAC by Bd. of Pharmacy, eff. 11-15-93)

INTERN PHARMACISTS

      NAC 639.262  Application for registration; issuance of certificate of registration; maintenance of records relating to internship. (NRS 639.070, 639.137)

     1.  As required by NRS 639.137, an application for registration as an intern pharmacist must be made on a form furnished by the Board. If the applicant is enrolled in a college of pharmacy or a department of pharmacy of a university approved by the Board, the application must include the name, telephone number and mailing address of the person at the college of pharmacy or the department of pharmacy of the university who will be making and maintaining the records relating to the internship of the applicant.

     2.  Upon approval of the application, the Executive Secretary shall issue a certificate of registration as required by NRS 639.137.

     3.  Except as otherwise provided in subsection 4, if an applicant is enrolled in a college of pharmacy or a department of pharmacy of a university approved by the Board, the college of pharmacy or the department of pharmacy of the university at which the applicant is enrolled shall prepare and maintain records relating to the participation of the applicant in his or her internship as an intern pharmacist. The records must include, without limitation, a copy of the documentation provided to the college of pharmacy or the department of pharmacy of the university pursuant to subsection 5 of NAC 639.266, if any.

     4.  If an applicant participates in an internship after he or she has graduated from a college of pharmacy, a department of pharmacy of a university or a foreign school, the applicant shall prepare and maintain records relating to his or her participation in the internship. The records must include, without limitation, a copy of the documentation provided to the applicant pursuant to subsection 5 of NAC 639.266, if any.

     (Added to NAC by Bd. of Pharmacy by R019-03, eff. 10-21-2003)

      NAC 639.264  Employment at pharmacy as part of internship. (NRS 639.070, 639.137)  A pharmacy for which an intern pharmacist works as part of an internship to fulfill the requirements of paragraph (d) of subsection 1 of NRS 639.120 may:

     1.  Allow the intern pharmacist to work at the pharmacy without pay if the intern pharmacist is receiving credit for the internship from the college of pharmacy or the department of pharmacy of the university approved by the Board at which the intern pharmacist is enrolled; or

     2.  Employ the intern pharmacist with pay if the intern pharmacist:

     (a) Has graduated from a college of pharmacy, a department of pharmacy of a university or a foreign school; or

     (b) Is enrolled in a college of pharmacy or a department of pharmacy of a university approved by the Board and is working for the pharmacy during a break from attendance at the college of pharmacy or the department of pharmacy of the university, including, without limitation, the summer vacation months or a holiday break.

     (Added to NAC by Bd. of Pharmacy by R019-03, eff. 10-21-2003)

      NAC 639.266  Supervision and training: Service as preceptor; duties; evaluation of internship. (NRS 639.070, 639.137)

     1.  Except as otherwise prohibited by law or by an order of the Board, any registered pharmacist may serve as preceptor to an intern pharmacist.

     2.  If an intern pharmacist is enrolled in a college of pharmacy or a department of pharmacy of a university approved by the Board, the college of pharmacy or the department of pharmacy of the university at which the intern pharmacist is enrolled shall establish a scope of duties that may be engaged in by the intern pharmacist during his or her internship and shall provide the scope of duties to the intern pharmacist before the internship begins. The scope of duties must be based upon the courses that the intern pharmacist has completed. The intern pharmacist shall, before his or her internship begins, provide the scope of duties established for him or her by the college of pharmacy or the department of pharmacy of the university to any preceptor responsible for his or her supervision and training.

     3.  Except as otherwise provided in subsection 4, a preceptor shall allow an intern pharmacist under his or her supervision to perform duties to the fullest extent practicable that are primarily related to:

     (a) The selling of controlled substances, poisons, dangerous drugs and devices;

     (b) The compounding of prescription drugs;

     (c) The filling of prescriptions and the dispensing of prescription drugs;

     (d) Preparing and maintaining such records and reports as are required by state and federal law;

     (e) Counseling patients as required by NAC 639.707 concerning prescription drugs dispensed to the patients;

     (f) The practice of pharmacy as that term is defined in NRS 639.0124; and

     (g) Administering immunizations by an intranasal, intramuscular or subcutaneous injection in accordance with a written protocol established by a physician pursuant to NAC 639.2971.

     4.  A preceptor shall not allow an intern pharmacist under his or her supervision to perform any duties that:

     (a) Are outside of the scope of duties established for the intern pharmacist pursuant to subsection 2; or

     (b) In the professional judgment of the preceptor, the intern pharmacist is not able to perform safely and professionally.

     5.  A preceptor shall:

     (a) Document the number of hours worked by each intern pharmacist under his or her supervision;

     (b) Maintain that documentation; and

     (c) Provide a copy of that documentation to:

          (1) The college of pharmacy or the department of pharmacy of the university at which the intern pharmacist is enrolled if the intern pharmacist is enrolled in a college of pharmacy or a department of pharmacy of a university approved by the Board; or

          (2) The intern pharmacist if the intern pharmacist has graduated from a college of pharmacy, a department of pharmacy of a university or a foreign school.

     6.  If the intern pharmacist is enrolled in a college of pharmacy or a department of pharmacy of a university approved by the Board, the preceptor supervising the intern pharmacist shall provide written notice to the college of pharmacy or the department of pharmacy of the university at which the intern pharmacist is enrolled if the preceptor or the pharmacy for which the preceptor works terminates the internship of the intern pharmacist. The notice must state with specificity the reasons for the termination of the internship.

     7.  In addition to the notice provided pursuant to subsection 6, a preceptor supervising an intern pharmacist who is enrolled in a college of pharmacy or a department of pharmacy of a university approved by the Board shall provide written notice to the Board if the internship of the intern pharmacist is terminated because the intern pharmacist:

     (a) Was arrested for, charged with or convicted of a crime that was alleged to have been committed by the intern pharmacist while participating in his or her internship at the pharmacy;

     (b) Committed an act that, in the judgment of the preceptor, was a violation of one or more provisions of Nevada or federal law relating to the practice of pharmacy; or

     (c) Committed an act that, in the judgment of the preceptor, was a violation of one or more of the policies or procedures of the pharmacy at which the intern pharmacist was participating in his or her internship.

Ê The notice must state with specificity the reasons for the termination of the internship.

     8.  Except as otherwise provided in subsection 9, the college of pharmacy or the department of pharmacy of the university at which any intern pharmacist is enrolled shall provide the intern pharmacist with a form to evaluate the quality of his or her internship at a pharmacy upon completion of the internship at the pharmacy. If a representative of the college of pharmacy or the department of pharmacy of the university discusses any of the comments made on the evaluation form with a preceptor who supervised the intern pharmacist or with any representative of the pharmacy at which the intern pharmacist was participating in his or her internship, the representative of the college of pharmacy or the department of pharmacy of the university shall not attribute any of the comments made on the evaluation to the intern pharmacist.

     9.  A college of pharmacy or a department of pharmacy of a university is not required to provide an intern pharmacist who participates in an internship after he or she has graduated from the college of pharmacy or the department of pharmacy of the university with a form to evaluate the quality of his or her internship at a pharmacy.

     10.  As used in this section, “preceptor” means a registered pharmacist who:

     (a) Has accepted responsibility for the supervision and training of an intern pharmacist; and

     (b) Provides direct and immediate supervision to the intern pharmacist.

     (Added to NAC by Bd. of Pharmacy by R019-03, eff. 10-21-2003; A by R115-08, 9-18-2008)

      NAC 639.268  Supervision and training: Responsibilities of registered pharmacist. (NRS 639.070, 639.137)  A registered pharmacist who has accepted responsibility for the supervision and training of an intern pharmacist is responsible for all acts performed by the intern pharmacist working under his or her supervision. All prescriptions compounded, dispensed or filled by an intern pharmacist and all records and reports prepared by an intern pharmacist must bear the legible initials of both the intern and the registered pharmacist who is supervising him or her.

     [Bd. of Pharmacy, § 639.195, eff. 6-26-80]—(Substituted in revision for NAC 639.705)

PHYSICIAN ASSISTANTS

      NAC 639.269  “Physician assistant” defined. (NRS 639.070)  As used in NAC 639.269 to 639.295, inclusive, unless the context otherwise requires, “physician assistant” includes a physician assistant as defined in NRS 633.107.

     (Added to NAC by Bd. of Pharmacy by R015-03, eff. 10-21-2003)

      NAC 639.270  Scope. (NRS 639.070, 639.1373)  The provisions of NAC 639.269 to 639.295, inclusive:

     1.  Regulate the issuance of registration certificates to physician assistants;

     2.  Control the prescribing and dispensing of controlled substances, poisons, dangerous drugs and devices by physician assistants;

     3.  Set registration fees; and

     4.  Establish grounds for the suspension or revocation of registration certificates of physician assistants.

     [Bd. of Pharmacy, § 639.350, eff. 6-26-80]—(NAC A 2-6-90; 9-10-90; 10-24-97)

      NAC 639.272  Requirements for registration certificate. (NRS 639.070, 639.1373)

     1.  The application of a physician assistant for:

     (a) A registration certificate to prescribe controlled substances, poisons, dangerous drugs and devices or to prescribe poisons, dangerous drugs and devices; or

     (b) A registration certificate to prescribe and dispense controlled substances, poisons, dangerous drugs and devices or to prescribe and dispense poisons, dangerous drugs and devices,

Ê must be in writing and filed with the Executive Secretary.

     2.  Each application for a registration certificate to prescribe controlled substances, poisons, dangerous drugs and devices or to prescribe poisons, dangerous drugs and devices must include:

     (a) The name, address, social security number and telephone number of the applicant;

     (b) A copy of the license issued by the Board of Medical Examiners or certificate issued by the State Board of Osteopathic Medicine that authorizes the applicant to prescribe controlled substances, poisons, dangerous drugs and devices or to prescribe poisons, dangerous drugs and devices;

     (c) The name, address and telephone number of the applicant’s supervising physician; and

     (d) Any other information requested by the Board.

     3.  Each application for a registration certificate to prescribe and dispense controlled substances, poisons, dangerous drugs and devices or to prescribe and dispense poisons, dangerous drugs and devices must include:

     (a) The name, address, social security number and telephone number of the applicant;

     (b) A copy of the license issued by the Board of Medical Examiners or certificate issued by the State Board of Osteopathic Medicine that authorizes the applicant to prescribe and dispense controlled substances, poisons, dangerous drugs and devices or to prescribe and dispense poisons, dangerous drugs and devices;

     (c) The name, address and telephone number of the applicant’s supervising physician; and

     (d) Any other information requested by the Board.

     4.  Each physician assistant who applies for a registration certificate pursuant to subsection 3 must:

     (a) Personally appear before the Board for determination and assignment of the specific authority to be granted to the physician assistant if the physician assistant:

          (1) Responded affirmatively to any of the questions on the application regarding his or her character or competency; or

          (2) Is requested to do so by the Board; and

     (b) Pass an examination administered by the Board on the law relating to pharmacy.

     5.  Each physician assistant to whom a registration certificate is issued must be registered to a supervising physician.

     (Added to NAC by Bd. of Pharmacy, eff. 10-26-83; A 2-6-90; 9-10-90; 10-17-91; 10-1-93; 10-24-97; R006-01, 11-1-2001; R120-09, 1-28-2010)

      NAC 639.277  Change in location of practice or supervising physician. (NRS 639.070)  A physician assistant shall notify the Board in writing of a change in the location of the practice of the physician assistant or a change of his or her supervising physician not later than 10 days after the change occurs.

     (Added to NAC by Bd. of Pharmacy, eff. 2-6-90; A 9-10-90; 10-24-97)

      NAC 639.280  Scope of authority to prescribe and dispense. (NRS 639.070, 639.1373)

     1.  Except as otherwise provided in subsections 2 and 3, a physician assistant who is authorized to prescribe and dispense controlled substances, poisons, dangerous drugs and devices or to prescribe and dispense poisons, dangerous drugs and devices may prescribe and dispense a controlled substance, poison, dangerous drug and device or a poison, dangerous drug and device, as applicable, only:

     (a) For a legitimate medical purpose; and

     (b) In such amounts as are authorized by the supervising physician of the physician assistant except that the amounts must not exceed a 365-day supply.

     2.  A physician assistant who is authorized to prescribe and dispense dangerous drugs may dispense any method of birth control in any quantity ordered by prescription.

     3.  The limitation set forth in paragraph (b) of subsection 1 does not apply to any method of birth control prescribed or dispensed by a physician assistant.

     4.  A physician assistant who prescribes or dispenses drugs to a patient under the direction of a supervising physician or pursuant to NRS 454.00958 shall do so by a written prescription, unless the prescription is issued as an oral order to a pharmacy.

     [Bd. of Pharmacy, § 639.360, eff. 6-26-80]—(NAC A 10-17-86; 2-6-90; 9-10-90; 5-22-96; 10-24-97; R015-03, 10-21-2003)

      NAC 639.283  Prescriptions: Orders on charts of hospitalized patients. (NRS 639.070, 639.1373)  A physician assistant shall not write a prescription in the form of an order on the chart of a patient in a hospital unless the physician assistant is authorized by the hospital’s rules and has filed a copy of his or her form for prescriptions with the pharmacy of the hospital. The form must be approved by the Board.

     (Added to NAC by Bd. of Pharmacy, eff. 2-6-90)

      NAC 639.285  Security and storage of controlled substances and drugs. (NRS 639.070, 639.1373)

     1.  All controlled substances and dangerous drugs which are in the possession of a physician assistant must be kept in a locked storage area. Access to the storage area must be restricted to the persons described in NRS 453.375.

     2.  Physician assistants working intermittently at satellite facilities, such as clinics, must transport the drugs on each trip to and from those locations unless authorized by the Board to store them at those locations.

     3.  Biologicals and other drugs must be refrigerated if that requirement is stated on the manufacturer’s label.

     [Bd. of Pharmacy, § 639.370, eff. 6-26-80]—(NAC A 2-6-90)

      NAC 639.290  Substitution in case of illness or absence. (NRS 639.070, 639.1373)  When a physician assistant possessing a registration certificate to prescribe and dispense controlled substances, poisons, dangerous drugs and devices or to prescribe and dispense poisons, dangerous drugs and devices is ill or absent from his or her duties, another physician assistant possessing such a registration certificate may perform the duties of the absent physician assistant with the consent and under the supervision of the supervising physician of the absent physician assistant. An inventory of drugs must be taken before the substitute begins his or her duties and again taken when the returning physician assistant resumes his or her duties. The inventories must be attested to by the signature of the supervising physician and copies submitted to the Executive Secretary upon the request of the Board.

     [Bd. of Pharmacy, § 639.365, eff. 6-26-80]—(NAC A 2-6-90; 9-10-90; 10-24-97)

      NAC 639.295  Grounds for denial of application or suspension or revocation of registration. (NRS 639.070, 639.1373, 639.210)  The Board may deny the application of any physician assistant or suspend or revoke the registration of the physician assistant if he or she:

     1.  Is not of good moral character;

     2.  Is guilty of habitual intemperance;

     3.  Becomes or is under the influence of liquor, any depressant drug or a controlled substance while on duty, unless the drug or substance has been taken pursuant to a physician’s prescription;

     4.  Is guilty of unprofessional conduct or conduct contrary to the public interest;

     5.  Is addicted to the use of any controlled substance;

     6.  Has been convicted of a violation of any federal law or law of any other state relating to controlled substances;

     7.  Has been convicted of a felony or other crime involving moral turpitude, dishonesty or corruption;

     8.  Has willfully made to the Board or its authorized representative any false written statement which is material to the administration or enforcement of any provision of chapter 453, 454 or 639 of NRS;

     9.  Has obtained registration by filing any application, record or affidavit, or any information in support thereof, which is false or fraudulent;

     10.  Has violated any provision of the Federal Food, Drug and Cosmetic Act or any other state or federal law or regulation relating to prescription drugs;

     11.  Has violated, attempted to violate, assisted or abetted in the violation of, or conspired to violate any law or regulation relating to the practice of pharmacy;

     12.  Has failed to renew the registration by failing to pay the renewal fee;

     13.  Has failed to maintain the security of his or her drug supply;

     14.  Has violated, attempted to violate, assisted or abetted in the violation of, or conspired to violate any provision of this regulation;

     15.  Has supplied patients with prescriptions that are presigned in blank by the physician; or

     16.  Has violated any provision of chapter 453, 454, 585 or 639 of NRS.

     [Bd. of Pharmacy, § 639.375, eff. 6-26-80]—(NAC A 2-6-90)

IMMUNIZATION BY PHARMACISTS AND INTERN PHARMACISTS

      NAC 639.297  “Immunization” defined. (NRS 639.070)  As used in NAC 639.297 to 639.2978, inclusive, unless the context otherwise requires, “immunization” means the act of inducing antibody formation through the introduction of a drug into the human body.

     (Added to NAC by Bd. of Pharmacy by R009-01, eff. 11-1-2001)

      NAC 639.2971  Authorization; contents of and deviation from written protocol. (NRS 454.213, 639.070, 639.137)

     1.  A physician may establish a written protocol authorizing pharmacists to administer immunizations by an intranasal, intramuscular or subcutaneous injection. Except as otherwise limited by the physician pursuant to subsection 4, any pharmacist who is trained and certified in accordance with NAC 639.2973 may subscribe to the written protocol and administer immunizations in compliance with the protocol. Such a protocol must contain:

     (a) The name of the physician who is authorizing the administration of immunizations by a pharmacist;

     (b) The immunizations that may be administered by a pharmacist;

     (c) Detailed policies and procedures that a pharmacist must follow while administering immunizations, including, without limitation, procedures to follow in the case of adverse reactions or emergencies following administration;

     (d) A procedure for the review of the protocol and its operation by the physician at least once annually, and the making and keeping of a record of the review;

     (e) When appropriate, specific instructions related to the age of the patient;

     (f) Except as otherwise provided in subsection 2, a restriction that a pharmacist may not delegate his or her authority to administer an immunization;

     (g) A restriction that a pharmacist may not administer an immunization except at an authorized location, which location may not be the home of the patient, unless the patient resides in a licensed facility for long-term care or in a hospital;

     (h) A requirement that the immunizations will be administered according to all applicable federal, state and local laws; and

     (i) The signature of the physician authorizing the administration of the immunizations and the time period for which the written protocol is effective.

     2.  An intern pharmacist may administer immunizations by an intranasal, intramuscular or subcutaneous injection under the direct and immediate supervision of a pharmacist who has subscribed to a written protocol established by a physician.

     3.  If a physician orders a deviation from the written protocol for the benefit of a specific patient, the physician shall note the deviations from the written protocol in the record of the patient.

     4.  A physician may include restrictions to a written protocol established by the physician pursuant to subsection 1 by limiting the protocol to any of the following:

     (a) A specific pharmacist or pharmacists;

     (b) A specific location or locations;

     (c) The administration of a specific immunization or immunizations; or

     (d) Other limitations as the physician determines necessary.

     (Added to NAC by Bd. of Pharmacy by R009-01, eff. 11-1-2001; A by R142-03, 4-8-2004; R180-05, 12-29-2005; R115-08, 9-18-2008)

      NAC 639.2972  Duties of authorizing physician. (NRS 454.213, 639.070, 639.137)  A physician who has authorized pharmacists to administer immunizations by establishing a written protocol shall supervise the implementation of the protocol by each pharmacist who has subscribed to the protocol and by each intern pharmacist acting under the direct and immediate supervision of the pharmacist by:

     1.  Being readily accessible to the pharmacist or intern pharmacist or the patient when the pharmacist is authorized to administer the immunizations for consultation, assistance and direction; and

     2.  If required by the written protocol, reviewing a periodic status report from a pharmacist or intern pharmacist concerning any problems, complications or emergencies encountered while administering immunizations.

     (Added to NAC by Bd. of Pharmacy by R009-01, eff. 11-1-2001; A by R180-05, 12-29-2005; R115-08, 9-18-2008)

      NAC 639.2973  Training and certification to administer immunizations. (NRS 454.213, 639.070, 639.137)

     1.  Before a pharmacist may administer an immunization pursuant to a written protocol or before an intern pharmacist acting under the direct and immediate supervision of a pharmacist may administer such immunizations, the pharmacist or intern pharmacist must be trained and certified to administer immunizations by completing a course approved by the Accreditation Council for Pharmacy Education that includes:

     (a) Certification in life-saving techniques pursuant to the American Heart Association’s Basic Cardiac Life Support for Health Care Providers or its equivalent;

     (b) Education and practical training, including, without limitation, written study materials regarding techniques for administering immunizations;

     (c) Evaluation of the knowledge and technique of the pharmacist or intern pharmacist in administering immunizations;

     (d) Instruction consistent with the current training guidelines of the Centers for Disease Control and Prevention; and

     (e) Except as otherwise provided in subsection 2, a minimum of 20 hours of instruction and practical training concerning:

          (1) The standards for pediatric, adolescent and adult immunization practices recommended and approved by the United States Public Health Service Advisory Committee on Immunization Practices;

          (2) Basic immunology, and vaccine and immunization protection;

          (3) Diseases that are preventable through vaccination and immunization;

          (4) Recommended immunization schedules;

          (5) Vaccine and immunization storage and management;

          (6) Informed consent;

          (7) Physiology and techniques for administration of immunizations;

          (8) Preimmunization and postimmunization assessment and counseling;

          (9) Immunization reporting and records management; and

          (10) Identification, response, documentation and reporting of adverse events.

     2.  In lieu of complying with the requirements of paragraph (e) of subsection 1, a pharmacist or an intern pharmacist who administers immunizations consisting exclusively of live attenuated influenza vaccine through the nasal passages of a person may complete a program of less than 20 hours of instruction which is accredited by the Accreditation Council for Pharmacy Education and includes instruction relating to:

     (a) The epidemiology of influenza;

     (b) The pathophysiology, clinical presentation, diagnosis, prevention and treatment of influenza;

     (c) The administration, storage and handling of influenza vaccines; and

     (d) The counseling of patients who will be immunized with the vaccine.

     (Added to NAC by Bd. of Pharmacy by R009-01, eff. 11-1-2001; A by R187-03, 4-8-2004; R180-05, 12-29-2005; R115-08, 9-18-2008)

      NAC 639.2974  Certification in basic cardiac life support; continuing education. (NRS 454.213, 639.070, 639.137)  A pharmacist who administers immunizations or an intern pharmacist acting under the direct and immediate supervision of a pharmacist who administers immunizations shall:

     1.  Maintain certification in basic cardiac life support from the American Heart Association; and

     2.  On or before October 31 of each year, complete:

     (a) At least 2 hours of continuing education in a course or courses that address the life cycle of diseases, drugs and administration of immunizations; or

     (b) A course provided by the Centers for Disease Control and Prevention regarding epidemiology and prevention of diseases which are preventable through immunization.

     (Added to NAC by Bd. of Pharmacy by R009-01, eff. 11-1-2001; A by R180-05, 12-29-2005)

      NAC 639.2975  Legal possession and control of drugs administered as immunizations; drugs to counteract adverse reactions. (NRS 454.213, 639.070, 639.137)

     1.  The drugs administered as immunizations by a pharmacist or an intern pharmacist acting under the direct and immediate supervision of a pharmacist must be in the legal possession of:

     (a) The pharmacy that employs the pharmacist or intern pharmacist who will be administering the immunizations, which pharmacy is responsible for the drugs and the maintenance of records of administration of the immunizations; or

     (b) The physician who has established a written protocol for the administration of the immunizations, which physician is responsible for the drugs and the maintenance of records of administration of the immunizations.

     2.  The drugs used for immunizations must be transported and stored at the proper temperatures indicated for the drugs by the manufacturer.

     3.  While engaged in the administration of immunizations, a pharmacist or an intern pharmacist acting under the direct and immediate supervision of a pharmacist may have in his or her custody and control the drugs for immunization that are identified in the written protocol and any other dangerous drugs listed in the written protocol to treat an adverse reaction.

     4.  If a pharmacist or an intern pharmacist acting under the direct and immediate supervision of a pharmacist administers immunizations at a location other than a pharmacy, the pharmacist or intern pharmacist must return all unused drugs to the pharmacy or physician responsible for the drugs.

     (Added to NAC by Bd. of Pharmacy by R009-01, eff. 11-1-2001; A by R180-05, 12-29-2005; R115-08, 9-18-2008)

      NAC 639.2976  Reporting of certain information concerning immunizations. (NRS 454.213, 639.070, 639.137)  A pharmacist or an intern pharmacist acting under the direct and immediate supervision of a pharmacist who administers immunizations shall report the information required for inclusion in the Immunization Information System established by the Department of Health and Human Services pursuant to NRS 439.265 and the regulations adopted pursuant thereto.

     (Added to NAC by Bd. of Pharmacy by R009-01, eff. 11-1-2001; A by R180-05, 12-29-2005; R115-08, 9-18-2008)

      NAC 639.2977  Maintenance of records. (NRS 454.213, 639.070, 639.137)

     1.  Each record required to be made pursuant to NAC 639.297 to 639.2978, inclusive, must be kept for at least 2 years by the pharmacist or intern pharmacist administering the immunization and the pharmacy or physician who possessed the drugs administered. Such records must be available for inspection and copying by the Board or its representative, or any other authorized federal, state or local law enforcement or regulatory agency.

     2.  Records required pursuant to this section may be maintained in an alternative data retention system, including, without limitation, a computer data processing system or direct imaging system, if:

     (a) The records maintained in the alternative system contain all the information required for a written record; and

     (b) The data processing system is capable of producing a printed copy of the record upon the request of the Board, its representative or any other authorized federal, state or local law enforcement or regulatory agency.

     (Added to NAC by Bd. of Pharmacy by R009-01, eff. 11-1-2001; A by R180-05, 12-29-2005)

      NAC 639.2978  Confidentiality of records. (NRS 454.213, 639.070, 639.137)

     1.  A pharmacist or an intern pharmacist acting under the direct and immediate supervision of a pharmacist shall provide adequate security to prevent unauthorized access to confidential records of immunizations. If confidential health information is not transmitted directly between a pharmacy and a physician, but is transmitted through a data communication device, the confidential health information must not be viewed or used by the operator of the data communication device unless the operator is specifically authorized to obtain confidential information pursuant to this subsection.

     2.  Except as otherwise provided in NRS 49.245, the confidential records of immunizations are privileged and may be released only to:

     (a) The patient or the authorized agent of the patient;

     (b) Physicians and other pharmacists or intern pharmacists acting under the direct and immediate supervision of pharmacists when, in the professional judgment of the pharmacist or intern pharmacist, such release is necessary to protect the health and well-being of the patient;

     (c) The Board or other federal, state or local agencies authorized by law to receive such information;

     (d) A law enforcement agency engaged in the investigation of a suspected violation involving a controlled substance or dangerous drug;

     (e) A person employed by any state agency that licenses a physician if such a person is engaged in the performance of his or her official duties; or

     (f) An insurance carrier or other third party payor authorized by a patient to receive such information.

     3.  The provisions of this section must not be construed to affect or alter the provisions of NRS 49.215 to 49.245, inclusive, relating to the confidentiality of communications between a doctor and a patient.

     (Added to NAC by Bd. of Pharmacy by R009-01, eff. 11-1-2001; A by R180-05, 12-29-2005)

CONTINUING PROFESSIONAL EDUCATION

      NAC 639.300  Definitions. (NRS 639.070, 639.2176)  As used in NAC 639.300 to 639.390, inclusive, unless the context otherwise requires, the words and terms defined in NAC 639.305 to 639.320, inclusive, have the meanings ascribed to them in those sections.

     [Bd. of Pharmacy, § 639.070, eff. 6-26-80]—(NAC A 10-17-86)

      NAC 639.305  “Acceptable materials” defined. (NRS 639.070, 639.2176)  “Acceptable materials” means material for continuing education which:

     1.  Complies with the statutory limits regarding the scope of continuing education; and

     2.  Is offered by a provider although the material is not endorsed by the Board, or has been submitted to and endorsed by the Board.

     [Bd. of Pharmacy, § 639.075, eff. 6-26-80]—(NAC A 10-17-86)

      NAC 639.310  “Accredited material” defined. (NRS 639.070, 639.2176)  “Accredited material” means material for continuing education which has been endorsed by the Board after review by the Board, by its advisory committee on continuing education, by the Accreditation Council for Pharmacy Education or by a board of pharmacy of another state.

     [Bd. of Pharmacy, § 639.080, eff. 6-26-80]—(NAC A 10-17-86)

      NAC 639.315  “Continuing education unit” defined. (NRS 639.070, 639.2176)  “Continuing education unit” means 1 full hour devoted to approved continuing education, consisting of accredited or acceptable material.

     [Bd. of Pharmacy, § 639.085, eff. 6-26-80]—(NAC A 10-17-86)

      NAC 639.320  “Provider” defined. (NRS 639.070, 639.2176)  “Provider” means any person recognized by the Board as responsible and competent to provide material for continuing education which is accredited or acceptable.

     [Bd. of Pharmacy, § 639.090, eff. 6-26-80]—(NAC A 10-17-86)

      NAC 639.330  Registration and reregistration: Continuing education required; submission of proof. (NRS 639.070, 639.2176)

     1.  Except as otherwise provided in NAC 639.335, the Board will not issue a certificate as a registered pharmacist to any person pursuant to NRS 639.133, or renew the certificate of any registered pharmacist, until the applicant submits proof to the Board of receipt of 30 continuing education units within the biennium immediately preceding the current renewal period. The continuing education units must include not less than:

     (a) Fifteen continuing education units in accredited programs; and

     (b) One continuing education unit earned:

          (1) In a jurisprudence program approved or presented by the Board relating to the practice of pharmacy or the law relating to pharmacy in this State; or

          (2) By attending an entire day of any meeting of the Board if:

               (I) The Board meets for not less than 4 hours on that day; and

               (II) The registered pharmacist attends the entire day of the meeting regardless of the length of time that the Board meets on that day.

     2.  A registered pharmacist who attends a meeting of the Board as set forth in subsection 1 is entitled to receive credit for four continuing education units.

     3.  No applicant may carry over any excess continuing education units earned in a previous biennium for purposes of compliance with the requirements of this section.

     4.  Work-related experience acquired in fields other than the practice of pharmacy is not acceptable as credit toward the requirements of continuing education established by NRS 639.2171 to 639.2176, inclusive, and NAC 639.300 to 639.390, inclusive.

     [Bd. of Pharmacy, § 639.100, eff. 6-26-80]—(NAC A 10-17-91; R068-02, 8-6-2002; R040-07, 10-31-2007)

      NAC 639.333  Registration and reregistration: Acceptance of certificate issued by another state as proof of compliance with requirements for continuing education. (NRS 639.070, 639.2176)  The Board will accept a certificate of registration issued by another state as proof of compliance with the requirements for continuing professional education if:

     1.  The certificate of registration is valid for no more than 2 years;

     2.  The requirements for continuing professional education in the state which issued the certificate of registration are equal to or exceed the requirements for continuing professional education in this State; and

     3.  The pharmacist is registered in Nevada but does not currently practice in Nevada.

     (Added to NAC by Bd. of Pharmacy, eff. 6-16-86)

      NAC 639.335  Registration and reregistration: Exceptions to requirement of continuing education. (NRS 639.070, 639.2176)

     1.  Applicants within the following categories are excused from full compliance with NAC 639.330:

     (a) An applicant for certification or renewal is exempt for 2 years after receipt of a degree in pharmacy conferred by an accredited school or college of pharmacy.

     (b) An applicant who is registered pursuant to NRS 639.134 need complete only a number of continuing education units proportional to the number of months remaining until the next date for biennial renewal following his or her registration. Proration will be made at the rate of 1 1/4 units per month.

     (c) An applicant who is residing and practicing outside of this State is exempt from the requirement of one continuing education unit in a jurisprudence program.

     2.  An applicant may earn all his or her required continuing education units in acceptable programs which are not accredited if the applicant is:

     (a) A student of a health profession and has attended at least 15 hours of classroom instruction during a calendar year;

     (b) On active duty in the Armed Forces and stationed outside of this State; or

     (c) Residing and practicing outside of this State.

     [Bd. of Pharmacy, § 639.105, eff. 6-26-80]—(NAC A 10-17-86; 10-17-91)

      NAC 639.340  Providers of continuing education: Request for recognition; grant, denial or withdrawal of recognition. (NRS 639.070, 639.2176)  Any person seeking recognition as a provider must notify the Board of his or her intent to provide material or programs for continuing education and request recognition by the Board. The request will be granted if the Board finds that the person applying for recognition is competent to provide material or programs for continuing education, and the Board will communicate its recognition by mail. Recognition may be denied or withdrawn if the Board finds that the person has:

     1.  Failed to furnish material as advertised;

     2.  Engaged in any misleading or deceptive practice;

     3.  Failed to furnish material as required by law or NAC 639.300 to 639.390, inclusive;

     4.  Failed to comply with the laws or regulations governing continuing professional education in this State; or

     5.  If the material or programs are not accredited by the Accreditation Council for Pharmacy Education, failed to submit the material or programs to the Board at least 60 days before providing the material or programs.

     [Bd. of Pharmacy, § 639.110, eff. 6-26-80]—(NAC A 10-17-86; R130-05, 11-17-2005)

      NAC 639.345  Providers of continuing education: Records required; issuance of certificates of completion. (NRS 639.070, 639.2176)  Each provider shall:

     1.  Keep records sufficient to document:

     (a) The participation of each pharmacist;

     (b) The course or program in which the pharmacist participated;

     (c) Whether the pharmacist completed the program or course; and

     (d) The number of continuing education units awarded to the pharmacist.

Ê Such records must be maintained for a period of 4 years after completion of the course or program.

     2.  Furnish to each participant who completes a course or program a certificate of completion which contains the following information:

     (a) The name of the participant.

     (b) The name of the provider of the course or program.

     (c) A description of the course or program.

     (d) The number of continuing education units completed.

     (e) The date of completion.

     (f) The course designation, either accredited or acceptable.

     [Bd. of Pharmacy, § 639.115, eff. 6-26-80]—(NAC A 10-17-86)

      NAC 639.350  Providers of continuing education: List of participants; reference to accreditation; information to be transmitted to Board. (NRS 639.070, 639.2176)

     1.  Each provider of material:

     (a) Shall maintain a list of all participants in the program for 4 years; and

     (b) May use only the wording authorized in NAC 639.365 with reference to the provider’s accreditation in this State.

     2.  In the case of any material, course or program intended to be presented at a specific time and place, the provider shall, within 60 days after completion of the course or program, transmit to the Board the following information:

     (a) The names and the number of participants in the program or course.

     (b) Any material changes in the program or course made since notice of accreditation was issued by the Board.

     (c) The date, time and location of the presentation.

     (d) The number of hours awarded for continuing education units.

     (e) A brief description of the program, including the principal objective of the presentation.

     [Bd. of Pharmacy, § 639.120, eff. 6-26-80]—(NAC A 10-17-86)

      NAC 639.360  Accreditation of material, course or program. (NRS 639.070, 639.2176)

     1.  A provider who seeks accreditation for any material, course or program must submit it to the Board or its designee for review. The Board will notify the provider of the accreditation or denial thereof within 60 days after the submission of a completed application. In a notice of accreditation, the Board will designate the number of units of continuing education for which the course or program is accredited. Accreditation expires 2 years after issuance, unless sooner renewed.

     2.  In determining whether or not any submitted material, course or program should be accredited, the Board must be satisfied that:

     (a) The material, course or program is presented by a provider;

     (b) A certificate of completion will be issued to each participant who completes the course or program;

     (c) The program includes some mechanism whereby each participant is allowed to evaluate the course with respect to the comprehensibility of the material;

     (d) A complete syllabus is included;

     (e) The material, course or program is accurate, applicable to pharmacy and of adequate technical quality; and

     (f) If the material, course or program is not accredited by the Accreditation Council for Pharmacy Education, the material, course or program is submitted to the Board at least 60 days before the material, course or program is provided.

     [Bd. of Pharmacy, § 639.130, eff. 6-26-80]—(NAC A 10-26-83; 10-17-86; 4-28-88; R130-05, 11-17-2005)

      NAC 639.365  Advertising, announcements and other promotional material. (NRS 639.070, 639.2176)

     1.  A provider may hold himself or herself out as a provider of the material, course or program for continuing education under NRS 639.2171 to 639.2176, inclusive.

     2.  A provider of any accredited material, course or program may state in advertising, announcements or other promotional materials:

 

This course (or program) has been designated ACCREDITED by the State Board of Pharmacy for ................ continuing education units. This designation expires on ................................ (date)

 

     3.  A provider of any acceptable material, course or program may state in announcements, advertising or other promotional materials:

 

This course (or program) has been designated as ACCEPTABLE under the guidelines for continuing education of the State Board of Pharmacy and has been assigned ................ units of credit toward continuing education.

 

     [Bd. of Pharmacy, § 639.135, eff. 6-26-80]—(NAC A 10-17-86)

      NAC 639.370  Materials for continuing education: Formats of programs; subject matter. (NRS 639.070, 639.2176)

     1.  Approved programs for continuing education may consist of lectures, seminars, classes or correspondence courses. Presentations may be live or be given by audiotape or videotape. Material may be studied privately or in groups.

     2.  A provider of material for continuing education has primary responsibility for the format and presentation of the material and may designate or restrict the manner in which the material is presented.

     3.  Material for continuing education may cover any subject pertinent to the socioeconomic and legal aspects of health care, the properties and actions of drugs and dosage forms, and the etiology, characteristics and therapeutics of the disease state and may include:

     (a) Pharmacology.

     (b) Biochemistry.

     (c) Physiology.

     (d) Pharmaceutical chemistry.

     (e) Pharmacy administration.

     (f) Pharmacy jurisprudence.

     (g) Public health and communicable diseases.

     (h) Management of a professional practice.

     (i) Anatomy.

     (j) Histology.

     (k) Other subject matter in the curricula of the accredited colleges and schools of pharmacy.

Ê Matter outside of these areas is subject to acceptance or rejection by the Board.

     [Bd. of Pharmacy, § 639.140, eff. 6-26-80]

      NAC 639.380  Advisory Committee on Continuing Education: Creation; number of members. (NRS 639.070, 639.2176)  The Advisory Committee on Continuing Education is hereby created. The Committee consists of five members.

     [Bd. of Pharmacy, § 639.150, eff. 6-26-80]—(NAC A 10-17-86)

      NAC 639.385  Advisory Committee on Continuing Education: Composition; powers and duties; quorum; review of materials for continuing education. (NRS 639.070, 639.2176)

     1.  The composition of the Committee is as follows:

     (a) A member of the Board, who is Chair of the Committee.

     (b) The Executive Secretary, who is Vice Chair of the Committee.

     (c) Three members appointed by the Chair of the Committee and approved by the Board.

     2.  The Committee:

     (a) May adopt internal administrative policies and procedures.

     (b) With the approval of the Board, shall establish criteria for accrediting and evaluating any material, course or program for continuing education which is not already accredited by the Accreditation Council for Pharmacy Education.

     (c) May select a panel of reviewers to assist in the evaluation of various categories of materials, courses and programs for continuing education.

     (d) Shall evaluate the material, course or program based on the Committee’s own criteria, together with any reports from reviewers, and recommend to the Board for its final decision the accreditation of programs and the number of units of continuing education to be awarded to the programs.

     (e) May adopt such rules as are necessary for its operation.

     (f) Shall advise the Board on all matters relating to continuing education.

     (g) May collect from each provider of continuing education a fee sufficient to allow this function of the Board to be self-supporting.

     3.  A quorum of the Committee is three members, at least one of whom must be the Chair or Vice Chair.

     4.  A provider wishing to have any material, course or program accredited must submit to the Committee:

     (a) All the printed or recorded material intended to be distributed to participants;

     (b) Biographical information on the persons who are responsible for the content of the course;

     (c) Outlines of specifications for and the overall objectives of the presentations, if a major portion of the course or program consists of oral presentations;

     (d) A copy of the provider’s statement of evaluation; and

     (e) An estimate of the appropriate number of units of continuing education to be awarded for completing the course or program.

     5.  The material so submitted may be evaluated by the Committee or, where appropriate, may be transmitted to members of a panel for its evaluation.

     [Bd. of Pharmacy, § 639.155, eff. 6-26-80]—(NAC A 10-26-83; 10-17-86)

      NAC 639.390  Certificate of completion: Retention by pharmacist; copy to be submitted to Board upon request. (NRS 639.070, 639.2176)  A certificate of completion awarded to a participating pharmacist must be retained by the participating pharmacist for 4 years following his or her completion of the course or program of continuing education, but a copy of the certificate must be submitted to the Board upon its request for the purpose of verifying his or her completion of the course or program.

     [Bd. of Pharmacy, § 639.160, eff. 6-26-80]—(NAC A 10-26-83)

REMOTE SITES AND TELEPHARMACIES

      NAC 639.391  Pharmacist or dispensing practitioner required to obtain certificate of registration to dispense controlled substances or dangerous drugs at remote site. (NRS 639.070, 639.0727)

     1.  A pharmacist or dispensing practitioner who wishes to establish a remote site must obtain a certificate of registration from the Board pursuant to NAC 639.742 to dispense controlled substances or dangerous drugs at the remote site.

     2.  Notwithstanding the issuance of a certificate pursuant to subsection 1, if the Board grants a license to operate a pharmacy at a location that is within the service area of a remote site, the pharmacist or dispensing practitioner that established the remote site must close the remote site.

     (Added to NAC by Bd. of Pharmacy by R037-10, eff. 10-15-2010)

      NAC 639.392  Telepharmacies and associated remote sites required to be located within State; requirements concerning accessibility of pharmacist or dispensing practitioner; procedure during interruption of communicative access between telepharmacy and remote site. (NRS 639.070, 639.0727)

     1.  A telepharmacy and each associated remote site must be physically located within this State.

     2.  A pharmacist or dispensing practitioner must be physically present in the telepharmacy and accessible for communication with an associated remote site via computer link, video link and audio link at all times that the remote site is in operation.

     3.  If the communicative access via computer link, video link and audio link between a remote site and its telepharmacy is interrupted or otherwise unavailable, the pharmaceutical technician or dispensing technician operating the remote site shall not perform any act authorized pursuant to NAC 639.391 to 639.399, inclusive, until the communicative access is restored.

     (Added to NAC by Bd. of Pharmacy by R037-10, eff. 10-15-2010)

      NAC 639.393  Requirements for pharmaceutical technicians and dispensing technicians. (NRS 639.070, 639.0727)

     1.  A pharmacist who is responsible for the operation of a remote site shall ensure that a pharmaceutical technician who is employed to dispense controlled substances or dangerous drugs at the remote site has at least 1 year of experience as a pharmaceutical technician.

     2.  A dispensing practitioner who is responsible for the operation of a remote site shall verify that a dispensing technician employed at the remote site is competent by ensuring that the dispensing technician has met the requirements of NAC 639.7425 and has received a certificate of registration pursuant to that section.

     (Added to NAC by Bd. of Pharmacy by R037-10, eff. 10-15-2010)

      NAC 639.394  Supervision of pharmaceutical technicians and dispensing technicians. (NRS 639.070, 639.0727)  In any remote site, a pharmacist or dispensing practitioner may not supervise more than three pharmaceutical technicians or dispensing technicians, as applicable, at one time.

     (Added to NAC by Bd. of Pharmacy by R037-10, eff. 10-15-2010)

      NAC 639.395  Transmission of new prescription to telepharmacy; consultation with pharmacist or dispensing practitioner required before accessing controlled substances or dangerous drugs at remote site; prerequisites for dispensing at remote site. (NRS 639.070, 639.0727)

     1.  A pharmaceutical technician or dispensing technician who operates a remote site shall transmit a copy of any new prescription which the technician receives to the telepharmacy via computer link or other secured electronic means and retain the original prescription in the records maintained at the remote site.

     2.  A pharmaceutical technician or dispensing technician must consult with a pharmacist or dispensing practitioner, as appropriate, at the telepharmacy via computer link, video link or audio link to obtain approval before accessing the stock of controlled substances and dangerous drugs maintained at the remote site.

     3.  A pharmacist or dispensing practitioner shall not authorize a pharmaceutical technician or dispensing technician at a remote site to dispense a controlled substance or dangerous drug unless the pharmacist or dispensing practitioner has:

     (a) Consulted with the technician;

     (b) Visually verified via computer link, video link or audio link that:

          (1) The controlled substance or dangerous drug selected by the technician is correct; and

          (2) The label prepared by the technician is correct; and

     (c) Verified that the information entered by the technician into the computerized system for recording information concerning prescriptions is correct.

     4.  A pharmacist or dispensing practitioner shall only authorize a pharmaceutical technician or dispensing technician at a remote site to dispense a controlled substance or dangerous drug to a patient who resides in the service area of the remote site or whose residence is closer to the remote site than to a telepharmacy.

     (Added to NAC by Bd. of Pharmacy by R037-10, eff. 10-15-2010)

      NAC 639.396  Requirements for maintenance of records. (NRS 639.070, 639.0727)

     1.  Except as otherwise provided in this section, a pharmacist or dispensing practitioner who is responsible for the operation of a remote site shall maintain at the remote site and at the associated telepharmacy a record of each drug that is received, stored, dispensed, returned or otherwise dealt with at the remote site, including, without limitation, any record that is required to be maintained by state or federal law. The records so maintained must include, without limitation:

     (a) Each prescription dispensed at the remote site;

     (b) At the remote site, the initials of the technician who dispensed the controlled substance or dangerous drug;

     (c) At the telepharmacy, the initials of the pharmacist or dispensing practitioner who authorized the controlled substance or dangerous drug to be dispensed at the remote site;

     (d) Each controlled substance or dangerous drug that is transferred between the stock of drugs maintained at the remote site and the stock of drugs maintained at the telepharmacy; and

     (e) At the telepharmacy, documentation of any counseling provided by a pharmacist or dispensing practitioner at the telepharmacy that was provided via computer link, video link or audio link to a patient or person caring for a patient at the remote site.

     2.  The pharmacist or dispensing practitioner who is responsible for the operation of a remote site shall ensure that each record which is maintained at the remote site, including, without limitation, each record of a prescription, is maintained in a manner that makes it readily apparent whether the prescription was dispensed at the remote site or at the telepharmacy.

     (Added to NAC by Bd. of Pharmacy by R037-10, eff. 10-15-2010)

      NAC 639.397  Requirements for labeling. (NRS 639.070, 639.0727)

     1.  A pharmacist or dispensing practitioner who is responsible for the operation of a remote site shall ensure that the computer system used at the telepharmacy and the remote site is able to generate a label for a prescription at either location in the manner prescribed pursuant to NRS 639.2801.

     2.  The label generated pursuant to subsection 1 must include on the label of each prescription the initials of:

     (a) The pharmacist or dispensing practitioner who authorized the controlled substance or dangerous drug to be dispensed at the remote site; and

     (b) The pharmaceutical technician or dispensing technician who dispensed the controlled substance or dangerous drug at the remote site.

     (Added to NAC by Bd. of Pharmacy by R037-10, eff. 10-15-2010)

      NAC 639.398  Establishment of policies and procedures for operation of remote site; monthly inspections. (NRS 639.070, 639.0727)  The pharmacist or dispensing practitioner who is responsible for the operation of a remote site shall:

     1.  Establish written policies and procedures for the operation of the remote site to ensure:

     (a) Compliance with all applicable statutes and regulations;

     (b) The safe and effective dispensing of controlled substances and dangerous drugs at the remote site; and

     (c) The proper accounting of controlled substances and dangerous drugs at the remote site.

     2.  Personally inspect the remote site at least monthly to ensure that the remote site and each pharmaceutical technician or dispensing technician, as applicable, who operates the remote site is in compliance with:

     (a) All applicable statutes and regulations; and

     (b) The policies and procedures established pursuant to subsection 1.

     3.  Make a record of each inspection conducted pursuant to subsection 2.

     (Added to NAC by Bd. of Pharmacy by R037-10, eff. 10-15-2010)

      NAC 639.399  Responsibility of pharmacist or dispensing practitioner concerning dispensing of controlled substances or dangerous drugs at remote site. (NRS 639.070, 639.0727)  A pharmacist or dispensing practitioner who is responsible for the operation of a remote site and who authorizes a pharmaceutical technician or dispensing technician at the remote site to dispense a controlled substance or dangerous drug is responsible for and must be held accountable for the dispensing of the controlled substance or dangerous drug at the remote site.

     (Added to NAC by Bd. of Pharmacy by R037-10, eff. 10-15-2010)

OFF-SITE PHARMACY PRACTICE

      NAC 639.401  Pharmacist authorized to engage in practice of pharmacy only at licensed pharmacy; exceptions. (NRS 639.070)  Except as otherwise provided in NAC 639.403 and 639.412, a registered pharmacist may engage in the practice of pharmacy only at the site of a licensed pharmacy.

     (Added to NAC by Bd. of Pharmacy by R180-07, eff. 9-18-2008)

      NAC 639.403  Application required for pharmacist to engage in practice of pharmacy at site other than licensed pharmacy; exemption for pharmacists who administer immunizations. (NRS 639.070)

     1.  Except as otherwise provided in subsection 2, a registered pharmacist may apply to the Board to engage in the practice of pharmacy at a site other than the site of a licensed pharmacy by submitting an application on a form prescribed by the Board. An application must be approved before a pharmacist may commence any practice pursuant to this section. The application must include, without limitation:

     (a) The name of the pharmacist;

     (b) A description of the services that the pharmacist intends to provide at the site;

     (c) The location at which the pharmacist will provide the services;

     (d) An identification of the types of patients or other persons to whom the pharmacist intends to provide the services;

     (e) An identification of the types of pharmacies or other entities to whom the pharmacist intends to provide the services;

     (f) A description of all resources, both paper and electronic, that will be available to the pharmacist in the course of providing the services;

     (g) The days and hours during which the pharmacist intends to provide the services;

     (h) An explanation of the policy of the pharmacist for users of the services when the pharmacist is unavailable;

     (i) An explanation of the policy of the pharmacist regarding the confidentiality and security of the patient data that will be gathered, made and maintained as part of the services which are provided, including, without limitation, paper and electronic records;

     (j) Whether the services provided will be affiliated with, an adjunct of or otherwise related to a licensed pharmacy; and

     (k) A description of the business plan for the services provided.

     2.  A registered pharmacist may not submit an application pursuant to subsection 1 if he or she provides services:

     (a) Pursuant to the provisions of NAC 449.15347;

     (b) Pursuant to the provisions of NAC 449.6138;

     (c) Pursuant to the provisions of NAC 449.722;

     (d) Pursuant to the provisions of NAC 449.74531;

     (e) Pursuant to the provisions of NAC 449.9905 and 639.4996;

     (f) Pursuant to the provisions of subsection 2 of NAC 639.465;

     (g) Pursuant to the provisions of NAC 639.690;

     (h) Voluntarily or without compensation, regardless of whether the services are provided individually or through an employer; or

     (i) Pursuant to a medication therapy management program approved pursuant to 42 C.F.R. § 423.153(d).

     3.  A registered pharmacist who administers immunizations pursuant to a written protocol established in accordance with NAC 639.297 to 639.2978, inclusive, is not required to submit an application pursuant to this section for purposes of administering the immunizations at the authorized location.

     (Added to NAC by Bd. of Pharmacy by R180-07, eff. 9-18-2008)

      NAC 639.406  Hearing to approve or deny application from pharmacist. (NRS 639.070)

     1.  Upon submission of an application pursuant to NAC 639.403, the Board will schedule a hearing before the Board. At the hearing, the Board will consider the application and any other relevant information to determine whether the practice and services proposed in the application will be provided in a manner that is safe and in the best interests of the health, safety and welfare of the public. The Board may consider, without limitation, the following factors in determining whether to approve, deny or modify such an application:

     (a) The information contained in the application;

     (b) The education, experience and expertise of the applicant;

     (c) The disciplinary history of the applicant, if any; and

     (d) Whether the applicant has sufficient malpractice or other liability insurance.

     2.  At the hearing, the Board may request that the applicant modify his or her application.

     3.  If the Board approves an application, the Board will provide the applicant with documentation indicating the approval and setting forth the terms and conditions under which the applicant may provide the services approved by the Board.

     4.  If the Board denies an application, the Board will provide the applicant with a written notice of the denial indicating the reasons for the denial and identifying any deficiencies in the application.

     (Added to NAC by Bd. of Pharmacy by R180-07, eff. 9-18-2008)

      NAC 639.409  Grounds for revocation, suspension or placement of restrictions on approval granted to pharmacist to practice pharmacy at site other than licensed pharmacy. (NRS 639.070, 639.210)  The Board may revoke, suspend or place restrictions on the approval granted to a registered pharmacist to practice pharmacy at a site other than the site of a licensed pharmacy pursuant to NAC 639.406 based upon proof that:

     1.  The pharmacist has violated the terms and conditions under which he or she was approved by the Board to provide the services; or

     2.  During the course of providing the services, the pharmacist has committed one or more acts that are grounds for disciplinary action pursuant to this chapter or chapter 639 of NRS.

     (Added to NAC by Bd. of Pharmacy by R180-07, eff. 9-18-2008)

      NAC 639.412  Application for licensed pharmacy to use services of one or more pharmacists at site other than licensed pharmacy. (NRS 639.070)

     1.  Except as otherwise provided in subsection 2, a licensed pharmacy may apply to the Board to use the services of one or more registered pharmacists, including, without limitation, pharmacists employed by or under contract with the pharmacy, to engage in the practice of pharmacy at a site other than the site of the licensed pharmacy by submitting an application on a form prescribed by the Board. The application must include, without limitation:

     (a) The name of the pharmacy;

     (b) A description of the services that the pharmacy intends to provide at the site;

     (c) The location at which the pharmacy will provide the services;

     (d) An identification of the types of patients or other persons or entities to whom the pharmacy intends to provide the services;

     (e) A description of all resources, both paper and electronic, that will be available to the pharmacy in the course of providing the services;

     (f) The days and hours during which the pharmacy intends to provide the services;

     (g) An explanation of the policy of the pharmacy for users of the service when a pharmacist is unavailable;

     (h) An explanation of the policy of the pharmacy regarding the confidentiality and security of the patient data that will be gathered, made and maintained as part of the services which are provided, including, without limitation, paper and electronic records; and

     (i) A description of the business plan for the services provided.

     2.  A pharmacy may not submit an application pursuant to subsection 1 to use the services of a registered pharmacist who is prohibited from submitting an application pursuant to subsection 2 of NAC 639.403.

     (Added to NAC by Bd. of Pharmacy by R180-07, eff. 9-18-2008)

      NAC 639.415  Hearing to approve or deny application from licensed pharmacy. (NRS 639.070)

     1.  Upon submission of an application pursuant to NAC 639.412, the Board will schedule a hearing before the Board. At the hearing, the Board will consider the application and any other relevant information to determine whether the practice and services proposed in the application will be provided in a manner that is safe and in the best interests of the health, safety and welfare of the public. The Board may consider, without limitation, the following factors in determining whether to approve, deny or modify such an application:

     (a) The information contained in the application;

     (b) The disciplinary history of the applicant, if any; and

     (c) Whether the applicant has sufficient malpractice or other liability insurance.

     2.  At the hearing, the Board may request that the applicant modify the application.

     3.  If the Board approves an application, the Board will provide the pharmacy whose application is approved with documentation indicating the approval and setting forth the terms and conditions under which the pharmacists employed by or under contract with the pharmacy may offer the services approved by the Board.

     4.  If the Board denies an application, the Board will provide the applicant with a written notice of the denial indicating the reasons for the denial and identifying any deficiencies in the application.

     (Added to NAC by Bd. of Pharmacy by R180-07, eff. 9-18-2008)

      NAC 639.418  Grounds for revocation, suspension or placement of restrictions on approval granted to licensed pharmacy to use services of one or more pharmacists at site other than licensed pharmacy. (NRS 639.070, 639.210)  The Board may revoke, suspend or place restrictions on the approval granted to a licensed pharmacy to use the services of one or more registered pharmacists to engage in the practice of pharmacy at a site other than the site of the licensed pharmacy pursuant to NAC 639.415 based upon proof that:

     1.  The pharmacy has violated the terms and conditions under which the pharmacy was approved by the Board to provide the services; or

     2.  During the course of providing the services approved by the Board, the pharmacy has committed one or more acts that are grounds for disciplinary action pursuant to this chapter or chapter 639 of NRS.

     (Added to NAC by Bd. of Pharmacy by R180-07, eff. 9-18-2008)

INTERNET PHARMACIES

General Provisions

      NAC 639.420  Definitions. (NRS 639.070, 639.0725, 639.23288)  As used in NAC 639.420 to 639.428, inclusive, unless the context otherwise requires, the words and terms defined in NAC 639.422 and 639.424 have the meanings ascribed to them in those sections.

     (Added to NAC by Bd. of Pharmacy by R165-01, eff. 12-17-2001)

      NAC 639.422  “Certified Internet pharmacy” defined. (NRS 639.070, 639.0725, 639.23288)  “Certified Internet pharmacy” means an Internet pharmacy that has been certified by the Board pursuant to NAC 639.426.

     (Added to NAC by Bd. of Pharmacy by R165-01, eff. 12-17-2001)

      NAC 639.424  “Internet pharmacy” defined. (NRS 639.070, 639.0725, 639.23288)  “Internet pharmacy” has the meaning ascribed to it in NRS 639.00865.

     (Added to NAC by Bd. of Pharmacy by R165-01, eff. 12-17-2001)

Certification

      NAC 639.426  Requirements for approval of application. (NRS 639.070, 639.0725, 639.23288)

     1.  A licensed pharmacy may practice as an Internet pharmacy only if the pharmacy is certified by the Board pursuant to this section. To be certified by the Board pursuant to this section, a pharmacy must apply to the Board for certification on an application provided by the Board.

     2.  The Board will grant an application for certification as an Internet pharmacy pursuant to this section if:

     (a) The pharmacy is certified by the Verified Internet Pharmacy Practice Sites program of the National Association of Boards of Pharmacy; or

     (b) The Board determines that the pharmacy satisfies the requirements of subsection 3.

     3.  The Board will grant an application for certification pursuant to paragraph (b) of subsection 2 if the Board determines that the pharmacy:

     (a) Is licensed to practice pharmacy in each state in which the pharmacy will practice pharmacy;

     (b) Maintains and enforces policies and procedures which ensure that:

          (1) The pharmacy is able to establish the authenticity of a prescription which the pharmacy receives;

          (2) The pharmacy will not fill any prescription which has been previously filled by another pharmacy, and if the pharmacy fills any prescription, that prescription will not also be filled by another pharmacy;

          (3) The identity of the patient and the prescribing practitioner is verified to be authentic;

          (4) A prescription is filled in compliance with all applicable federal and state laws;

          (5) A patient or the caregiver of the patient may make a complaint to the pharmacy regarding the prescription of the patient, and if such a complaint is made, the complaint will be investigated thoroughly, the results of the investigation will be communicated to the patient or caregiver and, if the investigation reveals that the operations of the pharmacy resulted in an error in the processing or filling of the prescription, appropriate remedial action will be taken by the pharmacy;

          (6) The pharmacy will communicate to a patient or a prescribing practitioner any delay that might jeopardize or alter the drug therapy of the patient with respect to delivering the prescribed drug or device; and

          (7) The pharmacy will communicate to a patient information regarding recalls of drugs and the appropriate means to dispose of expired, damaged or unusable drugs or devices;

     (c) Obtains and maintains patient information necessary to facilitate review of drug utilization and counseling of patients pursuant to any applicable statutes;

     (d) Provides review of drug utilization and counseling of patients pursuant to the applicable statutes in the state in which the patient resides;

     (e) Maintains controls of its computer system, information concerning patients and other such confidential information and documents to prevent unauthorized or unlawful access to all such confidential information and documents;

     (f) Complies with applicable federal and state laws regarding:

          (1) The dispensing of prescription drugs;

          (2) Recordkeeping related to the patients served by the pharmacy, the purchase of prescription drugs, and the sale and dispensing of prescription drugs; and

          (3) The sale of over-the-counter products, including, without limitation, any special requirements related to products that have been identified as precursors to the manufacture or compounding of illegal drugs;

     (g) Ships prescriptions to a patient using a secure and traceable means; and

     (h) Ships prescriptions to a patient using packaging or devices which will ensure that the prescription is maintained within appropriate standards pertaining to temperature, light and humidity as described in the United States Pharmacopeia - National Formulary, as adopted by reference in paragraph (c) of subsection 1 of NAC 639.670.

     (Added to NAC by Bd. of Pharmacy by R165-01, eff. 12-17-2001; A by R035-06, 9-18-2008)

      NAC 639.428  Access to premises and records; suspension for noncompliance. (NRS 639.070, 639.0725, 639.23288)

     1.  By applying for and being granted certification as a certified Internet pharmacy pursuant to NAC 639.426, a certified Internet pharmacy shall be deemed to have given its consent to:

     (a) Allow free access, at all times during business hours, to all places where drugs, medicines, poisons, devices or appliances are kept and to all records regarding the purchase, sale, dispensing and shipping of, and all other dealings with, such drugs, medicines, poisons, devices or appliances, to members of the Board and its inspectors and investigators, investigators of the Investigation Division of the Department of Public Safety, inspectors for the Food and Drug Administration, and other persons authorized by the Board to inspect or investigate at the Board’s direction and control.

     (b) Provide records or copies of records by mail, electronic mail or other means, within a reasonable time as established by the person making the request for the records or copies of records, to members of the Board and its inspectors and investigators, investigators of the Investigation Division of the Department of Public Safety, inspectors for the Food and Drug Administration, and other persons authorized by the Board to inspect or investigate at the Board’s direction and control.

     2.  If a certified Internet pharmacy fails to comply with any provision of this section, the Executive Secretary may summarily suspend the certification and license of the Internet pharmacy until proceedings can be initiated pursuant to NRS 639.241 to 639.2576, inclusive. The Executive Secretary may lift a summary suspension imposed under this subsection if the Executive Secretary determines that the Internet pharmacy has provided the requested access or records.

     (Added to NAC by Bd. of Pharmacy by R165-01, eff. 12-17-2001)

CANADIAN PHARMACIES

      NAC 639.430  Licensure: Requirement; application. (NRS 639.070, 639.0725, 639.2328)

     1.  A pharmacy located in Canada shall not dispense, sell or otherwise provide prescription drugs to a resident of this State unless the pharmacy holds a valid license issued by the Board pursuant to NRS 639.2328.

     2.  A pharmacy located in Canada that wishes to obtain a license pursuant to NRS 639.2328 must submit an application to the Board on a form provided by the Board. The application must be signed by the owner or chief executive officer of the pharmacy, who must certify that the contents of the application are true and correct to the best of his or her knowledge, information and belief.

     3.  The staff of the Board shall not forward to the Board for the Board’s consideration an application for licensure submitted by a Canadian pharmacy until the staff determines that the application is complete.

     (Added to NAC by Bd. of Pharmacy by R040-06, eff. 5-4-2006)

      NAC 639.432  Restrictions on dispensing drugs. (NRS 639.070, 639.0725, 639.23284)

     1.  A Canadian pharmacy licensed to provide mail order service pursuant to NRS 639.2328 may dispense under those provisions only a drug that:

     (a) Appears in:

          (1) The Orange Book; and

          (2) The HC-DPD;

     (b) Has been manufactured in accordance with standards established by:

          (1) The Food and Drug Administration of the United States Department of Health and Human Services; or

          (2) The Therapeutic Products Directorate of Health Canada;

     (c) Is in a strength that appears in both the Orange Book and the HC-DPD; and

     (d) Is drawn from the inventory of the pharmacy that is maintained at the pharmacy.

     2.  A Canadian pharmacy licensed to provide mail order service pursuant to NRS 639.2328 may not dispense under those provisions:

     (a) A drug that is in any of the following forms:

          (1) A liquid form, except for ophthalmic solutions;

          (2) An intravenous form; or

          (3) A form that requires refrigeration or other special handling for shipment;

     (b) A generic version of a drug, unless the generic version of the drug is “A-rated” in the Orange Book; or

     (c) A drug that has been approved for sale without a prescription in Canada but for which a prescription is required in the United States, unless the patient has provided a prescription for the drug to the pharmacy.

     3.  As used in this section:

     (a) “HC-DPD” means the Drug Product Database, copyright Her Majesty the Queen in Right of Canada, as amended, that is managed by Health Canada. Access to the database may be obtained on the Internet at the Internet address http://www.hc-sc.gc.ca/dhp-mps/prodpharma/databasdon/index_e.html.

     (b) “Orange Book” means the list of “Approved Drug Products with Therapeutic Equivalence Evaluations,” as amended, that is published by the Center for Drug Evaluation and Research of the Food and Drug Administration of the United States Department of Health and Human Services. A copy of the list may be obtained on the Internet at the Internet address http://www.fda.gov/cder/orange/obannual.pdf.

     (Added to NAC by Bd. of Pharmacy by R040-06, eff. 5-4-2006)

      NAC 639.434  Standards of practice. (NRS 639.070, 639.0725)

     1.  A Canadian pharmacy licensed to provide mail order service pursuant to NRS 639.2328 shall:

     (a) Maintain a toll-free telephone number and an electronic mail address at which a patient may contact and communicate with a pharmacist employed by the pharmacy;

     (b) Ensure that a pharmacist employed by the pharmacy contacts a patient’s prescribing practitioner in the United States regarding a prescription for the patient:

          (1) If the prescription was electronically transmitted to the pharmacy in any manner other than directly from the office of the prescribing practitioner in the United States, to verify the authenticity and contents of the prescription; and

          (2) Before making any change to the prescription that deviates from the prescription as written by the prescribing practitioner in the United States;

     (c) Ensure that, before a prescription from a prescribing practitioner in the United States is transmitted to a prescribing practitioner in Canada for approval, a pharmacist employed by the pharmacy:

          (1) Personally enters the data regarding the prescription into the pharmacy’s computer system; or

          (2) Verifies that the data regarding the prescription was entered correctly into the pharmacy’s computer system by another employee of the pharmacy; and

     (d) Ensure that the pharmacists employed by the pharmacy make and maintain a record, either on paper or in the pharmacy’s computer system, that readily identifies the pharmacist who, with respect to a prescription:

          (1) Entered or verified the data regarding the prescription pursuant to paragraph (c); and

          (2) Filled the prescription or verified the correctness of the prescription, if the prescription was filled by an employee other than a pharmacist.

Ê The records required pursuant to this paragraph must be maintained by the pharmacy for at least 2 years and be made available, upon request, for inspection by the staff of the Board.

     2.  A Canadian pharmacy licensed to provide mail order service pursuant to NRS 639.2328 shall not direct or otherwise allow a patient to have his or her prescription dispensed by or to otherwise use the services of a pharmacy that is not licensed by the Board.

     3.  If a Canadian pharmacy licensed to provide mail order service pursuant to NRS 639.2328 does not have in stock a drug with which to dispense a patient’s prescription and is unable to transfer the prescription to another pharmacy licensed pursuant to NRS 639.2328 that is able to dispense the prescription, the Canadian pharmacy shall:

     (a) Ensure that a pharmacist employed by the pharmacy contacts the patient’s prescribing practitioner in the United States to obtain authorization to change the prescription to a drug that the pharmacy has in stock; or

     (b) Within sufficient time to ensure that the drug therapy of the patient will not be interrupted or disturbed, contact the patient to inform him or her that the pharmacy cannot dispense the prescription.

     (Added to NAC by Bd. of Pharmacy by R040-06, eff. 5-4-2006)

      NAC 639.436  Dissemination of certain contact information; printing of certain information on label of prescription. (NRS 639.070, 639.0725)

     1.  In addition to complying with the requirements of NRS 639.23286 and NAC 639.708, a Canadian pharmacy licensed to provide mail order service pursuant to NRS 639.2328 shall ensure that each of the following is published on the Internet website, if any, of the pharmacy and printed upon any written materials provided by the pharmacy to a patient:

     (a) The normal business hours of the pharmacy;

     (b) The toll-free telephone number of the pharmacy; and

     (c) The electronic mail address of the pharmacy.

     2.  In addition to complying with the requirements of NRS 639.2801, a Canadian pharmacy licensed to provide mail order service pursuant to NRS 639.2328 shall ensure that each of the following is printed on the label of a prescription:

     (a) The name of the prescribing practitioner in the United States with a designator proximate to the name such as “US” or “USA” or a similar designator indicating that the practitioner is from the United States; and

     (b) The name of the prescribing practitioner in Canada with a designator proximate to the name such as “CAN” or “CANADA” or a similar designator indicating that the practitioner is from Canada.

Ê If the pharmacy is unable to print one or both of the names of the prescribing practitioners or their proximate national designators directly upon the label of the prescription, the pharmacy may include such information on auxiliary labels affixed to the container in which the prescription is dispensed.

     (Added to NAC by Bd. of Pharmacy by R040-06, eff. 5-4-2006)

MEDICAL FACILITIES AND CORRECTIONAL INSTITUTIONS

General Provisions

      NAC 639.440  Definitions. (NRS 639.070)  As used in NAC 639.440 to 639.490, inclusive, unless the context otherwise requires, the words and terms defined in NAC 639.441 to 639.460, inclusive, have the meanings ascribed to them in those sections.

     (Added to NAC by Bd. of Pharmacy, eff. 3-27-90; A 9-12-91)

      NAC 639.441  “Administer” defined. (NRS 639.070)  “Administer” means the direct application of a drug or medicine, whether by injection, inhalation, ingestion, or any other means, to the body of a patient or the subject of research.

     (Added to NAC by Bd. of Pharmacy, eff. 3-27-90)

      NAC 639.442  “Chart order” defined. (NRS 639.070)  “Chart order” means an order entered on the chart of an inpatient in a medical facility licensed by the Division of Public and Behavioral Health of the Department of Health and Human Services or on the chart of a patient under emergency treatment in a hospital by a practitioner or on the written or oral order of a practitioner authorizing the administration of a drug to the patient.

     (Added to NAC by Bd. of Pharmacy, eff. 3-27-90)

      NAC 639.445  “Compound” and “compounding” defined. (NRS 639.070)  “Compound” or “compounding” means to form or create a composite product by combining two or more different ingredients.

     (Added to NAC by Bd. of Pharmacy, eff. 3-27-90)

      NAC 639.446  “Consultant pharmacist” defined. (NRS 639.070)  “Consultant pharmacist” means a pharmacist retained by a medical facility or correctional institution under contract to consult with the facility or institution in areas that relate to the practice of pharmacy.

     (Added to NAC by Bd. of Pharmacy, eff. 3-27-90; A 9-12-91)

      NAC 639.4465  “Correctional institution” defined. (NRS 639.070)  “Correctional institution” means any penal facility used for confinement of persons or any facility used for detention of juveniles, which is operated by or under the supervision of a subdivision of the State. The term includes a jail.

     (Added to NAC by Bd. of Pharmacy, eff. 9-12-91)

      NAC 639.447  “Deliver” and “delivery” defined. (NRS 639.070)  “Deliver” or “delivery” means the actual, constructive, or attempted transfer of a controlled substance or dangerous drug from one person to another, whether or not there is an agency relationship.

     (Added to NAC by Bd. of Pharmacy, eff. 3-27-90; A 9-12-91)

      NAC 639.448  “Device” defined. (NRS 639.070)  “Device” means any instrument, apparatus or contrivance, including its components, parts and accessories, intended:

     1.  For use in the diagnosis, cure, mitigation, treatment or prevention of disease in persons or animals; or

     2.  To affect the structure of any function of the body of a person or an animal.

     (Added to NAC by Bd. of Pharmacy, eff. 3-27-90)

      NAC 639.449  “Direct copy” defined. (NRS 639.070)  “Direct copy” includes an electronic or carbonized copy.

     (Added to NAC by Bd. of Pharmacy, eff. 3-27-90)

      NAC 639.450  “Dispense” defined. (NRS 639.070)  “Dispense” means the furnishing of a controlled substance or dangerous drug in any amount greater than that necessary for the present and immediate needs of the ultimate user. The term does not include the furnishing of a controlled substance or dangerous drug by a pharmacy in a medical facility to an inpatient of the medical facility in which the pharmacy is located.

     (Added to NAC by Bd. of Pharmacy, eff. 3-27-90; A 9-12-91)

      NAC 639.451  “Distribute” defined. (NRS 639.070)  “Distribute” means to deliver other than by administering or dispensing a controlled substance, dangerous drug or other drug.

     (Added to NAC by Bd. of Pharmacy, eff. 3-27-90; A 9-12-91)

      NAC 639.452  “Floor stock” defined. (NRS 639.070)  “Floor stock” means drugs or devices not labeled for a specific patient and maintained at a nursing station or other department of a medical facility or correctional institution, excluding the pharmacy, for the purpose of administering to a patient of the facility or institution.

     (Added to NAC by Bd. of Pharmacy, eff. 3-27-90; A 9-12-91)

      NAC 639.453  “Formulary” defined. (NRS 639.070)  “Formulary” means a list of drugs approved by an appropriate committee that evaluates, appraises and selects from among the various available drugs and drug products those drugs considered most useful in caring for patients.

     (Added to NAC by Bd. of Pharmacy, eff. 3-27-90)

      NAC 639.455  “Investigational drug” defined. (NRS 639.070)  “Investigational drug” means a new drug intended for investigational use by experts qualified to evaluate the safety and effectiveness of the drug as authorized by the Food and Drug Administration.

     (Added to NAC by Bd. of Pharmacy, eff. 3-27-90)

      NAC 639.456  “IV admixture” defined. (NRS 639.070)  “IV admixture” means the compounding of parenteral solutions by aseptic procedures.

     (Added to NAC by Bd. of Pharmacy, eff. 3-27-90)

      NAC 639.457  “Medical facility” defined. (NRS 639.070)  “Medical facility” includes:

     1.  A surgical center for ambulatory patients;

     2.  An obstetric center;

     3.  An independent center for emergency medical care;

     4.  An agency to provide nursing in the home;

     5.  A facility for intermediate care;

     6.  A facility for skilled nursing;

     7.  A hospice;

     8.  A hospital;

     9.  A psychiatric hospital;

     10.  A facility for the treatment of irreversible renal disease; and

     11.  A rural clinic.

     (Added to NAC by Bd. of Pharmacy, eff. 3-27-90)

      NAC 639.4575  “Pharmacy” defined. (NRS 639.070)  “Pharmacy” means an area in a medical facility or correctional institution where drugs are stored, compounded, delivered, dispensed and distributed to other areas or departments of the facility or institution or dispensed to an ultimate user.

     (Added to NAC by Bd. of Pharmacy, eff. 9-12-91)

      NAC 639.458  “Prescription” defined. (NRS 639.070)

     1.  “Prescription” means:

     (a) An order given individually for the person for whom a drug is prescribed, directly from a practitioner, or his or her agent, to a pharmacist or indirectly by means of an order signed by the practitioner.

     (b) A chart order written for an inpatient specifying drugs that the inpatient is to take home upon his or her discharge.

     2.  The term does not include a chart order written for an inpatient for use while he or she is an inpatient.

     (Added to NAC by Bd. of Pharmacy, eff. 3-27-90)

      NAC 639.459  “Unit dose” defined. (NRS 639.070)  “Unit dose” means medication packaged in packages containing only a single unit of medication.

     (Added to NAC by Bd. of Pharmacy, eff. 3-27-90)

      NAC 639.460  “Unit of use” defined. (NRS 639.070)  “Unit of use” means:

     1.  Medication intended to provide a specific dosage as a single dose; or

     2.  More than one dose of medication packaged as a single unit to provide a specific dosage.

     (Added to NAC by Bd. of Pharmacy, eff. 3-27-90)

      NAC 639.461  Licensing. (NRS 639.070, 639.071)

     1.  A separate license to conduct a pharmacy in a hospital must be obtained for each location of a hospital which is required to obtain a license from the Bureau of Regulatory Health Services of the Division of Public and Behavioral Health of the Department of Health and Human Services. A hospital may apply for more than one license to conduct an institutional pharmacy at a location.

     2.  Retail, nuclear and other pharmaceutical functions may be performed within a hospital under the license to conduct a pharmacy. If a hospital is required to obtain only one license from the Bureau of Regulatory Health Services of the Division of Public and Behavioral Health of the Department of Health and Human Services for a pharmacy, the pharmacy may serve inpatients in an institutional satellite operation without obtaining a separate license to conduct such a pharmacy. A pharmacy which serves outpatients in an institutional satellite operation is required to obtain a separate license to conduct such a pharmacy.

     (Added to NAC by Bd. of Pharmacy, eff. 3-27-90; A 9-11-91; 9-12-91)

      NAC 639.462  Biennial registration. (NRS 639.070, 639.071, 639.072)

     1.  A pharmacy shall register biennially with the Board on a form provided by the Board. A list of each type of pharmaceutical service provided by the pharmacy that would otherwise be required to be licensed must be included.

     2.  For a pharmacy in a medical facility, the registration form must be signed by:

     (a) The managing pharmacist of the pharmacy; and

     (b) The chief executive officer of the hospital in which the pharmacy is located.

     3.  The chief executive officer must agree to comply with the regulations adopted by the Board governing pharmacies.

     4.  The registration form must state whether the pharmacy is a sole ownership and, if so, include the name of the owner. If the pharmacy is owned by a partnership, the registration form must include the names of the partners. If the pharmacy is owned by a corporation, the registration form must include the names of the corporate officers.

     5.  If the pharmacy is owned or operated by a management or consulting firm:

     (a) The registration form must include the name of the firm or the operator; and

     (b) The firm must be registered by the Drug Enforcement Administration, unless the firm:

          (1) Enters into a contract with the hospital in which the pharmacy is located that assigns the responsibility for the controlled substances to the hospital; and

          (2) The firm maintains dual responsibility for the controlled substances.

     (Added to NAC by Bd. of Pharmacy, eff. 3-27-90; A 9-12-91)

      NAC 639.463  Change of ownership. (NRS 639.070, 639.170)

     1.  If a pharmacy changes ownership, it must obtain a new and separate registration from the Board.

     2.  The fee established in NRS 639.170 will be charged for the issuance of a new certificate of registration.

     (Added to NAC by Bd. of Pharmacy, eff. 3-27-90; A 9-12-91)

Standards of Operation

      NAC 639.464  Scope of services in hospital or correctional institution. (NRS 639.070, 639.071, 639.072)  In a hospital or correctional institution:

     1.  The scope of services provided by a pharmacy must be consistent with the needs of the patients for medication as determined by the medical staff, managing pharmacist and other health care professionals involved in delivering or administering drugs in the hospital or correctional institution in which the pharmacy is located.

     2.  Pharmaceutical services may include, but are not limited to:

     (a) Interpreting orders for prescriptions and medication.

     (b) Compounding, dispensing, distributing, labeling and administering drugs and devices.

     (c) Monitoring drug therapy.

     (d) Therapeutic interchange.

     (e) Participating in evaluations of the uses of drugs and the selection of drug products.

     (f) Ensuring the proper and safe storage and distribution of drugs and devices, and the maintenance of proper records related thereto.

     (g) Providing information related to drugs, including, but not limited to, the proper dosages, hazards and the optimal use of drugs and devices.

     (h) Supervising pharmaceutical technicians and pharmaceutical technicians in training.

     (i) Conducting research.

     3.  As used in this section, “therapeutic interchange” means the dispensing of one drug in place of another pursuant to guidelines approved by an appropriate committee of the medical staff.

     (Added to NAC by Bd. of Pharmacy, eff. 3-27-90; A 9-12-91; 11-15-93)

      NAC 639.4645  Maintenance of registration certificates required. (NRS 639.070, 639.071)  If the primary function of a pharmacy in a hospital is the provision of inpatient services, the pharmacy shall maintain registration certificates and current renewal receipts thereof for all pharmacists, intern pharmacists and pharmaceutical technicians together in one location within the pharmacy. The certificates must be readily available for review upon the request of the Board.

     (Added to NAC by Bd. of Pharmacy, eff. 10-17-91)

      NAC 639.465  Managing pharmacist. (NRS 639.070, 639.071, 639.072)

     1.  A pharmacy located in a:

     (a) Hospital with 100 beds or more; or

     (b) Correctional institution housing 1,500 inmates or more,

Ê must have one full-time managing pharmacist. That pharmacist may be a managing pharmacist for only one such pharmacy.

     2.  Each pharmacy located in a:

     (a) Hospital with less than 100 beds; or

     (b) Correctional facility housing less than 1,500 inmates,

Ê must have one managing pharmacist who is retained as a consultant, or who is employed part-time or full-time.

     (Added to NAC by Bd. of Pharmacy, eff. 3-27-90; A 9-12-91; R015-05, 10-31-2005; R098-07, 12-4-2007)

      NAC 639.466  Consultant pharmacist. (NRS 639.070, 639.071, 639.072)

     1.  A consultant pharmacist may be the managing pharmacist of a pharmacy.

     2.  A consultant pharmacist and the medical facility or correctional institution that employs the consultant pharmacist must enter into a written employment contract. The contract must be made available to the Board upon request.

     (Added to NAC by Bd. of Pharmacy, eff. 3-27-90; A 9-12-91)

      NAC 639.467  Staff pharmacists. (NRS 639.070, 639.071, 639.072)

     1.  The managing pharmacist of a pharmacy must be assisted by a sufficient number of additional registered pharmacists as are required to operate the pharmacy competently and safely, and to meet adequately the needs of the hospital or correctional institution in which the pharmacy is located.

     2.  Staff pharmacists shall assist the managing pharmacist in carrying out the duties enumerated in NAC 639.468.

     3.  A staff pharmacist is responsible for any delegated act performed by pharmaceutical technicians under his or her supervision.

     (Added to NAC by Bd. of Pharmacy, eff. 3-27-90; A 9-12-91)

      NAC 639.468  Establishment of policies, procedures and systems. (NRS 639.070, 639.071, 639.072)  The managing pharmacist of a pharmacy shall establish policies, procedures and systems related to the following matters, without limitation:

     1.  Preparation of parenteral medications compounded within the pharmacy.

     2.  Supervision of the admixture of parenteral products and training of personnel in incompatible admixtures if they are not performed within the pharmacy.

     3.  Supervision of the bulk compounding of drugs.

     4.  Procurement and storage of all materials in the pharmacy, including drugs, chemicals and biologicals.

     5.  Participation in the development of a formulary for the medical facility or correctional institution in which the pharmacy is located, subject to the approval of the appropriate committee at the facility or institution.

     6.  Distribution of drugs to be administered to patients, pursuant to an original or a direct copy of a practitioner’s order for medication.

     7.  Filling and labeling of all containers from which drugs are to be distributed or dispensed.

     8.  Maintenance and availability in the pharmacy, and in areas where care is provided to inpatients, of:

     (a) A sufficient inventory of emergency drugs;

     (b) The telephone numbers of poison control centers and other organizations for emergency assistance; and

     (c) Such other materials and information as are considered necessary by the appropriate committee.

     9.  Recording of all transactions of the pharmacy required by applicable state and federal laws.

     10.  Participation in those aspects of the medical facility’s program to evaluate care provided to patients that relate to the use and effectiveness of pharmaceutical materials.

     11.  Participation in teaching and research programs at the medical facility.

     12.  Carrying out the policies and decisions of the appropriate committee relating to pharmaceutical services of the medical facility.

     13.  Labeling, storage and distribution of investigational drugs, and maintenance of information in the pharmacy and nursing stations where such drugs are being administered concerning the dosage form, route of administration, strength, uses, side effects, interactions and symptoms of toxicity of those drugs.

     (Added to NAC by Bd. of Pharmacy, eff. 3-27-90; A 9-12-91)

      NAC 639.4685  Handling of medications in correctional institutions without pharmacies. (NRS 639.070, 639.072)  A correctional institution that does not have a pharmacy may store medications to be dispensed to an ultimate user pursuant to the following requirements:

     1.  The responsible practitioner or authority shall develop written plans, establish procedures and provide space and accessories for the secure storage, control, administration and disposal of all such drugs in consultation with a pharmacist and the manager of the facility. Such plans, procedures, space or accessories must include:

     (a) Cabinets, closets and refrigeration units that are lockable.

     (b) Procedures for administration or delivery of medicines to inmates as prescribed.

     (c) Procedures for confirming the fact that the inmate has ingested the medication.

     (d) A procedure for recording the fact that prescribed medications have or have not been administered, by whom the medication was administered and, if the medication was not administered, the reason it was not administered.

     (e) A policy prohibiting the administration, distribution, delivery or dispensing of drugs by inmates.

     (f) A policy limiting the length of time medications may be administered without further medical evaluation.

     (g) A requirement that the pharmacist prepare, at least annually, a written report on the status of services by the pharmacy in the institution which must be delivered to the responsible practitioner or authority and the manager of the facility.

     (h) Procedures describing the circumstances and methods for contacting the pharmacist.

     2.  Procedures related to the handling of medication and the classifications of personnel who are authorized to handle medication must include provisions for the:

     (a) Procurement of medication;

     (b) Storage of medication;

     (c) Administration of medication;

     (d) Disposal of medication; and

     (e) Providing of medication to inmates upon their release.

     (Added to NAC by Bd. of Pharmacy, eff. 9-12-91)

      NAC 639.469  Standards for premises. (NRS 639.070, 639.071, 639.072)

     1.  A pharmacy shall have adequate space necessary for the storage, compounding, labeling, dispensing, distribution and sterile preparation of drugs prepared in the pharmacy.

     2.  The pharmacy must be kept clean and arranged in an orderly manner. All required equipment must be clean and in good operating condition.

     3.  A sink with hot and cold running water must be available to all personnel of the pharmacy and must be maintained in a sanitary condition at all times.

     4.  The pharmacy must be well lighted and ventilated.

     5.  The temperature of the pharmacy must be maintained within a range compatible with the proper storage of drugs. The temperature of the refrigerator must be maintained within the range set forth in subsection 1 of NAC 639.527.

     6.  The pharmacy must have a locked storage area for controlled substances listed in schedule II and other controlled substances requiring additional security.

     7.  Flammable materials must be stored in a designated area. The area must meet the requirements of local and state fire laws.

     (Added to NAC by Bd. of Pharmacy, eff. 3-27-90; A 9-12-91; R128-10, 12-16-2010)

      NAC 639.470  Security of premises. (NRS 639.070, 639.071, 639.072)

     1.  All areas occupied by a pharmacy must be able to be locked to prevent access by unauthorized personnel.

     2.  All personnel of the pharmacy, while on duty, are responsible for the security of the pharmacy and shall provide adequate safeguards against the theft or diversion of controlled substances and dangerous drugs and the records of those drugs.

     (Added to NAC by Bd. of Pharmacy, eff. 3-27-90; A 9-12-91)

      NAC 639.472  Maintenance of reference library. (NRS 639.070, 639.071, 639.072)  A pharmacy must maintain a reference library that includes the following:

     1.  A current copy of:

     (a) All state statutes and regulations relating to the practice of pharmacy and to the sale of drugs and controlled substances; and

     (b) The Federal Controlled Substances Act (Title II of Pub. L. 91-513, Oct. 27, 1970, 84 Stat. 1242) and the regulations adopted pursuant thereto or an official publication describing the requirements of that act and the regulations adopted pursuant thereto.

     2.  The American Hospital Formulary Service, with current supplements, or Facts and Comparisons, with current supplements.

     3.  At least one current text in one of the following subjects:

     (a) Theoretical and practical pharmacy.

     (b) Pharmacology.

     (c) Therapeutics.

     4.  A current text relating to each of the following:

     (a) Compatibility information, if parenteral admixture is performed by the pharmacy;

     (b) Information concerning the interaction of drugs; and

     (c) Information concerning antidotes.

     5.  Current copies of one of the following:

     (a) United States Pharmacopeia - National Formulary, as adopted by reference in paragraph (c) of subsection 1 of NAC 639.670;

     (b) United States Pharmacopeia - Drug Information; or

     (c) Remington’s Pharmaceutical Sciences.

     6.  A current copy of the Food and Drug Administration Approved Drug Products.

     (Added to NAC by Bd. of Pharmacy, eff. 3-27-90; A 9-12-91; R035-06, 9-18-2008)

      NAC 639.473  Procurement and storage of drugs. (NRS 639.070, 639.071, 639.072)

     1.  The managing pharmacist of a pharmacy is responsible for the procurement and storage of drugs in that pharmacy. The managing pharmacist shall determine the specifications of all drugs procured by the medical facility or correctional institution in which the pharmacy is located.

     2.  A drug may not be dispensed or distributed after the expiration date of the drug.

     3.  Outdated drugs must be removed from stock and identified and maintained separately from other stock until disposal.

     (Added to NAC by Bd. of Pharmacy, eff. 3-27-90; A 9-12-91)

      NAC 639.474  Development and use of formulary. (NRS 639.070, 639.071, 639.072)  A formulary must be developed and available for use by the managing or consultant pharmacist of a pharmacy.

     (Added to NAC by Bd. of Pharmacy, eff. 3-27-90; A 9-12-91)

      NAC 639.475  Preparation and labeling of admixtures. (NRS 639.070, 639.071, 639.072)

     1.  The managing pharmacist shall provide written guidelines for preparing parenteral admixture products to ensure that all pharmaceutical requirements are met.

     2.  A label must be affixed to the container of any admixture. The label must include, but is not limited to:

     (a) The name of the patient for whom the admixture was prepared and the facility’s or institution’s identification of that patient;

     (b) The name and amount of the drugs added;

     (c) The name of the basic solution;

     (d) The name, initials or identifying code of the pharmacist who prepared or verified the admixture; and

     (e) The expiration date of the solution.

     (Added to NAC by Bd. of Pharmacy, eff. 3-27-90; A 9-12-91)

      NAC 639.476  Prepackaging of drugs. (NRS 639.070, 639.071, 639.072)

     1.  A pharmacy may prepackage drugs in quantities suitable for distribution within the facility or institution. The prepackaging may be performed only by a pharmacist or a pharmaceutical technician.

     2.  The label of a prepackaged unit must include:

     (a) The generic or trade name of the drug, its strength and the dosage form;

     (b) The lot number;

     (c) The expiration date of the drug; and

     (d) The quantity of the drug if the unit dose does not equal the unit of use.

     3.  A record of a prepackaged drug must be maintained that includes:

     (a) The generic or trade name of the drug, its strength and the dosage form;

     (b) The pharmacy’s lot number;

     (c) The name of the manufacturer;

     (d) The manufacturer’s lot number;

     (e) The manufacturer’s expiration date for the drug;

     (f) The quantity per package, if more than one tablet or capsule is in a unit dose package;

     (g) The number of packages;

     (h) The date it was packaged and the assigned expiration date; and

     (i) The initials of the responsible pharmacist.

     4.  Stock packages, prepackaged units and control records must be inspected by the pharmacist before the drugs may be included in regular stock.

     (Added to NAC by Bd. of Pharmacy, eff. 3-27-90; A 9-12-91; 11-15-93)

      NAC 639.477  Policies and procedures for distribution of drugs. (NRS 639.070, 639.071, 639.072)

     1.  All medical facilities and correctional institutions shall develop and carry out written policies and procedures for the distribution of drugs in that facility or institution. The standards for accreditation of the American Correctional Association and the National Commission of Correctional Health Care must be used as a guideline for these policies and procedures by a correctional institution. The standards for accreditation of the American Correctional Association may be obtained by writing to the American Correctional Association, Publishing and Periodicals Division, 206 North Washington Street, Suite 200, Alexandria, Virginia 22314, or by calling (800) 222-5646 ext. 0129. The standards of accreditation of the National Commission of Correctional Health Care may be obtained by writing to the National Commission of Correctional Health Care, 1145 West Diversey Parkway, Chicago, Illinois 60614.

     2.  The written policies and procedures must include procedures regarding:

     (a) Controlled substances.

     (b) Investigational drugs.

     (c) Prepackaging and manufacturing.

     (d) Stop orders.

     (e) Orders for medication.

     (f) Physicians’ orders.

     (g) Floor stocks.

     (h) Reports of adverse reactions.

     (i) Drugs brought into the facility by patients.

     (j) Medications for furloughs.

     (k) The self-administration of drugs.

     (l) Emergency supplies of drugs.

     (m) A formulary.

     (n) Monthly inspections of nursing stations and storage areas for drugs.

     (o) Samples of drugs.

     (p) Reports of defects in drug products.

     (q) The recall of drugs.

     (r) Outdated drugs.

     (s) The routine distribution of medication for inpatients.

     (t) The preparation and distribution of IV admixtures.

     (u) The handling of orders for medication if a pharmacist is not on duty.

     (v) Requests for drugs that are not listed on the formulary.

     (w) Administering medication.

     (Added to NAC by Bd. of Pharmacy, eff. 3-27-90; A 9-12-91)

      NAC 639.478  Limitations on distribution of drugs. (NRS 639.070, 639.071, 639.072)

     1.  A drug may be given to a patient in a medical facility or correctional institution only on the order of a practitioner or an agent of the practitioner.

     2.  A drug may be distributed in a medical facility or correctional institution only from the original or a direct copy of the practitioner’s order for medication.

     3.  A controlled substance listed in schedule II may be distributed to outpatients only pursuant to a written prescription.

     (Added to NAC by Bd. of Pharmacy, eff. 3-27-90; A 9-12-91)

      NAC 639.479  Withdrawal of drugs when full-time pharmacist is absent. (NRS 639.070, 639.071, 639.072)  If a medical facility or correctional institution encompasses a pharmacy with a full-time pharmacist, and a practitioner orders a drug for administration to a patient of the facility or institution while the pharmacy is closed:

     1.  Prescription drugs and devices may be removed from the pharmacy only in sufficient quantities for immediate therapeutic needs.

     2.  Only a designated licensed nurse or practitioner may remove those drugs and devices.

     3.  The person authorized to make the withdrawal shall make a record at the time of the withdrawal containing:

     (a) The name of the patient;

     (b) The name of the device or drug withdrawn;

     (c) If a drug is withdrawn, its strength and the dosage form;

     (d) The dose prescribed;

     (e) The quantity taken;

     (f) The time and date of the withdrawal; and

     (g) The signature of the person making the withdrawal.

     4.  The original or a direct copy of the order for the medication must be forwarded to the pharmacy.

     5.  The pharmacist shall verify the withdrawal as soon as practicable, but not later than:

     (a) Seventy-two hours after the time of the withdrawal for a pharmacist in a medical facility; or

     (b) Ninety-six hours after the time of the withdrawal for a pharmacist in a correctional institution.

     (Added to NAC by Bd. of Pharmacy, eff. 3-27-90; A 9-12-91)

      NAC 639.480  Withdrawal of drugs when part-time or consultant pharmacist is absent. (NRS 639.070, 639.071, 639.072)  If a medical facility or correctional institution has a pharmacy with a part-time or consultant pharmacist, and a practitioner orders a drug for administration to a patient of the facility or institution while the pharmacist is not on duty or the pharmacy is closed:

     1.  Controlled substances, dangerous drugs and devices may be removed from the pharmacy only in sufficient quantities for therapeutic needs.

     2.  Only a designated licensed nurse or practitioner may remove those drugs and devices.

     3.  The person authorized to remove the drugs and devices shall make a record at the time of the withdrawal containing:

     (a) The name of the patient;

     (b) The name of the device or drug withdrawn;

     (c) If a drug is withdrawn, its strength and the dosage form;

     (d) The dose prescribed;

     (e) The quantity taken;

     (f) The time and date of the withdrawal; and

     (g) The signature of the person making the withdrawal.

     4.  The original or a direct copy of the order for the medication must be forwarded to the pharmacy.

     5.  The pharmacist shall verify the withdrawal:

     (a) Personally at least every 90 days; and

     (b) By reviewing the records made pursuant to subsection 3 at least every 30 days during the intervals between the pharmacist’s personal verifications.

     (Added to NAC by Bd. of Pharmacy, eff. 3-27-90; A 9-11-91; 9-12-91; R077-08, 8-26-2008)

      NAC 639.481  Withdrawal of drugs when facility uses floor stock and pharmacy is closed. (NRS 639.070, 639.071, 639.072)  If a medical facility or correctional institution uses a full or partial floor stock to distribute drugs and its pharmacy is closed:

     1.  Controlled substances, dangerous drugs and devices may be removed from the pharmacy only in the original manufacturer’s container or prepackaged container.

     2.  Only a designated licensed nurse or practitioner may remove those drugs and devices.

     3.  The person authorized to make the withdrawal shall make a record at the time of the withdrawal containing:

     (a) The name of the device or drug withdrawn;

     (b) If a drug is withdrawn, its strength and the dosage form;

     (c) The quantity removed;

     (d) The location of the floor stock;

     (e) The date and the time of the withdrawal; and

     (f) The signature of the person making the withdrawal.

     4.  A pharmacist shall verify the withdrawal pursuant to the following schedule:

     (a) In a facility or institution with a full-time pharmacist, the withdrawal must be verified as soon as practicable, but not later than:

          (1) Seventy-two hours after the time of the withdrawal for a pharmacist in a medical facility; or

          (2) Ninety-six hours after the time of the withdrawal for a pharmacist in a correctional institution.

     (b) In a facility or institution with a part-time or consultant pharmacist, the withdrawal must be verified after a reasonable interval, but not later than 30 days after the withdrawal.

     (Added to NAC by Bd. of Pharmacy, eff. 3-27-90; A 9-11-91; 9-12-91)

Records

      NAC 639.482  Maintenance and availability of records. (NRS 639.070, 639.071, 639.072)

     1.  Each record required to be kept pursuant to NAC 639.483 to 639.489, inclusive, must be kept by a pharmacy for at least 2 years after the date of the record.

     2.  Records maintained by a pharmacy must be made available for inspection and copying upon the request of the Board, its representatives, or another authorized local, state or federal law enforcement agency.

     (Added to NAC by Bd. of Pharmacy, eff. 3-27-90; A 9-12-91)

      NAC 639.483  Statutes applicable to maintenance of records. (NRS 639.070, 639.071, 639.072)  A pharmacy must maintain records for outpatients pursuant to the provisions of chapters 453, 454 and 639 of NRS governing retail pharmacies.

     (Added to NAC by Bd. of Pharmacy, eff. 3-27-90; A 9-12-91)

      NAC 639.484  Contents and maintenance of chart orders. (NRS 639.070, 639.071, 639.072)

     1.  Each original chart order must contain:

     (a) The patient’s name and the medical facility’s or correctional institution’s identification of that patient;

     (b) The name of the drug, its strength and the route of administration;

     (c) Directions for the use of the drug;

     (d) The date; and

     (e) The practitioner’s signature. Any verbal order signed by a practitioner’s agent must be cosigned by the practitioner.

     2.  An original chart order must be maintained in the medical records of the patient along with the record of the administration of the medication.

     (Added to NAC by Bd. of Pharmacy, eff. 3-27-90; A 9-12-91; R190-01, 3-4-2002)

      NAC 639.485  Maintenance of records for controlled substances. (NRS 639.070, 639.071, 639.072)

     1.  A pharmacy shall maintain records for controlled substances:

     (a) In a readily retrievable manner.

     (b) In a manner that establishes the receipt, distribution and destruction of all controlled substances handled by the pharmacy.

     2.  A pharmacy shall maintain a perpetual inventory of any controlled substance listed in schedule II.

     3.  Records of the distribution of controlled substances listed in schedule II, schedule III or schedule IV must include:

     (a) The name of the drug, dosage form and strength.

     (b) The name of the pharmacist distributing or authorizing the distribution of the controlled substance.

     (c) The name of the authorized person receiving the controlled substance. This information may be included on the record of administration.

     (d) The location to which the controlled substance is being distributed.

     (e) Controlled substances returned to the pharmacy.

     (f) A record of any waste of any prepared or partially administered dose of a controlled substance, which must be witnessed and cosigned by another person who is licensed to provide medical care.

     (Added to NAC by Bd. of Pharmacy, eff. 3-27-90; A 9-12-91; R156-99, 3-1-2000)

      NAC 639.486  Maintenance of records of controlled substances administered from floor stock. (NRS 639.070, 639.071, 639.072)

     1.  A pharmacy shall maintain records of controlled substances administered from floor stock. The records must include:

     (a) The name of the patient to whom the controlled substance was administered.

     (b) The name of the controlled substance, its dosage form and strength.

     (c) The time and date on which the controlled substance was administered to the patient.

     (d) The quantity of the controlled substance administered.

     (e) The signature of the person removing the controlled substance.

     (f) Controlled substances returned to the pharmacy.

     (g) A record of any waste of a controlled substance which, except as otherwise provided in subsection 2, must be witnessed and cosigned by another person who is licensed to provide medical care.

     2.  A record of any waste of a controlled substance kept pursuant to subsection 1 is not required to be witnessed and cosigned as required by subsection 1 if:

     (a) The record of waste is for a controlled substance which was administered by a practitioner authorized to administer anesthesia; and

     (b) Other current, complete and accurate records for the controlled substance administered and wasted are created and maintained.

     3.  Records maintained pursuant to this section must be maintained separately from records of patients.

     (Added to NAC by Bd. of Pharmacy, eff. 3-27-90; A 9-12-91; 5-22-96; R157-99, 3-1-2000; R042-04, 5-25-2004)

      NAC 639.487  Maintenance of additional records. (NRS 639.070, 639.071, 639.072)  In addition to any other requirements for keeping records, a pharmacy shall maintain the following records:

     1.  Copy 3 of the order form of the Drug Enforcement Administration (DEA 222C), properly dated, initialed and filed, copies of each unaccepted or defective order form, and any attached statements or other documents.

     2.  Suppliers’ invoices of controlled substances and dangerous drugs. The pharmacist or other personnel of the pharmacy shall clearly record on each invoice the actual date on which the controlled substance or dangerous drug was received.

     3.  Suppliers’ credit memos for controlled substances and dangerous drugs.

     4.  The biennial inventory of controlled substances required by the Drug Enforcement Administration.

     5.  Any reports of theft or significant loss of controlled substances submitted to the Drug Enforcement Administration.

     6.  Reports of the surrender or destruction of controlled substances or dangerous drugs, or both, to an appropriate state or federal agency.

     7.  A register book for nonprescription drugs listed in schedule V.

     (Added to NAC by Bd. of Pharmacy, eff. 3-27-90; A 9-12-91)

      NAC 639.488  Maintenance of records for distribution of controlled substances to another pharmacy or practitioner. (NRS 639.070, 639.071, 639.072)

     1.  If a pharmacy distributes controlled substances listed in schedule III, IV or V to another pharmacy or a practitioner, it shall maintain invoices showing:

     (a) The actual date of distribution;

     (b) The name, strength and quantity of controlled substances distributed;

     (c) The distributing pharmacy’s name, address and registration number given to it by the Drug Enforcement Administration; and

     (d) The name, address and registration number of the pharmacy or practitioner to whom the controlled substances were distributed.

     2.  If a pharmacy distributes controlled substances listed in schedule I or II to another pharmacy or a practitioner, it shall maintain Copy 1 of the order form of the Drug Enforcement Administration (DEA 222C) furnished by the pharmacy or practitioner to whom the controlled substances were distributed. The form must show the quantity of controlled substances distributed and the actual date of distribution.

     (Added to NAC by Bd. of Pharmacy, eff. 3-27-90; A 9-12-91)

      NAC 639.489  Separation of certain records. (NRS 639.070, 639.071, 639.072)

     1.  Except for records of distributions from floor stock, records of controlled substances listed in schedules I and II must be maintained separately from other records maintained by a pharmacy.

     2.  Records of controlled substances listed in schedules III, IV and V may be maintained either separately from all other records maintained by the pharmacy or in such form that the records are readily retrievable.

     (Added to NAC by Bd. of Pharmacy, eff. 3-27-90; A 9-12-91)

      NAC 639.490  Permission to use centralized system for keeping records. (NRS 639.070, 639.071, 639.072)  A pharmacy wishing to use a centralized system for keeping records must submit written notification to the Regional Director of the Drug Enforcement Administration by registered or certified mail. A copy of the notification must be submitted to the Board. Unless the pharmacy is informed by the Regional Director that permission to keep central records is denied, the pharmacy may begin to maintain such records 14 days after receipt of the notification by the Regional Director. A copy of the notification must be maintained by the pharmacy.

     (Added to NAC by Bd. of Pharmacy, eff. 3-27-90; A 9-12-91)

Chart Order Processing Services

      NAC 639.491  Definitions. (NRS 639.070)  As used in NAC 639.491 to 639.4917, inclusive, unless the context otherwise requires, the words and terms defined in NAC 639.4911 to 639.4914, inclusive, have the meanings ascribed to them in those sections.

     (Added to NAC by Bd. of Pharmacy by R015-05, eff. 10-31-2005; A by R098-07, 12-4-2007)

      NAC 639.4911  “Chart order” defined. (NRS 639.070)  “Chart order” has the meaning ascribed to it in NAC 639.442.

     (Added to NAC by Bd. of Pharmacy by R015-05, eff. 10-31-2005)

      NAC 639.49115  “Chart order processing services” defined. (NRS 639.070)  “Chart order processing services” means nondispensary pharmaceutical services that are provided by a pharmacy to a hospital or correctional institution, including, without limitation:

     1.  Receiving, interpreting and clarifying a chart order received from a hospital or correctional institution;

     2.  Entering information regarding a chart order into the computerized data system of a hospital or correctional institution;

     3.  Interpreting clinical data regarding a patient of a hospital or correctional institution;

     4.  Performing therapeutic interventions regarding a patient of a hospital or correctional institution;

     5.  Providing information to the appropriate staff of a hospital or correctional institution regarding a chart order submitted by the hospital or correctional institution; and

     6.  Providing information regarding the treatment of a patient of a hospital or correctional institution.

     (Added to NAC by Bd. of Pharmacy by R098-07, eff. 12-4-2007)

      NAC 639.4912  “Correctional institution” defined. (NRS 639.070)  “Correctional institution” has the meaning ascribed to it in NAC 639.4465.

     (Added to NAC by Bd. of Pharmacy by R015-05, eff. 10-31-2005)

      NAC 639.4913  “Off-site pharmaceutical service provider” defined. (NRS 639.070)  “Off-site pharmaceutical service provider” means a pharmacy that provides remote chart order processing services to a hospital or correctional institution that is owned by the same entity as the pharmacy or with which the pharmacy has contracted to provide remote chart order processing services.

     (Added to NAC by Bd. of Pharmacy by R015-05, eff. 10-31-2005)

      NAC 639.4914  “Remote chart order processing services” defined. (NRS 639.070)  “Remote chart order processing services” means chart order processing services provided by an off-site pharmaceutical service provider to a hospital or correctional institution, including, without limitation, transferring information regarding a chart order from the off-site pharmaceutical service provider to members of the staff of the hospital or correctional institution that submitted the chart order.

     (Added to NAC by Bd. of Pharmacy by R015-05, eff. 10-31-2005; A by R098-07, 12-4-2007)

      NAC 639.4915  Provision of services by pharmacies within certain hospitals and correctional institutions. (NRS 639.070, 639.071, 639.072)  A pharmacy located within a hospital or correctional institution that is required to have a full-time managing pharmacist pursuant to NAC 639.465 shall provide chart order processing services to the hospital or correctional institution. The pharmacy shall provide the chart order processing services by:

     1.  Operating at all times; or

     2.  Employing a pharmacist who is on duty at all times that the pharmacy is operating and either:

     (a) Employing a pharmacist who is available at all times that the pharmacy is not operating; or

     (b) Contracting with an off-site pharmaceutical service provider that is available at all times that the pharmacy is not operating.

     (Added to NAC by Bd. of Pharmacy by R015-05, eff. 10-31-2005; A by R098-07, 12-4-2007)

      NAC 639.4916  Provision of remote services by pharmacist employed by off-site pharmaceutical service provider. (NRS 639.070)

     1.  A pharmacist who is employed by an off-site pharmaceutical service provider to provide remote chart order processing services to a hospital or correctional institution pursuant to NAC 639.4915 must:

     (a) Be licensed to practice in Nevada;

     (b) Be trained in the policies and procedures of the hospital or correctional institution regarding all policies and procedures of the hospital or correctional institution with which the pharmacist must comply, including, without limitation, the provision of pharmaceutical services, security and confidentiality of patient records;

     (c) Except as otherwise provided in subsection 3, be provided with the same computerized system and access to data regarding a patient for whom a chart order has been submitted that would be available to a pharmacist employed by the pharmacy located within the hospital or correctional institution, including, without limitation:

          (1) The height, weight and age of the patient and any allergies that the patient may have;

          (2) The medical records regarding any medications prescribed to the patient;

          (3) The results of any relevant laboratory tests, to the extent that those results are available in the computerized system of the hospital or correctional institution;

          (4) The health history and notes regarding physical examinations, to the extent that the information is available in the computerized system of the hospital or correctional institution;

          (5) Any notes provided by a physician, nurse or other medical staff of the institution, to the extent that those notes are available in the computerized system of the hospital or correctional institution;

          (6) A legible copy of the chart order that is available through a scanned image in the computerized system of the hospital or correctional institution or by facsimile machine; and

          (7) Any other information that is available in the computerized system of the hospital or correctional institution that is relevant or necessary for the pharmacist to provide pharmaceutical services; and

     (d) Demonstrate to the off-site pharmaceutical service provider that the pharmacist is competent and knowledgeable in the use of the computerized system of the hospital or correctional institution and in providing pharmaceutical services in a hospital or correctional institution.

     2.  Before a pharmacist who is employed by an off-site pharmaceutical service provider provides remote chart order processing services to a hospital or correctional institution, the pharmacist must review any relevant information regarding the patient for whom a chart order has been submitted. The pharmacist must, before approving a chart order to be filled, evaluate:

     (a) The overutilization or underutilization of a medication;

     (b) Therapeutic duplication;

     (c) The appropriateness of the prescribed dosage and route of administration;

     (d) The appropriateness of the directions for use of the medication;

     (e) The appropriateness of the duration of the treatment with the prescribed medication;

     (f) Any contraindications of the medication and a particular disease, ailment or allergy of the patient;

     (g) Any contraindications or interactions between multiple medications prescribed for the patient; and

     (h) The potential abuse or misuse of a medication.

     3.  In an emergency, a pharmacist may render remote chart order processing services without being provided with all of the information required by paragraph (c) of subsection 1 if the pharmacist believes, in his or her professional judgment, that he or she has received sufficient information from the staff of the hospital or correctional institution to render the services.

     4.  A pharmacist who is employed by an off-site pharmaceutical service provider may refuse to approve the filling of a chart order if, in the judgment of the pharmacist, the chart order is not safe or reasonable for the patient. A pharmacist who refuses to approve the filling of a chart order pursuant to this subsection must notify the hospital or correctional institution as soon as practicable that he or she has refused to approve the filling of the chart order.

     5.  Each time that a pharmacist who is employed by an off-site pharmaceutical service provider provides remote chart order processing services pursuant to this section, the pharmacist shall make a notation in the computerized system of the hospital or correctional institution that indicates:

     (a) The name or other identifier of the pharmacist;

     (b) The date and time that the pharmacist provided the services and, if applicable, approved the filling of a chart order; and

     (c) The specific services provided by the pharmacist.

     6.  The managing pharmacist of a pharmacy that has a contract with or is owned by the same entity as an off-site pharmaceutical service provider may limit the remote chart order processing services provided by a pharmacist employed by the off-site pharmaceutical service provider.

     (Added to NAC by Bd. of Pharmacy by R015-05, eff. 10-31-2005)

      NAC 639.4917  Policies and procedures of off-site pharmaceutical service providers. (NRS 639.070)  Each off-site pharmaceutical service provider shall establish and follow policies and procedures for:

     1.  Protecting the confidentiality and integrity of patient information;

     2.  Assuring that pharmacists employed by the off-site pharmaceutical service provider comply with the provisions of NAC 639.4916;

     3.  Complying with all applicable state and federal statutes, regulations and rules, including, without limitation, maintaining records;

     4.  Ensuring that its records are made readily accessible to members of the Board and employees, agents and designees of the Board;

     5.  Conducting an ongoing program for the improvement of the provision of pharmaceutical services that is designed to objectively and systematically monitor and evaluate the quality and appropriateness of patient care, improve patient care and resolve problems identified by the program;

     6.  Performing an annual review of the program conducted pursuant to subsection 5;

     7.  Assuring that the pharmacists employed by the off-site pharmaceutical service provider are able to communicate with identified employees of the hospital or correctional institution as necessary to provide pharmaceutical services, including, without limitation, communicating with pharmacists employed by the hospital or correctional institution; and

     8.  The provision of pharmaceutical services at times when the off-site pharmaceutical service provider temporarily or permanently cannot provide such services.

     (Added to NAC by Bd. of Pharmacy by R015-05, eff. 10-31-2005)

FACILITIES FOR INTERMEDIATE CARE AND FACILITIES FOR SKILLED NURSING

      NAC 639.492  Definitions. (NRS 639.070, 639.071)  As used in NAC 639.492 to 639.498, inclusive, unless the context otherwise requires:

     1.  “Director” means the director of nurses of a facility.

     2.  “Facility” means a facility for intermediate care as defined in NRS 449.0038 or a facility for skilled nursing as defined in NRS 449.0039.

     (Added to NAC by Bd. of Pharmacy, eff. 7-1-92)

      NAC 639.494  Prescriptions for controlled substances: Accountability record; handling of unused portions. (NRS 639.070, 639.071)

     1.  Each prescription for a controlled substance which is administered to a patient at a facility must be accompanied by the controlled substances accountability record. The record must include:

     (a) The patient’s name;

     (b) The name of the controlled substance;

     (c) The date the facility received the controlled substance from the pharmacy;

     (d) The signature of the employee of the facility who received the controlled substance;

     (e) The number of the prescription;

     (f) The total dosage units of the controlled substance;

     (g) The strength of the controlled substance;

     (h) The date and time each dosage of the controlled substance is administered and the signature of the person administering the controlled substance; and

     (i) The number of dosage units of the controlled substance which remain after the administration of the controlled substance is completed, including:

          (1) The number of dosage units disposed;

          (2) The date of the disposition of the dosage units;

          (3) The signature of the director or a licensed nurse designated by the director; and

          (4) The signature of the licensed consulting pharmacist of the facility or a pharmacist designated by the licensed consulting pharmacist.

     2.  Any unused portion of the controlled substance must be immediately delivered to the director for destruction pursuant to NAC 639.498. The director shall ensure the security of those controlled substances.

     3.  The director shall establish a procedure to ensure that the number of dosage units remaining in each unused portion of a controlled substance corresponds to the information contained in the controlled substances accountability record.

     (Added to NAC by Bd. of Pharmacy, eff. 7-1-92)

      NAC 639.496  Maintenance of accountability record; examination of chart orders; issuance of receipt for controlled substances delivered to coroner. (NRS 639.070, 639.071)

     1.  The director shall keep each controlled substances accountability record which accompanies a prescription for a controlled substance in an alphabetical file by the patient’s name. The record must be kept on the premises of the facility for at least 2 years after the controlled substance is destroyed.

     2.  The Board may examine the chart orders of a physician at the facility in conjunction with the controlled substances accountability records for the prescription of the controlled substances prescribed by the physician.

     3.  A coroner shall issue a receipt to the director for any controlled substance which the facility delivers to him or her. The receipt must include the information set forth in paragraphs (a), (b), (e) and (f) of subsection 1 of NAC 639.494.

     (Added to NAC by Bd. of Pharmacy, eff. 7-1-92)

      NAC 639.498  Destruction of certain controlled substances: Requirement; procedure. (NRS 639.070, 639.071)

     1.  Except as otherwise provided in subsection 2:

     (a) At least once each month, the director or a licensed consulting pharmacist shall destroy, on the premises of the facility, the controlled substances described in subsection 1 of NAC 639.050.

     (b) If the director destroys the controlled substances, the licensed consulting pharmacist shall witness the destruction of the controlled substances. If the licensed consulting pharmacist destroys the controlled substances, the director shall witness the destruction of the controlled substances.

     2.  The director may designate a nurse licensed pursuant to chapter 632 of NRS to carry out his or her duties pursuant to this section. The licensed consulting pharmacist may designate a pharmacist licensed pursuant to chapter 639 of NRS to carry out his or her duties pursuant to this section.

     3.  The controlled substances must be destroyed by:

     (a) Flushing them down the toilet or hopper;

     (b) If a container for waste disposal is used, placing the controlled substances in the water in the container for disposal; or

     (c) If the controlled substance is stored in a vial, ampule or other glass container, breaking the container and placing its contents into a container for waste disposal.

     (Added to NAC by Bd. of Pharmacy, eff. 7-1-92)

SURGICAL CENTERS FOR AMBULATORY PATIENTS

      NAC 639.4985  Definitions. (NRS 639.070, 639.071)  As used in NAC 639.4985 to 639.4998, inclusive, unless the context otherwise requires, the words and terms defined in NAC 639.4987, 639.4989 and 639.4991 have the meanings ascribed to them in those sections.

     (Added to NAC by Bd. of Pharmacy by R116-08, eff. 9-18-2008)

      NAC 639.4987  “Compounding” defined. (NRS 639.070, 639.071)  “Compounding” has the meaning ascribed to it in NRS 639.0053.

     (Added to NAC by Bd. of Pharmacy by R116-08, eff. 9-18-2008)

      NAC 639.4989  “Drug” defined. (NRS 639.070, 639.071)  “Drug” has the meaning ascribed to it in NRS 639.007.

     (Added to NAC by Bd. of Pharmacy by R116-08, eff. 9-18-2008)

      NAC 639.4991  “Investigational drug” defined. (NRS 639.070, 639.071)  “Investigational drug” has the meaning ascribed to it in NAC 639.455.

     (Added to NAC by Bd. of Pharmacy by R116-08, eff. 9-18-2008)

      NAC 639.4992  Dispensing of controlled substances: Registration and licensing required. (NRS 639.070, 639.071)  Each surgical center for ambulatory patients shall:

     1.  Register with the Board and the Drug Enforcement Administration of the United States Department of Justice to dispense controlled substances;

     2.  Ensure that each practitioner who dispenses controlled substances in the surgical center is registered with the Board and the Drug Enforcement Administration of the United States Department of Justice; and

     3.  Require each person employed to work in a pharmacy of the surgical center for ambulatory patients and any person with whom the surgical center for ambulatory patients has entered into a contract to provide pharmaceutical services to possess a current state license or certificate to provide such services.

     (Added to NAC by Bd. of Pharmacy, eff. 10-24-97)

      NAC 639.4996  Establishment and review of policies and procedures by pharmacist. (NRS 639.070, 639.071)

     1.  A surgical center for ambulatory patients shall employ or enter into a contract with a pharmacist to establish policies and procedures which:

     (a) Are consistent with the policies and procedures developed pursuant to NAC 639.477;

     (b) Require the maintenance of records in accordance with the provisions of NAC 639.485 and 639.486;

     (c) Address the purchase, storage, maintenance of records and dispensing of drugs and investigational drugs;

     (d) Require maintenance of a perpetual inventory of all controlled substances;

     (e) Prescribe the procedure for quarantining and destroying drugs and investigational drugs that are expired, adulterated, mislabeled or otherwise unsafe for human use;

     (f) Require the storage of drugs and investigational drugs in accordance with the specifications of the manufacturer;

     (g) Ensure that the surgical center dispenses drugs and investigational drugs in accordance with applicable state and federal laws; and

     (h) Ensure that all compounding is:

          (1) Performed by a registered pharmacist in accordance with the provisions of this chapter and chapter 639 of NRS; or

          (2) If performed by an employee of the surgical center, other than a registered pharmacist, performed:

               (I) In accordance with the provisions of this chapter and chapter 639 of NRS;

               (II) In a location designated for compounding that is clean and disinfected before each act of compounding; and

               (III) By a person who has completed training for the type of compounding that will be performed.

     2.  The policies and procedures established pursuant to subsection 1 must be maintained, reviewed at least annually, and dated upon adoption and amendment.

     3.  The pharmacist employed by or contracted with a surgical center for ambulatory patients pursuant to subsection 1 may establish the policies and procedures required pursuant to that subsection with the assistance of a practitioner or an employee or contractor of the surgical center.

     (Added to NAC by Bd. of Pharmacy, eff. 10-24-97; A by R116-08, 9-18-2008)

      NAC 639.4998  Duties of pharmacist who establishes policies and procedures. (NRS 639.070, 639.071)  A pharmacist employed by or contracted with a surgical center for ambulatory patients pursuant to NAC 639.4996 shall:

     1.  Visit the surgical center at least once each month to:

     (a) Evaluate the effectiveness of the policies and procedures established pursuant to NAC 639.4996; and

     (b) Confirm that the surgical center is complying with those policies and procedures, the provisions of this section and NAC 639.4996;

     2.  Maintain documentation of each visit that the pharmacist makes pursuant to subsection 1;

     3.  Conduct an audit at least once each month using a sufficient number of records of the surgical center, including, without limitation, records of patients and records relating to the purchasing, storing and dispensing of drugs and investigational drugs, which must be randomly selected, to determine whether:

     (a) The records indicate that the drugs and investigational drugs are dispensed in a safe and effective manner in accordance with accepted standards of practice and the specifications of the manufacturer;

     (b) Drugs and investigational drugs are diluted in accordance with accepted standards of practice or pursuant to the specifications of the manufacturer;

     (c) The records demonstrate:

          (1) That a discrepancy does not exist in the number of drugs and investigational drugs that are in vials designated by the manufacturer for a single use which are dispensed and the number of patients who receive such drugs and investigational drugs; and

          (2) That drugs, not including investigational drugs, which are in vials designated by the manufacturer for a single use and any remaining medication in those vials are discarded after use;

     (d) The records demonstrate that drugs, not including investigational drugs, which are in vials designated by the manufacturer for more than one use are discarded when the medication in the vials has expired or not more than 28 days after the initial breach of the vial;

     (e) The employees of the surgical center properly maintain accurate records relating to drugs and investigational drugs; and

     (f) The employees of the surgical center properly monitor and maintain the perpetual inventory required pursuant to paragraph (d) of subsection 1 of NAC 639.4996; and

     4.  Submit a written report, including, without limitation, a written explanation, to the Board not later than 5 business days after the pharmacist determines that:

     (a) The surgical center is violating a state or federal law which affects the care and safety of a patient;

     (b) There is a discrepancy of 5 percent or more between the actual quantity of a controlled substance in the possession of the surgical center and the amount of the controlled substance that should be in the possession of the surgical center according to the records of the surgical center, including, without limitation:

          (1) Purchase orders and invoices for the controlled substance;

          (2) Records which indicate the removal of the controlled substance from the storage area;

          (3) Patient records;

          (4) Records which indicate the return of the controlled substance to the manufacturer;

          (5) Records which indicate that the controlled substance was destroyed; and

          (6) Any other record for the controlled substance;

     (c) The surgical center has intentionally or recklessly failed to create or maintain a record required by the policies and procedures established pursuant to NAC 639.4996;

     (d) The surgical center is administering a drug or an investigational drug in violation of accepted standards of practice or the specifications of the manufacturer; or

     (e) The surgical center is engaged in a practice which endangers the health, safety or welfare of a patient or employee of the surgical center.

     (Added to NAC by Bd. of Pharmacy by R116-08, eff. 9-18-2008)

PHARMACIES IN GENERAL

      NAC 639.500  Ownership of pharmacies; application to conduct a pharmacy. (NRS 639.070, 639.231)

     1.  A person, as that term is defined in NRS 0.039, or the State of Nevada or any of its political subdivisions, may own more than one pharmacy.

     2.  An applicant for a license to conduct a pharmacy in this State must submit to the Board a complete and accurate application on a form provided by the Board, along with the requisite fees. The staff of the Board shall return the application to the applicant if the application is incomplete or does not include the requisite fees.

     [Bd. of Pharmacy, § 639.180, eff. 6-26-80]—(NAC A 1-26-94; R076-00, 9-5-2000)

      NAC 639.5005  Representative of pharmacy: General requirements; exceptions; approval; enforcement. (NRS 639.070, 639.231)

      1.  Except as otherwise provided in this subsection, an applicant for a license, or a licensee with a license, to conduct a pharmacy shall designate at least one natural person who will be the representative of the pharmacy. The Board will not issue a license to an applicant or renew the license of a licensee that is required to designate a representative of a pharmacy pursuant to this section unless the Board determines that the designated natural person meets the qualifications set forth in subsection 2 and approves that natural person to be the designated representative of the pharmacy. The requirement to designate a representative set forth in this subsection does not apply to:

     (a) An applicant or a licensee that is a publicly traded corporation;

     (b) An applicant or licensee whose pharmacy is determined by the Board to be located within a large retail store, including, without limitation, a grocery store, variety store or department store under common ownership; or

     (c) An applicant or licensee in which a majority interest of the applicant or licensee is owned by a pharmacist who is:

          (1) Licensed by the Board; and

          (2) A resident of this State.

     2.  Except as otherwise provided in subsection 3, the Board will approve a natural person to be a representative of a pharmacy if the applicant for a license to conduct a pharmacy or the licensee presents proof satisfactory to the Board that the natural person:

     (a) Has been employed for at least 6,000 hours in a pharmacy or with a wholesaler in a capacity related to the dispensing and distribution of, and recordkeeping relating to, prescription drugs;

     (b) Has received a score of at least 75 percent on an examination given by the Board regarding federal and state laws and pharmacy practices; and

     (c) Is at least 21 years of age.

     3.  The Board may, based upon any of the grounds set forth in NRS 639.210, refuse to approve a natural person for service as the representative of a pharmacy, regardless of whether the person is otherwise qualified.

     4.  A representative of a pharmacy designated pursuant to this section:

     (a) Must be actively involved in and aware of the actual daily operation of the pharmacy;

     (b) Must be employed full-time in a managerial level position in the pharmacy;

     (c) Must be physically present at the site of the pharmacy during regular business hours, except when the absence of the representative is authorized, including sick leaves, vacation leaves and other authorized absences; and

     (d) May serve in this representative capacity for only one pharmacy at a time.

     5.  A pharmacy that is required to designate a natural person as its representative pursuant to this section shall not open or operate the pharmacy unless that representative is actually employed full-time in the operation of the pharmacy and is physically present at the site of the pharmacy during regular working hours, not including sick leave, vacation leave and other authorized absences from work. If the natural person designated as the representative of a pharmacy leaves the employ of the pharmacy, thus leaving the pharmacy without a representative in violation of this section, the pharmacy shall:

     (a) Immediately cease conducting business until another qualified natural person is approved by the Board to serve as the representative of the pharmacy; and

     (b) Not later than 48 hours after that person leaves its employ, notify the Board that the person designated as the representative of the pharmacy has left the employ of the pharmacy.

     6.  Before a pharmacy that is in violation of this section because the natural person designated as the representative of the pharmacy left the employ of the pharmacy may continue conducting business:

     (a) The pharmacy must designate, on a form provided by the Board, a new natural person to serve as the representative of the pharmacy; and

     (b) The Board must approve the natural person so designated.

     7.  A pharmacy that operates without a representative in violation of this section is subject to the immediate suspension of its license until it employs a qualified natural person to be its representative. The Board will consider such a suspension to be an involuntary closure subject to the provisions of NAC 639.570, entitling the staff of the Board to close the pharmacy until it designates and employs a qualified natural person as its representative.

     (Added to NAC by Bd. of Pharmacy by R076-00, eff. 9-5-2000; A by R010-11, 11-1-2001)

      NAC 639.5007  Terms and conditions of license to conduct pharmacy for applicant required to designate representative. (NRS 639.070, 639.231)  If a license to conduct a pharmacy is issued for an applicant that is required to designate a natural person as a representative of the pharmacy pursuant to NAC 639.5005, the Board may impose any term or condition on the license that the Board determines necessary and appropriate to ensure that the license is used only to conduct the legitimate practice of pharmacy, including, without limitation:

     1.  Setting an expiration date for the license;

     2.  Restricting the conduct of the pharmacy by the licensee to activities determined by the Board;

     3.  Restricting the drugs that may be purchased by the pharmacy to only those drugs necessary to fill prescriptions;

     4.  Prohibiting the pharmacy from selling, transferring, distributing, dispensing or otherwise providing prescription drugs to any person other than a patient with a prescription;

     5.  Requiring the conduct of random audits by the Board of the practices of the pharmacy to ensure that the pharmacy is complying with any term or condition imposed by the Board on the license of the pharmacy;

     6.  Requiring the pharmacy to enter into a contract to act as the primary provider of prescription drugs to a facility licensed to provide health care services and to provide evidence satisfactory to the Board that the pharmacy has entered into such a contract; and

     7.  Requiring the pharmacy to provide evidence satisfactory to the Board that it is able to pay the costs of overhead necessary to conduct the pharmacy according to any term or condition imposed by the Board on the license of the pharmacy.

     (Added to NAC by Bd. of Pharmacy by R010-01, eff. 11-1-2001; A by R034-07, 12-17-2009)

      NAC 639.501  Inspections; provision of self-assessment form. (NRS 639.070)

     1.  Before the Board will issue a new license to operate a pharmacy to any person, a satisfactory inspection of the premises of the pharmacy must be conducted by a member of the staff of the Board.

     2.  A member of the staff of the Board shall inspect each licensed pharmacy annually and at any other time deemed necessary by the staff of the Board.

     3.  Before an annual inspection of a licensed pharmacy, the Board will provide a self-assessment form to the pharmacy that includes:

     (a) A questionnaire concerning statutory and regulatory compliance pursuant to which the pharmacy must assess its physical plant and operations to assure that the pharmacy is in compliance with all applicable statutes and regulations; and

     (b) An assessment of the workplace pursuant to which the pharmacy must assess its volume of work and prescriptions, personnel, workflow and technological devices that assist in the work of the pharmacy.

     4.  The managing pharmacist of a pharmacy or the designee of the owner of the pharmacy may obtain self-assessment forms from the Board in addition to the form provided pursuant to subsection 3 at any time for his or her own use.

     (Added to NAC by Bd. of Pharmacy by R162-99, eff. 3-1-2000)

      NAC 639.5012  Confidentiality and use of self-assessment and accompanying documentation. (NRS 639.070)

     1.  An assessment of the workplace completed by a pharmacy as part of the self-assessment, and all documentation accompanying the assessment, that are submitted to a member of the staff of the Board pursuant to NAC 639.5016 are confidential. The Board will destroy such an assessment of the workplace and all accompanying documentation within 6 months after the Board receives the assessment and documentation.

     2.  The staff of the Board may compile and analyze such data provided in assessments of the workplace as the Board deems appropriate, except that the staff shall not provide to any member of the Board or otherwise publish any compilation or analysis completed by the staff unless the staff has redacted from the compilation or analysis all information by which an individual pharmacy could be identified. The Board will not use data provided in an assessment of the workplace against the pharmacy that completed the assessment for any disciplinary purpose.

     (Added to NAC by Bd. of Pharmacy by R162-99, eff. 3-1-2000)

      NAC 639.5014  Completion of self-assessment form before annual inspections; suggestions relating to compliance by or improvement of pharmacy. (NRS 639.070)

     1.  The managing pharmacist of a pharmacy or the designee of the owner of the pharmacy shall complete a self-assessment form before each annual inspection of the pharmacy by a member of the staff of the Board.

     2.  The managing pharmacist or the designee of the owner who completes a self-assessment form may make:

     (a) Notes and comments on the self-assessment form to explain his or her answers; and

     (b) Suggestions on the self-assessment form relating to the compliance by or improvement of the pharmacy.

     3.  If the managing pharmacist or the designee of the owner makes any suggestion on a self-assessment form of the pharmacy relating to the compliance by or improvement of the pharmacy, he or she shall submit, in accordance with any policies and procedures of the pharmacy, a copy of the self-assessment form to the senior management of the pharmacy. If the managing pharmacist or designee of the owner believes that his or her suggestions are necessary for the care of the patients of the pharmacy and that the senior management of the pharmacy has not responded appropriately, the managing pharmacist or the designee of the owner may contact the Board, which will take such action relating to the suggestion as the Board deems appropriate.

     (Added to NAC by Bd. of Pharmacy by R162-99, eff. 3-1-2000)

      NAC 639.5016  Annual inspections: Review of self-assessment form; notes regarding discrepancies or deficiencies; correction of discrepancies or deficiencies. (NRS 639.070)

     1.  Whenever a member of the staff of the Board conducts an annual inspection of a pharmacy, the managing pharmacist of the pharmacy or the designee of the owner of the pharmacy shall provide the member of the staff of the Board with a completed self-assessment form of the pharmacy. A member of the staff of the Board conducting an annual inspection of a pharmacy shall review a self-assessment form of the pharmacy with the managing pharmacist of the pharmacy or a pharmacist on duty in the pharmacy at the time of the inspection to verify that all the information contained in the self-assessment form of the pharmacy is true and complete.

     2.  If, during the annual inspection of a pharmacy, the member of the staff of the Board conducting the inspection finds any discrepancies between the information contained in the self-assessment form of the pharmacy and the actual state or condition of the pharmacy, or if the member of the staff of the Board finds any other deficiencies or conditions in the pharmacy or its operation that are not otherwise in compliance with the applicable statutes and regulations governing the operation of a pharmacy and dispensing of drugs, the member of the staff of the Board shall make a note of the discrepancy, deficiency or condition in his or her inspection.

     3.  A pharmacy shall correct a discrepancy, deficiency or condition noted by a member of the staff of the Board pursuant to subsection 2 within a reasonable time, as determined by the member of the staff of the Board who noted the discrepancy, deficiency or condition. Any failure by a managing pharmacist or an owner of a pharmacy, or both, to correct a discrepancy, deficiency or condition in a timely manner as required by this subsection constitutes unprofessional conduct pursuant to subsection 4 of NRS 639.210 and may serve as the basis for such disciplinary action against the managing pharmacist or owner of the pharmacy, or both, as the staff of the Board deems appropriate.

     (Added to NAC by Bd. of Pharmacy by R162-99, eff. 3-1-2000)

      NAC 639.5018  Protection of employee providing answers, information or suggestions on self-assessment form or during inspections. (NRS 639.070)  A pharmacy shall not terminate, or otherwise negatively affect in any way, the employment of an employee of the pharmacy who:

     1.  In good faith, provides truthful answers, information or suggestions relating to the compliance by or improvement of the pharmacy in the preparation or completion of a self-assessment form for the pharmacy;

     2.  Transmits a copy of a self-assessment form to the senior management of the pharmacy or the Board pursuant to subsection 3 of NAC 639.5014; or

     3.  In good faith, provides truthful information to any member of the staff of the Board as part of an inspection of the pharmacy pursuant to NAC 639.5016.

     (Added to NAC by Bd. of Pharmacy by R162-99, eff. 3-1-2000)

      NAC 639.5019  Annual review by Board of provisions of NAC 639.501 to 639.5019, inclusive. (NRS 639.070)  The Board will review the provisions of NAC 639.501 to 639.5019, inclusive, at its first regularly scheduled meeting following July 1 of each year to consider and suggest amendments to and deletions from the provisions of NAC 639.501 to 639.5019, inclusive, including the repeal of the sections.

     (Added to NAC by Bd. of Pharmacy by R162-99, eff. 3-1-2000)

      NAC 639.503  Maintenance in pharmacy of current statutes, regulations and reference material. (NRS 639.070)  Except as otherwise provided in NAC 639.472:

     1.  All licensed pharmacies must maintain at all times and make available to pharmacists, intern pharmacists and other employees, copies of all current state statutes and regulations relating to the practice of pharmacy and to the sale of drugs and controlled substances.

     2.  Each licensed pharmacy must maintain in its prescription department reference materials in the form of the latest editions of pharmaceutical texts, or their equivalent which are on a computer program or disc. The reference materials must be readily retrievable as necessary to conduct the practice of pharmacy and must include, without limitation, information on:

     (a) Preparation and compounding of prescriptions;

     (b) Biological and therapeutical equivalencies of drugs;

     (c) Pharmacology and pharmacokinetics;

     (d) Indications and usage of drugs;

     (e) Contraindications of, adverse reactions to and warnings about drugs;

     (f) Dosage and administrations of drugs; and

     (g) Overdosages of drugs.

     (Added to NAC by Bd. of Pharmacy, eff. 6-25-82; A 3-27-90; R158-99, 3-1-2000)

      NAC 639.505  Maintenance in pharmacy of reports of inspection, warning notices and special bulletins. (NRS 639.070)  A copy of each report of inspection, issued by a member of the Board or its administrative staff, together with any warning notice or special bulletin issued by the Board, must be maintained on the premises of the pharmacy in such a manner as to make these documents readily available on request for 2 years after the date of issue unless earlier destruction is authorized.

     [Bd. of Pharmacy, § 639.230, eff. 6-26-80]

      NAC 639.510  Maintenance and storage of pharmaceutical stock. (NRS 639.070)

     1.  The owner, manager, operator, managing pharmacist or pharmacist in charge of a licensed pharmacy shall maintain in the pharmacy a representative stock of dangerous drugs, controlled substances, chemicals, biologicals and devices in sufficient quantity to provide adequate pharmaceutical services for the people of the community which the pharmacy serves.

     2.  The managing pharmacist of a pharmacy:

     (a) Is responsible for, and must have knowledge and control of, the acquisition and disposition by the pharmacy of the stock of the pharmacy; and

     (b) Shall ensure that the records relating to the acquisition or disposition of the stock of the pharmacy are maintained as required by law.

     3.  The dangerous drugs, controlled substances, chemicals, biologicals and devices kept in the stock of a pharmacy must meet all of such standards of purity and strength as established by current official compendia or as established on the appropriate labels, and must be properly stored. Any preparation which varies from such standards of purity and strength or becomes unfit for use from deterioration or other cause must not be carried in stock and must be destroyed in a manner provided by law when so ordered by an agent of the Board.

     [Bd. of Pharmacy, § 639.225, eff. 6-26-80]—(NAC A by R159-99, 3-1-2000)

      NAC 639.512  Class A and B packaging: Label; expiration date; log. (NRS 639.070)

     1.  This section only applies to Class A and B packaging as defined in the United States Pharmacopoeia.

     2.  Each unit dose of a controlled substance or dangerous drug packaged or repackaged by a pharmacy must contain a label which specifies:

     (a) The generic or trade name;

     (b) The strength;

     (c) The expiration date; and

     (d) Where applicable, an internal control number or the lot number of the bulk package.

     3.  A unit dose of a controlled substance or dangerous drug packaged or repackaged by a pharmacy, including a hospital pharmacy, must be dispensed before the expiration date thereof. For the purposes of this section, “expiration date” means the date 12 months after the date of the packaging or repackaging of the substance or dangerous drug. No expiration date may exceed the original manufacturer’s expiration date.

     4.  Each pharmacy must maintain a log containing, with respect to each controlled substance or dangerous drug packaged or repackaged by the pharmacy:

     (a) The generic name, trade name and manufacturer;

     (b) The strength;

     (c) The manufacturer’s expiration date;

     (d) Where applicable, an internal control number;

     (e) The lot number of the bulk packaging;

     (f) The date of packaging or repackaging;

     (g) The number of doses packaged or repackaged; and

     (h) The initials of the pharmacist.

     (Added to NAC by Bd. of Pharmacy, eff. 12-3-84; A by R016-01, 11-1-2001)

      NAC 639.513  Class C packaging: Expiration date. (NRS 639.070)  Each controlled substance or dangerous drug packaged as Class C or below as defined in the United States Pharmacopoeia must have an expiration date of 60 days after the packaging or repackaging unless a stability study satisfactory to the Board has been performed on the controlled substance or dangerous drug.

     (Added to NAC by Bd. of Pharmacy, eff. 12-3-84)

      NAC 639.515  Stock of drugs in facility for skilled nursing or intermediate care. (NRS 639.070, 639.2327)

     1.  A facility for skilled nursing or a facility for intermediate care may maintain a stock of the following drugs for emergency treatment for inpatients:

 


Analgesic-CII

Analgesic-non CII

Anesthetics, local

Antiarrhythmics

Antibiotics

     Orally

     Intravenous

Anticholinergic

Antidiarrheal

Antihistamine

Antihypertensive

Antinauseants

Antipsychotic

Bronchodilators

Calcium injectable

Dextrose injection

Diazepam

Digoxin

Diuretic injectable

Epinephrine

Glucagon

Heparin

Insulin

Intravenous solutions

Magnesium sulfate

Muscle relaxant

Naloxone

Nitroglycerin tablets

Normal saline

Phenobarbital

Phenytoin

Potassium chloride

Pressor amine

Protamine

Sodium bicarbonate

Steroids

Vitamin K

Water for injection

 

     2.  The quantity of each drug stocked must not exceed 20 units of each drug at each nursing station in the facility.

     3.  All drugs must be stored and maintained in unit dosages, if manufactured in that form.

     [Bd. of Pharmacy, § 639.425, eff. 6-26-80]—(NAC A 12-3-84; 6-16-86; 2-18-88; 11-9-95; R065-08, 9-18-2008)

      NAC 639.517  Nurse employed by medical facility or agency to provide nursing in the home may maintain stock of certain drugs. (NRS 639.070)

     1.  A registered nurse employed by a medical facility or an agency to provide nursing in the home may, at the direction of the medical director of the facility or agency, maintain a stock of the following drugs for the emergency treatment of patients:

     (a) Diphenhydramine;

     (b) Epinephrine;

     (c) Heparin;

     (d) Normal saline;

     (e) Thrombolytics; and

     (f) Water for injection.

     2.  As used in this section:

     (a) “Agency to provide nursing in the home” has the meaning ascribed to it in NRS 449.0015.

     (b) “Medical facility” has the meaning ascribed to it in NRS 449.0151.

     (Added to NAC by Bd. of Pharmacy by R015-99, eff. 11-3-99)

      NAC 639.520  Security of prescription departments. (NRS 639.070)

     1.  The prescription department of every pharmacy must be separated from the merchandising or public areas of the premises by a barrier extending not less than 5 feet above the floor level and of sufficient width to make dangerous drugs, controlled substances, narcotics, poisons or restricted devices inaccessible to unauthorized persons. The barrier must be constructed of solid material and contain at least one gate or door permitting access by the pharmacist. Each gate or door must be secured by a dead-bolt lock that can be opened from the outside only by a key. The gate or door may be secured by a combination lock during the hours of business.

     2.  The registered pharmacist on duty:

     (a) Shall maintain possession of the key to the prescription department. Any additional keys to the prescription department must be kept in a locked box which is:

          (1) Operated with a key that is accessible to only licensed pharmacists within the pharmacy department; and

          (2) Maintained in a secure place that is inaccessible to unauthorized persons.

     (b) Is responsible for securing the prescription department at all times when the registered pharmacist is not personally present in the department except when he or she is in the immediate area and can observe and exercise control over the prescription department.

     (c) If the pharmacy is located within a store or business, shall ensure that all dangerous drugs, controlled substances, narcotics, poisons and restricted devices that are delivered onto the premises of the store or business are immediately placed and secured in the pharmacy department under the physical control of the pharmacist on duty.

     3.  The Executive Secretary may permit an alternative type of physical security if, in his or her opinion, the alternative type will be sufficient to make the drugs, controlled substances, narcotics, poisons and restricted devices inaccessible to any unauthorized person.

     4.  Except as otherwise provided by law or regulation, no person other than a registered pharmacist may enter the prescription department of a pharmacy unless the person is on business directly concerning the operation, maintenance or repair of the prescription department and a pharmacist employed in the prescription department is physically present at the same time.

     5.  Except as otherwise provided in subsection 6 or 7, a pharmacy shall maintain on its premises an alarm system that is operational 24 hours a day and that is monitored by a central station for control which is approved by Underwriters Laboratories Inc.

     6.  Except as otherwise provided in subsection 7, a pharmacy that is located within a building in which at least one employee of the person who owns the building is present 24 hours a day may, in lieu of the alarm system required pursuant to subsection 5, maintain on the premises of the pharmacy an alarm system that is:

     (a) Equipped with an audible alarm that is:

          (1) Operational 24 hours a day;

          (2) Of sufficient decibels to alert more than one person in the building that an unauthorized entry has been made into the pharmacy; and

          (3) Devised in such a manner as to provide notification to the managing pharmacist or the designee of the managing pharmacist when such an authorized entry has been made; and

     (b) Not monitored by a central station for control.

     7.  A pharmacy in a hospital or correctional institution and any pharmacy that is staffed 24 hours a day is exempt from the provisions of subsections 5 and 6.

     [Bd. of Pharmacy, § 639.245, eff. 6-26-80]—(NAC A 12-3-84; R116-98, 9-9-98; R160-99, 3-1-2000)

      NAC 639.523  Physical address for delivery of drugs. (NRS 639.070)

     1.  A pharmacy which purchases drugs and which is required pursuant to NAC 639.5005 to designate a natural person as a representative of the pharmacy shall have the drugs shipped to the pharmacy and shall physically receive the drugs at the physical address for which the Board has issued the license of the pharmacy.

     2.  The drugs purchased by a pharmacy must not be drop-shipped to any address other than the physical address of the pharmacy to which the Board has issued the license of the pharmacy. As used in this subsection, “drop-shipped” means a direct shipment of drugs to any location other than the pharmacy by the manufacturer or wholesaler of the drugs.

     3.  A pharmacist employed by a pharmacy shall acknowledge on every invoice that the drugs listed in the invoice were physically received by the pharmacy at the physical address to which the Board has issued the license of the pharmacy.

     (Added to NAC by Bd. of Pharmacy by R010-01, eff. 11-1-2001)

      NAC 639.525  Minimum requirements for work area and equipment. (NRS 639.070)

     1.  The prescription department in each licensed pharmacy must contain the following minimum work area and equipment for the compounding and dispensing of drugs:

     (a) A prescription counter on which to work, with a free working surface of not less than 3 feet in width and 2 feet in depth for each person who is compounding or dispensing drugs within the prescription department, including, without limitation, each registered pharmacist and pharmaceutical technician who is compounding or dispensing drugs within the prescription department. This working surface must be reserved for and restricted solely to the compounding and dispensing of drugs.

     (b) A free floor space behind the prescription counter that is not less than 8 feet in length and 4 feet in width.

     (c) A refrigerator that is equipped with:

          (1) A thermometer to ensure proper control of temperature; and

          (2) A programmable device for monitoring temperature which includes an alarm that records when the temperature falls outside the range required by subsection 1 of NAC 639.527.

     (d) A sink that is suitable for cleaning the required pharmaceutical equipment and is supplied with hot and cold running water, soap and detergent, and a clean and sanitary disposal container for wastes.

     (e) If the pharmacy compounds prescriptions that require the measurement of weight, scales and balances for medium and light weighing, at least one of which must be sensitive to 1/2 grain, with weights, including, without limitation, apothecary and avoirdupois, from 1/2 grain to 4 ounces and from 0.02 gm to 100 gm.

     (f) Capsule and tablet counters and other devices and equipment necessary to compound and dispense drugs.

     (g) A facsimile machine that:

          (1) Uses paper of such quality; and

          (2) Prints in such a manner,

Ê that documents printed by the machine are usable and readable for at least 2 years. As used in this paragraph, “facsimile machine” includes, without limitation, a computer that has a facsimile modem through which documents can be sent and received.

     2.  In addition to the requirements of subsection 1, the prescription department in a licensed pharmacy may contain a freezer that is used to store medicine. If the prescription department in a licensed pharmacy contains such a freezer, the freezer must be equipped with a programmable device for monitoring temperature which includes an alarm that records when the temperature falls outside the range required by subsection 2 of NAC 639.527.

     [Bd. of Pharmacy, § 639.220, eff. 6-26-80]—(NAC A 3-27-90; 8-27-96; 9-6-96; R117-98, 9-9-98; R013-99 & R112-99, 11-3-99; R128-10, 12-16-2010)

      NAC 639.526  Drive-through facilities. (NRS 639.070)

     1.  Except as otherwise provided in subsection 3, if a licensee provides pharmaceutical services by means of a drive-through facility, the drive-through facility must:

     (a) Be constructed and maintained in a manner, and with materials, that secures the premises of the pharmacy from unlawful or unauthorized access.

     (b) Be readily accessible to the personnel of the pharmacy who are authorized to be in the prescription department.

     (c) Provide two-way visual and auditory communication between the personnel of the pharmacy and a patient receiving pharmaceutical services by means of the drive-through facility.

     (d) Be equipped with a computer terminal that is part of the pharmacy’s computerized system for recording information concerning prescriptions. The terminal must be so located within the prescription department that personnel of the pharmacy when providing pharmaceutical services to a patient by means of the drive-through facility can use the computer terminal without losing visual or auditory communication with the patient.

     (e) Be so equipped that a pharmacist, or intern pharmacist under the supervision of a pharmacist, can provide a patient receiving pharmaceutical services by means of the drive-through facility with the counseling required in NAC 639.707 without losing visual or auditory communication with the patient.

     2.  A licensee shall not provide pharmaceutical services by means of a drive-through facility that does not include a window, or other opening, in the exterior wall of the pharmacy unless the licensee first applies for, and obtains, the approval of the Board.

     3.  The Board may, upon application, and for good cause shown, waive or modify any requirement set forth in this section.

     4.  As used in this section:

     (a) “Drive-through facility” means any combination of structural, mechanical, electronic or other elements located within and without the prescription department of a licensed pharmacy that enables the personnel of the pharmacy to provide pharmaceutical services to a patient who drives a vehicle to the pharmacy without the personnel of the pharmacy leaving the prescription department or the patient leaving his or her vehicle. The term includes, without limitation, a window or other opening in the exterior wall of a prescription department of a licensed pharmacy, alone, or in conjunction with one or more mechanical, electronic or other devices.

     (b) “Licensee” means a person licensed by the Board pursuant to NRS 639.231 to conduct a pharmacy.

     (c) “Patient” includes a person caring for a patient.

     (Added to NAC by Bd. of Pharmacy by R154-04, eff. 10-22-2004)

      NAC 639.527  Required temperature in refrigerator or freezer used to store medicine. (NRS 639.070)

     1.  The temperature in a refrigerator that is used to store medicine in the prescription department of a pharmacy must be maintained between 36 degrees Fahrenheit and 46 degrees Fahrenheit.

     2.  The temperature in:

     (a) A freezer section of a refrigerator described in subsection 1 if the freezer section is used to store medicine must be maintained below 32 degrees Fahrenheit; and

     (b) A freezer that is used to store medicine in the prescription department of a pharmacy must be maintained below 32 degrees Fahrenheit.

     3.  If the temperature in a refrigerator, freezer section of a refrigerator, or freezer is outside the range required by subsection 1 or 2, as applicable:

     (a) The person who discovers that the temperature is outside the range, regardless of whether the discovery was made with the assistance of the alarm on a programmable device required pursuant to NAC 639.525, shall:

          (1) Make a record documenting the temperature and, if applicable, the reading from the programmable device; and

          (2) Inform the managing pharmacist of the temperature in the refrigerator, freezer section of the refrigerator, or freezer;

     (b) The managing pharmacist shall ensure that action is taken to correct the temperature in the refrigerator, freezer section of the refrigerator, or freezer and, after verifying that such corrective action has been taken, shall initial the record made pursuant to paragraph (a); and

     (c) A pharmacist shall inspect the contents of the refrigerator, freezer section of the refrigerator, or freezer, as applicable, to determine whether the contents of the refrigerator, freezer section of the refrigerator, or freezer are safe to keep or should be discarded. If the pharmacist determines that those contents must be discarded, the pharmacist shall ensure that the contents are discarded.

     (Added to NAC by Bd. of Pharmacy by R128-10, eff. 12-16-2010)

      NAC 639.528  Preparation and storage of food in prescription department of pharmacy. (NRS 639.070)

     1.  Food for consumption by the public must not be prepared in the prescription department of a pharmacy.

     2.  A pharmacist or a member of the staff of a pharmacy may prepare food in the prescription department of the pharmacy if the food is for his or her own personal consumption.

     3.  No food or beverage may be stored in:

     (a) A refrigerator that is used to store medicine in the prescription department of a pharmacy;

     (b) The freezer section of such a refrigerator if the freezer section is used to store medicine; or

     (c) A freezer that is used to store medicine in the prescription department of a pharmacy.

     (Added to NAC by Bd. of Pharmacy by R117-98, eff. 9-9-98; A by R032-09, 10-27-2009; R128-10, 12-16-2010)

      NAC 639.530  Sanitation; required washbasins; exception. (NRS 639.070)

     1.  Waste material must not be allowed to collect on the floors, counters or other portions of a pharmacy, and adequate waste receptacles must be provided.

     2.  All persons authorized to work within the prescription department must keep themselves and their apparel in a clean and sanitary condition.

     3.  Each pharmacy must have a washbasin which is supplied with hot and cold running water. The washbasin must be located within the pharmacy and be readily available to any person authorized by law to work in the prescription department.

     4.  In addition to the washbasin required pursuant to subsection 3, and except as otherwise provided in this subsection, a pharmacy that is built or remodeled after November 1, 1996, must contain a lavatory with a toilet and washbasin within or adjoining the pharmacy. A pharmacy that is remodeled after November 1, 1996, may ask the Board for an exception to this requirement and the Board will, if it deems it appropriate, grant the exception.

     [Bd. of Pharmacy, § 639.235, eff. 6-26-80]—(NAC A 9-6-96)

      NAC 639.535  Remodeling or relocation of pharmacy or prescription department. (NRS 639.070)  Before undertaking a structural remodeling or relocation of a pharmacy or a prescription department within the premises of a licensed pharmacy, the licensee shall notify the Executive Secretary in writing and pay to the Board an inspection fee of $75.

     [Bd. of Pharmacy, § 639.240, eff. 6-26-80]

      NAC 639.540  Notice of employment and termination of employment of certain pharmaceutical professionals. (NRS 639.070)  The owner, manager, operator or other person in charge of any pharmacy, as that term is defined in NRS 639.012, shall, within 10 days after the employment or termination of employment of a registered pharmacist, intern pharmacist, pharmaceutical technician or pharmaceutical technician in training, give written notice to the Executive Secretary of that employment or termination. The notice must include the name, residential address and certificate number of the employee or former employee.

     [Bd. of Pharmacy, § 639.190, eff. 6-26-80]—(NAC A 11-15-93)

      NAC 639.542  Identification of persons employed by pharmacy. (NRS 639.070)  Each person employed by a pharmacy shall wear identification that clearly identifies the person by name and the classification of his or her registration.

     (Added to NAC by Bd. of Pharmacy, eff. 11-15-93)

      NAC 639.556  Meal periods and rest periods for employees of pharmacy. (NRS 639.070, 639.220)

     1.  Except as otherwise provided in this section and NRS 639.220:

     (a) The owner of a pharmacy shall permit each employee of the pharmacy to take meal periods and rest periods as required by NRS 608.019 or any applicable collective bargaining agreement; and

     (b) A pharmacy may schedule a regular time during which a pharmacist employed by the pharmacy may take a meal period.

     2.  If there is more than one pharmacist on duty at the time that a pharmacist takes a meal period, the pharmacist who is taking the meal period may, at his or her discretion, remain on the premises of the pharmacy or leave the premises of the pharmacy.

     3.  Except as otherwise provided in NRS 639.220, if a pharmacist is the only pharmacist on duty at the time he or she takes a meal period, the pharmacist may, at his or her discretion, remain on the premises of the pharmacy or leave the premises of the pharmacy. If the pharmacist chooses to remain on the premises of the pharmacy, the pharmacist may not be interrupted or disturbed to conduct his or her work as a pharmacist, unless the pharmacist has agreed to such an interruption. If the pharmacist chooses to leave the premises of the pharmacy, the pharmacist shall:

     (a) Close and secure the pharmacy pursuant to NAC 639.520; and

     (b) Post a sign that is visible to the public stating the time the pharmacist will return from the meal break.

     4.  A pharmacy that is closed and secured during the meal period of a pharmacist pursuant to subsection 3 may accept a prescription during the meal period if:

     (a) The prescription is placed by the patient or the patient’s agent or representative in a secure container or receptacle that ensures that the prescription cannot be seen, removed or damaged until it is retrieved by a pharmacist or other authorized employee of the pharmacy; or

     (b) An authorized employee of the pharmacy personally accepts and secures the prescription from the patient or the patient’s agent or representative outside the closed and secured premises of the pharmacy.

     5.  A pharmacy may require a pharmacist to remain on the premises of the pharmacy during a rest period, but may not require the pharmacist to serve the public during the rest period. The pharmacist may, at the discretion of the pharmacist, agree to have his or her rest period interrupted.

     6.  The provisions of this section do not affect any other provision of law regarding the practice of pharmacy.

     (Added to NAC by Bd. of Pharmacy by R152-05, eff. 12-29-2005)

      NAC 639.570  Involuntary closure of pharmacy. (NRS 639.070)

     1.  Upon an involuntary closure of a pharmacy, the licensee shall immediately surrender to the Board all controlled substances and dangerous drugs, and all order forms therefor, which are owned or controlled by the licensee on the premises of the pharmacy. A member of the Board or one of its inspectors shall immediately take possession of and hold all such substances, drugs and forms.

     2.  The controlled substances, dangerous drugs and forms so surrendered will be held in trust by the Board for the licensee. The substances and drugs so held will forthwith be inventoried, packaged, sealed and stored at the expense of the licensee in a place determined by the Board to be appropriately secure.

     3.  A licensee has 60 days after the effective date of the involuntary closure to make arrangements for the lawful sale or other disposition of the controlled substances and dangerous drugs so inventoried and stored. If no such sale or disposition is made by the licensee within the 60-day period, the Board will make arrangements for the sale or other disposition of the substances and drugs for the benefit of the licensee, and will account for them to the licensee. Upon disposition of the substances and drugs, the order forms will be returned to the Drug Enforcement Administration.

     4.  The licensee shall cooperate with the Board to promote the efficient administration of this section.

     5.  As used in this section, “involuntary closure” of a pharmacy includes:

     (a) Closure as a result of action by the Federal Government, the State of Nevada or the governing body of any county or city within the State of Nevada;

     (b) The revocation or suspension of any license issued to a pharmacy by the Board; or

     (c) Any other involuntary closure, including an involuntary adjudication of bankruptcy, an appointment of a receiver or an entry of an order of closure by a court of competent jurisdiction.

     [Bd. of Pharmacy, § 639.275, eff. 6-26-80]

      NAC 639.575  Voluntary closure of pharmacy. (NRS 639.070)

     1.  Whenever any pharmacy licensed by the Board is closed for more than 5 consecutive days for any reason other than an involuntary closure, the licensee shall notify the Board of the closure. The notice must be in writing, be given not more than 5 days after the closure, and state the reason or reasons for the closure and the anticipated period of the closure. Upon receipt of the notice, the Board will make such arrangements as it deems appropriate to provide adequate and continued security of all the controlled substances, dangerous drugs, chemicals and poisons which are owned or controlled by the licensee or on the premises of the pharmacy.

     2.  If the licensee of a pharmacy dies or becomes legally disabled by a cause other than a mental illness for which provision is made in NRS 639.211 and the disability does not result in an involuntary closure, a member of the Board or one of its inspectors shall forthwith take custody of all controlled substances and dangerous drugs which are owned or controlled by the licensee or are on the premises of the pharmacy and thereupon proceed in the manner provided in NAC 639.570. The Board will also make such arrangements as it deems appropriate to provide adequate and continued security for all the chemicals and poisons which are owned or controlled by the licensee or are on the premises of the pharmacy.

     3.  The licensee shall cooperate with the Board to promote the efficient administration of this section.

     [Bd. of Pharmacy, § 639.280, eff. 6-26-80]

      NAC 639.580  Permanent closure of pharmacy. (NRS 639.070)

     1.  If the licensee of a pharmacy ceases to do business and permanently closes the pharmacy the licensee must:

     (a) Place a sign in the front window of the pharmacy notifying the public of the name and address of the pharmacy to which the prescription files have been transferred. The sign must remain so placed for a period of 30 days unless sooner removed by the landlord or a new tenant.

     (b) Return to the Executive Secretary his or her pharmacy license and license renewal certificates.

     (c) Prepare separate inventories in duplicate of the controlled substances and dangerous drugs on the premises at the time of the closure and provide the purchaser thereof with copies of the inventories. Copies of the inventories must be retained by the seller and the purchaser for 2 years.

     (d) If the licensee is transferring prescription files for controlled substances or dangerous drugs, comply with the provisions of NAC 639.713 and 639.714, and ensure that:

          (1) The information relating to the refill of each prescription is included on the prescription; or

          (2) If the licensee maintains his or her prescription files on a computer system, the information relating to the refill of each prescription is accessible by the computer system of the pharmacy to which the information is transferred.

     (e) Notify the Executive Secretary in writing of:

          (1) The method of disposition of the controlled substances and dangerous drugs;

          (2) The name of the purchaser; and

          (3) The kinds and amounts transferred.

     2.  The licensee shall cooperate with the Board to promote the efficient administration of this section.

     [Bd. of Pharmacy, § 639.285, eff. 6-26-80]—(NAC A 7-17-96)

NUCLEAR PHARMACIES

      NAC 639.5802  Definitions. (NRS 639.070)  As used in NAC 639.5802 to 639.584, inclusive, unless the context otherwise requires, the words and terms defined in NAC 639.5804 to 639.5814, inclusive, have the meanings ascribed to them in those sections.

     (Added to NAC by Bd. of Pharmacy, eff. 11-9-95)

      NAC 639.5804  “Agreement state” defined. (NRS 639.070)  “Agreement state” means any state with which the Nuclear Regulatory Commission has entered into an effective agreement pursuant to section 274(b) of the Atomic Energy Act of 1954, 42 U.S.C. § 2021(b).

     (Added to NAC by Bd. of Pharmacy, eff. 11-9-95)

      NAC 639.5806  “Authentication of product history” defined. (NRS 639.070)  “Authentication of product history” means identifying the purchasing source, the ultimate destination and any intermediate handling of any component of a radiopharmaceutical or other drug.

     (Added to NAC by Bd. of Pharmacy, eff. 11-9-95)

      NAC 639.5808  “Procedures to assure the quality of radiopharmaceuticals” defined. (NRS 639.070)  “Procedures to assure the quality of radiopharmaceuticals” means all activities necessary to assure the quality of the process used to provide radiopharmaceutical services, including, but not limited to, authentication of product history and maintenance of any records required by an appropriate regulatory agency.

     (Added to NAC by Bd. of Pharmacy, eff. 11-9-95)

      NAC 639.581  “Qualified nuclear pharmacist” defined. (NRS 639.070)  “Qualified nuclear pharmacist” means a nuclear pharmacist who meets the requirements set forth in NAC 639.5818.

     (Added to NAC by Bd. of Pharmacy, eff. 11-9-95)

      NAC 639.5812  “Radiopharmaceutical services” defined. (NRS 639.070)  “Radiopharmaceutical services” means the procurement, storage, handling, compounding, preparation, labeling, testing to control the quality of, dispensation, distribution, transfer, recordkeeping and disposal of radiochemicals, radiopharmaceuticals and ancillary drugs. The term includes procedures to assure the quality of radiopharmaceuticals, radiological health activities, consulting activities associated with the use of radiopharmaceuticals, health physics and any other activities required for the provision of pharmaceutical care.

     (Added to NAC by Bd. of Pharmacy, eff. 11-9-95)

      NAC 639.5814  “Testing to control the quality of radiopharmaceutical” defined. (NRS 639.070)  “Testing to control the quality of radiopharmaceutical” means the performance of appropriate chemical, biological and physical tests on a compounded radiopharmaceutical and the interpretation of the resulting data to determine its suitability for use in humans and animals.

     (Added to NAC by Bd. of Pharmacy, eff. 11-9-95)

      NAC 639.5816  “Radiopharmaceutical” interpreted. (NRS 639.070)  The Board interprets the term “radiopharmaceutical” as defined in NRS 639.0143 to include any biological product which is labeled with a radionuclide or intended solely to be labeled with a radionuclide.

     (Added to NAC by Bd. of Pharmacy, eff. 11-9-95)

      NAC 639.5818  Nuclear pharmacist: Certification; training and instruction; affidavit of experience and training. (NRS 639.070)  A nuclear pharmacist must hold a current license issued by the Board and must:

     1.  Be certified as a nuclear pharmacist by the Board of Pharmaceutical Specialties, an affiliate of the American Pharmacists Association; or

     2.  Satisfy each of the following requirements:

     (a) Meets minimum standards of training for status as an authorized user of radioactive material and is licensed by the Nuclear Regulatory Commission or an agreement state.

     (b) Has successfully completed a minimum of 200 contact hours of instruction in nuclear pharmacy and the safe handling and use of radioactive materials from a nationally accredited college of pharmacy or a training program recognized by the Nuclear Regulatory Commission or an agreement state. The minimum required hours must be apportioned as follows:

          (1) Radiation physics and instrumentation (85 hours);

          (2) Protection against radiation (45 hours);

          (3) Mathematics pertaining to the use and measurement of radioactivity (20 hours);

          (4) Radiation biology (20 hours); and

          (5) Radiopharmaceutical chemistry (30 hours).

     (c) Has attained a minimum of 500 hours of clinical or practical training in nuclear pharmacy under the supervision of a qualified nuclear pharmacist in the following areas, as described in the current Nuclear Pharmacy Practice Standards adopted by the American Pharmacists Association:

          (1) Procuring radioactive materials;

          (2) Compounding radiopharmaceuticals;

          (3) Performing routine testing to control the quality of radiopharmaceuticals;

          (4) Dispensing radiopharmaceuticals;

          (5) Distributing radiopharmaceuticals;

          (6) Carrying out basic procedures for protection against radiation; and

          (7) Consulting and educating persons engaged in nuclear medicine, patients, pharmacists, other health professionals and the general public.

     (d) Has submitted an affidavit of experience and training to the Board.

     (Added to NAC by Bd. of Pharmacy, eff. 11-9-95)

      NAC 639.582  Permit to operate. (NRS 639.070)  The Board will issue a permit to operate a nuclear pharmacy only to a person who is a qualified nuclear pharmacist or who employs a qualified nuclear pharmacist. The permit to operate a nuclear pharmacy is effective only as long as the pharmacy also holds a current license issued by the Nuclear Regulatory Commission. Copies of reports of any inspection conducted by the Nuclear Regulatory Commission must be made available on request for inspection by the Board.

     (Added to NAC by Bd. of Pharmacy, eff. 11-9-95)

      NAC 639.5822  Space and equipment requirements; floor plan. (NRS 639.070)  A nuclear pharmacy must have adequate space and equipment commensurate with the scope of services it provides and must meet the minimum space requirements established for all pharmacies in the State. A nuclear pharmacy must include, but is not limited to, an area for the:

     1.  Preparation and dispensation of radiopharmaceuticals.

     2.  Shipment and receipt of radioactive material.

     3.  Storage of radioactive material.

     4.  Decay of radioactive waste.

Ê An application for a permit to operate a nuclear pharmacy must include a detailed floor plan of the nuclear pharmacy. The Board must approve any subsequent material change to the floor plan.

     (Added to NAC by Bd. of Pharmacy, eff. 11-9-95)

      NAC 639.5824  Security. (NRS 639.070)  A nuclear pharmacy must be totally enclosed and be able to be locked to prevent access by unauthorized personnel.

     (Added to NAC by Bd. of Pharmacy, eff. 11-9-95)

      NAC 639.5826  Records. (NRS 639.070)  The records of acquisition, inventory and disposition of all radioactive drugs and other radioactive materials of a nuclear pharmacy must be maintained in accordance with the statutes and regulations of the Board, the Nuclear Regulatory Commission or an agreement state.

     (Added to NAC by Bd. of Pharmacy, eff. 11-9-95)

      NAC 639.5828  Quality assurance procedures for radiopharmaceuticals. (NRS 639.070)  A nuclear pharmacy must compound and dispense radiopharmaceuticals in accordance with the accepted procedures to assure the quality of radiopharmaceuticals.

     (Added to NAC by Bd. of Pharmacy, eff. 11-9-95)

      NAC 639.583  Dispensing or transferring radiopharmaceuticals. (NRS 639.070)  A radiopharmaceutical must be dispensed only pursuant to a prescription order received from a licensed practitioner authorized by the Nuclear Regulatory Commission or an agreement state to possess, use and administer such a drug. A radiopharmaceutical may be transferred to a person who is authorized to possess and use such a drug for nonclinical applications.

     (Added to NAC by Bd. of Pharmacy, eff. 11-9-95)

      NAC 639.5832  Oral order for radiopharmaceutical: Requirement to keep record; contents of record. (NRS 639.070)  After receiving an oral order for a radiopharmaceutical, a nuclear pharmacy immediately must reduce the order to writing or record the order in a data processing system and must include, without limitation, the following information:

     1.  The name of the institution and the prescriber or prescriber’s agent.

     2.  The date of dispensation and the calibration time of the radiopharmaceutical.

     3.  The name of the procedure.

     4.  The name of the radiopharmaceutical.

     5.  The dose or quantity of the radiopharmaceutical.

     6.  The serial number assigned to the order for the radiopharmaceutical.

     7.  Any specific instructions of the prescriber.

     8.  The initials of the person who received the order.

     9.  The initials of the person who dispensed the order.

     10.  If an order is for a radiopharmaceutical for therapeutic use or use in a blood product, the name of the patient must be obtained and recorded before dispensing the radiopharmaceutical.

     (Added to NAC by Bd. of Pharmacy, eff. 11-9-95)

      NAC 639.5834  Outer shield of radiopharmaceutical container: Label required; contents of label. (NRS 639.070)  The immediate outer shield of the container of a radiopharmaceutical to be dispensed must be labeled with:

     1.  The name and address of the pharmacy.

     2.  The name of the prescriber.

     3.  The date of dispensation.

     4.  The serial number assigned to the order for the radiopharmaceutical.

     5.  The standard radiation symbol.

     6.  The words “CAUTION RADIOACTIVE MATERIAL.”

     7.  The name of the procedure.

     8.  The radionuclide and chemical form.

     9.  The amount of radioactivity and the date and time of the calibration.

     10.  If the radiopharmaceutical is a liquid, the volume.

     11.  If the radiopharmaceutical is a solid, the number of items or weight.

     12.  If the radiopharmaceutical is a gas, the number of ampules or vials.

     13.  The molybdenum 99 content in accordance with the limitations prescribed in the United States Pharmacopeia - National Formulary, as adopted by reference in paragraph (c) of subsection 1 of NAC 639.670.

     14.  The name of the patient or the words “Physician’s Use Only” in the absence of a patient’s name.

     15.  If the prescription is for a radiopharmaceutical for therapeutic use or use in a blood product, the patient’s name must appear on the label. The requirements of this subsection are met if the name of the patient is readily retrievable from the prescriber upon demand.

     (Added to NAC by Bd. of Pharmacy, eff. 11-9-95; A by R035-06, 9-18-2008)

      NAC 639.5836  Inner label of radiopharmaceutical container; contents. (NRS 639.070)  The immediate inner label of a container of a radiopharmaceutical to be dispensed must be labeled with:

     1.  The name of the pharmacy.

     2.  The standard radiation symbol.

     3.  The words “CAUTION RADIOACTIVE MATERIAL.”

     4.  The identity of the radionuclide.

     5.  The chemical form.

     6.  The name of the procedure.

     7.  The serial number assigned to the order for the radiopharmaceutical.

     (Added to NAC by Bd. of Pharmacy, eff. 11-9-95)

      NAC 639.5838  Records of nuclear pharmacy when radiopharmaceutical is dispensed pursuant to investigational new drug application: Contents. (NRS 639.070)  If a radiopharmaceutical is dispensed pursuant to the authority of an investigational new drug application approved by the United States Food and Drug Administration, the records of a nuclear pharmacy must include:

     1.  An investigator’s protocol for the preparation of the radiopharmaceutical;

     2.  A copy of the approval form or letter of the internal review board of the institution; and

     3.  A letter from the manufacturer or sponsor indicating that the physician requesting the radiopharmaceutical is a qualified investigator.

     (Added to NAC by Bd. of Pharmacy, eff. 11-9-95)

      NAC 639.584  Required equipment. (NRS 639.070)  A nuclear pharmacy must have the following equipment:

     1.  A radionuclide dose calibrator.

     2.  A refrigerator.

     3.  A single or multiple channel well scintillation counter containing the isotopes sodium iodide, thallium, germanium and lithium.

     4.  A radiochemical fume hood and filter system with suitable equipment for sampling air.

     5.  An area survey meter.

     6.  At least two Geiger Mueller survey meters, including one high-range meter.

     7.  A microscope and hemacytometer.

     8.  A laminar airflow hood and appropriate supplies to ensure sterile practices for parenteral solutions.

     9.  Radiation shields for syringes and vials.

     10.  A lead-shielded drawing station.

     11.  Decontamination supplies.

     12.  Appropriate supplies to perform procedures to assure the quality of radiopharmaceuticals.

     13.  Lead transport shields for syringes and vials.

     14.  USA Type A, 7A transport containers approved by the Department of Transportation and other labels and supplies for shipping radioactive materials.

     (Added to NAC by Bd. of Pharmacy, eff. 11-9-95)

WHOLESALERS

      NAC 639.585  Definitions. (NRS 639.070)  As used in NAC 639.585 to 639.607, inclusive, unless the context otherwise requires, the words and terms defined in NAC 639.587 to 639.592, inclusive, have the meanings ascribed to them in those sections.

     (Added to NAC by Bd. of Pharmacy, eff. 7-16-92; A 10-1-93; R013-01, 11-1-2001; R049-04, 2-28-2005; R218-05, 5-4-2006; R097-07, 10-31-2007; R051-07, 12-4-2007; R122-07, 1-30-2008)

      NAC 639.587  “Facility” defined. (NRS 639.070)  “Facility” means a facility of a wholesaler where prescription drugs are stored, handled, repackaged or offered for sale.

     (Added to NAC by Bd. of Pharmacy, eff. 7-16-92)

      NAC 639.588  “Manufacturer” defined. (NRS 639.070)  “Manufacturer” has the meaning ascribed to it in NRS 639.009.

     (Added to NAC by Bd. of Pharmacy, eff. 7-16-92)

      NAC 639.589  “Ongoing relationship” defined. (NRS 639.070)  “Ongoing relationship” means a continuing business relationship in which a wholesaler distributes a manufacturer’s prescription drugs which is established pursuant to NAC 639.594.

     (Added to NAC by Bd. of Pharmacy, eff. 7-16-92)

      NAC 639.5895  “Purchaser” defined. (NRS 639.070)  “Purchaser” means a pharmacy or practitioner that purchases a prescription drug from a wholesaler licensed pursuant to NRS 639.233.

     (Added to NAC by Bd. of Pharmacy by R049-04, eff. 2-28-2005)

      NAC 639.5897  “Purchasing wholesaler” defined. (NRS 639.070)  “Purchasing wholesaler” means a wholesaler that purchases a prescription drug from a wholesaler licensed pursuant to NRS 639.233.

     (Added to NAC by Bd. of Pharmacy by R049-04, eff. 2-28-2005)

      NAC 639.5902  “Statement of prior sales” defined. (NRS 639.070)  “Statement of prior sales” has the meaning ascribed to it in NRS 639.535.

     (Added to NAC by Bd. of Pharmacy by R218-05, eff. 5-4-2006)

      NAC 639.5905  “Supplier” defined. (NRS 639.070)  “Supplier” means a wholesaler that sells a prescription drug to a wholesaler licensed pursuant to NRS 639.233.

     (Added to NAC by Bd. of Pharmacy by R049-04, eff. 2-28-2005)

      NAC 639.592  “Wholesaler” defined. (NRS 639.070)  “Wholesaler” has the meaning ascribed to it in NRS 639.016.

     (Added to NAC by Bd. of Pharmacy, eff. 7-16-92)

      NAC 639.593  Licensing requirements; consideration of transaction as wholesale transaction; transferability and renewal of license. (NRS 639.070, 639.100, 639.500)

     1.  Each applicant for a license to engage in the wholesale distribution of prescription drugs must submit an application to the Board. The application must be made on a form furnished by the Board. The application must include:

     (a) The name, business address and telephone number of the applicant and the address of the facility, if different from the address of the applicant;

     (b) All trade or business names used by the applicant;

     (c) The address, telephone number and name of the person who manages the facility;

     (d) The type of ownership or operation of the facility;

     (e) Except as otherwise provided in subsection 7:

          (1) A complete set of fingerprints from each person required to submit fingerprints pursuant to NRS 639.500; and

          (2) Written permission from each person who submitted fingerprints authorizing the Board to forward the fingerprints to the Central Repository for Nevada Records of Criminal History for submission to the Federal Bureau of Investigation for its report; and

     (f) If the applicant is a:

          (1) Natural person, the name of the person.

          (2) Partnership, the name of the partnership and the name of each partner.

          (3) Corporation, the name and title of each officer and director of the corporation, the corporate name and the state of incorporation, and the name of the parent company, if any.

          (4) Sole proprietorship, the name of the sole proprietor and the name of the business entity.

     2.  If a wholesaler distributes prescription drugs from more than one facility, the wholesaler must obtain a license for each facility.

     3.  The Board will not consider the sale or distribution of a prescription drug to be a wholesale transaction if the sale, distribution or other transaction involving the prescription drug is a sale, distribution or other transaction in which:

     (a) A wholesaler licensed by the Board or the relevant authority of another state sells, distributes or otherwise provides a prescription drug to a wholesaler or pharmacy licensed by the Board;

     (b) Both the transferring wholesaler and the transferee are wholly owned by a common owner; and

     (c) The common owner is a publicly traded corporation.

Ê For the purposes of this subsection, a wholesaler whose transaction does not comply with the provisions of paragraphs (a), (b) and (c) may apply to the Board to consider the transaction of the wholesaler not to be a wholesale transaction if the wholesaler provides proof that is satisfactory to the Board that the proposed transaction will not endanger the public and is not proposed for the purpose of evading the provisions of this chapter and chapter 639 of NRS. The Board will consider such a transaction to be a wholesale transaction until the Board approves the application of the wholesaler.

     4.  An applicant shall submit to the Board any change in the information required by this section within 30 days after the change occurs.

     5.  A license issued by the Board is not transferable.

     6.  Except as otherwise provided in subsection 7, each wholesaler applying for renewal of a license to engage in the wholesale distribution of prescription drugs must submit:

     (a) A complete set of fingerprints from each person required to submit fingerprints pursuant to NRS 639.500; and

     (b) Written permission from each person who submitted fingerprints authorizing the Board to forward the fingerprints to the Central Repository for Nevada Records of Criminal History for submission to the Federal Bureau of Investigation for its report.

     7.  Unless the Board otherwise requires, a wholesaler is not required to submit fingerprints pursuant to subsection 6 if:

     (a) The wholesaler’s securities are publicly traded and regulated by the Securities Exchange Act of 1934, as amended, 15 U.S.C. §§ 78a et seq.;

     (b) The wholesaler is owned by a corporation whose securities are publicly traded and regulated by the Act;

     (c) The wholesaler is accredited by the National Association of Boards of Pharmacy under the Verified-Accredited Wholesale Distributors program;

     (d) The wholesaler is a manufacturer of prescription drugs; or

     (e) The wholesaler is a facility that distributes prescription drugs manufactured by a single manufacturer.

     (Added to NAC by Bd. of Pharmacy, eff. 7-16-92; A by R013-01, 11-1-2001; R049-04, 2-28-2005; R218-05, 5-4-2006; R051-07, 12-4-2007)

      NAC 639.5931  Submission of fingerprints: Required method. (NRS 639.070, 639.500, 639.505)  A person who is required to submit a complete set of his or her fingerprints to the Board pursuant to NRS 639.500 or 639.505 or NAC 639.593 must submit the fingerprints electronically in a format prescribed by the Board.

     (Added to NAC by Bd. of Pharmacy by R097-07, eff. 10-31-2007)

      NAC 639.5932  Provisional license: Prerequisites for issuance. (NRS 639.070, 639.500)  The Board may issue a provisional license to an applicant pursuant to subsection 3 of NRS 639.500, if the applicant:

     1.  Submits evidence satisfactory to the Board establishing that the applicant is licensed in another state as a wholesaler, that such license is in good standing and that the applicant is not:

     (a) Under investigation;

     (b) Subject to an administrative action; or

     (c) Otherwise engaged in litigation,

Ê for a matter related to the practice of the applicant.

     2.  Provides to the Board a list of all sources from which the applicant obtained prescription drugs during the 12 months immediately preceding the date on which the application was submitted.

     3.  Provides to the Board a list of all customers to whom the applicant sold or otherwise provided prescription drugs during the 12 months immediately preceding the date on which the application was submitted.

     4.  Provides all other documents as may be requested by the Board.

     (Added to NAC by Bd. of Pharmacy by R218-05, eff. 5-4-2006)

      NAC 639.5935  Representative of wholesaler: General requirements; exceptions; approval; enforcement. (NRS 639.070, 639.100)

     1.  Except as otherwise provided in this subsection, an applicant for a license, or a licensee with a license, to operate as a wholesaler shall designate at least one natural person to serve as the representative of the wholesaler. The Board will not issue or renew a license of an applicant or licensee that is required to designate a representative of a wholesaler pursuant to this section unless the Executive Secretary determines that the designated natural person meets the qualifications set forth in subsection 2 and approves that natural person to be the designated representative of the wholesaler. The requirement to designate a representative set forth in this subsection does not apply to:

     (a) An applicant that is a publicly traded corporation; or

     (b) An applicant in which a majority interest of the applicant is owned by a pharmacist who is:

          (1) Licensed by the Board;

          (2) A resident of this State; and

          (3) Not an owner of any interest in a pharmacy licensed by the Board.

     2.  Except as otherwise provided in subsection 3, the Board will approve a natural person as the representative of a wholesaler if the applicant for a license to operate as a wholesaler or the licensee presents proof satisfactory to the Executive Secretary that the natural person:

     (a) Has been employed for at least 6,000 hours in a pharmacy or with a wholesaler in a capacity related to the dispensing and distribution of, and recordkeeping relating to, prescription drugs;

     (b) Has received a score of at least 75 percent on an examination given by the Board regarding federal and state laws and wholesaler practices; and

     (c) Is at least 21 years of age.

     3.  The Board may, based upon any of the grounds set forth in NRS 639.210, refuse to approve a natural person for service as the representative of a wholesaler, regardless of whether the person is otherwise qualified.

     4.  A representative of a wholesaler designated pursuant to this section:

     (a) Must be actively involved in and aware of the actual daily operation of the wholesaler;

     (b) Must be employed full-time in a managerial level position with the wholesaler;

     (c) Must be physically present at the facility of the wholesaler during regular business hours, except when the absence of the representative is authorized, including sick leave, vacation leave and other authorized absences; and

     (d) May serve in this representative capacity for only one wholesaler at a time.

     5.  A wholesaler that is required to designate a natural person as its representative pursuant to this section shall not open or operate a facility unless that representative is actually employed full-time in the operation of the wholesaler and is physically present at the facility of the wholesaler during regular working hours, not including sick leave, vacation leave and other authorized absences from work. If the natural person designated as the representative of a wholesaler leaves the employ of the wholesaler, thus leaving the wholesaler without a representative in violation of this section, the wholesaler shall:

     (a) Immediately cease conducting business until another qualified natural person is approved by the Board to serve as the representative of the wholesaler; and

     (b) Not later than 48 hours after that person leaves its employ, notify the Board that the person designated as the representative of the wholesaler has left the employ of the wholesaler.

     6.  Before a wholesaler that is in violation of this section because the natural person designated as the representative of the wholesaler left the employ of the wholesaler may continue conducting business:

     (a) The wholesaler must designate, on a form provided by the Board, a new natural person to serve as the representative of the wholesaler; and

     (b) The Executive Secretary must approve the natural person so designated.

     7.  A wholesaler that operates without a representative in violation of this section is subject to the immediate suspension of its license until it employs a qualified natural person to be its representative. The Executive Secretary may take such action as deemed necessary to secure the facility of the wholesaler and to ensure that the wholesaler does not conduct business during the period of the suspension.

     (Added to NAC by Bd. of Pharmacy by R013-01, eff. 11-1-2001)

      NAC 639.5937  Bond or other security: Amount required from certain wholesalers; reduction of amount; substitution. (NRS 639.070, 639.515)

     1.  Unless the Board otherwise requires, a wholesaler shall file with the Board a bond or other security in the amount of $25,000 pursuant to NRS 639.515 if the wholesaler is:

     (a) Accredited by the National Association of Boards of Pharmacy under the Verified-Accredited Wholesale Distributors program;

     (b) A manufacturer of prescription drugs; or

     (c) A facility that distributes prescription drugs manufactured by a single manufacturer.

     2.  The Board will reduce the bond or other security to the amount of $5,000 if any wholesaler described in subsection 1 has been licensed with the Board for 5 consecutive years or more.

     3.  Any bond or other security filed with the Board pursuant to subsection 1 may be substituted by a different bond or other security of equal value. The Board will release the previous bond or other security to the applicant upon receipt of the new bond or security.

     (Added to NAC by Bd. of Pharmacy by R051-07, eff. 12-4-2007)

      NAC 639.5938  Filing of single bond for multiple sites. (NRS 639.070, 639.515)  Upon application from a wholesaler, the Board may allow a single bond:

     1.  Of $100,000 to serve as the bond required pursuant to NRS 639.515, for multiple sites if all sites are owned by a common owner who has a net worth of more than $25,000,000. The owner must provide evidence satisfactory to the Board demonstrating adequate net worth.

     2.  In an amount determined by the Board to serve as the bond required pursuant to NRS 639.515, for multiple sites where the wholesaler participates exclusively in transactions that the Board considers not to be a wholesale transaction pursuant to subsection 3 of NAC 639.593.

     (Added to NAC by Bd. of Pharmacy by R218-05, eff. 5-4-2006)

      NAC 639.594  Establishment of ongoing relationship. (NRS 639.070, 639.100, 639.595)

     1.  An ongoing relationship between a wholesaler and a manufacturer must be established by:

     (a) A written franchise, license or other agreement between a manufacturer and wholesaler to distribute prescription drugs;

     (b) The presence of the wholesaler on a list of distributors with which the manufacturer does business, created by the manufacturer and located on a publicly accessible website maintained by the manufacturer; or

     (c) The existence of the purchase by the wholesaler of at least 5,000 sales units of prescription drugs from the manufacturer within the 12 months immediately preceding the transaction for which the wholesaler claims to have an ongoing relationship and:

          (1) The Board or a purchasing wholesaler verifying the purchase with the manufacturer at its main corporate office in the United States; or

          (2) The wholesaler maintaining invoices showing that the purchase was made directly from the manufacturer which include an account number assigned by the manufacturer to the wholesaler’s address of record on file with the Board.

     2.  The records establishing an ongoing relationship between a wholesaler and a manufacturer must be:

     (a) If the facility is located within this State, maintained at the facility of the wholesaler throughout the period that such a relationship exists;

     (b) Maintained for 3 years after the termination of any such relationship; and

     (c) Available for review and copying by the Board or by any authorized representative of a federal, state or local agency.

     3.  An ongoing relationship between a wholesaler and a manufacturer may be attributed to an affiliated wholesaler if:

     (a) The affiliated wholesaler is licensed by the Board or the relevant authority of another state;

     (b) The wholesaler who has the ongoing relationship with the manufacturer and the affiliated wholesaler are wholly owned by a common owner; and

     (c) The common owner is a publicly traded corporation.

     4.  As used in this section, “sales unit” means any standard container or unit of packaging used by the manufacturer for the prescription drug.

     (Added to NAC by Bd. of Pharmacy, eff. 7-16-92; A by R013-01, 11-1-2001; R049-04, 2-28-2005)

      NAC 639.595  Qualifications of employees who engage in storage or distribution of drugs. (NRS 639.070)  Each wholesaler licensed by the Board shall ensure that any person the wholesaler employs who engages in the storage or distribution of drugs in a facility has the education and experience necessary to engage safely and lawfully in the storage or distribution of those drugs.

     (Added to NAC by Bd. of Pharmacy, eff. 7-16-92)

      NAC 639.596  Facilities: General requirements; maintenance of stock. (NRS 639.070)

     1.  Each facility must:

     (a) Provide adequate lighting of at least 25 foot-candles;

     (b) Provide an adequate area for the storage of the prescription drugs within the facility in such a manner as to facilitate access to those drugs;

     (c) Be maintained in a clean and orderly condition;

     (d) Be free from infestation by insects, rodents, birds or vermin;

     (e) Be secure from entry by unauthorized persons;

     (f) Be equipped with an alarm system to detect entry to the facility after business hours; and

     (g) Maintain a stock of prescription drugs on its shelves sufficient to serve the expected and ordinary needs of the practitioners and pharmacies with which it ordinarily transacts business.

     2.  If a wholesaler sells or deals in controlled substances, the wholesaler shall maintain a representative stock sufficient to serve the expected and ordinary needs of the practitioners and pharmacies with which it ordinarily transacts business.

     3.  A wholesaler shall not maintain any stock of controlled substances unless it ordinarily sells controlled substances to the practitioners and pharmacies with which it ordinarily transacts business.

     (Added to NAC by Bd. of Pharmacy, eff. 7-16-92; A by R013-01, 11-1-2001)

      NAC 639.597  Facilities: Security. (NRS 639.070)

     1.  Access to the facility must be kept to a minimum and be well-controlled.

     2.  The outside perimeter of the facility must be properly lighted.

     3.  Access to the area of the facility where the controlled substances are stored must be limited to authorized persons.

     4.  The area of the facility where controlled substances are stored must be securely enclosed with a material made of steel of at least 10 gauge in thickness with openings not more than 2 1/2 inches wide. The material must be mounted on steel posts which must be at least 1 inch in diameter. The posts must be placed not more than 10 feet apart. If the material does not extend to the structural ceiling of the facility, the ceiling of the enclosed area must be constructed of material made of steel at least 10 gauge in thickness with openings not more than 2 1/2 inches wide. A lighter gauge mesh may be used for the ceiling of a large enclosed area if the walls of the area are at least 14 feet in height.

     5.  Access to the enclosed area must be limited to persons who are responsible for ensuring the security of the controlled substances stored within that enclosed area. The enclosed area must be equipped with a security system which includes an alarm that will transmit a signal to a local law enforcement agency or a private business which provides security services if an unauthorized person obtains access to the enclosed area.

     6.  The Executive Secretary may approve an alternate method for ensuring the security of the area where the controlled substances are stored if he or she determines that the method will ensure that entry to the area is accessible only to authorized persons.

     (Added to NAC by Bd. of Pharmacy, eff. 7-16-92)

      NAC 639.5975  Prescription drugs: Restrictions on purchase and receipt; disposal of certain drugs. (NRS 639.070, 639.595)

     1.  Except as otherwise provided in this section, a wholesaler shall not purchase or otherwise receive a prescription drug from:

     (a) Any person who is not a wholesaler or manufacturer; or

     (b) A wholesaler if any previous seller of the drug was not a wholesaler or a manufacturer.

     2.  A wholesaler may receive a prescription drug from a person who is not a wholesaler or manufacturer if the prescription drug was originally purchased by that person from the wholesaler.

     3.  A wholesaler that was not the original wholesaler which sold prescription drugs to a person who is not a wholesaler or manufacturer may receive the prescription drugs if:

     (a) The person no longer does business with the original wholesaler;

     (b) The original wholesaler no longer does business with the person; or

     (c) The original wholesaler refuses to allow the return of the prescription drugs.

     4.  A wholesaler shall not:

     (a) Receive from a person who is not a wholesaler or manufacturer an amount or quantity of a prescription drug larger than the amount or quantity that was originally sold by the original wholesaler to that person;

     (b) Pay that person an amount, either in cash or credit, that is more than:

          (1) The amount the person originally paid to the original wholesaler for the prescription drug; or

          (2) The price the receiving wholesaler would have charged that person for the prescription drug at the time of the return; or

     (c) Purchase a contraband drug or a counterfeit drug.

     5.  A wholesaler that receives a prescription drug from a person who is not a wholesaler or manufacturer pursuant to this section may dispose of the prescription drug by:

     (a) Destroying the prescription drug;

     (b) Selling the prescription drug to another person who is not a wholesaler or manufacturer;

     (c) Selling the prescription drug to another wholesaler; or

     (d) Providing the prescription drug to another wholesaler or the manufacturer of the prescription drug solely for the purposes of destruction or disposal.

     6.  If a wholesaler:

     (a) Sells a prescription drug to another person who is not a wholesaler or manufacturer pursuant to paragraph (b) of subsection 5, the wholesaler is not required to provide a “Statement Identifying Prior Sales of Prescription Drugs by Wholesalers Required by the Prescription Drug Marketing Act” described in NAC 639.603.

     (b) Sells or provides a prescription drug to another wholesaler or the manufacturer of the prescription drug pursuant to paragraph (c) or (d) of subsection 5, the wholesaler must provide a “Statement Identifying Prior Sales of Prescription Drugs by Wholesalers Required by the Prescription Drug Marketing Act” as described in NAC 639.603 for that sale and must indicate on the statement that the prescription drug was received from the person from whom the wholesaler accepted the prescription drug.

     (Added to NAC by Bd. of Pharmacy by R013-01, eff. 11-1-2001; A by R049-04, 2-28-2005)

      NAC 639.5977  Prescription drugs: Sale to purchasing wholesaler. (NRS 639.070, 639.595)

     1.  For each sale of a prescription drug to a purchasing wholesaler, the wholesaler must, as a reasonable assurance that the purchasing wholesaler is in compliance with the provisions of subparagraph (2) of paragraph (c) of subsection 2 of NRS 639.595:

     (a) Before the sale of the prescription drug, obtain from the purchasing wholesaler a written statement that contains a representation by the purchasing wholesaler that, for transactions which occur in this State, the purchasing wholesaler will only sell the prescription drug to a pharmacy or practitioner;

     (b) Possess written correspondence between the wholesaler and the purchasing wholesaler or between the purchasing wholesaler and other purchasers that evidences the compliance by the purchasing wholesaler with the provisions of subparagraph (2) of paragraph (c) of subsection 2 of NRS 639.595; and

     (c) Ensure that the following statement is written on the face of the invoice or other document which evidences the sale and on the face of any “Statement Identifying Prior Sales of Prescription Drugs by Wholesalers Required by the Prescription Drug Marketing Act” described in NAC 639.603 that accompanied the sale of the prescription drug printed in all capital letters and in at least 10-point type:

 

NEVADA LAW REQUIRES THAT YOU MUST SELL THE PRESCRIPTION DRUGS SOLD TO YOU AS SET FORTH IN THIS DOCUMENT ONLY TO PHARMACIES OR PRACTITIONERS. THE SALE OF ANY OF THE PRESCRIPTION DRUGS SOLD TO YOU AS SET FORTH IN THIS DOCUMENT TO ANY PERSON OR BUSINESS OTHER THAN A PHARMACY OR PRACTITIONER WILL RESULT IN A TERMINATION OF FUTURE SALES AND MAY SUBJECT YOU TO OTHER PENALTIES AS PRESCRIBED BY LAW.

 

     2.  For the purposes of this section, the Board will consider the sale by a wholesaler to a purchasing wholesaler whose sole function is to distribute prescription drugs to pharmacies under common ownership with the purchasing wholesaler to be a sale to a pharmacy.

     (Added to NAC by Bd. of Pharmacy by R049-04, eff. 2-28-2005)

      NAC 639.598  Prescription drugs: Storage. (NRS 639.070)

     1.  Each wholesaler shall store prescription drugs held in the facility in the manner prescribed in the United States Pharmacopeia - National Formulary, as adopted by reference in paragraph (c) of subsection 1 of NAC 639.670.

     2.  If there are no specific requirements concerning the temperature at which a prescription drug must be stored, the drug must be stored at a controlled room temperature as defined in the United States Pharmacopeia - National Formulary, as adopted by reference in paragraph (c) of subsection 1 of NAC 639.670.

     3.  Each wholesaler shall provide the appropriate manual, electromechanical or electrical equipment to record the temperature and humidity of the area where the prescription drugs are stored.

     (Added to NAC by Bd. of Pharmacy, eff. 7-16-92; A by R035-06, 9-18-2008)

      NAC 639.599  Prescription drugs: Examination of shipments; actions upon determination of certain conditions. (NRS 639.070, 639.595)

     1.  Each wholesaler shall, upon receiving a prescription drug, examine each outside shipping container of the drug and any accompanying document, including, without limitation, the invoice, the shipping record and the “Statement Identifying Prior Sales of Prescription Drugs by Wholesalers Required by the Prescription Drug Marketing Act” described in NAC 639.603, to determine its identity and to prevent the acceptance of a prescription drug that is:

     (a) Counterfeit;

     (b) Deemed to be adulterated or misbranded in accordance with the provisions of chapter 585 of NRS;

     (c) Mislabeled;

     (d) Damaged or compromised by improper handling, storage or temperature control;

     (e) From a foreign or unlawful source; or

     (f) Manufactured, packaged, labeled or shipped in violation of any state or federal law relating to prescription drugs.

Ê The examination must be sufficient to detect any damage to the container which would indicate contamination or other damage to the contents of the container.

     2.  Each wholesaler shall examine each outgoing shipment of prescription drugs to identify the prescription drugs contained in the shipment and to ensure that the prescription drugs contained in the shipment are not damaged and have been stored under proper conditions.

     3.  If a wholesaler determines that a prescription drug has one or more of the conditions set forth in paragraphs (a) to (f), inclusive, of subsection 1, the wholesaler:

     (a) If the prescription drug is not subject to a recall or withdrawn from the market, shall:

          (1) Separate the prescription drug from other prescription drugs; and

          (2) Provide to the Board, not later than 10 business days after the inspection, a written notice that includes:

               (I) The name and address of the supplier of the prescription drug;

               (II) The name of the prescription drug;

               (III) The lot number and expiration date of the prescription drug;

               (IV) The quantity of the prescription drug;

               (V) Whether the wholesaler returned the prescription drug to the supplier or decided to destroy the prescription drug;

               (VI) The reason for the action taken by the wholesaler; and

               (VII) If the prescription drug was returned to the supplier, the date on which the prescription drug was returned to the supplier.

     (b) If the prescription drug is not subject to a recall or withdrawn from the market, may return the prescription drug to the supplier or destroy the prescription drug.

     4.  Within 48 hours after receipt by the Board of a notice required pursuant to subsection 3, a member of the staff of the Board shall inspect the prescription drug at the facility of the wholesaler and may impound or remove the prescription drug. If the member of the staff of the Board does not impound or remove the prescription drug, the wholesaler may return the prescription drug to the supplier or destroy the drug.

     (Added to NAC by Bd. of Pharmacy, eff. 7-16-92; A by R049-04, 2-28-2005)

      NAC 639.601  Prescription drugs: Separation and disposal of certain drugs. (NRS 639.070)

     1.  A prescription drug that is outdated, damaged, deteriorated, misbranded or adulterated must be separated from other prescription drugs until it is destroyed or returned to the supplier.

     2.  A prescription drug whose immediate or sealed outer or secondary container has been opened or used must be identified as such and separated from other prescription drugs until it is destroyed or returned to the supplier.

     3.  If a prescription drug is returned to a wholesaler by a purchaser or purchasing wholesaler under conditions which cast doubt on the prescription drug’s safety, identity, strength, quality or purity, the wholesaler shall destroy the prescription drug or return it to the supplier unless, after conducting an examination, testing or other investigation, the wholesaler determines that the prescription drug complies with the appropriate standards of safety, identity, strength, quality and purity as prescribed in the package insert as approved by the Food and Drug Administration or in the United States Pharmacopeia - National Formulary, as adopted by reference in paragraph (c) of subsection 1 of NAC 639.670. The wholesaler shall keep a record of any examination, testing or other investigation conducted and make any records available for inspection by the Board.

     4.  Unless the reason a prescription drug must be destroyed or returned to the supplier is related to the expiration date of the prescription drug, a wholesaler that is required to destroy a prescription drug or return it to the supplier pursuant to subsection 3 shall provide to the Board a written notice that includes:

     (a) The name of the prescription drug;

     (b) The lot number and expiration date of the prescription drug;

     (c) The quantity of the prescription drug;

     (d) The name and address of the business that returned the prescription drug to the wholesaler;

     (e) Whether the wholesaler will:

          (1) Return the prescription drug to the supplier; or

          (2) Destroy the prescription drug; and

     (f) The reason for the action taken by the wholesaler.

     5.  Within 48 hours after receipt by the Board of a notice required pursuant to subsection 4, a member of the staff of the Board shall inspect the prescription drug at the facility of the wholesaler and may impound or remove the prescription drug. If the member of the staff of the Board does not impound or remove the prescription drug, the wholesaler may return the prescription drug to the supplier or destroy the prescription drug.

     (Added to NAC by Bd. of Pharmacy, eff. 7-16-92; A by R049-04, 2-28-2005; R035-06, 9-18-2008)

      NAC 639.6015  Prescription drugs: Destruction. (NRS 639.070)  If a wholesaler in this State decides to destroy a prescription drug pursuant to NAC 639.5975, 639.599 or 639.601, the wholesaler shall:

     1.  Segregate the prescription drug in a manner that will ensure that the prescription drug cannot be sold or otherwise used; and

     2.  Destroy the prescription drug and its packaging in such a manner that the prescription drug cannot be resold or used and which is in compliance with any applicable laws or regulations concerning the destruction of drugs and drug packaging.

     (Added to NAC by Bd. of Pharmacy by R049-04, eff. 2-28-2005)

      NAC 639.602  Prescription drugs: Records. (NRS 639.070, 639.595)

     1.  Each wholesaler shall make and maintain a record of its inventory and of each transaction relating to the receipt and distribution or other disposition of a prescription drug. The record must include, without limitation:

     (a) The purchase order, correspondence and any other document evidencing that the wholesaler ordered the prescription drug from the supplier;

     (b) The invoice or other document provided to the wholesaler by the supplier concerning the purchase of the prescription drug;

     (c) The shipping record, which may be a manifest, shipping label, shipping bill or any similar document, evidencing the shipment of the prescription drug from the supplier to the wholesaler;

     (d) The purchase order, correspondence and any other document evidencing that the purchaser or purchasing wholesaler ordered the prescription drug from the wholesaler;

     (e) The invoice or other document provided by the wholesaler when the purchaser or purchasing wholesaler purchased the prescription drug;

     (f) The shipping record evidencing the shipment of the prescription drug from the wholesaler to the purchaser or purchasing wholesaler;

     (g) A copy of the license of the supplier that sold the prescription drug to the wholesaler;

     (h) If the supplier has an ongoing relationship with a manufacturer, a copy of the records maintained pursuant to NAC 639.594 which must be obtained by the wholesaler before the wholesaler may sell a prescription drug received from the supplier; and

     (i) One or more of the documents required by NAC 639.5977 as reasonable assurance that the purchasing wholesaler is in compliance with subparagraph (2) of paragraph (c) of subsection 2 of NRS 639.595.

     2.  The wholesaler shall maintain the records described in subsection 1 for at least 3 years after the receipt, distribution or other disposition of the prescription drug. The records must be made available for copying and inspection by any person authorized to inspect those records.

     3.  Except as otherwise provided in this subsection, a wholesaler shall maintain the records required by this section at the facility. If the records are maintained by a computer, the records must be immediately retrievable and readily available for inspection.

     4.  If the records are not maintained at the facility because the facility is located outside of this State and are not immediately retrievable by computer, the records must be made available for inspection within 2 working days after a request is made by a person authorized to examine those records.

     (Added to NAC by Bd. of Pharmacy, eff. 7-16-92; A by R013-01, 11-1-2001; R049-04, 2-28-2005)

      NAC 639.603  Prescription drugs: Requirements regarding statements of prior sales. (NRS 639.070, 639.595)

     1.  Except as otherwise provided in paragraph (a) of subsection 6 of NAC 639.5975 and NAC 639.6035, each wholesaler shall provide a statement of prior sales identifying each sale of a prescription drug before the prescription drug is sold to another wholesaler or to a pharmacy when supplying prescription drugs if the wholesaler:

     (a) Has not established an ongoing relationship with the manufacturer from whom the prescription drug was purchased; or

     (b) Purchased the prescription drug from another wholesaler.

     2.  The statement of prior sales must:

     (a) Be in writing and bear the title “Statement Identifying Prior Sales of Prescription Drugs by Wholesalers Required by the Prescription Drug Marketing Act”;

     (b) Include all necessary identifying information concerning each sale in the chain of distribution of the product from the manufacturer or wholesaler;

     (c) Accompany all prescription drugs purchased from a wholesaler, even if they are resold to another distributor;

     (d) Include the business name and address of the person from whom the prescription drug was purchased;

     (e) Include the date of the sale; and

     (f) Include the:

          (1) Name of the prescription drug;

          (2) Strength of the prescription drug;

          (3) Size of the container;

          (4) Number of containers;

          (5) Lot number of the prescription drug; and

          (6) Name of the manufacturer of the finished dosage form.

     3.  Each statement of prior sales must be:

     (a) Maintained by the buyer and the wholesaler for 3 years;

     (b) Except as otherwise provided in subsection 4, available for copying or inspection upon a request by an authorized representative of any federal, state or local agency, a manufacturer of prescription drugs or a pharmacist or practitioner who purchases prescription drugs from the wholesaler; and

     (c) Maintained by the wholesaler at its facility.

     4.  If a wholesaler cannot provide a statement of prior sales upon request made pursuant to paragraph (b) of subsection 3 because the wholesaler purchased a prescription drug with a particular lot number from more than one source, the wholesaler must provide:

     (a) Copies of all of the “Statements Identifying Prior Sales of Prescription Drugs by Wholesalers Required by the Prescription Drug Marketing Act,” as described in subsection 2, that relate to the prescription drug with the particular lot number; or

     (b) A statement certifying how much of a prescription drug the wholesaler purchased directly from the drug’s manufacturer and how much of the prescription drug the wholesaler purchased from other wholesalers, which must accurately account for the wholesaler’s purchases of a prescription drug for the 12 months immediately preceding the request and may be made in the form of a percentage, ratio or per unit accounting. The wholesaler must provide, upon request, all “Statements Identifying Prior Sales of Prescription Drugs by Wholesalers Required by the Prescription Drug Marketing Act” that were the basis for the statement made pursuant to this paragraph.

     5.  Beginning February 15, 2007, a wholesaler shall transmit to the Board, on or before the 15th day of each month, the information collected pursuant to subsection 2 for all statements of prior sales made for the immediately preceding month regarding the sale of a prescription drug to:

     (a) Each customer in Nevada; and

     (b) Each wholesaler located in Nevada.

Ê The information required by this subsection must be transmitted by electronic mail to the Board or to a website established by the Board in a format required by the Board.

     (Added to NAC by Bd. of Pharmacy, eff. 7-16-92; A 10-1-93; R049-04, 2-28-2005; R218-05, 5-4-2006)

      NAC 639.6035  Prescription drugs: Exclusion of certain transactions from statements of prior sales. (NRS 639.070)  A wholesaler shall not report the following transactions on a statement of prior sales:

     1.  A transaction that the Board considers not to be a wholesale transaction pursuant to subsection 3 of NAC 639.593.

     2.  The return of a prescription drug to a wholesaler who appears on the statement of prior sales for the prescription drug at an earlier point in the chain of distribution.

     (Added to NAC by Bd. of Pharmacy by R218-05, eff. 5-4-2006)

      NAC 639.604  Maintenance and availability of list of wholesalers with whom manufacturer has ongoing relationship. (NRS 639.070, 639.100, 639.595)  Each manufacturer shall maintain at its principal place of business a list of wholesalers with whom the manufacturer has an ongoing relationship. The list must be available for inspection upon a request by any authorized representative of a federal, state or local agency. The manufacturer shall provide a copy of the list upon request. The manufacturer may charge a fee to cover the cost of copying the list.

     (Added to NAC by Bd. of Pharmacy, eff. 7-16-92; A 10-1-93)

      NAC 639.605  Establishment and maintenance of policies and procedures regarding prescription drugs. (NRS 639.070, 639.595)

     1.  Each wholesaler shall establish written policies and procedures for the receipt, security, storage, inventory and distribution of prescription drugs.

     2.  The written policies and procedures must include:

     (a) A procedure for identifying, recording and reporting any losses or thefts of prescription drugs.

     (b) A procedure for correcting any errors or inaccuracies concerning the wholesaler’s inventory.

     (c) A procedure that requires the oldest approved stock of a prescription drug to be distributed first. The procedure may allow deviation from that requirement if the deviation is temporary and appropriate.

     (d) A procedure relating to the recall or withdrawal of a prescription drug because of:

          (1) Any action taken at the request of the Food and Drug Administration or other federal agency or state or local law enforcement agency or other governmental agency, including the Board;

          (2) Any voluntary action taken by a manufacturer to remove defective or potentially defective drugs from the market; or

          (3) Any action taken by a manufacturer to promote public health and safety by the replacement of existing prescription drugs with an improved product or new design of a package.

     (e) A procedure for the operation of a facility in the event of a strike, fire, flood or other natural disaster or emergency.

     (f) A procedure to ensure that any outdated prescription drug is separated from other drugs that are not outdated and is destroyed or returned to the manufacturer. The procedure must provide for the establishment and maintenance of written records of the disposition of each outdated prescription drug. The wholesaler shall keep the records for 3 years after the disposition of the prescription drug.

     (g) A procedure to gather, make and maintain all records required pursuant to NRS 639.234 and NAC 639.585 to 639.607, inclusive.

     (h) A procedure to ensure that all prescription drugs received are examined pursuant to NAC 639.599 and 639.601.

     (i) A procedure to ensure that the prescription drugs are not contraband drugs or counterfeit drugs.

     3.  As used in this section:

     (a) “Contraband drug” means a prescription drug that is offered for sale by a purchaser to a wholesaler in violation of an agreement to which the purchaser is a party or is otherwise in privity of contract that would prohibit or otherwise disallow such a sale or resale.

     (b) “Counterfeit drug” means a prescription drug that is adulterated, mislabeled or misbranded pursuant to chapter 585 of NRS.

     (Added to NAC by Bd. of Pharmacy, eff. 7-16-92; A by R049-04, 2-28-2005)

      NAC 639.6053  Wholesaler who employs person to sell or market drug, medicine or chemical: Annual submission of certain information to Board; review and contents of marketing code of conduct; exemption. (NRS 639.070, 639.570)

     1.  Except as otherwise provided in subsections 2 and 6, on or before June 1 of each year, a wholesaler who employs a person to sell or market a drug, medicine or chemical in this State shall submit to the Board the information required pursuant to subsection 2 of NRS 639.570.

     2.  If a wholesaler described in subsection 1 uses, without modification, the Code on Interactions with Healthcare Professionals, as adopted by reference in NAC 639.060, as its marketing code of conduct, the wholesaler may indicate this on its submittal in lieu of submitting a copy of its marketing code of conduct.

     3.  If a wholesaler described in subsection 1:

     (a) Develops its own marketing code of conduct; or

     (b) Uses a modified version of the Code on Interactions with Healthcare Professionals, as adopted by reference in NAC 639.060, as its marketing code of conduct,

Ê the staff of the Board shall review the marketing code of conduct to ensure that it addresses the subjects listed in subsection 4.

     4.  A marketing code of conduct submitted pursuant to this section and subsection 2 of NRS 639.570 must address the following subjects:

     (a) The basis of interactions;

     (b) Informational presentations by or on behalf of a wholesaler;

     (c) Third-party educational or professional meetings;

     (d) The use of consultants;

     (e) Speaker training meetings;

     (f) Scholarships and educational funds;

     (g) Educational and practice-related items;

     (h) Independence of decision making; and

     (i) Adherence to the marketing code of conduct.

     5.  If the staff of the Board determines that a marketing code of conduct submitted by a wholesaler described in subsection 1 does not address each of the subjects set forth in subsection 4, the marketing code of conduct shall be deemed incomplete and noncompliant with the provisions of this section and subsection 2 of NRS 639.570.

     6.  The provisions of this section do not apply to a wholesaler whose sole function is to distribute prescription drugs to pharmacies if the wholesaler and the pharmacy to which the prescription drugs are distributed are wholly owned by a common owner.

     (Added to NAC by Bd. of Pharmacy by R122-07, eff. 1-30-2008)

      NAC 639.6055  Submission of certain information regarding sales and marketing staff: Submission of form after initial submittal; method of submission. (NRS 639.070, 639.570)

     1.  If a wholesaler has submitted to the Board the information required pursuant to NAC 639.6053 at least once, the wholesaler may subsequently submit to the Board, on a form provided by the Board, the information that has remained the same and the information that has changed from the date of the previous submission, in lieu of submitting the information required annually pursuant to NAC 639.6053.

     2.  The submission of information to the Board pursuant to this section and NAC 639.6053 may be made by:

     (a) Mail or personal delivery of a printed copy of the information required;

     (b) Electronic mail to the Board at the electronic mail address pharmacy@pharmacy.nv.gov; or

     (c) Such other technological means as the Board may develop, including, without limitation, through the use of the Internet website of the Board.

     (Added to NAC by Bd. of Pharmacy by R122-07, eff. 1-30-2008)

      NAC 639.6057  Submission of certain information regarding sales and marketing staff: Incomplete, improperly completed or noncompliant submittal; correction of deficiencies. (NRS 639.070, 639.570)

     1.  The Board will refuse a submittal of information from a wholesaler pursuant to NAC 639.6053 or 639.6055 if the submittal is incomplete. The Board will treat such an incomplete submittal as noncompliant for the purposes of NRS 639.570.

     2.  If the staff of the Board determines that a submittal of information pursuant to NAC 639.6053 or 639.6055 is incomplete, improperly completed or noncompliant, the staff shall, as soon as practicable, notify the wholesaler who submitted the information that the submittal is incomplete, improperly completed or noncompliant and provide the wholesaler with instructions for correcting the deficiencies in the submittal. The Board may retain an incomplete, improperly completed or noncompliant submittal or return the submittal to the wholesaler.

     3.  If the staff of the Board provides notice of an incomplete, improperly completed or noncompliant submittal to a wholesaler pursuant to this section, the wholesaler must comply with the instructions for correcting the deficiencies in the submittal within 120 days after the receipt of the instructions. Within the 120-day period, the wholesaler may request a meeting with the staff of the Board to discuss the deficiencies in its submittal. If the wholesaler corrects the deficiencies in its submittal within the 120-day period, the Board will accept and file the submittal.

     (Added to NAC by Bd. of Pharmacy by R122-07, eff. 1-30-2008)

      NAC 639.606  Establishment and maintenance of lists regarding certain personnel. (NRS 639.070)  Each wholesaler shall establish and maintain a list of the officers, directors, managers of the facility and any persons who have access to the facility. The list must include a description of their duties and a summary of their qualifications.

     (Added to NAC by Bd. of Pharmacy, eff. 7-16-92)

      NAC 639.6065  Annual submission of certain reports or proof to Board. (NRS 639.070, 639.505)

     1.  A wholesaler who:

     (a) Does not have a facility in the State of Nevada; and

     (b) Is a corporation whose securities are publicly traded and regulated by the Securities Exchange Act of 1934, as amended, 15 U.S.C. §§ 78a et seq., or is owned by a corporation whose securities are publicly traded and regulated by the Act,

Ê may submit to the Board a copy of its annual report that is filed with the Securities and Exchange Commission. The Board may deem a copy of the report as satisfying the requirement for an updated list pursuant to NRS 639.505.

     2.  A wholesaler who is accredited by the National Association of Boards of Pharmacy under the Verified-Accredited Wholesale Distributors Program may submit annually to the Board a copy of its most current proof of accreditation issued by the National Association of Boards of Pharmacy. The Board may deem a copy of the proof of accreditation as satisfying the requirement for an updated list pursuant to NRS 639.505.

     3.  A wholesaler who is a manufacturer of prescription drugs or a facility that distributes prescription drugs manufactured by a single manufacturer may submit annually to the Board a copy of its most current proof of registration with the Food and Drug Administration as a manufacturer or distributor. The Board may deem a copy of the proof of registration as satisfying the requirement for an updated list pursuant to NRS 639.505.

     (Added to NAC by Bd. of Pharmacy by R218-05, eff. 5-4-2006; A by R051-07, 12-4-2007)

      NAC 639.607  Inspections; examination of records and procedures; copies of documents. (NRS 639.070)

     1.  Each wholesaler shall allow a member of the staff of the Board to:

     (a) Inspect its facility and any motor vehicles it uses to transport prescription drugs; and

     (b) Examine its records and procedures for the operation of the facility,

Ê during normal business hours.

     2.  If a member of the staff of the Board wishes to make copies of documents of the wholesaler and the number of copies will exceed 50 pages, the member of the staff of the Board may, in his or her discretion, copy the documents at the facility of the wholesaler or remove the documents to make copies at a commercial facility for reproduction mutually agreed upon by the wholesaler and the member of the staff of the Board. Upon request, the member of the staff of the Board who removes documents for the purpose of copying them pursuant to this section shall provide a receipt to the wholesaler which describes the documents removed.

     (Added to NAC by Bd. of Pharmacy, eff. 7-16-92; A by R049-04, 2-28-2005)

MANUFACTURERS

      NAC 639.609  “Manufacturer” defined. (NRS 639.070)  As used in NAC 639.609 to 639.619, inclusive, unless the context otherwise requires, the term “manufacturer” has the meaning ascribed to it in NRS 639.009.

     (Added to NAC by Bd. of Pharmacy by R122-07, eff. 1-30-2008)

      NAC 639.610  Minimum standards for premises. (NRS 639.070)  The premises occupied by any person holding a manufacturer’s permit or the premises to be occupied by any applicant for such a permit must meet the following minimum standards:

     1.  The premises must be well lighted and well ventilated and must be maintained in a clean and orderly manner.

     2.  Adequate lavatory and toilet facilities and dressing areas must be provided, and washbasins to be used in connection with those facilities must be supplied with hot and cold running water. All such facilities must be maintained in a clean and orderly condition and in good repair.

     3.  The building must be constructed in such a manner as to provide maximum security and must be equipped with an adequate alarm system.

     [Bd. of Pharmacy, § 639.420, eff. 6-26-80]—(NAC A 5-14-92)

      NAC 639.615  Equipment and requirements for operation; employees. (NRS 639.070)

     1.  Any person to whom a manufacturer’s permit has been issued shall provide and maintain the following equipment if it is needed in the operation of the business, and shall comply with the following requirements as they apply to the operation of the business:

     (a) If drugs requiring refrigeration are stocked, the holder of the permit shall provide refrigerators for proper storage.

     (b) The area in which drugs are stocked must be arranged so that dangerous drugs, chemicals, poisons, controlled substances and devices are not accessible to unauthorized persons.

     (c) Drugs which are damaged, deteriorated, misbranded, adulterated or outdated must be stored in an area separate from the area containing the drugs, chemicals, poisons, controlled substances or devices which are to be sold or distributed for resale.

     (d) The holder of a permit shall maintain such records as may be necessary to provide accountability for the disposition of dangerous drugs, controlled substances, chemicals and devices.

     (e) Equipment must be provided and maintained as may be considered necessary and consistent with the licensed operation, and maintained in proper working order at all times.

     2.  All persons who in the course of their employment with a manufacturer handle any drugs, chemicals or devices shall keep themselves and their apparel in a clean and sanitary condition.

     [Bd. of Pharmacy, § 639.415, eff. 6-26-80]—(NAC A 5-14-92)—(Substituted in revision for NAC 639.600)

      NAC 639.616  Manufacturer who employs person to sell or market drug, medicine or chemical: Annual submission of certain information to Board; review and contents of marketing code of conduct. (NRS 639.070, 639.570)

     1.  Except as otherwise provided in subsection 2, on or before June 1 of each year, a manufacturer who employs a person to sell or market a drug, medicine or chemical in this State shall submit to the Board the information required pursuant to subsection 2 of NRS 639.570.

     2.  If a manufacturer described in subsection 1 uses, without modification, the Code on Interactions with Healthcare Professionals, as adopted by reference in NAC 639.060, as its marketing code of conduct, the manufacturer may indicate this on its submittal in lieu of submitting a copy of its marketing code of conduct.

     3.  If a manufacturer described in subsection 1:

     (a) Develops its own marketing code of conduct; or

     (b) Uses a modified version of the Code on Interactions with Healthcare Professionals, as adopted by reference in NAC 639.060, as its marketing code of conduct,

Ê the staff of the Board shall review the marketing code of conduct to ensure that it addresses the subjects listed in subsection 4.

     4.  A marketing code of conduct submitted pursuant to this section and subsection 2 of NRS 639.570 must address the following subjects:

     (a) The basis of interactions;

     (b) Informational presentations by or on behalf of a manufacturer;

     (c) Third-party educational or professional meetings;

     (d) The use of consultants;

     (e) Speaker training meetings;

     (f) Scholarships and educational funds;

     (g) Educational and practice-related items;

     (h) Independence of decision making; and

     (i) Adherence to the marketing code of conduct.

     5.  If the staff of the Board determines that a marketing code of conduct submitted by a manufacturer does not address each of the subjects set forth in subsection 4, the marketing code of conduct shall be deemed incomplete and noncompliant with the provisions of this section and subsection 2 of NRS 639.570.

     (Added to NAC by Bd. of Pharmacy by R122-07, eff. 1-30-2008)

      NAC 639.617  Manufacturer who employs person to sell or market device or appliance: Annual submission of certain information to Board; review and contents of marketing code of conduct. (NRS 639.070, 639.570)

     1.  Except as otherwise provided in subsection 2, on or before June 1 of each year, a manufacturer who employs a person to sell or market a device or appliance in this State shall submit to the Board the information required pursuant to subsection 2 of NRS 639.570.

     2.  If a manufacturer described in subsection 1 uses, without modification, the Code of Ethics on Interactions with Health Care Professionals, as adopted by reference in NAC 639.060, as its marketing code of conduct, the manufacturer may indicate this on its submittal in lieu of submitting a copy of its marketing code of conduct.

     3.  If a manufacturer described in subsection 1:

     (a) Develops its own marketing code of conduct; or

     (b) Uses a modified version of the Code of Ethics on Interactions with Health Care Professionals, as adopted by reference in NAC 639.060, as its marketing code of conduct,

Ê the staff of the Board shall review the marketing code of conduct to ensure that it addresses the subjects listed in subsection 4.

     4.  A marketing code of conduct submitted by a manufacturer pursuant to this section and subsection 2 of NRS 639.570 must address the following subjects:

     (a) Providing or sponsoring product training and education;

     (b) Supporting third-party educational conferences;

     (c) Sales and promotional meetings;

     (d) Arrangements with consultants;

     (e) Gifts;

     (f) Providing reimbursement and other economic information; and

     (g) Grants and other charitable donations.

     5.  If the staff of the Board determines that a marketing code of conduct submitted by a manufacturer does not address each of the subjects set forth in subsection 4, the marketing code of conduct shall be deemed incomplete and noncompliant with the provisions of this section and subsection 2 of NRS 639.570.

     (Added to NAC by Bd. of Pharmacy by R122-07, eff. 1-30-2008)

      NAC 639.618  Submission of certain information regarding sales and marketing staff: Submission of form after initial submittal; method of submission. (NRS 639.070, 639.570)

     1.  If a manufacturer has submitted to the Board the information required pursuant to NAC 639.616 or 639.617 at least once, the manufacturer may subsequently submit to the Board, on a form provided by the Board, the information that has remained the same and the information that has changed from the date of the previous submission, in lieu of submitting the information required annually pursuant to NAC 639.616 or 639.617, as applicable.

     2.  The submission of information to the Board pursuant to this section and NAC 639.616 and 639.617 may be made by:

     (a) Mail or personal delivery of a printed copy of the information required;

     (b) Electronic mail to the Board at the electronic mail address pharmacy@pharmacy.nv.gov; or

     (c) Such other technological means as the Board may develop, including, without limitation, through the use of the Internet website of the Board.

     (Added to NAC by Bd. of Pharmacy by R122-07, eff. 1-30-2008)

      NAC 639.619  Submission of certain information regarding sales and marketing staff: Incomplete, improperly completed or noncompliant submittal; correction of deficiencies. (NRS 639.070, 639.570)

     1.  The Board will refuse a submittal of information from a manufacturer pursuant to NAC 639.616, 639.617 or 639.618 if the submittal is incomplete. The Board will treat such an incomplete submittal as noncompliant for the purposes of NRS 639.570.

     2.  If the staff of the Board determines that a submittal of information pursuant to NAC 639.616, 639.617 or 639.618 is incomplete, improperly completed or noncompliant, the staff shall, as soon as practicable, notify the manufacturer who submitted the information that the submittal is incomplete, improperly completed or noncompliant and provide the manufacturer with instructions for correcting the deficiencies in the submittal. The Board may retain an incomplete, improperly completed or noncompliant submittal or return the submittal to the manufacturer.

     3.  If the staff of the Board provides notice of an incomplete, improperly completed or noncompliant submittal to a manufacturer pursuant to this section, the manufacturer must comply with the instructions for correcting the deficiencies in the submittal within 120 days after the receipt of the instructions. Within the 120-day period, the manufacturer may request a meeting with the staff of the Board to discuss the deficiencies in its submittal. If the manufacturer corrects the deficiencies in its submittal within the 120-day period, the Board will accept and file the submittal.

     (Added to NAC by Bd. of Pharmacy by R122-07, eff. 1-30-2008)

WAREHOUSES

      NAC 639.620  Definitions. (NRS 639.070)  As used in NAC 639.620 to 639.644, inclusive, unless the context otherwise requires, the words and terms defined in NAC 639.621 to 639.629, inclusive, have the meanings ascribed to them in those sections.

     (Added to NAC by Bd. of Pharmacy, eff. 10-1-93; A by R218-05, 5-4-2006)

      NAC 639.621  “Authorized person” defined. (NRS 639.070)  “Authorized person” means a person who is authorized by an authorized warehouse to have access to its facility.

     (Added to NAC by Bd. of Pharmacy, eff. 10-1-93)

      NAC 639.622  “Authorized warehouse” defined. (NRS 639.070)  “Authorized warehouse” means a warehouse or other business in this State that receives, stores or ships prescription drugs and goods pursuant to a written contract with a manufacturer, wholesaler, pharmacy or chain warehouse under which the authorized warehouse acts solely as the agent or bailee of the manufacturer, wholesaler, pharmacy or chain warehouse. The term includes a third-party logistics provider.

     (Added to NAC by Bd. of Pharmacy, eff. 10-1-93; A by R218-05, 5-4-2006)

      NAC 639.623  “Chain warehouse” defined. (NRS 639.070)  “Chain warehouse” means a facility engaged exclusively in the sale or distribution of a prescription drug by intercompany transfer within this State.

     (Added to NAC by Bd. of Pharmacy, eff. 10-1-93)

      NAC 639.624  “Facility” defined. (NRS 639.070)  “Facility” means the area of an authorized warehouse used for the receipt, storage and shipping of prescription drugs and goods.

     (Added to NAC by Bd. of Pharmacy, eff. 10-1-93)

      NAC 639.625  “Goods” defined. (NRS 639.070)  “Goods” means all items produced by a manufacturer that are regulated by the Board, other than prescription drugs.

     (Added to NAC by Bd. of Pharmacy, eff. 10-1-93)

      NAC 639.626  “Manufacturer” defined. (NRS 639.070)  “Manufacturer” has the meaning ascribed to it in NRS 639.009.

     (Added to NAC by Bd. of Pharmacy, eff. 10-1-93)

      NAC 639.627  “Pharmacy” defined. (NRS 639.070)  “Pharmacy” has the meaning ascribed to it in NRS 639.012.

     (Added to NAC by Bd. of Pharmacy, eff. 10-1-93)

      NAC 639.6282  “Third-party logistics provider” defined. (NRS 639.070)  “Third-party logistics provider” means a business that contracts with a manufacturer to provide or coordinate warehousing, distribution or other services on behalf of the manufacturer without taking title to or ownership of the prescription drugs and without authority to direct the sale or disposition of the prescription drugs.

     (Added to NAC by Bd. of Pharmacy by R218-05, eff. 5-4-2006)

      NAC 639.629  “Wholesaler” defined. (NRS 639.070)  “Wholesaler” has the meaning ascribed to it in NRS 639.016 and is limited to a person licensed or registered by the proper regulatory agencies in one or more states that license or otherwise register wholesalers of prescription drugs.

     (Added to NAC by Bd. of Pharmacy, eff. 10-1-93)

      NAC 639.6305  Third-party logistics providers: General requirements. (NRS 639.070)  A third-party logistics provider in this State shall obtain a license to engage in business as an authorized warehouse pursuant to, and shall otherwise comply with, the provisions of NAC 639.620 to 639.644, inclusive.

     (Added to NAC by Bd. of Pharmacy by R218-05, eff. 5-4-2006)

      NAC 639.631  Licensing: General requirements. (NRS 639.070)

     1.  An applicant for a license to engage in business as an authorized warehouse must submit an application to the Board. The application must be made on a form furnished by the Board. The application must include:

     (a) The name, business address and telephone number of the applicant and the address of the facility of the applicant if it is not the same as the business address of the applicant;

     (b) All trade or business names used by the applicant;

     (c) The name, address and telephone number of the person who manages the facility;

     (d) The type of ownership or operation of the facility; and

     (e) If the applicant is:

          (1) A natural person, the name of the person.

          (2) A partnership, the name of the partnership and the name of each general or limited partner.

          (3) A corporation, the name and title of each officer and director of the corporation, the corporate name and the state of incorporation and the name of the corporation’s parent company, if any.

          (4) A sole proprietorship, the name of the sole proprietor and the name of the business entity.

     2.  If an authorized warehouse receives, stores or ships prescription drugs from more than one facility, the authorized warehouse must obtain a license for each facility.

     3.  An applicant shall submit to the Board any change in the information required by this section within 30 days after the change occurs.

     4.  A license issued by the Board pursuant to this section is not transferable.

     (Added to NAC by Bd. of Pharmacy, eff. 10-1-93)

      NAC 639.633  Contracts authorizing receipt, storage and shipment of prescription drugs and goods. (NRS 639.070)

     1.  An authorized warehouse may receive, store and ship prescription drugs and goods only for a manufacturer, wholesaler, pharmacy or chain warehouse with whom it has a written contract. The written contract must include, but is not limited to:

     (a) The name and address of the main office of the manufacturer, wholesaler, pharmacy or chain warehouse;

     (b) The address of each location from which the manufacturer, wholesaler, pharmacy or chain warehouse may ship prescription drugs or goods to the authorized warehouse;

     (c) The number of the license or registration issued to the manufacturer, wholesaler, pharmacy or chain warehouse by each state from which prescription drugs or goods may be shipped to the authorized warehouse;

     (d) A specific acknowledgment that the authorized warehouse will receive, store and ship prescription drugs and goods as the agent and bailee of the manufacturer, wholesaler, pharmacy or chain warehouse and that ownership of the prescription drugs and goods does not transfer to the authorized warehouse;

     (e) A provision requiring the authorized warehouse to return to the manufacturer, wholesaler, pharmacy or chain warehouse any prescription drugs and goods received that are labeled or addressed to any person other than the manufacturer, wholesaler, pharmacy or chain warehouse;

     (f) A provision requiring the authorized warehouse to perform acts related to the receipt, storage and shipping of prescription drugs and goods in accordance with the instructions of the manufacturer, wholesaler, pharmacy or chain warehouse;

     (g) A provision limiting the payments required to be made by the manufacturer, wholesaler, pharmacy or chain warehouse to payments for the rental of space, equipment, personnel and other costs necessary to carry out the instructions of the manufacturer, wholesaler, pharmacy or chain warehouse;

     (h) A provision prohibiting the authorized warehouse from opening any containers received from the manufacturer, wholesaler, pharmacy or chain warehouse, except at the specific direction of the manufacturer, wholesaler, pharmacy or chain warehouse; and

     (i) A statement that any receipt issued by the authorized warehouse is not negotiable.

     2.  An authorized warehouse shall furnish a copy of the written contract to the Board upon request. If the request is submitted in person, the copy must be provided immediately. If the request is not submitted in person, the copy must be provided within 2 business days.

     (Added to NAC by Bd. of Pharmacy, eff. 10-1-93)

      NAC 639.634  Enforcement of statutory liens. (NRS 639.070)

     1.  An authorized warehouse that intends to enforce any statutory lien it may have against a manufacturer, wholesaler, pharmacy or chain warehouse with whom it has contracted shall notify the Board in writing of its intent to enforce the lien.

     2.  Upon receipt of the notice, the Board will determine whether the claim of the authorized warehouse is valid. The authorized warehouse shall provide any documentation or evidence requested by the Board to verify its claim.

     3.  If the Board determines that the claim of the authorized warehouse is valid, the Board will impound the prescription drugs and goods that are the subject of the lien, cause an inventory of the impounded items to be conducted and segregate those items. The authorized warehouse shall continue to store the impounded items at its expense.

     4.  The Board will give written notice of the claim of the authorized warehouse to the manufacturer, wholesaler, pharmacy, chain warehouse and any other person who claims an interest in the prescription drugs and goods, in person, or by registered or certified mail to the last known address of the person to be notified. The notice will include:

     (a) A statement of the claim of the authorized warehouse;

     (b) A copy of the inventory of the impounded items;

     (c) A demand for payment within a specified time of not less than 10 days after the receipt of the notice;

     (d) A conspicuous statement that the items will be sold to satisfy the claim of the authorized warehouse unless the claim is paid within the specified time; and

     (e) A statement that the manufacturer, wholesaler, pharmacy, chain warehouse or other person claiming an interest in the prescription drugs and goods may refute the claim of the authorized warehouse by providing to the Board any documentation or evidence that supports his or her position within the time designated in the notice.

     5.  The Board will attempt to reconcile the dispute informally if it receives documentation or evidence from the manufacturer, wholesaler, pharmacy, chain warehouse or other person claiming an interest in the prescription drugs and goods that refutes the claim of the authorized warehouse. If any portion of the dispute is reconciled, the Board will release the impounded prescription drugs and goods to carry out the purposes of the reconciliation. If the dispute is not reconciled, the parties shall submit the dispute to binding arbitration in accordance with the rules and procedures of the American Arbitration Association. The costs of the arbitration must be borne by the parties to the dispute.

     6.  If the arbitrator resolves all or any portion of the dispute in favor of the manufacturer, wholesaler, pharmacy, chain warehouse or other person claiming an interest in the prescription drugs and goods, the Board will release the impounded prescription drugs and goods in accordance with the decision of the arbitrator.

     7.  The Board will sell the impounded prescription drugs and goods for the satisfaction of the claim of the authorized warehouse if:

     (a) The arbitrator resolves all or any portion of the dispute in favor of the authorized warehouse; or

     (b) The manufacturer, wholesaler, pharmacy, chain warehouse or other person claiming an interest in the prescription drugs and goods fails to provide documentation or evidence refuting the claim of the authorized warehouse within the time set forth in the Board’s notice.

     8.  A sale will be conducted by the Board as follows:

     (a) The Board will notify all wholesalers licensed by the Board, the manufacturer, wholesaler, pharmacy or chain warehouse and any other person claiming an interest in the prescription drugs and goods of its intent to sell the items to the highest responsible bidder and of the terms and conditions for submitting a bid. The Board will allow the manufacturer, wholesaler, pharmacy, chain warehouse or other person claiming an interest in the items to redeem the prescription drugs and goods upon payment of the claim of the authorized warehouse, including the costs incurred by the authorized warehouse to enforce its claim, before the consummation of the bidding procedure.

     (b) The Board may divide the prescription drugs and goods into lots or portions if necessary to facilitate an efficient and effective sale.

     (c) The Board will accept the highest responsible bid received for the prescription drugs and goods.

     (d) Any bid accepted by the Board must be paid in cash or by a certified or cashier’s check made payable to the Board.

     (e) The Board will distribute all money received from the sale in the following order of priority:

          (1) To the Board in such an amount as is necessary to pay the expenses of impounding the prescription drugs and goods, causing an inventory of those items to be conducted and conducting the sale.

          (2) To the authorized warehouse to satisfy its claim, including all costs and charges incurred by the authorized warehouse until the day of the sale.

          (3) To any person who has established an interest in the prescription drugs and goods to the satisfaction of the Board, other than the manufacturer, wholesaler, pharmacy or chain warehouse.

          (4) To the manufacturer, wholesaler, pharmacy or chain warehouse.

     9.  The authorized warehouse:

     (a) Shall not conduct a sale of the prescription drugs and goods pursuant to NRS 104.7206 or 104.7210.

     (b) May not purchase prescription drugs and goods at any sale unless it is also licensed by the Board as a wholesaler.

     (c) Shall execute such documents as are required by the Board to indemnify the Board and hold it harmless from any liability arising as a result of the authorized warehouse exercising its rights pursuant to this section.

     (d) Shall pay all costs related to the exercise of its rights pursuant to this section, including any costs incurred by the Board to impound the prescription drugs and goods, cause an inventory of those items to be conducted and conduct the sale that are not paid pursuant to subparagraph (1) of paragraph (e) of subsection 8.

     10.  A wholesaler who in good faith purchases prescription drugs or goods at any sale conducted by the Board pursuant to this section takes the items free of any rights of persons against whom the lien of the authorized warehouse was valid.

     11.  The rights provided by this section are in addition to all other rights allowed by law to a creditor against his or her debtor.

     (Added to NAC by Bd. of Pharmacy, eff. 10-1-93)

      NAC 639.635  Cessation of operation. (NRS 639.070)

     1.  If an authorized warehouse intends to cease operation, it shall notify the Board and the manufacturer, wholesaler, pharmacy or chain warehouse with whom it has entered into a contract to receive, store or ship prescription drugs and goods. The notice must be sent by certified mail not later than 30 days before the authorized warehouse intends to cease operation.

     2.  If an authorized warehouse ceases operation, it shall arrange with the manufacturer, wholesaler, pharmacy or chain warehouse with whom it has contracted for the return of any prescription drugs or goods in its possession or for the shipment of those prescription drugs and goods to another authorized warehouse or wholesaler.

     3.  On the day it ceases operation, the authorized warehouse shall allow a representative of the Board to inspect the premises of the authorized warehouse in order to verify that all prescription drugs and goods have been removed from the premises. The Board will impound any prescription drugs and goods remaining on the premises of the authorized warehouse, cause an inventory of those items to be conducted and sell the items pursuant to the provisions of NAC 639.634. Money received from the sale will be distributed on the basis that the amount needed to satisfy the claim of the authorized warehouse is zero.

     (Added to NAC by Bd. of Pharmacy, eff. 10-1-93)

      NAC 639.636  Change in legal ownership of facility resulting from legal proceeding. (NRS 639.070)

     1.  If there is a change in the legal ownership of the facility of an authorized warehouse resulting from a legal proceeding such as a voluntary or involuntary proceeding in bankruptcy or a receivership, the authorized warehouse shall notify the Board within 5 days after the change in ownership.

     2.  Upon the change in ownership, the authorized warehouse may arrange to return any prescription drugs and goods in its possession to the manufacturer, wholesaler, pharmacy or chain warehouse with whom it has contracted or to ship the items to another authorized warehouse or wholesaler.

     3.  The Board may inspect, impound and cause to be conducted an inventory of the prescription drugs and goods in the possession of the authorized warehouse if it determines that the change in legal ownership of the facility may endanger the safety, health or welfare of members of the general public.

     (Added to NAC by Bd. of Pharmacy, eff. 10-1-93)

      NAC 639.637  Facilities: General requirements. (NRS 639.070)  The facility of an authorized warehouse must:

     1.  Have adequate lighting of at least 25 foot-candles;

     2.  Have an adequate area for the storage of prescription drugs and goods that facilitates access to those items;

     3.  Be maintained in a clean, orderly condition;

     4.  Be free from infestation by insects, rodents, birds or vermin;

     5.  Be secure from entry by unauthorized persons; and

     6.  Be equipped with an alarm system to detect entry into the facility after business hours.

     (Added to NAC by Bd. of Pharmacy, eff. 10-1-93)

      NAC 639.638  Facilities: Security. (NRS 639.070)

     1.  Access to the facility of an authorized warehouse must be limited to authorized persons and kept to a minimum. An authorized warehouse is liable for the acts of all authorized persons while they are at the facility.

     2.  A facility must be located in a discrete area and have a permanent or semipermanent barrier such as a wall, fence or other physical barrier that restricts unauthorized entry.

     3.  Except as otherwise provided in subsection 4:

     (a) The portion of a facility used to store prescription drugs must be securely enclosed with a material made of steel that is at least 10 gauge in thickness with openings not more than 2 1/2 inches wide. The material must be mounted on steel posts which must be at least 1 inch in diameter and placed not more than 10 feet apart. If the material does not extend to the structural ceiling of the facility, the ceiling of the enclosed area must be constructed of material made of steel that is at least 10 gauge in thickness with openings not more than 2 1/2 inches wide. A mesh made of a lighter gauge may be used for the ceiling of a large enclosed area if the walls of the area are at least 14 feet high.

     (b) The enclosed area of a facility that is used to store prescription drugs must be equipped with a security system that includes an alarm that transmits a signal to local law enforcement agencies or a private business that provides security services if an unauthorized person obtains access to the enclosed area.

     4.  The Executive Secretary may approve an alternate method of ensuring the security of a facility if he or she determines that the method will ensure that access to the facility is limited to authorized persons.

     (Added to NAC by Bd. of Pharmacy, eff. 10-1-93)

      NAC 639.639  Prescription drugs: Storage. (NRS 639.070)

     1.  Each authorized warehouse shall store prescription drugs held in the facility in the manner prescribed in the United States Pharmacopeia - National Formulary, as adopted by reference in paragraph (c) of subsection 1 of NAC 639.670.

     2.  If there are no specific requirements concerning the temperature at which a prescription drug must be stored, the drug must be stored at a controlled room temperature as defined in the United States Pharmacopeia - National Formulary, as adopted by reference in paragraph (c) of subsection 1 of NAC 639.670.

     3.  Each authorized warehouse shall provide the appropriate manual, electromechanical or electrical equipment to record the temperature and humidity of the area where the prescription drugs are stored.

     (Added to NAC by Bd. of Pharmacy, eff. 10-1-93; A by R035-06, 9-18-2008)

      NAC 639.640  Prescription drugs: Shipment. (NRS 639.070)

     1.  Each authorized warehouse shall, upon receiving a prescription drug, examine each outside shipping container of the drug to determine its identity and to prevent the acceptance of a contaminated prescription drug that is otherwise unfit for distribution. The examination must be sufficiently adequate to detect any damage to the container which would indicate contamination or other damage to the contents of the container.

     2.  Each authorized warehouse shall examine each outgoing shipment of prescription drugs to identify the prescription drugs contained in the shipment and to ensure that the prescription drugs contained in the shipment are not damaged and have been stored under proper conditions.

     3.  An authorized warehouse shall return any damaged containers to the manufacturer, wholesaler, pharmacy or chain warehouse with whom it has contracted or destroy the container in accordance with the policies and procedures established pursuant to NAC 639.642.

     (Added to NAC by Bd. of Pharmacy, eff. 10-1-93)

      NAC 639.641  Prescription drugs: Records. (NRS 639.070)

     1.  An authorized warehouse shall establish and maintain a record of each transaction relating to the receipt, storage and shipment of a prescription drug. The record must include:

     (a) The manufacturer of the prescription drug or the wholesaler, pharmacy or chain warehouse that placed the drug in the authorized warehouse;

     (b) The address of the location from which the prescription drug was shipped;

     (c) The identity and quantity of the prescription drug received or shipped or, if that information is not known, the lot number or other identification number by which the container may be specifically identified; and

     (d) The date of the receipt and the shipment of the prescription drug.

     2.  An authorized warehouse shall maintain such records for at least 2 years after the receipt or shipment of the prescription drug. The records must be made available for copying and inspection by any person authorized to inspect those records.

     3.  Except as otherwise provided in this subsection, an authorized warehouse shall maintain the records required by this section at the building where the facility is located. If the records are maintained by a computer, the records must be immediately retrievable and readily available for inspection. If the records are not maintained at the facility and are not immediately retrievable by computer, the records must be made available for inspection within 2 working days after a request is made by a person authorized to examine those records.

     (Added to NAC by Bd. of Pharmacy, eff. 10-1-93)

      NAC 639.642  Establishment of policies and procedures regarding prescription drugs. (NRS 639.070)

     1.  An authorized warehouse shall establish written policies and procedures for the receipt, security, storage and shipment of prescription drugs and goods and for maintaining the records required by NAC 639.641.

     2.  The written policies and procedures must include:

     (a) A procedure for identifying, recording and reporting any losses or thefts of prescription drugs and goods.

     (b) A procedure for correcting any errors or inaccuracies concerning the records maintained by the authorized warehouse.

     (c) A procedure for the operation of a facility in the event of a strike, fire, flood or other natural disaster or emergency.

     (d) A procedure for establishing the qualifications, identity and recognition of authorized persons who are allowed access to the facility.

     (e) A procedure for the return or destruction of damaged prescription drugs or goods.

     (Added to NAC by Bd. of Pharmacy, eff. 10-1-93)

      NAC 639.643  Inspections; examination of records and procedures. (NRS 639.070)  Each authorized warehouse shall allow the Board and any other person authorized to do so to:

     1.  Inspect its facility and any motor vehicles it uses to transport prescription drugs and goods; and

     2.  Examine its records and procedures for the operation of the facility,

Ê during normal business hours.

     (Added to NAC by Bd. of Pharmacy, eff. 10-1-93)

      NAC 639.644  Enforcement. (NRS 639.070)

     1.  The Board may bring an action to enjoin the activities of an authorized warehouse pursuant to NRS 639.097 or take any other action authorized by law if the warehouse has not obtained a license to engage in business as an authorized warehouse.

     2.  An authorized warehouse that fails to comply with any of the provisions of NAC 639.620 to 639.643, inclusive, is subject to disciplinary action pursuant to NRS 639.241 to 639.2576, inclusive.

     (Added to NAC by Bd. of Pharmacy, eff. 10-1-93; A by R218-05, 5-4-2006)

VETERINARY DRUGS

      NAC 639.650  Fee for and scope of permit to sell; penalty for late registration; prohibited sales; refrigeration. (NRS 639.070, 639.2345)  In compliance with NRS 639.2345, the Board hereby adopts the following provisions to regulate the retail sale of prescription and nonprescription veterinary drugs:

     1.  The fee for a biennial permit, valid for a 2-year period commencing November 1 of each even-numbered year, is $300. The permit includes authorization for the sale of hypodermic devices.

     2.  The Board will assess a penalty for failure to register or reregister within the time prescribed by statute or regulation in the amount of 50 percent of the registration fee for each period of delinquency or fraction thereof. The penalty is in addition to the registration fee for each such period or fraction thereof.

     3.  Prescription drugs and hypodermic devices must not be sold on a self-service basis.

     4.  Biologicals and other drugs must be kept refrigerated if the requirement is stated on the manufacturer’s label.

     [Bd. of Pharmacy, § 639.430, eff. 6-26-80]—(NAC A by R038-06, 5-4-2006)

      NAC 639.660  Restriction on use of rabies vaccine. (NRS 639.070)  Rabies vaccine for veterinary use, whether live or killed, is restricted to:

     1.  Use by a veterinarian or a physician.

     2.  Use by a person upon a prescription of a veterinarian or dispensed by a veterinarian.

     [Bd. of Pharmacy, § 639.435, eff. 6-26-80]

COMPOUNDING AND DISPENSING DRUG PRODUCTS

General Provisions

      NAC 639.661  Definitions. (NRS 639.070, 639.2807)  As used in NAC 639.661 to 639.690, inclusive, unless the context otherwise requires, the words and terms defined in NAC 639.6611 to 639.6677, inclusive, have the meanings ascribed to them in those sections.

     (Added to NAC by Bd. of Pharmacy, eff. 7-7-94; A by R035-06, 9-18-2008)

      NAC 639.6611  “Active ingredient” defined. (NRS 639.070)  “Active ingredient” means an ingredient added to a compounded drug product which provides the therapeutic effect desired from the compounded drug product. The term does not include an inert ingredient.

     (Added to NAC by Bd. of Pharmacy by R035-06, eff. 9-18-2008)

      NAC 639.6613  “Ante-area” defined. (NRS 639.070)  “Ante-area” has the meaning ascribed to it in chapter 797 of the United States Pharmacopeia - National Formulary, as adopted by reference in paragraph (c) of subsection 1 of NAC 639.670.

     (Added to NAC by Bd. of Pharmacy by R035-06, eff. 9-18-2008)

      NAC 639.6615  “Barrier isolator cabinet” defined. (NRS 639.070)  “Barrier isolator cabinet” means a device the interior of which creates an ISO Class 5 environment and provides an impermeable barrier to outside air at all times while it is being used for compounding purposes. The term includes, without limitation, compounding aseptic isolators and compounding aseptic containment isolators.

     (Added to NAC by Bd. of Pharmacy by R035-06, eff. 9-18-2008)

      NAC 639.6617  “Beyond-use date” defined. (NRS 639.070)  “Beyond-use date” has the meaning ascribed to it in chapter 797 of the United States Pharmacopeia - National Formulary, as adopted by reference in paragraph (c) of subsection 1 of NAC 639.670.

     (Added to NAC by Bd. of Pharmacy by R035-06, eff. 9-18-2008)

      NAC 639.6619  “Buffer area” defined. (NRS 639.070)  “Buffer area” has the meaning ascribed to it in chapter 797 of the United States Pharmacopeia - National Formulary, as adopted by reference in paragraph (c) of subsection 1 of NAC 639.670.

     (Added to NAC by Bd. of Pharmacy by R035-06, eff. 9-18-2008)

      NAC 639.6621  “Chart order” defined. (NRS 639.070)  “Chart order” has the meaning ascribed to it in NAC 639.442.

     (Added to NAC by Bd. of Pharmacy by R035-06, eff. 9-18-2008)

      NAC 639.6623  “Component” defined. (NRS 639.070)  “Component” means an ingredient that is used to compound a drug product, including, without limitation, an ingredient that does not appear on the labeling of the compounded drug product.

     (Added to NAC by Bd. of Pharmacy by R035-06, eff. 9-18-2008)

      NAC 639.6625  “Compound” and “compounding” defined. (NRS 639.070)

     1.  Except as otherwise provided in subsection 2, “compound” and “compounding” mean:

     (a) The preparation, mixing or assembling of a drug product of which at least one component is a prescription drug; and

     (b) The packaging and labeling incident to the preparation, mixing or assembling of a drug product for the purpose of selling or dispensing the drug product pursuant to a prescription or chart order.

     2.  The terms “compound” and “compounding” do not include the mixing or reconstituting of a nonsterile drug product that is performed in accordance with:

     (a) The directions contained in the labeling of the drug product that have been approved by the Food and Drug Administration and provided by the manufacturer of the drug product; or

     (b) Any other directions provided by the manufacturer of the drug product that are consistent with the labeling of the drug product that have been approved by the Food and Drug Administration.

     (Added to NAC by Bd. of Pharmacy by R035-06, eff. 9-18-2008)

      NAC 639.6627  “Compounding aseptic containment isolator” defined. (NRS 639.070)  “Compounding aseptic containment isolator” has the meaning ascribed to it in chapter 797 of the United States Pharmacopeia - National Formulary, as adopted by reference in paragraph (c) of subsection 1 of NAC 639.670.

     (Added to NAC by Bd. of Pharmacy by R035-06, eff. 9-18-2008)

      NAC 639.6629  “Compounding aseptic isolator” defined. (NRS 639.070)  “Compounding aseptic isolator” has the meaning ascribed to it in chapter 797 of the United States Pharmacopeia - National Formulary, as adopted by reference in paragraph (c) of subsection 1 of NAC 639.670.

     (Added to NAC by Bd. of Pharmacy by R035-06, eff. 9-18-2008)

      NAC 639.663  “Cytotoxic” defined. (NRS 639.070, 639.2807)  “Cytotoxic” means having the capability of killing living cells.

     (Added to NAC by Bd. of Pharmacy, eff. 7-7-94)

      NAC 639.6631  “Drug product” defined. (NRS 639.070)  “Drug product” means a commercially manufactured drug or nutrient that has been evaluated for safety and efficacy by the Food and Drug Administration.

     (Added to NAC by Bd. of Pharmacy by R035-06, eff. 9-18-2008)

      NAC 639.6633  “Gloved fingertip sampling” defined. (NRS 639.070)  “Gloved fingertip sampling” has the meaning ascribed to it in chapter 797 of the United States Pharmacopeia - National Formulary, as adopted by reference in paragraph (c) of subsection 1 of NAC 639.670.

     (Added to NAC by Bd. of Pharmacy by R035-06, eff. 9-18-2008)

      NAC 639.6635  “Hazardous drug” defined. (NRS 639.070)  “Hazardous drug” means:

     1.  A compounded drug product in which one or more of the components of the compounded drug product produce one or more of the following characteristics in humans or animals:

     (a) Carcinogenicity;

     (b) Teratogenicity or other developmental toxicity;

     (c) Reproductive toxicity;

     (d) Organ toxicity at low doses; or

     (e) Genotoxicity; or

     2.  A compounded drug product in which the structure and toxicity profiles of the compounded drug product mimic an existing drug product which has components that produce one or more of the characteristics set forth in subsection 1.

     (Added to NAC by Bd. of Pharmacy by R035-06, eff. 9-18-2008)

      NAC 639.6637  “High-risk sterile compounded drug product” defined. (NRS 639.070)  “High-risk sterile compounded drug product” means a sterile compounded drug product which is compounded by a pharmacist or a pharmaceutical technician and which satisfies the requirements set forth in NAC 639.67067.

     (Added to NAC by Bd. of Pharmacy by R035-06, eff. 9-18-2008)

      NAC 639.6639  “Immediate-use sterile compounded drug product” defined. (NRS 639.070)  “Immediate-use sterile compounded drug product” means a sterile compounded drug product which is compounded by a pharmacist or a pharmaceutical technician and which satisfies the requirements set forth in NAC 639.67073.

     (Added to NAC by Bd. of Pharmacy by R035-06, eff. 9-18-2008)

      NAC 639.6641  “ISO Class 5” defined. (NRS 639.070)  “ISO Class 5” means the classification of an atmospheric environment that is made by the International Organization for Standardization based on an adaptation of Federal Standard 209E, as adopted by reference in paragraph (a) of subsection 1 of NAC 639.670, in which the atmospheric environment contains:

     1.  Less than 3,520 particles that are 0.5 micron or larger in diameter per cubic meter of air; or

     2.  Less than 100 particles that are 0.5 micron or larger in diameter per cubic foot of air.

     (Added to NAC by Bd. of Pharmacy by R035-06, eff. 9-18-2008)

      NAC 639.6643  “ISO Class 7” defined. (NRS 639.070)  “ISO Class 7” means the classification of an atmospheric environment that is made by the International Organization for Standardization based on an adaptation of Federal Standard 209E, as adopted by reference in paragraph (a) of subsection 1 of NAC 639.670, in which the atmospheric environment contains:

     1.  Less than 352,000 particles that are 0.5 micron or larger in diameter per cubic meter of air; or

     2.  Less than 10,000 particles that are 0.5 micron or larger in diameter per cubic foot of air.

     (Added to NAC by Bd. of Pharmacy by R035-06, eff. 9-18-2008)

      NAC 639.6645  “ISO Class 8” defined. (NRS 639.070)  “ISO Class 8” means the classification of an atmospheric environment that is made by the International Organization for Standardization based on an adaptation of Federal Standard 209E, as adopted by reference in paragraph (a) of subsection 1 of NAC 639.670, in which the atmospheric environment contains:

     1.  Less than 3,520,000 particles that are 0.5 micron or larger in diameter per cubic meter of air; or

     2.  Less than 100,000 particles that are 0.5 micron or larger in diameter per cubic foot of air.

     (Added to NAC by Bd. of Pharmacy by R035-06, eff. 9-18-2008)

      NAC 639.6647  “Low-risk sterile compounded drug product” defined. (NRS 639.070)  “Low-risk sterile compounded drug product” means a sterile compounded drug product which is compounded by a pharmacist or a pharmaceutical technician and which satisfies the requirements set forth in NAC 639.67061.

     (Added to NAC by Bd. of Pharmacy by R035-06, eff. 9-18-2008)

      NAC 639.6649  “Media fill test” defined. (NRS 639.070)  “Media fill test” has the meaning ascribed to it in chapter 797 of the United States Pharmacopeia - National Formulary, as adopted by reference in paragraph (c) of subsection 1 of NAC 639.670.

     (Added to NAC by Bd. of Pharmacy by R035-06, eff. 9-18-2008)

      NAC 639.665  “Medical facility” defined. (NRS 639.070, 639.2807)  “Medical facility” has the meaning ascribed to it in NRS 449.0151.

     (Added to NAC by Bd. of Pharmacy, eff. 7-7-94)

      NAC 639.6655  “Medium-risk sterile compounded drug product” defined. (NRS 639.070)  “Medium-risk sterile compounded drug product” means a sterile compounded drug product which is compounded by a pharmacist or a pharmaceutical technician and which satisfies the requirements set forth in NAC 639.67065.

     (Added to NAC by Bd. of Pharmacy by R035-06, eff. 9-18-2008)

      NAC 639.6665  “Nonsterile compounded drug product” defined. (NRS 639.070)  “Nonsterile compounded drug product” means a drug product the preparation and dispensing of which require compounding and which is not required to be sterile as described in NAC 639.6677.

     (Added to NAC by Bd. of Pharmacy by R035-06, eff. 9-18-2008)

      NAC 639.667  “Nursing personnel” defined. (NRS 639.070, 639.2807)  “Nursing personnel” means an employee of:

     1.  A medical facility who is licensed pursuant to chapter 632 of NRS;

     2.  A nursing pool as defined in NRS 449.0153; or

     3.  An agency to provide nursing in the home as defined in NRS 449.0015.

     (Added to NAC by Bd. of Pharmacy, eff. 7-7-94)

      NAC 639.6673  “Parenteral nutrition” defined. (NRS 639.070)  “Parenteral nutrition” means nutrients provided intravenously.

     (Added to NAC by Bd. of Pharmacy by R035-06, eff. 9-18-2008)

      NAC 639.6677  “Sterile compounded drug product” defined. (NRS 639.070)  “Sterile compounded drug product” means a drug product the preparation and dispensing of which require compounding and which is required to be sterile by either the provisions of chapter 797 of the United States Pharmacopeia - National Formulary, as adopted by reference in paragraph (c) of subsection 1 of NAC 639.670, or the provisions of NAC 639.661 to 639.690, inclusive.

     (Added to NAC by Bd. of Pharmacy by R035-06, eff. 9-18-2008)

      NAC 639.670  Adoption of certain publications by reference; revision of publication after adoption. (NRS 639.070, 639.2807)

     1.  The Board hereby adopts by reference the following:

     (a) Federal Standard 209E, “Airborne Particulate Cleanliness Classes in Cleanrooms and Clean Zones,” as revised on September 11, 1992, by the Institute of Environmental Sciences. A copy of this publication may be obtained free of charge at the Internet address http://www.set3.com/papers/209e.pdf.

     (b) NSF International Standard 49, “Class II (Laminar Flow) Biosafety Cabinetry,” NSF/ANSI 49-2007, 2007 edition. A copy of this standard may be obtained from Techstreet, 3916 Ranchero Drive, Ann Arbor, Michigan 48108, or at the Internet address http://www.techstreet.com/, for the price of $160.

     (c) United States Pharmacopeia - National Formulary, 2008 edition, published by the United States Pharmacopeial Convention. A copy of this publication may be obtained from the United States Pharmacopeial Convention, Customer Service Department, 12601 Twinbrook Parkway, Rockville, Maryland 20852, or at the Internet address http://www.usp.org/products/, for the price of $755.

     (d) The Food Chemicals Codex, 6th edition, published by the United States Pharmacopeial Convention. A copy of this publication may be obtained from the United States Pharmacopeial Convention, Customer Service Department, 12601 Twinbrook Parkway, Rockville, Maryland 20852, or at the Internet address http://www.usp.org/products/, for the price of $495.

     (e) Reagent Chemicals: Specifications and Procedures, 10th edition, published by the American Chemical Society. A copy of this publication may be obtained from the Oxford University Press, 2001 Evans Road, Cary, North Carolina 27513, or at the Internet address http://www.oup-usa.org, for the price of $274.50.

     (f) Appendix A of Publication No. 2004-165, “Alert: Preventing Occupational Exposures to Antineoplastic and Other Hazardous Drugs in Health Care Settings,” published by the National Institute for Occupational Safety and Health. A copy of this publication may be obtained free of charge by telephone at (800) 232-4636 or at the Internet address http://www.cdc.gov/niosh/docs/2004-165/.

     2.  The Board will periodically review the standards and publications adopted by reference pursuant to paragraphs (b) to (f), inclusive, of subsection 1 and determine within 120 days after the review whether any change made to those standards or publications is appropriate for application in this State. If the Board does not disapprove a change to an adopted standard or publication within 120 days after the review, the change is deemed to be approved by the Board.

     (Added to NAC by Bd. of Pharmacy, eff. 8-14-87; A 7-7-94; R035-06, 9-18-2008)

Standards for Compounding and Dispensing Generally

      NAC 639.6701  Inspection of materials and equipment; recordkeeping. (NRS 639.070)

     1.  A pharmacy or pharmacist engaged in the practice of compounding drug products shall:

     (a) Inspect and either approve or reject, without limitation, each component, container, closure, label and other material used in the process of compounding each drug product;

     (b) Ensure the proper use, cleanliness and maintenance of any equipment used in the process of compounding each drug product; and

     (c) Prepare the records required to be prepared pursuant to NAC 639.661 to 639.690, inclusive, concerning the compounding of each drug product to ensure that an error has not occurred in the process of compounding each drug product.

     2.  A pharmacy or pharmacist engaged in the practice of compounding drug products may not allow any food or drink to be stored or consumed in or at an area or room in the pharmacy that is designated for compounding.

     (Added to NAC by Bd. of Pharmacy by R035-06, eff. 9-18-2008)

      NAC 639.67013  Competency and proficiency of certain pharmaceutical personnel. (NRS 639.070)

     1.  A pharmacy engaged in the practice of compounding drug products and dispensing compounded drug products shall ensure that each pharmacist and pharmaceutical technician engaged in the practice of compounding drug products:

     (a) Is competent and proficient in compounding the drug products that the pharmacist or pharmaceutical technician will be authorized and expected to compound;

     (b) Complies with the provisions of NAC 639.661 to 639.690, inclusive, concerning the drug products which the pharmacist or pharmaceutical technician compounds and the compounded drug products which the pharmacist or pharmaceutical technician dispenses at the pharmacy; and

     (c) Receives, on an ongoing basis, sufficient training to maintain that competency and proficiency.

     2.  A pharmacy engaged in the practice of compounding drug products and dispensing compounded drug products shall evaluate the competency and proficiency of a pharmacist and pharmaceutical technician:

     (a) If the pharmacist or pharmaceutical technician is newly hired or is newly assigned to compound drug products, before the pharmacy authorizes the pharmacist or pharmaceutical technician to compound drug products; and

     (b) If the pharmacist or pharmaceutical technician will be assigned to compound drug products that involve a higher level of risk than the drug products which the pharmacist or pharmaceutical technician had previously been trained to compound, before the pharmacy authorizes the pharmacist or pharmaceutical technician to compound those drug products.

     (Added to NAC by Bd. of Pharmacy by R035-06, eff. 9-18-2008)

      NAC 639.67015  Establishment of policies and procedures. (NRS 639.070)

     1.  A pharmacy engaged in the practice of compounding drug products shall establish and maintain written policies and procedures for compounding drug products to ensure that each final compounded drug product has the identity, strength, quality and purity which the compounded drug product is purported or represented to have. Such policies and procedures must include, without limitation:

     (a) Policies and procedures for:

          (1) The processes used by the pharmacy to compound drug products;

          (2) The equipment used by the pharmacy to compound drug products;

          (3) Ensuring that the actual weights and measures of each component are within plus or minus 5 percent of the theoretical weights and measures required for the drug products compounded by the pharmacy;

          (4) Tracking, recalling and destroying the drug products compounded by the pharmacy, which must include a requirement that the pharmacy ensure that all drug products which could have been compounded with a particular component be located, recalled and destroyed; and

          (5) Identifying the drug products or components of drug products that will be considered hazardous drugs.

     (b) Control procedures for monitoring each final compounded drug product and validating the compounding processes that may be responsible for causing variability in the final compounded drug product.

     (c) Control procedures to ensure that:

          (1) Each component is accurately weighed, measured or subdivided, as appropriate;

          (2) Any variation in the actual yield of a drug product compounded by the pharmacy is within plus or minus 10 percent of the theoretical yield of the compounded drug product; and

          (3) If a component is transferred from its original storage container to a new storage container, the new storage container is labeled with the date of the transfer and information that is sufficient to trace the contents of the new container to the original storage container.

     2.  A member of the staff of the Board may require a pharmacy engaged in the practice of compounding drug products to provide a sample of a drug product that is being compounded at the time of the request and any records related to that compounded drug product for purposes of testing the compounded drug product for compliance with the provisions of NAC 639.661 to 639.690, inclusive. The Board will share the costs of testing such a sample equally with the pharmacy.

     3.  If a sample tested pursuant to subsection 2 does not comply with the provisions of NAC 639.661 to 639.690, inclusive, the Board will notify the pharmacy of the failure to comply and the pharmacy must:

     (a) Provide to the Board a written plan for remediating or addressing the noncompliance; and

     (b) If requested by a member of the staff of the Board, provide an additional sample of the compounded drug product for testing. The costs of a test conducted pursuant to this paragraph must be paid solely by the pharmacy.

     4.  If the sample provided to the Board pursuant to paragraph (b) of subsection 3 does not comply with the provisions of NAC 639.661 to 639.690, inclusive, the Board will take such action as it deems necessary to correct the noncompliance or to prevent further noncompliance, including, without limitation:

     (a) Suspending the license of the pharmacy pursuant to NRS 639.210;

     (b) Suspending the ability of the pharmacy to compound certain drug products; and

     (c) Requiring the pharmacy to perform any other remedial or protective measures the Board deems necessary to correct the noncompliance or to prevent further noncompliance.

     (Added to NAC by Bd. of Pharmacy by R035-06, eff. 9-18-2008)

      NAC 639.67017  Use of automated compounding devices. (NRS 639.070)

     1.  A pharmacy may use an automated compounding device to:

     (a) Assist with the compounding of a drug product; or

     (b) Produce a final compounded drug product.

     2.  If a pharmacy uses an automated compounding device as described in subsection 1, the pharmacy shall establish and maintain written policies and procedures, in addition to the policies and procedures established and maintained pursuant to NAC 639.67015, that address:

     (a) The qualifications that a pharmacist or a pharmaceutical technician must have to use the automated compounding device;

     (b) The routine maintenance and cleaning required to be performed on the automated compounding device which, at a minimum, satisfies the requirements for maintenance and cleaning established by the manufacturer of the automated compounding device; and

     (c) The testing required to be performed on the automated compounding device to ensure that the automated compounding device is measuring and dispensing the components of the compounded drug product and manufacturing the final compounded drug product within tolerances of not more than plus or minus 5 percent.

     3.  If a pharmacy uses an automated compounding device to assist with the compounding of a drug product for parenteral nutrition, the pharmacy shall establish safe maximum limits for each additive that may be used in compounding such a drug product. The pharmacy shall ensure that:

     (a) The automated compounding device will cease compounding the drug product for parenteral nutrition if a maximum limit for an additive will be exceeded until a pharmacist, after consultation with the prescribing practitioner, makes changes to or validates the correctness of the prescription or chart order; or

     (b) If an automated compounding device cannot be programmed to cease the compounding process as described in paragraph (a):

          (1) The automated compounding device is equipped with an audible alarm or some other mechanism that will alert the pharmacist if a maximum limit for an additive has been exceeded; and

          (2) The pharmacy has written policies and procedures to prevent the continuation of the compounding process once a maximum limit for an additive has been exceeded until a pharmacist, after consultation with the prescribing practitioner, makes changes to or validates the correctness of the prescription or chart order.

     4.  If the pharmacy uses a computerized order entry system in conjunction with the automated compounding device, the pharmacy must ensure that the computerized order entry system will cease processing the order if a maximum limit for an additive will be exceeded until a pharmacist, after consultation with the prescribing practitioner, makes changes to or validates the correctness of the prescription or chart order.

     5.  A pharmacy shall make and maintain records that evidence compliance by the pharmacy with the policies and procedures required by this section.

     (Added to NAC by Bd. of Pharmacy by R035-06, eff. 9-18-2008)

      NAC 639.67019  Retention of records. (NRS 639.070)

     1.  Except as otherwise provided in NAC 639.67055, each record required to be made pursuant to NAC 639.661 to 639.690, inclusive, must be:

     (a) Maintained by the pharmacy for which the record was made for at least 2 years after the date the record was made; and

     (b) Available for inspection and copying by the Board or its representative.

     2.  Records made and maintained by a pharmacy pursuant to NAC 639.67055 must be available for inspection and copying by the Board or its representative after the 6-month period required by NAC 639.67055 if the pharmacy maintains the records longer than the required 6-month period.

     (Added to NAC by Bd. of Pharmacy by R035-06, eff. 9-18-2008)

      NAC 639.6702  Records concerning drug products compounded in excess and in bulk quantities. (NRS 639.070)  For each compounded drug product that is in excess of the amount required by the prescription or chart order and each compounded drug product that is compounded in bulk quantities, the pharmacist who compounded or supervised the compounding of the compounded drug product shall prepare a record, either on paper or in the pharmacy’s computer system, that includes, without limitation:

     1.  The name of the compounded drug product;

     2.  A list of the components and quantities of components used to compound the drug product, including, without limitation, the manufacturer or supplier of the components used, the lot number of the components used and the expiration dates of the components used;

     3.  The internal control number assigned to the compounded drug product by the pharmacist or the number of the prescription of the compounded drug product;

     4.  The beyond-use date of the compounded drug product;

     5.  The date of preparation of the compounded drug product;

     6.  The initials of the pharmacist or pharmaceutical technician who compounded the compounded drug product;

     7.  If the drug product was compounded by a pharmaceutical technician, the initials of the pharmacist who supervised the pharmaceutical technician; and

     8.  The quantity of the final compounded drug product.

     (Added to NAC by Bd. of Pharmacy by R035-06, eff. 9-18-2008)

Standards for Compounding and Dispensing Nonsterile Products

      NAC 639.6703  Labeling. (NRS 639.070)

     1.  Each pharmacist engaged in the practice of compounding nonsterile compounded drug products shall label each nonsterile compounded drug product, including, without limitation, any amount of the nonsterile compounded drug product that is in excess of the amount required by the prescription or chart order and any nonsterile compounded drug product that is compounded in bulk quantities. The label must include, without limitation:

     (a) The name of the final compounded drug product or the name of each active ingredient present in the nonsterile compounded drug product and, as appropriate, the concentration of each active ingredient in the final compounded drug product;

     (b) The internal control number assigned to the compounded drug product by the pharmacist; and

     (c) The beyond-use date of the compounded drug product.

     2.  Except as otherwise provided in subsection 3 or in the published data or data of the manufacturer, or as otherwise determined to be earlier in the judgment of the pharmacist, the latest beyond-use date of a nonsterile compounded drug product is:

     (a) For nonaqueous liquids and solid formations, not later than the expiration date of the active ingredient present in the nonsterile compounded drug product with the earliest expiration date or 6 months after the date on which the nonsterile compounded drug product was compounded, whichever is earlier;

     (b) For compounds which contain nonsterile water, not later than 14 days after the date on which the nonsterile compounded drug product was compounded; and

     (c) For compounds other than those listed in paragraph (a) or (b), not later than the intended duration of the therapy or 30 days after the date on which the nonsterile compounded drug product was compounded, whichever is earlier.

     3.  Except as otherwise provided in subsection 7 of NRS 639.2801, a pharmacy may use a beyond-use date that is later than the dates described in subsection 2 if the pharmacy can prove by appropriate testing or published data that the nonsterile compounded drug product is safe and effective using the extended beyond-use date.

     4.  Each pharmacist engaged in the practice of compounding nonsterile compounded drug products shall ensure that each nonsterile compounded drug product, including, without limitation, any amount of the nonsterile compounded drug product that is in excess of the amount required by the prescription or chart order, and any nonsterile compounded drug product that is compounded in bulk quantities is stored in the pharmacy in a manner that:

     (a) Maintains the efficacy of the nonsterile compounded drug product; and

     (b) Ensures that the nonsterile compounded drug product remains free from contamination.

     (Added to NAC by Bd. of Pharmacy by R035-06, eff. 9-18-2008)

      NAC 639.67033  Environmental standards. (NRS 639.070)  A pharmacy engaged in the practice of compounding nonsterile compounded drug products shall:

     1.  Designate a specific area of the pharmacy in which nonsterile compounded drug products will be compounded;

     2.  Ensure that the area described in subsection 1 has adequate space in which to place, in an orderly manner, the equipment and materials that will be used in the compounding process;

     3.  Ensure that the area described in subsection 1 is cleaned using an antiseptic cleaning method before and after any compounding occurs in the area to prevent cross-contamination between the previously compounded drug products and any subsequently compounded drug products;

     4.  Ensure that any equipment used to compound a nonsterile compounded drug product is cleaned after the compounding of that drug product is completed to prevent cross-contamination from occurring when the equipment is used in the compounding process of any subsequently compounded drug products;

     5.  If the pharmacy compounds both nonsterile compounded drug products and sterile compounded drug products, ensure that none of the equipment which is used to compound nonsterile compounded drug products is used to compound sterile compounded drug products unless the equipment is cleaned and sanitized before the compounding of sterile compounded drug products begins; and

     6.  Ensure that any employee of the pharmacy who compounds nonsterile compounded drug products washes his or her hands with soap and water or with an antimicrobial agent before and after compounding nonsterile compounded drug products.

     (Added to NAC by Bd. of Pharmacy by R035-06, eff. 9-18-2008)

      NAC 639.67035  Establishment of policies and procedures. (NRS 639.070)  A pharmacy engaged in the practice of compounding nonsterile compounded drug products shall, in addition to the requirements of NAC 639.67015, establish and maintain written policies and procedures for compounding nonsterile compounded drug products to ensure that each final compounded drug product has the identity, strength, quality and purity which the compounded drug product is purported or represented to have. Such policies and procedures must include, without limitation:

     1.  Policies and procedures for:

     (a) Making and maintaining records concerning the components used to compound each nonsterile compounded drug product;

     (b) The amount of each component used to compound each nonsterile compounded drug product;

     (c) The order of each step in the process of compounding each nonsterile compounded drug product; and

     (d) Including the information listed in paragraphs (a), (b) and (c) on the original hard copy of the prescription maintained in the written records of the pharmacy or in a computer system that may be accessed to provide information:

          (1) For refilling the prescription; or

          (2) Requested by the staff of the Board.

     2.  Control procedures for monitoring each final nonsterile compounded drug product and validating the processes for compounding that may be responsible for causing variability in the final nonsterile compounded drug product. Such control procedures must include, without limitation, procedures for evaluating:

     (a) Any variation of more than plus or minus 10 percent in the weight of the capsules, tablets or any other solid form of a dosage of the same nonsterile compounded drug product;

     (b) The adequacy of mixing to ensure uniformity and homogeneity of each nonsterile compounded drug product;

     (c) If applicable, the clarity, completeness and pH of a nonsterile compounded drug product;

     (d) If applicable, the even distribution of coloring agents; and

     (e) Any variation of more than plus or minus 10 percent in the actual yield of a nonsterile compounded drug product compounded by the pharmacy as compared to the theoretical yield of the nonsterile compounded drug product.

     3.  Control procedures to ensure:

     (a) If the final nonsterile compounded drug product is a capsule, that the capsule is properly locked;

     (b) If the final nonsterile compounded drug product is a tablet or any other solid form of dosage, that the final compounded drug product is of a uniform size and is intact;

     (c) If the final nonsterile compounded drug product is a suppository, that the suppository is properly sealed;

     (d) If the final nonsterile compounded drug product is an oral liquid, that, to the extent possible, the liquid is palatable to the patient;

     (e) If the final nonsterile compounded drug product is a suspension, that the visible suspended particles are of uniform size and are readily dispersed upon shaking; and

     (f) If the final nonsterile compounded drug product is a topical compounded drug product, that the final compounded drug product is smooth and not gritty and has a uniform viscosity unless grittiness is required for a particular therapeutic purpose.

     (Added to NAC by Bd. of Pharmacy by R035-06, eff. 9-18-2008)

      NAC 639.67037  Safety procedures for storage, handling, compounding and disposal; training required. (NRS 639.070)

     1.  A pharmacy engaged in the practice of compounding nonsterile hazardous drugs shall:

     (a) Store the components of the hazardous drugs separately from all the other inventory at the pharmacy and in such a manner and location as to minimize the contamination of other drugs in and employees of the pharmacy;

     (b) Handle the components of the hazardous drugs with caution by using appropriate gloves while distributing, receiving, stocking, inventorying, and preparing for administering and disposing of the components of a hazardous drug or a final compounded drug product;

     (c) Ensure that an employee of the pharmacy involved with compounding hazardous drugs wears personal protective equipment, including, without limitation, gowns, face masks, eye protection, double gloves or chemotherapy gloves;

     (d) Dispose of all waste relating to compounding hazardous drugs in a manner that complies with any applicable state, federal and local laws and regulations; and

     (e) Ensure that any employees of the pharmacy who are known to the pharmacy to be at special risk with regard to the properties of the hazardous drugs are limited from exposure to those drugs.

     2.  A pharmacy engaged in the practice of compounding nonsterile hazardous drugs and dispensing compounded nonsterile hazardous drugs shall require each pharmacist and pharmaceutical technician who compounds nonsterile hazardous drugs to be trained in the storage, handling, compounding, safety procedures and disposal of such compounded drugs:

     (a) Before the pharmacy authorizes the pharmacist or pharmaceutical technician to compound a nonsterile hazardous drug that will be administered or dispensed to a patient; and

     (b) At least once each year thereafter.

     3.  The training required pursuant to subsection 2 must, at a minimum, include information concerning:

     (a) Safe manipulation practices that minimize exposure to the hazardous drug and protect employees of the pharmacy from any overt exposure to the hazardous drug;

     (b) Procedures for containment, cleaning and disposal with regard to breaks and spills; and

     (c) Treatment of employees of the pharmacy with regard to exposure by contact and inhalation.

     4.  The pharmacy shall make and keep a record of any training given pursuant to subsection 2.

     (Added to NAC by Bd. of Pharmacy by R035-06, eff. 9-18-2008)

Standards for Compounding and Dispensing Sterile Products

      NAC 639.6705  Environmental standards. (NRS 639.070)

     1.  Except as otherwise provided in NAC 639.67059, a pharmacy engaged in the practice of compounding sterile compounded drug products shall provide an ISO Class 5 environment.

     2.  If a pharmacy uses a laminar airflow hood as its ISO Class 5 environment within which to compound sterile compounded drug products, the pharmacy:

     (a) Shall ensure that the laminar airflow hood is located within a room with a buffer area that maintains an ISO Class 7 environment under normal conditions of use.

     (b) Shall maintain an ante-area or space in close proximity to any entrance to the room containing the laminar airflow hood that maintains an ISO Class 8 environment under normal conditions of use.

     (c) Shall ensure that the room that contains the laminar airflow hood maintains a constant temperature and humidity that:

          (1) Ensures the safety and efficacy of the compounded drug products, components and equipment; and

          (2) Provides an environment in which the employees of the pharmacy can work comfortably for the duration of the compounding that will be conducted in the room.

     (d) Shall require each employee of the pharmacy who enters the buffer area containing the laminar airflow hood to:

          (1) Remove all jewelry from his or her hands and arms;

          (2) Perform sanitizing scrubbing; and

          (3) Wear fresh protective clothing, including, without limitation, gowns, shoe covers or dedicated shoes, and hair covers, in the ante-area or space in close proximity to an entrance to the room and to remove all such items of protective clothing whenever the employee leaves the room. A gown may be used more than once within a 12-hour period if it is removed in the ante-area and is stored in the ante-area until it is used again.

     (e) Shall require an employee to wear nonpowdered gloves and a face mask and beard cover, as applicable, before the employee enters the buffer area.

     (f) Shall ensure, to the extent practicable, that all items located in or brought into the room containing the laminar airflow hood have nonporous, smooth, impermeable surfaces that:

          (1) Can withstand being cleaned repeatedly with a disinfectant; and

          (2) Do not shed particles which may become airborne in the room.

     (g) Must have floors, walls and ceilings in the room containing the laminar airflow hood that are made of materials that can withstand being cleaned and disinfected repeatedly with solutions and products.

     (h) Shall ensure, before any compounding can occur within the laminar airflow hood, that the laminar airflow hood is used according to the manufacturer’s directions with regard to starting and using the laminar airflow hood in a manner which ensures that the interior of the laminar airflow hood creates and maintains an ISO Class 5 environment.

     (i) Shall ensure that:

          (1) The ISO Class 5 environment is cleaned:

               (I) At the beginning of each work shift;

               (II) Before the compounding of each batch preparation begins;

               (III) At least every 30 minutes after the compounding of a sterile compounded drug product has begun during a period of continuous compounding activity;

               (IV) After there has been a spill within the ISO Class 5 environment; and

               (V) Whenever it is known or suspected that surface contamination exists as a result of a breach in procedure.

          (2) The counters and easily cleanable work surfaces in close proximity to the laminar airflow hood and in, or in close proximity to, the buffer area are cleaned at least once each day in which the ISO Class 5 environment is used and whenever a counter or surface may require cleaning as a result of its use throughout the working day.

          (3) The floors are cleaned at least once each day in which the ISO Class 5 environment is used and whenever the floors may require cleaning as a result of its use throughout the working day.

          (4) The walls, ceilings, storage, shelving and other surfaces that are not easily cleaned are cleaned at least once each month.

     3.  If a pharmacy uses a barrier isolator cabinet that maintains an ISO Class 5 environment at all times when it is in use as its ISO Class 5 environment within which to compound sterile compounded drug products, the pharmacy shall ensure that:

     (a) The barrier isolator cabinet is placed in the pharmacy at a location where:

          (1) The compounding may occur without interruption or inconvenience; and

          (2) The barrier isolator cabinet will not be compromised by its proximity to air vents, doorways or other pharmacy fixtures or equipment.

     (b) Before any compounding may occur within the barrier isolator cabinet, the barrier isolator cabinet is used according to the manufacturer’s directions with regard to starting and using the barrier isolator cabinet in a manner which ensures that the interior of the barrier isolator cabinet creates and maintains an ISO Class 5 environment.

     (c) The barrier isolator cabinet is cleaned:

          (1) At the beginning of each work shift;

          (2) Before the compounding of each batch preparation begins;

          (3) At least every 30 minutes after the compounding of a sterile compounded drug product has begun during a period of continuous compounding activity;

          (4) After there has been a spill within the ISO Class 5 environment; and

          (5) Whenever it is known or suspected that surface contamination exists as a result of a breach in procedure.

     (d) The counters and easily cleanable work surfaces in close proximity to the barrier isolator cabinet are cleaned at least once each day in which the barrier isolator cabinet is used and whenever a counter or surface may require cleaning as a result of its use throughout the working day.

     (e) The floors in close proximity to the barrier isolator cabinet are cleaned at least once each day in which the barrier isolator cabinet is used and whenever the floors may require cleaning as a result of its use throughout the working day.

     4.  A barrier isolator cabinet that cannot maintain an ISO Class 5 environment at all times when it is being used shall be deemed a laminar airflow hood for purposes of satisfying the requirements of this section.

     5.  As used in this section, “batch preparation” means the compounding of multiple units of sterile compounded drug products, not for immediate use, in a single process by the same person.

     (Added to NAC by Bd. of Pharmacy by R035-06, eff. 9-18-2008)

      NAC 639.67051  Air quality testing and certification. (NRS 639.070)

     1.  Except as otherwise provided in NAC 639.67059, a pharmacy engaged in the practice of compounding sterile compounded drug products shall test the air in each of its controlled environments to ensure that the environments attain the air quality required by the provisions of NAC 639.661 to 639.690, inclusive, for an ISO Class 5, ISO Class 7 or ISO Class 8 environment, as applicable.

     2.  The air quality testing required by subsection 1 must be performed randomly with regard to:

     (a) The time of day the air samples are collected;

     (b) The staff who is on duty when the samples are gathered; and

     (c) The locations within the pharmacy from which the samples are collected.

     3.  A pharmacy engaged in the practice of compounding sterile compounded drug products shall have its ISO Class 5 environment certified pursuant to subsection 4:

     (a) At least twice each year; and

     (b) Before compounding a sterile compounded drug product after:

          (1) A substantial change or renovation is made in the room that contains the laminar airflow hood or barrier isolator cabinet;

          (2) Sizeable equipment is placed in the room that contains the laminar airflow hood or barrier isolator cabinet;

          (3) The laminar airflow hood or barrier isolator cabinet is moved from the location at which the laminar airflow hood or barrier isolator cabinet was most recently tested; or

          (4) The laminar airflow hood or barrier isolator cabinet is repaired.

     4.  The certification required by subsection 3 must be completed by a person who is independent of the pharmacy requesting the certification and who is capable of certifying that the ISO Class 5 environment can satisfy and maintain the minimum requirements set forth in NAC 639.6641 for air quality under normal conditions of use.

     5.  A pharmacy engaged in the practice of compounding sterile compounded drug products shall have each of its ISO Class 7 and ISO Class 8 environments tested or certified pursuant to subsection 7 for particulates:

     (a) At least twice each year; and

     (b) Before compounding a sterile compounded drug product after:

          (1) A substantial change or renovation is made in the room that contains the laminar airflow hood or barrier isolator cabinet;

          (2) Sizeable equipment is placed in the room that contains the laminar airflow hood or barrier isolator cabinet;

          (3) The laminar airflow hood or barrier isolator cabinet is moved from the location at which the laminar airflow hood or barrier isolator cabinet was most recently tested; or

          (4) A laminar airflow hood or barrier isolator cabinet is added to or removed from the room that contains the laminar airflow hood or barrier isolator cabinet.

     6.  The air quality testing required by subsection 5 must be performed randomly with regard to:

     (a) The time of day the air samples are collected;

     (b) The staff who are on duty when the samples are gathered; and

     (c) The locations within the pharmacy from which the samples are collected.

     7.  The testing or certification required by subsection 5 must be completed by the pharmacy or by a person who is independent of the pharmacy requesting the certification and who is capable of testing or certifying that the ISO Class 7 or ISO Class 8 environment can satisfy and maintain the minimum requirements set forth in NAC 639.6643 and 639.6645, respectively, for air quality under normal conditions of use.

     8.  If the pharmacy performs the testing or certification required by subsection 5, the testing or certification process of the pharmacy must be validated semiannually by the managing pharmacist.

     9.  If any of the results of the air quality testing or certification required by this section exceed the tolerances set forth in NAC 639.6641, 639.6643 and 639.6645, for the particular controlled environment, the pharmacy shall take whatever action is necessary to remediate the deficiency and retest the environment until the environment produces results within the tolerances for the particular controlled environment.

     10.  The pharmacy shall make and maintain records concerning the air quality testing and certification and any corrections and retesting that were conducted pursuant to this section.

     (Added to NAC by Bd. of Pharmacy by R035-06, eff. 9-18-2008)

      NAC 639.67053  Tests for competency and proficiency of certain pharmaceutical personnel. (NRS 639.070)

     1.  Except as otherwise provided in subsections 4 and 5, a pharmacy engaged in the practice of compounding and dispensing sterile compounded drug products shall require each pharmacist and pharmaceutical technician who compounds sterile compounded drug products to pass a media fill test which must be conducted in the manner provided by chapter 797 of the United States Pharmacopeia - National Formulary, as adopted by reference in paragraph (c) of subsection 1 of NAC 639.670, and which must be commensurate to the highest level of risk of compounding sterile compounded drug products that the pharmacist or pharmaceutical technician will be authorized by the pharmacy to perform:

     (a) Before the pharmacy authorizes the pharmacist or pharmaceutical technician to compound a sterile compounded drug product that will be administered or dispensed to a patient;

     (b) At least once each year thereafter if the pharmacy authorizes the pharmacist or pharmaceutical technician to compound low-risk sterile compounded drug products or medium-risk sterile compounded drug products; and

     (c) At least twice each year thereafter if the pharmacy authorizes the pharmacist or pharmaceutical technician to compound high-risk sterile compounded drug products.

     2.  A pharmacy engaged in the practice of compounding and dispensing sterile compounded drug products shall ensure the competency and proficiency of each pharmacist and pharmaceutical technician at the highest level of risk of compounding sterile compounded drug products the pharmacist or pharmaceutical technician is authorized by the pharmacy to perform by:

     (a) Requiring the pharmacist or pharmaceutical technician to provide a sample for a gloved fingertip sampling which must be conducted in the manner provided by chapter 797 of the United States Pharmacopeia - National Formulary, as adopted by reference in paragraph (c) of subsection 1 of NAC 639.670;

     (b) Testing a sample taken from a surface cleaned by the pharmacist or pharmaceutical technician to determine sterility;

     (c) Ensuring the pharmacist or pharmaceutical technician receives, on an ongoing basis, sufficient training to maintain that competency and proficiency through attending in-house training programs or continuing education courses;

     (d) Observing the pharmacist or pharmaceutical technician as he or she compounds sterile compounded drug products; or

     (e) Correcting any error and initiating remedial measures for a pharmacist or pharmaceutical technician to take after an error has been noted with a sterile compounded drug product that was made or verified by the pharmacist or pharmaceutical technician.

     3.  A pharmacy shall make and maintain records concerning all the actions listed in subsection 2 which the pharmacy takes to ensure the competency and proficiency of each pharmacist and pharmaceutical technician who is authorized by the pharmacy to compound sterile compounded drug products.

     4.  A sterile compounded drug product that is compounded by a pharmacist or pharmaceutical technician who has not passed the media fill test required by paragraph (a) of subsection 1 may be dispensed and administered to a patient if:

     (a) The managing pharmacist of the pharmacy determines that it is appropriate to dispense and administer the sterile compounded drug product; and

     (b) The entire compounding process was personally witnessed by a pharmacist or pharmaceutical technician who passed the media fill test.

     5.  A pharmacy is not required to make a pharmacist or pharmaceutical technician pass a media fill test pursuant to paragraph (a) of subsection 1 if the pharmacist or pharmaceutical technician provides evidence of passing a media fill test:

     (a) Within the immediately preceding 9 months if the pharmacist or pharmaceutical technician will compound low-risk sterile compounded drug products and medium-risk sterile compounded products; or

     (b) Within the immediately preceding 5 months if the pharmacist or pharmaceutical technician will compound high-risk sterile compounded drug products.

     (Added to NAC by Bd. of Pharmacy by R035-06, eff. 9-18-2008)

      NAC 639.67055  Record verifying accuracy required to be made. (NRS 639.070)

     1.  For all sterile compounded drug products compounded by a pharmacy, other than an institutional pharmacy, and for all sterile drug products for parenteral nutrition and sterile antineoplastic drug products compounded by an institutional pharmacy, a pharmacist shall make a record verifying the accuracy of each sterile compounded drug product that the pharmacist:

     (a) Compounded;

     (b) Verified the accuracy of after it was compounded by a pharmaceutical technician; or

     (c) Dispensed for administration to a patient in a medical facility.

     2.  A pharmacist required to make a record pursuant to subsection 1 shall:

     (a) Make the record contemporaneous with the completion of the compounding, verifying or dispensing of the sterile compounded drug product;

     (b) Include in the record information identifying the patient for which the sterile compounded drug product was made and the date the sterile compounded drug product was compounded; and

     (c) Initial the record if it is a written record or enter an initial or other identifying mark onto the record if the record is made in a computerized system.

     3.  A pharmacy for which a record was made pursuant to subsection 1 shall ensure that the record is maintained for at least 6 months after the date the sterile compounded drug product was compounded, verified or dispensed.

     4.  If a sterile compounded drug product is compounded by a pharmaceutical technician, the pharmaceutical technician shall make a record of the compounding in the same manner as a pharmacist is required to make a record pursuant to this section.

     (Added to NAC by Bd. of Pharmacy by R035-06, eff. 9-18-2008)

      NAC 639.67057  Procedures following breach of seal of single-dose and multi-dose containers. (NRS 639.070)

     1.  If, in the course of compounding a drug product, the seal of a single-dose container, including, without limitation, a bag, bottle, syringe or vial of a sterile drug product, is breached, the time and date of the breach must be marked upon the container and the contents of the container may be used:

     (a) Within 1 hour after the breach of the seal if:

          (1) The breach occurred in an environment with an air quality that is worse than ISO Class 5; and

          (2) The container is subsequently stored in an environment with an air quality that is worse than ISO Class 7;

     (b) Within 6 hours after the breach of the seal if:

          (1) The breach of the seal occurred and the contents of the container were used in an environment with an air quality that satisfies or exceeds ISO Class 5; and

          (2) The container is subsequently stored in an environment with an air quality that satisfies or exceeds ISO Class 7; or

     (c) Within 24 hours after the breach of the seal if the breach occurred in an environment with an air quality that satisfies or exceeds ISO Class 5 and the container remains in an environment with an air quality that satisfies or exceeds ISO Class 5.

     2.  If, in the course of compounding a drug product, the seal of a multi-dose container is breached:

     (a) The container must be stored according to the requirements of the manufacturer; and

     (b) The contents of the container may be used within 28 days after the breach of the seal occurred.

     3.  Any drug product that is not used within the periods set forth in subsection 1 or 2 may not be used and must be destroyed.

     4.  If the seal of a single-use ampule is breached or the entire seal has been removed from a multi-use vial and the contents are not used at the time of the breach, the contents may not be used and must be destroyed.

     (Added to NAC by Bd. of Pharmacy by R035-06, eff. 9-18-2008)

      NAC 639.67059  Exemptions for certain institutional pharmacies. (NRS 639.070)  The Board may, upon application and for good cause shown, waive or modify any requirement set forth in NAC 639.6705 and 639.67051 for an institutional pharmacy engaged in the practice of compounding drug products if the institutional pharmacy serves an institution that:

     1.  Has less than 100 beds licensed for providing acute care; and

     2.  Is located in a county:

     (a) Whose population is less than 100,000; or

     (b) Whose population is 100,000 or more if the hospital is designated as a rural hospital by the Nevada Office of Rural Health within the University of Nevada School of Medicine.

     (Added to NAC by Bd. of Pharmacy by R035-06, eff. 9-18-2008)

      NAC 639.67061  Low-risk sterile compounding: Process and storage. (NRS 639.070)

     1.  A compounded drug product is a low-risk sterile compounded drug product if:

     (a) The compounded drug product is required to be sterile for its effective administration;

     (b) The sterile compounded drug product is at a low risk of contamination; and

     (c) One or more of the following conditions are present:

          (1) The compounding process involves aseptic manipulations that are performed entirely within an environment with an air quality of at least ISO Class 5 and uses only sterile ingredients, products, components and devices;

          (2) The compounding process involves only transferring, measuring and mixing manipulations and uses not more than three commercially manufactured sterile drug products or other entries of a sterile drug product into one container, including, without limitation, a bag or vial, to make the final compounded drug product;

          (3) The manipulations needed to compound the drug product are limited to aseptically opening ampules, penetrating sterile stoppers on vials with sterile needles and syringes, and transferring sterile liquids in sterile syringes to sterile administration devices, package containers or other sterile drug products and containers for storage and dispensing;

          (4) The final compounded drug product contains a volume of 15 milliliters or less of a radiopharmaceutical and has an expiration time of 18 hours or less per dosage unit, including, without limitation, a dosage unit of a radiopharmaceutical prepared from an eluate by using a molybdenum-99technetiym-99m generator; or

          (5) The final compounded drug product contains commercially manufactured cyclotron radiopharmaceuticals which contain preservatives and which have expiration times of 72 hours or less.

     2.  Unless sterility testing or potency limitations allow for a different period, the period of storage before administration of a low-risk sterile compounded drug product must not exceed:

     (a) Forty-eight hours at a controlled room temperature that is at least 20 degrees Celsius (68 degrees Fahrenheit) but not more than 25 degrees Celsius (77 degrees Fahrenheit);

     (b) Fourteen days at a temperature that is at least 2 degrees Celsius (36 degrees Fahrenheit) but not more than 8 degrees Celsius (46 degrees Fahrenheit); or

     (c) Forty-five days in a solid frozen state that is -10 degrees Celsius (14 degrees Fahrenheit) or colder.

     (Added to NAC by Bd. of Pharmacy by R035-06, eff. 9-18-2008)

      NAC 639.67063  Low-risk sterile compounding: Radiopharmaceutical drug products. (NRS 639.070)  If a nuclear pharmacy compounds radiopharmaceutical drug products, the nuclear pharmacy shall ensure that, in addition to satisfying the requirements of NAC 639.5828:

     1.  The radiopharmaceutical compounded drug products are compounded in a vertical laminar airflow hood or Class II type B2 biological safety cabinet that is located in an environment with an air quality of ISO Class 8 or higher;

     2.  Only shielded vials, syringes and other devices and containers specifically manufactured for use with radiopharmaceutical components are used in the compounding process;

     3.  Each employee of the nuclear pharmacy who will compound radiopharmaceutical drug products is trained and knowledgeable with regard to compounding, handling, cleaning and any special techniques used with radiopharmaceutical drug products; and

     4.  Any special equipment or device that is used to compound radiopharmaceutical products, including, without limitation, a molybdenum-99technetiym-99m generator, is used, stored and maintained according to the directions of the manufacturer of the equipment or device.

     (Added to NAC by Bd. of Pharmacy by R035-06, eff. 9-18-2008)

      NAC 639.67065  Medium-risk sterile compounding: Process and storage. (NRS 639.070)

     1.  A compounded drug product is a medium-risk sterile compounded drug product if:

     (a) The compounded drug product is required to be sterile for its effective administration;

     (b) The sterile compounded drug product is compounded using aseptic techniques pursuant to one of the conditions listed in NAC 639.67061 as a condition for a low-risk sterile compounded drug product; and

     (c) One or more of the following conditions are present:

          (1) Individual or small doses of sterile drug products are combined or pooled to prepare the final compounded drug product that will be administered to multiple patients or to one patient multiple times;

          (2) The compounding process includes complex aseptic manipulations other than a single-volume transfer;

          (3) The compounding process uses more than three commercially manufactured sterile drug products or other entries of a sterile drug product into one container, including, without limitation, a bag or vial, to make the final compounded drug product;

          (4) The final compounded drug product does not contain broad-spectrum bacteriostatic substances and will be administered over a period which exceeds 24 hours; or

          (5) The compounding process requires an unusually long duration, as determined by the managing pharmacist, including, without limitation, the period required to complete dissolution or homogeneous mixing.

     2.  Unless sterility testing or potency limitations allow for a different period, the period of storage before administration of a medium-risk sterile compounded drug product must not exceed:

     (a) Thirty hours at a controlled room temperature that is at least 20 degrees Celsius (68 degrees Fahrenheit) but not more than 25 degrees Celsius (77 degrees Fahrenheit);

     (b) Nine days at a temperature that is at least 2 degrees Celsius (36 degrees Fahrenheit) but not more than 8 degrees Celsius (46 degrees Fahrenheit); or

     (c) Forty-five days in a solid frozen state that is -10 degrees Celsius (14 degrees Fahrenheit) or colder.

     (Added to NAC by Bd. of Pharmacy by R035-06, eff. 9-18-2008)

      NAC 639.67067  High-risk sterile compounding: Process and storage. (NRS 639.070)

     1.  A compounded drug product is a high-risk sterile compounded drug product if:

     (a) The compounded drug product is required to be sterile for its effective administration;

     (b) The sterile compounded drug product is contaminated with or at a high risk of becoming contaminated with infectious microorganisms; and

     (c) One or more of the following conditions are present:

          (1) One or more of the ingredients or devices used in the compounding process are nonsterile; or

          (2) One or more of the ingredients or devices used in the compounding process were sterile but were exposed or are suspected of having been exposed for more than 1 hour to an air quality inferior to an ISO Class 5 environment.

     2.  Unless sterility testing or potency limitations allow for a different period, the period of storage before administration of a high-risk sterile compounded product must not exceed:

     (a) Twenty-four hours at a controlled room temperature that is at least 20 degrees Celsius (68 degrees Fahrenheit) but not more than 25 degrees Celsius (77 degrees Fahrenheit);

     (b) Three days at a temperature that is at least 2 degrees Celsius (36 degrees Fahrenheit) but not more than 8 degrees Celsius (46 degrees Fahrenheit); or

     (c) Forty-five days in a solid frozen state that is -10 degrees Celsius (14 degrees Fahrenheit) or colder.

     (Added to NAC by Bd. of Pharmacy by R035-06, eff. 9-18-2008)

      NAC 639.67069  High-risk sterile compounding: Sterilization. (NRS 639.070)

     1.  Except as otherwise provided in subsection 5, a pharmacy engaged in the practice of compounding and dispensing high-risk sterile compounded drug products shall ensure that each such compounded drug product is sterilized through filtration, by using steam in an autoclave or by dry heat. Except as otherwise provided in subsection 5, a pharmacist engaged in the practice of compounding high-risk sterile compounded drug products shall choose the method of sterilization that ensures the strength, purity, quality and packaging integrity of the final compounded drug product.

     2.  If a pharmacy sterilizes high-risk sterile compounded drug products using the filtration method, the pharmacy shall:

     (a) Use commercially available sterile filters that are:

          (1) Pyrogen-free and have a nominal porosity of 0.2 micron or 0.22 micron; and

          (2) Certified by the manufacturer to retain at least 107 microorganisms of a strain of Brevundimonas (Pseudomonas) diminuta on each square centimeter of upstream filter surface area under conditions similar to the conditions of sterilization of the high-risk compounded drug products;

     (b) Ensure that the filters used have sufficient capacity to permit the sterilization process to be completed rapidly and without compromising the sterility of the filtration process; and

     (c) Subject the filtration units to the manufacturer’s recommended integrity testing, including, without limitation, the bubble point test, after the filtration of the high-risk sterile compounded drug products is completed.

     3.  If a pharmacy sterilizes high-risk sterile compounded drug products using steam in an autoclave, the pharmacy shall:

     (a) Expose each high-risk sterile compounded drug product to steam at 121 degrees Celsius (250 degrees Fahrenheit) under a pressure of 15 pounds per square inch for the duration of the sterilization process;

     (b) Before starting the sterilization process, ensure that plastic, glass and metal devices are wrapped in low particle shedding paper or fabric or sealed in envelopes that prevent microbial penetration after the sterilization of the high-risk sterile compounded drug products is completed;

     (c) Ensure that the solutions that will be used to fill the vials which will be steam sterilized are passed through a filter having a porosity of not more than 1.2 microns to remove particulate matter immediately before filling those vials; and

     (d) Verify the mass of the container that will be sterilized using steam in an autoclave to ensure that the container will be sterile after the period of exposure in that autoclave.

     4.  If a pharmacy sterilizes high-risk sterile compounded drug products using dry heat, the pharmacy shall ensure that:

     (a) The heated air is filtered and evenly distributed by a blower throughout the chamber or oven used for the sterilization process; and

     (b) The chamber or oven used for the sterilization process is equipped with accurate temperature controls and a timer.

     5.  A pharmacy may only use dry heat as a method of sterilization for a high-risk sterile compounded drug product if the final high-risk sterile compounded drug product would be damaged by moisture or is impermeable to moisture.

     (Added to NAC by Bd. of Pharmacy by R035-06, eff. 9-18-2008)

      NAC 639.67071  High-risk sterile compounding: Testing of certain drug products. (NRS 639.070)

     1.  A pharmacy engaged in the practice of compounding and dispensing high-risk sterile compounded drug products for injection into the vascular system or central nervous system shall test a quantity of the high-risk sterile compounded drug product for:

     (a) Sterility using a membrane filtration method or an equivalent method, as determined by the Board, before any of the compounded drug product may be administered or dispensed to a patient; and

     (b) Excessive bacterial endotoxins using an appropriate test, as determined by the Board, for the particular product at issue before any of the compounded drug product may be administered or dispensed to a patient.

     2.  A pharmacy engaged in the practice of compounding and dispensing high-risk sterile compounded drug products for inhalation or ophthalmic use shall test a quantity of each such high-risk sterile compounded drug product for sterility.

     3.  The provisions of subsections 1 and 2 apply only to high-risk sterile compounded drug products:

     (a) Compounded in groups of more than 25 identical individual single-dose packages;

     (b) Compounded in multiple-dose vials for administration to multiple patients; or

     (c) That will be exposed for a period of more than:

          (1) Twelve hours to temperatures of at least 2 degrees Celsius (36 degrees Fahrenheit) but not more than 8 degrees Celsius (46 degrees Fahrenheit); or

          (2) Six hours to temperatures exceeding 8 degrees Celsius (46 degrees Fahrenheit) before the compounded drug product is sterilized.

     4.  If any high-risk sterile compounded drug product tested pursuant to this section tests positive for antimicrobial growth or endotoxin production, the high-risk sterile compounded drug product must not be administered or dispensed to a patient.

     (Added to NAC by Bd. of Pharmacy by R035-06, eff. 9-18-2008)

      NAC 639.67073  Immediate-use sterile compounding: Preparation and labeling. (NRS 639.070)

     1.  A sterile compounded drug product is an immediate-use sterile compounded drug product if:

     (a) The compounded drug product is intended only for the purpose of emergency care or immediate care of a patient;

     (b) The compounding of the drug product occurs in an environment other than an ISO Class 5 environment and the compounding process consists of simple aseptic measuring and transfer manipulations performed with not more than six sterile nonhazardous commercial drug products and diagnostic radiopharmaceutical drug products, excluding infusion solutions or diluents;

     (c) The preparation procedure occurs continuously without delays or interruptions and does not exceed 1 hour unless a period longer than 1 hour is required for the reconstitution of the compounded drug product;

     (d) During compounding and before the administration of the compounded drug product, no part of the drug product or critical surfaces and ingredients of the drug product is directly exposed to contact contamination, including, without limitation, human touch, cosmetic flakes or particulates, blood or other bodily substances of a person or nonsterile inanimate sources; and

     (e) Except as otherwise provided in paragraph (c), the administration of the compounded drug product begins not later than 1 hour after the start of the preparation of the compounded drug product and the compounded drug product is fully administered as soon as practicable but not longer than 24 hours after the administration of the compounded drug product began or the compounded drug product is disposed of promptly and safely.

     2.  If an immediate-use sterile compounded drug product is not immediately administered by direct injection into a patient by the person who compounded it, the compounded drug product must bear a label which includes, without limitation:

     (a) The name and, if the patient has an identification number, the identification number of the patient;

     (b) The name and amount of each ingredient of the compounded drug product;

     (c) The initials of the person who compounded the compounded drug product; and

     (d) The exact date and time of expiration of the compounded drug product.

     3.  An immediate-use sterile compounded drug product must not be stored for later use.

     (Added to NAC by Bd. of Pharmacy by R035-06, eff. 9-18-2008)

      NAC 639.67075  Immediate-use sterile compounding: Compounding standards. (NRS 639.070)

     1.  An immediate-use sterile compounded drug product that contains three or less commercial sterile drug products that will be stored more than 1 hour before administration is begun must comply with all compounding standards applicable to low-risk sterile compounded drug products.

     2.  An immediate-use sterile compounded drug product which contains more than three commercial sterile drug products or which requires complex manipulations or complex preparation must comply with all compounding standards applicable to medium-risk sterile compounded drug products.

     3.  An immediate-use sterile compounded drug product that contains one or more nonsterile ingredients or components must comply with all compounding standards applicable to high-risk sterile compounded drug products.

     (Added to NAC by Bd. of Pharmacy by R035-06, eff. 9-18-2008)

      NAC 639.67077  Sterile hazardous drugs: Safety procedures for storage, handling, compounding and disposal. (NRS 639.070)

     1.  A pharmacy engaged in the practice of compounding sterile hazardous drugs shall:

     (a) Store the components of the hazardous drugs separately from all the other inventory at the pharmacy and in such a manner and location as to minimize the contamination of other drugs in and employees of the pharmacy;

     (b) Handle the components of the hazardous drugs with caution by using appropriate gloves during preparation, handling and disposal of the components of the hazardous drug or final compounded drug product;

     (c) Compound the hazardous drugs pursuant to the requirements set forth in NAC 639.661 to 639.690, inclusive, and applicable to the risk level of the compounded hazardous drugs;

     (d) Ensure that an employee of the pharmacy involved with compounding hazardous drugs wears personal protective equipment, including, without limitation, gowns, gloves, face masks, hair covers, shoe covers or dedicated shoes, and, if the hazardous drugs contain one or more antineoplastic agents or it is recommended by the drug manufacturer, double gloves or chemotherapy gloves;

     (e) Dispose of all waste relating to the compounding of the hazardous drugs in a manner that complies with any applicable state, federal and local laws and regulations; and

     (f) Ensure that any employees of the pharmacy who are known to the pharmacy to be at special risk with regard to the properties of the hazardous drugs are limited from exposure to those drugs.

     2.  A pharmacy shall ensure that the process of compounding sterile hazardous drugs is performed only in an ISO Class 5 environment in either a biological safety cabinet or a compounding aseptic containment isolator if one or more of the components of the hazardous drug are:

     (a) An antineoplastic drug;

     (b) A radiopharmaceutical drug; or

     (c) A drug whose manufacturer has recommended that the drug only be compounded in an ISO Class 5 environment in either a biological safety cabinet or a compounding aseptic containment isolator.

     3.  The biological safety cabinet or compounding aseptic containment isolator described in paragraph (c) of subsection 2 must be vented to outside air during the compounding process through the use of high efficiency particulate air filtration if one or more of the components of the compounded hazardous drug are antineoplastic drugs.

     (Added to NAC by Bd. of Pharmacy by R035-06, eff. 9-18-2008)

      NAC 639.67079  Sterile hazardous drugs: Required training for certain pharmaceutical personnel. (NRS 639.070)

     1.  A pharmacy engaged in the practice of compounding sterile hazardous drugs and dispensing sterile compounded hazardous drugs shall require each pharmacist and pharmaceutical technician who compounds sterile hazardous drugs to be trained in the storage, handling, compounding, safety procedures and disposal of such compounded drugs:

     (a) Before the pharmacy authorizes the pharmacist or pharmaceutical technician to compound a sterile hazardous drug that will be administered or dispensed to a patient; and

     (b) At least once each year thereafter.

     2.  The training required pursuant to subsection 1 must include, at a minimum, information concerning:

     (a) Safe aseptic manipulation practices;

     (b) Negative pressure techniques for use with a biological safety cabinet, compounding aseptic containment isolator or compounding aseptic isolator;

     (c) The correct use of a vial transfer device in a closed system;

     (d) Procedures for containment, cleaning and disposal with regard to breaks and spills; and

     (e) Treatment of employees of the pharmacy with regard to contact and inhalation exposure.

     3.  The pharmacy shall make and keep a record of any training given pursuant to subsection 1.

     (Added to NAC by Bd. of Pharmacy by R035-06, eff. 9-18-2008)

Standards for Compounding and Dispensing Parenteral Solutions

      NAC 639.672  Reference materials required to be located in or immediately available to pharmacy. (NRS 639.070, 639.2807)  Any pharmacy engaged in the practice of compounding and dispensing parenteral solutions shall have current reference materials located in or immediately available to the pharmacy. The reference materials must include information on:

     1.  All drugs and chemicals used in services related to parenteral therapy; and

     2.  The activities involved in parenteral therapy, including manufacturing, dispensing, distribution and counseling.

     (Added to NAC by Bd. of Pharmacy, eff. 8-14-87)

      NAC 639.680  Labeling. (NRS 639.070, 639.2807)

     1.  In addition to any other requirements for labeling, the label of any parenteral solution must include:

     (a) The name and concentrations of all ingredients contained in the parenteral solution, including the primary solution; and

     (b) Instructions for storage and handling.

     2.  The label of a parenteral solution which is used by a patient in the patient’s home, in a facility for the dependent or in a medical facility which does not furnish the parenteral solution from a pharmacy located in that medical facility must include the telephone number of the pharmacy that furnished the parenteral solution.

     3.  Any cytotoxic agent must bear a special label which states:

     (a) “Chemotherapy - Dispose of Properly;” or

     (b) “Biohazard - Dispose of Properly.”

     4.  As used in this section, “biohazard” means a biological agent that may be hazardous to persons or the environment.

     (Added to NAC by Bd. of Pharmacy, eff. 8-14-87; A 7-7-94)

      NAC 639.682  Record for each patient. (NRS 639.070, 639.2807)

     1.  A pharmacy engaged in the practice of compounding and dispensing parenteral solutions shall have on the premises or readily accessible:

     (a) A record for each patient being treated with parenteral therapy;

     (b) A summary of the most recent hospitalization of the patient or the patient’s medical history; and

     (c) Any notes taken by the pharmacist concerning the progress of the patient which document any contact with the patient or the practitioner concerning the parenteral therapy.

     2.  In addition to any other requirements for keeping records, the following records must be maintained in the pharmacy:

     (a) Records concerning any prescriptions and medical supplies furnished to the patient.

     (b) Information relevant to the patient’s parenteral therapy, including, but not limited to:

          (1) The patient’s name, age, height, weight, sex and address and the telephone number of the location where the patient is receiving parenteral therapy;

          (2) The diagnosis of the patient; and

          (3) The patient’s history of medication, including his or her current regimen concerning diet and medication and any allergies to drugs or food.

     (c) Data of a laboratory relevant to the parenteral therapy.

     (d) If the patient is using a parenteral solution in the patient’s home, in a facility for the dependent or in a medical facility which does not furnish the parenteral solution from a pharmacy located in that medical facility, records indicating that the care of the patient is coordinated by the pharmacy, practitioner and nursing personnel before the administration of the parenteral solution, including:

          (1) Documentation of all orders for medication, laboratory tests or other treatment related to the medication of the patient.

          (2) Documentation of all orders given by a practitioner which were communicated to nursing personnel by a pharmacist.

          (3) Documentation that a total assessment of the patient has been performed.

          (4) Documentation that a plan for the parenteral therapy of the patient has been developed by the pharmacy. The plan must include:

               (I) The identification of any problem related to a drug that is administered to the patient; and

               (II) Any suggested solution for that problem and the monitoring of the results of the therapy.

     3.  As used in this section, “total assessment” means an evaluation of the circumstances of the administration of parenteral therapy to a patient in the patient’s home, in a facility for the dependent or in a medical facility which does not furnish the parenteral solution from a pharmacy located within that medical facility that includes a review of:

     (a) The state of the disease of the patient;

     (b) The regimen of medication of the patient;

     (c) The medical history of the patient;

     (d) Any therapies other than parenteral therapy administered to the patient; and

     (e) If the patient is using the parenteral solution in the patient’s home, the ability of the patient to receive parenteral therapy in his or her home.

     (Added to NAC by Bd. of Pharmacy, eff. 8-14-87; A 7-7-94)

      NAC 639.683  Delivery, storage and recordation of delivery. (NRS 639.070, 639.2807)  A managing pharmacist shall ensure that:

     1.  A sterile parenteral solution is furnished to a patient in a container which is capable of maintaining the appropriate temperature for the storage of the sterile parenteral solution;

     2.  A patient is advised of the appropriate conditions for the storage and disposal of the sterile parenteral solution; and

     3.  The delivery of a controlled substance listed in schedule II, as set forth in NAC 453.520, is documented and a receipt which indicates that the patient received that controlled substance is included with the records maintained at the pharmacy.

     (Added to NAC by Bd. of Pharmacy, eff. 7-7-94)

      NAC 639.686  Written policies and procedures for disposal of infectious materials and materials containing cytotoxic residues. (NRS 639.070, 639.2807)  In addition to the requirements of NAC 639.67015 and 639.67017, any pharmacy providing parenteral solutions shall have written policies and procedures for the disposal of infectious materials and materials containing cytotoxic residues. The procedures must contain methods for the cleanup of spills and must be in conformance with the regulations of the local health authority. The pharmacy shall ensure the return of infectious materials and materials containing cytotoxic residues to the pharmacy or shall inform the provider of care of the procedures for the proper destruction of such materials.

     (Added to NAC by Bd. of Pharmacy, eff. 8-14-87; A by R035-06, 9-18-2008)

      NAC 639.688  Written policies and procedures regarding provision of services related to parenteral therapy. (NRS 639.070, 639.2807)  In addition to the requirements of NAC 639.67015 and 639.67017, any pharmacy, other than an institutional pharmacy, engaged in the practice of compounding and dispensing parenteral solutions shall have written policies and procedures relating to:

     1.  The qualifications and training of employees of the pharmacy to compound and dispense parenteral solutions.

     2.  A determination of the necessity for administering the medication a patient requires in a parenteral form.

     3.  The compounding and control of the quality of parenteral solutions.

     4.  The distribution and delivery of parenteral solutions.

     5.  The clinical monitoring of parenteral therapy.

     6.  The availability of a practitioner, pharmacist and nursing personnel during the administration of parenteral therapy to a patient.

     7.  The availability of products and equipment which are necessary during the administration of parenteral therapy to a patient.

     8.  The communication of orders among the practitioner, pharmacist and nursing personnel for a patient who requires parenteral therapy.

     9.  The coordination of the care of a patient who requires parenteral therapy by the pharmacist, practitioner and nursing personnel, including documentation of participation in any conference relating to the care of that patient.

     10.  The education of a patient relating to:

     (a) The self-administration of a parenteral solution;

     (b) The proper maintenance and storage of a parenteral solution; and

     (c) The operation of devices used to administer parenteral solutions.

     11.  The cleaning and maintenance of equipment used to administer a parenteral solution furnished to a patient by the pharmacy.

     12.  The provision of services relating to parenteral therapy furnished by the pharmacy in an emergency.

     (Added to NAC by Bd. of Pharmacy, eff. 8-14-87; A 7-7-94; R035-06, 9-18-2008)

      NAC 639.690  Pharmacist: Consultation with patient; proper training in safe handling, compounding and therapy related to parenteral solutions. (NRS 639.070, 639.2807)

     1.  Any pharmacy furnishing parenteral solutions shall ensure that a pharmacist is available 24 hours a day for consultation with the patient and the patient’s primary provider of care concerning the proper use of any parenterals and related supplies furnished by the pharmacy.

     2.  The managing pharmacist shall ensure that all pharmacists engaging in compounding parenteral solutions have the proper training in the safe handling, compounding and therapy related to parenteral solutions, including cytotoxic agents.

     (Added to NAC by Bd. of Pharmacy, eff. 8-14-87; A 7-7-94)

PROVIDERS AND WHOLESALERS OF MEDICAL PRODUCTS

General Provisions

      NAC 639.693  Definitions. (NRS 639.070)  As used in NAC 639.693 to 639.6958, inclusive, unless the context otherwise requires, the words and terms defined in NAC 639.69305 to 639.6938, inclusive, have the meanings ascribed to them in those sections.

     (Added to NAC by Bd. of Pharmacy by R008-01, eff. 11-1-2001; A by R122-07, 1-30-2008; R033-07, 8-26-2008)

      NAC 639.69305  “Accreditation and certification organization” defined. (NRS 639.070)  “Accreditation and certification organization” means:

     1.  The American Board for Certification in Orthotics, Prosthetics & Pedorthics; or

     2.  The Board for Orthotist/Prosthetist Certification.

     (Added to NAC by Bd. of Pharmacy by R033-07, eff. 8-26-2008)

      NAC 639.6931  “Assistive equipment” defined. (NRS 639.070)  “Assistive equipment” means a medical product intended to aid a consumer in the performance of one or more bodily activities. The term includes, without limitation, a customized orthotic or prosthetic device, and a wheelchair, walker or other similar device. The term does not include respiratory equipment.

     (Added to NAC by Bd. of Pharmacy by R008-01, eff. 11-1-2001; A by R033-07, 8-26-2008)

      NAC 639.6932  “Consumer” defined. (NRS 639.070)  “Consumer” means the ultimate recipient or beneficiary of services and goods provided by a medical products provider.

     (Added to NAC by Bd. of Pharmacy by R008-01, eff. 11-1-2001)

      NAC 639.69325  “Customized orthotic or prosthetic device” defined. (NRS 639.070)  “Customized orthotic or prosthetic device” means a medical product that is built, assembled or altered specifically to accommodate the anatomy of a particular consumer, including, without limitation, a customized breast prosthesis and a customized mastectomy form.

     (Added to NAC by Bd. of Pharmacy by R033-07, eff. 8-26-2008)

      NAC 639.6933  “Health professional” defined. (NRS 639.070)  “Health professional” means a practitioner, a physical therapist, an occupational therapist, a registered nurse or a respiratory therapist.

     (Added to NAC by Bd. of Pharmacy by R008-01, eff. 11-1-2001)

      NAC 639.6934  “Life-sustaining equipment” defined. (NRS 639.070)  “Life-sustaining equipment” means a medical product that is necessary for a consumer to avoid exposure to a medically reasonable expectation of imminent death or serious injury. The term includes, without limitation, a ventilator. The term does not include an oxygen concentrator.

     (Added to NAC by Bd. of Pharmacy by R008-01, eff. 11-1-2001; A by R015-09, 10-27-2009)

      NAC 639.6935  “Medical products” defined. (NRS 639.070)

     1.  “Medical products” includes medical devices, equipment, supplies and gases intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease.

     2.  The term does not include:

     (a) Controlled substances;

     (b) Dangerous drugs, except medical gases and supplies that facilitate the use of a dangerous drug, including, without limitation, normal saline and other similar inert liquids;

     (c) Medical devices, equipment, supplies or gases the regulation of which is governed by any other board or agency other than the Board; and

     (d) Pressurized stockings that have a pressure rating of less than 20 millimeters of mercury.

     (Added to NAC by Bd. of Pharmacy by R008-01, eff. 11-1-2001; A by R033-07, 8-26-2008)

      NAC 639.6936  “Medical products provider” defined. (NRS 639.070)

     1.  “Medical products provider” means a person licensed pursuant to NAC 639.693 to 639.6958, inclusive, to sell, lease or otherwise provide medical products to a consumer in this State.

     2.  The term does not include:

     (a) A health professional who sells, leases or otherwise provides medical products to a consumer for use by that consumer pursuant to the order of a practitioner;

     (b) A pharmacy that sells, leases or otherwise provides medical products to a consumer for use by that consumer; or

     (c) An installer of medical gas systems, as that term is defined in NAC 477.137, who is registered pursuant to chapter 477 of NAC.

     (Added to NAC by Bd. of Pharmacy by R008-01, eff. 11-1-2001)

      NAC 639.6937  “Medical products wholesaler” defined. (NRS 639.070)

     1.  “Medical products wholesaler” means a person licensed pursuant to NAC 639.693 to 639.6958, inclusive, to sell, lease or otherwise provide medical products to a health care facility, agency, practitioner or provider in this State.

     2.  The term does not include:

     (a) A person who sells, leases or otherwise provides medical products to a consumer; or

     (b) An installer of medical gas systems, as that term is defined in NAC 477.137, who is registered pursuant to chapter 477 of NAC.

     (Added to NAC by Bd. of Pharmacy by R008-01, eff. 11-1-2001)

      NAC 639.6938  “Respiratory equipment” defined. (NRS 639.070)  “Respiratory equipment” means a medical product intended to assist a consumer in the act of breathing or intended to introduce a product or drug, other than a medical gas, into the lungs of a consumer.

     (Added to NAC by Bd. of Pharmacy by R008-01, eff. 11-1-2001)

      NAC 639.6939  Adoption by reference of code of ethics and code of professional conduct; revision of codes after adoption. (NRS 639.070)

     1.  The State Board of Pharmacy hereby adopts by reference:

     (a) The most recent version of the “Code of Ethics” of the Board for Orthotist/Prosthetist Certification, unless the State Board of Pharmacy gives notice pursuant to subsection 2 that the most recent version is not suitable for this State. The Code may be obtained, free of charge, from the Board for Orthotist/Prosthetist Certification, 7150 Columbia Gateway Drive, Suite G, Columbia, Maryland 21045, or at the Internet address http://www.bocusa.org.

     (b) The most recent version of the “Code of Professional Responsibility” of the American Board for Certification in Orthotics, Prosthetics & Pedorthics, unless the State Board of Pharmacy gives notice pursuant to subsection 2 that the most recent version is not suitable for this State. The Code may be obtained, free of charge, from the American Board for Certification in Orthotics, Prosthetics & Pedorthics, 330 John Carlyle Street, Suite 210, Alexandria, Virginia 22314, or at the Internet address http://www.abcop.org.

     2.  The State Board of Pharmacy will review each successive edition of the codes adopted by the Board pursuant to subsection 1 to ensure their suitability for this State. If the Board determines that an edition is not suitable for this State, the Board will hold a public hearing within 6 months after the date the code was revised to review its determination. If the Board does not revise its determination, the Board will give notice within 30 days after the hearing that the revised edition of the code is not suitable for this State.

     (Added to NAC by Bd. of Pharmacy by R033-07, eff. 8-26-2008)

      NAC 639.694  Administrator required. (NRS 639.070)

     1.  Except as otherwise provided in subsection 4, each medical products provider or medical products wholesaler shall employ an administrator at all times. The administrator must:

     (a) Be a natural person;

     (b) Have a high school diploma or its equivalent;

     (c) Have:

          (1) At least 1,500 hours of verifiable work experience relating to the products provided by the medical products provider or medical products wholesaler; or

          (2) An associate’s degree or higher degree from an accredited college or university in a field of study that is directly related to patient health care;

     (d) Be employed by the medical products provider or medical products wholesaler at the place of business or facility of the employer at least 40 hours per week or during all regular business hours if the business or facility is regularly open less than 40 hours per week; and

     (e) Be approved by the Board.

     2.  The administrator shall ensure that the operation of the business or facility complies with all applicable federal, state and local laws, regulations and rules.

     3.  A medical products provider or medical products wholesaler shall notify the staff of the Board of the cessation of employment of an administrator within 3 business days after the cessation of the employment. A medical products provider or medical products wholesaler shall notify the staff of the Board of the employment of a new administrator within 3 business days after the beginning of the employment.

     4.  A medical products provider or medical products wholesaler may not operate for more than 10 business days without an administrator. The Board may summarily suspend the operation of a business or facility that operates without an administrator.

     (Added to NAC by Bd. of Pharmacy by R008-01, eff. 11-1-2001; A by R033-09, 10-15-2010)

REVISER’S NOTE.

      The regulation of the State Board of Pharmacy filed with the Secretary of State on October 15, 2010 (LCB File No. R033-09), which amended this section, contains the following provision not included in NAC:

      “The amendatory provisions of subsection 1 of section 1 of this regulation [NAC 639.694] apply only to a person who begins employment as an administrator of a medical products provider or medical products wholesaler on or after October 15, 2010.”

 

      NAC 639.6941  Unprofessional conduct; responsibility of owner for acts of others. (NRS 639.070)

     1.  In addition to the acts described in NAC 639.945 which are applicable to medical products providers or medical products wholesalers, the following acts or practices by a medical products provider or a medical products wholesaler are declared to be, specifically but not by way of limitation, unprofessional conduct and conduct contrary to the public interest:

     (a) Any violation of these regulations or violation of any applicable federal, state or local laws related to the practices of the medical products provider or medical products wholesaler.

     (b) Loss of, or failure to maintain or renew, the required liability insurance.

     (c) Practicing, condoning, facilitating or collaborating with any form of unlawful discrimination against any person or group on the basis of race, color, sex, sexual orientation, age, religion, national origin, marital status, or mental or physical disability in providing any service or product to a consumer.

     (d) Failing to maintain the confidentiality of information regarding a consumer and disclosing such information without valid authorization, except where such a disclosure is required by law.

     (e) Performing or allowing any employee or agent of the medical products provider or medical products wholesaler to perform services beyond the training, competency, ability or knowledge of the employee or agent.

     (f) Submitting any claim for payment or reimbursement to any person or entity for products or services that is fraudulent, deceitful, unnecessary, or for any products or services not actually provided to a consumer.

     (g) Violating any provision of the Code of Ethics of the National Association for Medical Equipment Services, which is hereby adopted by reference, a copy of which may be obtained, free of charge, by writing to the American Association for Homecare, 2011 Crystal Drive, Suite 725, Arlington, Virginia 22202.

     (h) Violating any provision of the Code of Ethics of the Nevada Association of Medical Products Suppliers, which is hereby adopted by reference, a copy of which may be obtained, free of charge, by writing to the Nevada Association of Medical Products Suppliers, P.O. Box 61492, Boulder City, Nevada 89006-1492.

     (i) Engaging in any knowing or willful offer, payment, solicitation or receipt of any remuneration to induce referrals of sales, leases, or other provisions of medical products or services by any medical products provider, medical products wholesaler or health professional.

     (j) Violating any provision of the Standards of Practice and the Code of Ethics for the National Registry of Rehabilitation Technology Suppliers, which is hereby adopted by reference. The publication may be obtained from the National Registry of Rehabilitation Technology Suppliers, 6732 West Coal Mine Avenue, #379, Littleton, Colorado 80123-4573, for the price of $5 or free of charge at the Internet address http://www.nrrts.org/.

     2.  The owner of a medical products provider is responsible for the acts of his or her business administrator and employees.

     3.  The owner of a medical products wholesaler is responsible for the acts of his or her facility administrator and employees.

     (Added to NAC by Bd. of Pharmacy by R008-01, eff. 11-1-2001)

Licensing and Fees

      NAC 639.6942  Application for license; license required for each location; notification of change in information; license nontransferable; expiration. (NRS 639.070)

     1.  An applicant for a license to engage in business as a medical products provider or medical products wholesaler must submit an application to the Board on a form furnished by the Board. The application must include:

     (a) The name, mailing address and telephone number of the applicant;

     (b) The street address of the business or facility of the applicant, if different from the mailing address of the applicant;

     (c) All trade or business names used by the applicant;

     (d) The type of ownership or operation of the business or facility;

     (e) The name, address, telephone number and social security number of the person who manages the business or facility of the applicant;

     (f) If the applicant is:

          (1) A natural person, the name of the person;

          (2) A partnership, the name of the partnership and the name of each general or limited partner;

          (3) A corporation, the name and title of each officer and director of the corporation, the corporate name, the state of incorporation and the name of the corporation’s parent company, if any; or

          (4) A sole proprietorship, the name of the sole proprietor and the name of the business entity;

     (g) Proof of insurance required pursuant to NAC 639.6946;

     (h) The hours and days that the business will be regularly operated; and

     (i) All Medicare and Medicaid provider numbers registered to the business or its owner.

     2.  If a medical products provider sells, leases or otherwise provides medical products at more than one location, it must obtain a license for each location where medical products are sold, leased or otherwise provided.

     3.  An applicant shall notify the Board in writing of any change in the information required pursuant to this section within 30 days after the change occurs.

     4.  A license issued by the Board pursuant to this section:

     (a) Is not transferable; and

     (b) Expires on October 31 of each even-numbered year unless renewed before that date.

     (Added to NAC by Bd. of Pharmacy by R008-01, eff. 11-1-2001)

      NAC 639.6943  Licensing of practicing health professionals. (NRS 639.070)

     1.  The Board will not issue a license to conduct business as a medical products provider or medical products wholesaler to:

     (a) A practicing health professional; or

     (b) A partnership, corporation or association in which a practicing health professional has a controlling interest or in which ownership of 10 percent or more of the available stock is held by one or more practicing health professionals.

     2.  As used in this section, “practicing health professional” means a health professional who performs services within the scope of his or her licensure or registration in any capacity in a health care facility other than the facility of the medical products provider or medical products wholesaler.

     (Added to NAC by Bd. of Pharmacy by R008-01, eff. 11-1-2001; A by R151-05, 11-17-2005)

      NAC 639.6944  Licensing of applicants located outside of State. (NRS 639.070)

     1.  Any person who is located outside of this State and who intends to sell medical products to any consumer or medical products provider in this State on a regular basis must apply for an appropriate license pursuant to the provisions of NAC 639.693 to 639.6958, inclusive. Any medical products provider or medical products wholesaler that is located outside of this State must comply with the provisions of NAC 639.693 to 639.6958, inclusive, for any sale, lease or other disposition of medical products to any person in this State other than a medical products wholesaler or manufacturer that is licensed by the Board.

     2.  Any medical products provider or medical products wholesaler that is located outside of this State must submit evidence with any application pursuant to the provisions of NAC 639.693 to 639.6958, inclusive, that the medical products provider is licensed, permitted, registered or otherwise lawfully authorized by the state of residence of the medical products provider to engage in the same business for which the medical products provider is seeking licensure in this State.

     (Added to NAC by Bd. of Pharmacy by R008-01, eff. 11-1-2001)

      NAC 639.6945  Waiver of license fee. (NRS 639.070)

     1.  The Board may waive the license fee, or any part thereof, for a medical products provider that:

     (a) Is a tax-exempt charitable organization pursuant to 26 U.S.C. § 501(c);

     (b) Provides medical products to a majority of the consumers served by the medical products provider at no charge; and

     (c) Verifies to the satisfaction of the Board that at least 75 percent of the money of the medical products provider is used for bona fide charitable purposes.

     2.  A medical products provider that the Board has determined satisfies the requirements for a waiver of the license fee pursuant to subsection 1:

     (a) May:

          (1) Accept donations of medical products and food products;

          (2) Except as otherwise provided in paragraph (b), dispense donated medical equipment in an “as is” condition if:

               (I) The medical equipment does not require an order from a practitioner to be dispensed; and

               (II) The consumer or his or her caregiver or agent signs a waiver acknowledging that the consumer understands that the equipment is in an “as is” condition; and

          (3) Dispense a donated food product, other than a product for which an enteral or parenteral pump is required, if the food product is not adulterated and the medical products provider dispenses the food product before the expiration date set forth on the packaging of the food product.

     (b) May not dispense a donated medical product that bears an indication that the product was provided by or originated with another medical products provider unless it obtains the consent of the original medical products provider.

     (Added to NAC by Bd. of Pharmacy by R008-01, eff. 11-1-2001; A by R012-02, 5-31-2002; R033-07, 8-26-2008)

Medical Products Providers

      NAC 639.6946  Duties of providers; repair and maintenance of medical products; hours of operation; consumer complaints. (NRS 639.070)

     1.  Except as otherwise provided in NAC 639.6945, a medical products provider shall:

     (a) Provide services for all medical products sold, leased or otherwise provided by the medical products provider, including, without limitation, set up, repair and maintenance.

     (b) Employ an administrator and other employees sufficient to provide the services described in paragraph (a).

     (c) Ensure that each employee is trained to:

          (1) Use, set up, repair and maintain the medical products sold, leased or otherwise provided by the medical products provider that an employee is authorized to sell, lease or otherwise provide to a consumer; and

          (2) Instruct consumers concerning the use, set up and maintenance of the medical products sold, leased or otherwise provided by the medical products provider that an employee is authorized to sell, lease or provide to a consumer.

     (d) Maintain an inventory of medical products that is adequate to serve the needs of the consumers served by the medical products provider.

     (e) Maintain a suitable physical location, other than a residence, at which the medical products provider can:

          (1) Store inventory;

          (2) Repair or service any equipment which the medical products provider sells, leases or otherwise provides; and

          (3) Keep all current records related to the business of the medical products provider.

     (f) Have a functioning restroom containing a toilet and a sink with hot and cold water at the place of business of the medical products provider.

     (g) Maintain the place of business of the medical products provider in a clean, orderly and sanitary condition.

     (h) Ensure that the place of business complies at all times with applicable federal, state and local laws, regulations and rules, including, without limitation, applicable occupational safety rules, fire codes, building codes and health codes.

     (i) Maintain liability insurance of at least $1,000,000, which must include product liability insurance if the medical products provider:

          (1) Designs, fabricates or manufactures medical products; or

          (2) Substantially modifies commercially available medical products.

     (j) Maintain a log or other record regarding all repairs made to a medical product provided by the medical products provider. For a medical product repaired by the medical products provider, the log or record must identify:

          (1) The type of medical product;

          (2) The manufacturer;

          (3) The model or model number;

          (4) The serial number;

          (5) The date of the repair;

          (6) The specific repair made;

          (7) The name of the person or company who performed the repair; and

          (8) A certification that the medical product has been returned to the specifications of the manufacturer as a result of the repair.

     2.  If the medical products provider cannot certify that the repaired medical product has been returned to the specifications of the manufacturer as a result of the repair, the medical products provider must:

     (a) Determine whether the medical product can be safely and effectively used for a limited purpose, in which case the medical products provider must note that the medical product must only be used for a limited purpose and must ensure that the medical product is only used for such a limited purpose; or

     (b) Ensure that the medical product is removed from service and is not sold, leased or otherwise provided to any person without a written statement acknowledging that the medical product:

          (1) Was repaired;

          (2) Could not be repaired to the specifications of the manufacturer; and

          (3) Cannot be used by the consumer for the purposes for which the medical product was intended.

     3.  Any device used by a medical products provider to calibrate or test equipment must be accurate and must be maintained according to the directions and specifications of the manufacturer. The scales used to weigh reservoirs of liquid oxygen must be accurate and must be certified annually by the State Sealer of Consumer Equitability.

     4.  The business premises of any medical products provider must be open and accessible to the public and the Board at all times during regular hours of operation.

     5.  A medical products provider shall develop and use a written procedure for addressing consumer complaints, including, without limitation, procedures for maintaining a complaint file that documents all complaints from consumers and the resolution of each complaint.

     (Added to NAC by Bd. of Pharmacy by R008-01, eff. 11-1-2001; A by R033-07, 8-26-2008)

      NAC 639.6947  Change in controlling interest. (NRS 639.070)  Upon a change in the controlling interest of a medical products provider, the medical products provider shall:

     1.  Apply with the Board for a new license within 5 days after the completion of the transaction which changes the controlling interest;

     2.  Ensure that all servicing, maintenance or repair obligations outstanding at the time of the purchase are addressed without interruption or disruption to the service being received by the consumer; and

     3.  Not operate the business, except to service, maintain, repair or otherwise satisfy the outstanding obligations of the predecessor business, until the new owner is licensed by the Board.

     (Added to NAC by Bd. of Pharmacy by R008-01, eff. 11-1-2001)

      NAC 639.6948  Compliance with provisions by person or business who is not medical products provider. (NRS 639.070)  Any person or business that is not a medical products provider who sells, leases or otherwise provides medical products to a consumer must comply with NAC 639.693 to 639.6958, inclusive, for any sale, lease or other disposition of medical products as though that person were a medical products provider.

     (Added to NAC by Bd. of Pharmacy by R008-01, eff. 11-1-2001; A by R033-07, 8-26-2008)

      NAC 639.6949  Provision of medical products to consumer with or without bona fide order or prescription; tracking requirements. (NRS 639.070)

     1.  A medical products provider shall provide medical products for which an order of a practitioner is required to a consumer only after the receipt of a bona fide order or prescription from a practitioner.

     2.  A medical products provider may provide medical products for which an order of a practitioner is not required to a consumer with or without a bona fide order or prescription from a practitioner. If a written order or prescription is received from a practitioner or if a written record of an oral order or prescription is made by the medical products provider, the medical products provider shall keep and maintain the written record in the manner required by NAC 639.695.

     3.  For all medical devices and equipment to which the medical device tracking requirements of the Food and Drug Administration apply, the medical products provider must keep and maintain written records of the serial or tracking numbers for the medical devices and equipment.

     (Added to NAC by Bd. of Pharmacy by R008-01, eff. 11-1-2001)

      NAC 639.695  Maintenance of records. (NRS 639.070)  The records made or kept pursuant to NAC 639.6949 must be:

     1.  Kept in a file, chart or other storage system allowing the record to be retrieved by reference to the name of the consumer, the name of the practitioner, the date the product was provided or the type of medical product;

     2.  Retained for at least 5 years from the date the records are made or received;

     3.  Kept at the physical location of the business; and

     4.  Readily retrievable upon request by a member of the Board, or a person conducting an inspection or investigation on behalf of the Board.

     (Added to NAC by Bd. of Pharmacy by R008-01, eff. 11-1-2001)

      NAC 639.6951  Communications and advisement of options and use of medical products; written record. (NRS 639.070)

     1.  Before providing a medical product, a medical products provider shall identify and describe the commercially available choices and, where appropriate, custom fabricated choices available to meet the objectives of the consumer to:

     (a) The consumer, the consumer’s family or his or her agent;

     (b) The primary caregiver of the consumer, if any; and

     (c) The health professional of the consumer.

     2.  When providing medical products, a medical products provider shall communicate with and advise the consumer, the consumer’s agent or his or her primary caregiver about the proper use of the medical products, which communication and advisement must include, as appropriate:

     (a) The set up and use of the medical products;

     (b) The maintenance, servicing, cleaning and repair of the medical products;

     (c) The name, telephone number and related information of the medical products provider for emergency, subsequent or continuing care and service of the medical products;

     (d) Cautions regarding the use or modification of the medical products;

     (e) Information provided by the manufacturer of the medical products that will facilitate the optimal use of the medical products;

     (f) Information regarding any warranty or other consumer protection concerning the medical products;

     (g) The terms and conditions of the sale, lease or other disposition of the medical products; and

     (h) Any other information that, in the judgment of the medical products provider, will facilitate the safe and optimal use of the medical products by the consumer.

     3.  The medical products provider shall make a written record of all communications made pursuant to this section.

     (Added to NAC by Bd. of Pharmacy by R008-01, eff. 11-1-2001)

      NAC 639.6952  Communications concerning use of medical products provided by written or oral order or prescription; written record. (NRS 639.070)

     1.  When a medical products provider sells, leases or otherwise provides medical products to a consumer upon the written or oral order or prescription of a health professional, the medical products provider shall communicate with the health professional to ascertain:

     (a) The physical, functional and associated needs of the consumer; and

     (b) The therapeutic or ameliorative objectives to be met by the medical products that will be sold, leased or otherwise provided by the medical products provider.

     2.  When a medical products provider sells, leases or otherwise provides medical products to a consumer, the medical products provider shall communicate with the consumer, or the consumer’s family, caregiver or agent to ascertain and assess:

     (a) The safety of the environment in which the medical products will be used;

     (b) The ability of the consumer or the consumer’s family, caregiver or agent to comply with the instructions of the health professional of the consumer and medical products provider regarding the proper use of the medical products; and

     (c) The ability of the consumer or the consumer’s family, caregiver or agent to clean and maintain the medical products.

     3.  The medical products provider shall make a written record of all communications made pursuant to this section.

     (Added to NAC by Bd. of Pharmacy by R008-01, eff. 11-1-2001)

      NAC 639.6953  Assistive equipment. (NRS 639.070)

     1.  A medical products provider that sells, leases or otherwise provides assistive equipment shall:

     (a) Make measurements using the appropriate instruments and techniques to assure the optimal fit and function of the assistive equipment for the consumer;

     (b) Deliver, fit and adjust the assistive equipment so that the assistive equipment is fully operable when the medical products provider leaves the premises of the consumer;

     (c) Instruct the consumer, the family of the consumer or the primary caregiver of the consumer regarding the use, maintenance, servicing and cautions related to the assistive equipment;

     (d) Provide all warranty information regarding the assistive equipment, including, without limitation, any warranty provided by the medical products provider or any commercial warranty available for the assistive equipment; and

     (e) Respond to a request for service or repair of the assistive equipment not later than 3 business days after the request is received by the medical products provider, except that such service or repair need not be provided if the account of the consumer is not current with the medical products provider and such an exception is made in writing by the medical products provider to the consumer.

     2.  A medical products provider that sells, leases or otherwise provides assistive equipment shall develop and use quality assurance policies and procedures that require:

     (a) A review to determine the compatibility, utility and safety of assistive equipment that is custom designed and fabricated by the medical products provider when such equipment is used with assistive equipment that is commercially made;

     (b) A process of selecting materials used in custom designed and modified assistive equipment to assure that the materials are safe and durable; and

     (c) The making and keeping of records regarding communications with health professionals, consumers, and the family and agents of a consumer concerning assistive equipment.

     (Added to NAC by Bd. of Pharmacy by R008-01, eff. 11-1-2001)

      NAC 639.69533  Customized orthotic or prosthetic devices: Approval by Board required. (NRS 639.070)

     1.  A medical products provider, or an applicant for a license to engage in business as a medical products provider, that wishes to sell, lease or otherwise provide a customized orthotic or prosthetic device to a consumer must be approved by the Board. The medical products provider or applicant must apply for approval in the manner prescribed by the Board.

     2.  The Board will not give its approval unless the medical products provider or applicant submits evidence to the Board that the medical products provider or applicant:

     (a) Has employed, contracted with or otherwise retained the services of a person who is certified by an accreditation and certification organization; and

     (b) Except as otherwise provided in this subsection, possesses a facility at which to provide a customized orthotic or prosthetic device to a consumer:

          (1) That is accredited by an accreditation and certification organization; or

          (2) For which the medical products provider or applicant has applied to an accreditation and certification organization for accreditation.

Ê The provisions of paragraph (b) do not apply to a medical products provider or applicant if the only customized orthotic or prosthetic device to be provided by the medical products provider or applicant is a customized breast prosthesis or customized mastectomy form.

     3.  If the Board gives its approval to a medical products provider or applicant whose facility is not accredited by an accreditation and certification organization, the medical products provider or applicant shall:

     (a) Pursue its application for accreditation of the facility in good faith; and

     (b) Unless excused by the Board, obtain accreditation of the facility within 12 months after the submission of its application to the accreditation and certification organization.

     4.  The Board may withdraw its approval if the medical products provider:

     (a) Ceases to satisfy any condition set forth in this section for which the Board could have initially withheld its approval; or

     (b) Violates any provision of NAC 639.693 to 639.6958, inclusive.

     (Added to NAC by Bd. of Pharmacy by R033-07, eff. 8-26-2008)

      NAC 639.69535  Customized orthotic or prosthetic devices: Accessibility of services and confidentiality. (NRS 639.070)  A medical products provider that sells, leases or otherwise provides a customized orthotic or prosthetic device to a consumer shall:

     1.  Make available to its consumers the services of a person who is certified by an accreditation and certification organization.

     2.  Except as otherwise provided in NAC 639.69533, provide a customized orthotic or prosthetic device to a consumer only at a facility that is accredited by an accreditation and certification organization.

     3.  Provide emergency services to a consumer within 12 hours after the consumer or his or her caregiver or agent requests the services.

     4.  Keep confidential any records concerning the treatment of a consumer to whom the medical products provider sells, leases or otherwise provides a customized orthotic or prosthetic device.

     5.  Develop and use policies and procedures to ensure that a person employed, contracted with or otherwise retained by the medical products provider complies with the provisions of NAC 639.693 to 639.6958, inclusive.

     (Added to NAC by Bd. of Pharmacy by R033-07, eff. 8-26-2008)

      NAC 639.69537  Customized orthotic or prosthetic devices: Practitioner’s order required. (NRS 639.070)  An order from a practitioner is required in order to obtain a customized orthotic or prosthetic device from a medical products provider.

     (Added to NAC by Bd. of Pharmacy by R033-07, eff. 8-26-2008)

      NAC 639.6954  Medical gases and associated equipment or respiratory equipment. (NRS 639.070)

     1.  A medical products provider that sells, leases or otherwise provides medical gases and associated equipment, or respiratory equipment shall:

     (a) Comply with all applicable federal, state and local laws regarding the providing and transportation of such gases and equipment, including, without limitation, all requirements regarding the tracking and recalling of gases and equipment;

     (b) Comply with all applicable federal, state, and local laws regarding transfilling and repackaging of such gases;

     (c) Comply with all applicable federal, state and local laws, including, without limitation, fire codes, occupational safety rules, building codes and health codes;

     (d) Service equipment sold, leased or otherwise provided by the medical products provider according to the directions and specification of the manufacturer, regardless of where the equipment may be located at the time that the equipment is due for servicing;

     (e) Make and keep records regarding the servicing of equipment by the medical products provider; and

     (f) Provide only gases that are:

          (1) Medical grade; and

          (2) Intended for use by humans.

     2.  Before providing any equipment pursuant to this section, a medical products provider shall verify that the equipment:

     (a) Has been checked and is free of defects;

     (b) Is operating within the specifications of the manufacturer;

     (c) Has not been modified in any way that will jeopardize the effectiveness or safety of the equipment;

     (d) Does not present a hazard of fire or shock; and

     (e) Has all warning labels and tags that were provided by the manufacturer, wholesaler or seller of the equipment.

     3.  A medical products provider that sells, leases or otherwise provides medical gases and equipment or respiratory equipment shall develop and use policies and procedures that require:

     (a) Making and keeping records to track and recall all gases dispensed by the medical products provider, including, without limitation:

          (1) Recording the lot numbers of each cylinder or unit of gas provided;

          (2) Maintaining a written or computerized system to track and locate all gases and equipment provided by the medical products provider; and

          (3) Recording the serial numbers and model numbers of all equipment provided by the medical products provider;

     (b) Maintaining and cleaning equipment provided by the medical products provider, including, without limitation:

          (1) Documenting that the function and safety of the equipment was verified before the equipment was provided to the consumer;

          (2) Cleaning and disinfecting equipment pursuant to an established protocol to remove aerobic and anaerobic pathogens from the equipment to the specifications of the manufacturer for that equipment;

          (3) Making and keeping a material safety data sheet for the solutions and products used in cleaning and disinfecting the equipment;

          (4) Designating areas at the business of the medical products provider that must be used to store separately clean and unclean equipment; and

          (5) Designating a separate area at the business of the medical products provider that must be used to store quarantined equipment.

     4.  When a medical products provider provides oxygen, the medical products provider must also provide an emergency supply of oxygen, supplies and equipment to maintain therapy while the primary supply of oxygen and related equipment is inoperable or unusable.

     5.  In addition to any communication and advisement required pursuant to NAC 639.693 to 639.6958, inclusive, a medical products provider who provides medical gas and related equipment, or respiratory equipment, must advise the consumer receiving the medical gas and related equipment, or respiratory equipment, regarding:

     (a) Cleaning of the equipment;

     (b) Potential hazards and warning signs of malfunctioning or inadequately functioning equipment;

     (c) Maintenance procedures for the equipment;

     (d) The telephone number, contact name, and contact address for emergency servicing or repair of the equipment, and for routine servicing or repair of the equipment; and

     (e) The written materials about the equipment that are available from the medical products provider or the manufacturer of the equipment.

     6.  For the purposes of this section, “material safety data sheet” has the meaning ascribed to it in 29 C.F.R. § 1910.1200.

     (Added to NAC by Bd. of Pharmacy by R008-01, eff. 11-1-2001; A by R033-07, 8-26-2008)

      NAC 639.69543  Insulin pumps. (NRS 639.070)  A medical products provider that sells, leases or otherwise provides an insulin pump to a consumer shall provide training to the consumer or the consumer’s family, caregiver or agent in the proper use and maintenance of the pump and the procedures for dealing with a malfunction or other problem that may arise in the use of the pump. The training must be provided by a person who is certified by the manufacturer of the insulin pump in the operation of the pump.

     (Added to NAC by Bd. of Pharmacy by R033-07, eff. 8-26-2008)

      NAC 639.69545  Pressurized stockings. (NRS 639.070)

     1.  A pressurized stocking that has a pressure rating of 20 millimeters of mercury or more may not be sold, leased or otherwise provided to a consumer without an order from a practitioner.

     2.  A medical products provider that sells, leases or otherwise provides to a consumer a pressurized stocking that has a pressure rating of 20 millimeters of mercury or more shall provide training to the consumer or the consumer’s family, caregiver or agent in the use, maintenance and potential problems in the use of the stocking. The training must be provided by a person who is certified by the manufacturer of the pressurized stocking in the fitting and use of the stocking.

     (Added to NAC by Bd. of Pharmacy by R033-07, eff. 8-26-2008)

      NAC 639.6955  Life-sustaining equipment. (NRS 639.070)  A medical products provider who sells, leases or otherwise provides life-sustaining equipment shall:

     1.  Maintain a sufficient number of employees who are:

     (a) Trained to service and repair the life-sustaining equipment provided by the medical products provider; and

     (b) Available to service and repair the life-sustaining equipment within 1 hour of any call for service or repair;

     2.  Inform all consumers to whom the medical products provider has sold, leased or otherwise provided life-sustaining equipment of a toll-free telephone number that the consumer may call at any time the life-sustaining equipment has malfunctioned;

     3.  Ensure that information and procedures in the event of an emergency are in writing and attached to the life-sustaining equipment; and

     4.  Provide the consumer with sufficient emergency supplies and equipment, including, without limitation, redundant life-sustaining equipment, necessary to sustain the consumer until the medical products provider can service or repair the primary life-sustaining equipment. Redundant life-sustaining equipment provided pursuant to this subsection must operate in substantially the same manner as the primary life-sustaining equipment.

     (Added to NAC by Bd. of Pharmacy by R008-01, eff. 11-1-2001; A by R033-07, 8-26-2008)

      NAC 639.6956  Parenteral and enteral services and equipment. (NRS 639.070)  A medical products provider who sells, leases or otherwise provides parenteral and enteral services and equipment shall:

     1.  Provide a consumer with an orientation and a written checklist regarding:

     (a) Instructions for use of the equipment;

     (b) Cleaning procedures;

     (c) Safety precautions; and

     (d) Maintenance procedures;

     2.  Return as necessary to the premises of the consumer to demonstrate the use and maintenance of parenteral and enteral services and equipment; and

     3.  Deliver and review written instructions with the consumer to ensure the proper use and maintenance of the parenteral and enteral services and equipment.

     (Added to NAC by Bd. of Pharmacy by R008-01, eff. 11-1-2001)

Medical Products Wholesalers

      NAC 639.6957  Duties of wholesalers; repair and maintenance of medical products; hours of operation; consumer complaints. (NRS 639.070)

     1.  A medical products wholesaler shall:

     (a) Employ a facility administrator and other employees sufficient to operate, set up, repair, maintain and service all medical products sold, leased or otherwise provided by the medical products wholesaler.

     (b) Ensure that employees of the medical products wholesaler are trained to operate, set up, repair, maintain and service the medical products sold, leased or otherwise provided by the medical products wholesaler.

     (c) Ensure that employees of the medical products wholesaler are trained to instruct medical products providers regarding the operation, set up, repair, maintenance and service of all medical products sold, leased or otherwise provided by the medical products wholesaler.

     (d) Maintain an inventory of medical products necessary to serve the needs of the medical products providers served by the medical products wholesaler.

     (e) Maintain a suitable physical location, other than a residence, at which the medical products wholesaler can:

          (1) Store inventory;

          (2) Repair or service any equipment which the medical products wholesaler sells, leases or otherwise provides; and

          (3) Keep all current records related to the operation of the medical products wholesaler.

     (f) Have a functioning lavatory with a toilet and a sink with hot and cold water at the facility of the medical products wholesaler.

     (g) Maintain the facility of the medical products wholesaler in a clean, orderly and sanitary condition.

     (h) Ensure that the facility of the medical products wholesaler complies with all applicable federal, state and local laws, regulations and rules, including, without limitation, occupational safety rules, fire codes, building codes and health codes.

     (i) Maintain liability insurance of at least $1,000,000, which must include product liability insurance if the medical products wholesaler:

          (1) Designs, fabricates or manufactures a medical product; or

          (2) Substantially modifies a commercially available medical product.

     (j) Maintain a log or other record regarding all repairs made to medical products provided by the medical products wholesaler. For each medical product repaired by the medical products wholesaler, the log or record must identify:

          (1) The type of medical product;

          (2) The manufacturer;

          (3) The model or model number;

          (4) The serial number;

          (5) The date of the repair;

          (6) The specific repair made;

          (7) The name of the person or company who performed the repair; and

          (8) A certification that the medical product has been returned to the specifications of the manufacturer as a result of the repair.

     2.  If the medical products wholesaler cannot certify that the repaired medical product has been returned to the specifications of the manufacturer as a result of the repair, the medical products wholesaler must:

     (a) Determine whether the medical product can be safely and effectively used for a limited purpose, in which case the medical products wholesaler must note that the medical product can only be used for a limited purpose and must ensure that the medical product is only used for such limited purpose; or

     (b) Ensure that the medical product is removed from service and is not sold, leased or otherwise provided to any person without a written statement acknowledging that the medical product:

          (1) Was repaired;

          (2) Could not be brought up to the specifications of the manufacturer; and

          (3) Cannot be used for the purposes for which the medical product was intended.

     3.  Any device used by a medical products wholesaler to calibrate or test equipment must be accurate and must be maintained according to the directions and specifications of the manufacturer. The scales used to weigh reservoirs of liquid oxygen must be accurate and must be certified annually by the State Sealer of Consumer Equitability.

     4.  The physical premises of any medical products wholesaler must be open and accessible to the Board at all times during regular hours of operation.

     5.  The owner of a medical products wholesaler is responsible for the acts of his or her facility administrator and employees.

     (Added to NAC by Bd. of Pharmacy by R008-01, eff. 11-1-2001; A by R033-07, 8-26-2008)

      NAC 639.69573  Wholesaler who employs person to sell or market device or appliance: Annual submission of certain information to Board; review and contents of marketing code of conduct. (NRS 639.070, 639.570)

     1.  Except as otherwise provided in subsection 2, on or before June 1 of each year, a medical products wholesaler who employs a person to sell or market a device or appliance in this State shall submit to the Board the information required pursuant to subsection 2 of NRS 639.570.

     2.  If a medical products wholesaler who employs a person to sell or market a device or appliance in this State uses, without modification, the Code of Ethics on Interactions with Health Care Professionals, as adopted by reference in NAC 639.060, as its marketing code of conduct, the medical products wholesaler may indicate this on its submittal in lieu of submitting a copy of its marketing code of conduct.

     3.  If a medical products wholesaler:

     (a) Develops its own marketing code of conduct; or

     (b) Uses a modified version of the Code of Ethics on Interactions with Health Care Professionals, as adopted by reference in NAC 639.060, as its marketing code of conduct,

Ê the staff of the Board shall review the marketing code of conduct to ensure that it addresses the subjects listed in subsection 4.

     4.  A marketing code of conduct submitted by a medical products wholesaler pursuant to this section and subsection 2 of NRS 639.570 must address the following subjects:

     (a) Providing or sponsoring product training and education;

     (b) Supporting third-party educational conferences;

     (c) Sales and promotional meetings;

     (d) Arrangements with consultants;

     (e) Gifts;

     (f) Providing reimbursement and other economic information; and

     (g) Grants and other charitable donations.

     5.  If the staff of the Board determines that a marketing code of conduct submitted by a medical products wholesaler does not address each of the subjects set forth in subsection 4, the marketing code of conduct shall be deemed incomplete and noncompliant with the provisions of this section and subsection 2 of NRS 639.570.

     (Added to NAC by Bd. of Pharmacy by R122-07, eff. 1-30-2008)

      NAC 639.69575  Submission of certain information regarding sales and marketing staff: Submission of form after initial submittal; method of submission. (NRS 639.070, 639.570)

     1.  If a medical products wholesaler has submitted to the Board the information required pursuant to NAC 639.69573 at least once, the medical products wholesaler may subsequently submit to the Board, on a form provided by the Board, the information that has remained the same and the information that has changed from the date of the previous submission, in lieu of submitting the information required annually pursuant to NAC 639.69573.

     2.  The submission of information to the Board pursuant to this section and NAC 639.69573 may be made by:

     (a) Mail or personal delivery of a printed copy of the information required;

     (b) Electronic mail to the Board at the electronic mail address pharmacy@pharmacy.nv.gov; or

     (c) Such other technological means as the Board may develop, including, without limitation, through the use of the Internet website of the Board.

     (Added to NAC by Bd. of Pharmacy by R122-07, eff. 1-30-2008)

      NAC 639.69577  Submission of certain information regarding sales and marketing staff: Incomplete, improperly completed or noncompliant submittal; correction of deficiencies. (NRS 639.070, 639.570)

     1.  The Board will refuse a submittal of information from a medical products wholesaler pursuant to NAC 639.69573 or 639.69575 if the submittal is incomplete. The Board will treat such an incomplete submittal as noncompliant for the purposes of NRS 639.570.

     2.  If the staff of the Board determines that a submittal of information pursuant to NAC 639.69573 or 639.69575 is incomplete, improperly completed or noncompliant, the staff shall, as soon as practicable, notify the medical products wholesaler who submitted the information that the submittal is incomplete, improperly completed or noncompliant and provide the medical products wholesaler with instructions for correcting the deficiencies in the submittal. The Board may retain an incomplete, improperly completed or noncompliant submittal or return the submittal to the medical products wholesaler.

     3.  If the staff of the Board provides notice of an incomplete, improperly completed or noncompliant submittal to a medical products wholesaler pursuant to this section, the medical products wholesaler must comply with the instructions for correcting the deficiencies in the submittal within 120 days after the receipt of the instructions. Within the 120-day period, the medical products wholesaler may request a meeting with the staff of the Board to discuss the deficiencies in its submittal. If the medical products wholesaler corrects the deficiencies in its submittal within the 120-day period, the Board will accept and file the submittal.

     (Added to NAC by Bd. of Pharmacy by R122-07, eff. 1-30-2008)

Disciplinary Action

      NAC 639.6958  Summary suspension of license. (NRS 639.070)

     1.  The Executive Secretary may summarily suspend the license of a medical products provider or medical products wholesaler upon receiving evidence sufficient to cause the Executive Secretary to reasonably believe that a medical products provider or medical products wholesaler is:

     (a) Operating without liability insurance;

     (b) Operating without a license;

     (c) Operating without a business administrator or a facility administrator; or

     (d) Engaging in practices that are fraudulent or deceitful.

     2.  The Executive Secretary shall immediately provide written notice to the medical products provider or medical products wholesaler that informs the medical products provider or medical products wholesaler of:

     (a) The factual and legal reasons for the summary suspension; and

     (b) The right of the medical products provider or medical products wholesaler to provide the Board with any evidence or information that would show that either the factual or legal reasons for the summary suspension are incorrect.

     3.  The Executive Secretary may take whatever action he or she deems reasonably necessary to secure the medical products and premises, and to ensure that the medical products provider or medical products wholesaler does not conduct business during the summary suspension.

     4.  The Executive Secretary shall release the medical products provider or medical products wholesaler from the summary suspension upon receiving evidence satisfactory to the Executive Secretary from the medical products provider or medical products wholesaler that the deficiency noted in the written notice has been remedied.

     5.  Within 10 days after summarily suspending the license of a medical products provider or medical products wholesaler, the Executive Secretary shall serve upon the medical products provider or medical products wholesaler an accusation pursuant to NRS 639.241. A hearing on the accusation must be set for the next regularly scheduled meeting of the Board.

     (Added to NAC by Bd. of Pharmacy by R008-01, eff. 11-1-2001)

TRADE PRACTICES

      NAC 639.700  Performance of certain acts by pharmacists and pharmaceutical interns only. (NRS 639.070)  Except as otherwise provided in subsection 2 of NAC 639.245, the following acts may be performed only by a registered pharmacist, or by a registered pharmaceutical intern acting under the direct supervision of a registered pharmacist:

     1.  Taking new orders for prescriptions or chart orders over the telephone;

     2.  Identifying, evaluating and interpreting a prescription;

     3.  Interpreting the clinical data contained in a patient’s medication system or chart;

     4.  Consulting with a prescribing practitioner, nurse or other health care professional, or the authorized agent thereof;

     5.  Determining the efficacy of a drug, a regimen, the substitution of a generic drug for a drug prescribed by brand name or the substitution of one drug therapy for another;

     6.  Taking responsibility for all activities of pharmaceutical technicians to ensure that those activities are performed completely, safely and without risk of harm to patients;

     7.  Counseling a patient or a person caring for a patient and rendering any other advice or information regarding drugs or medications; and

     8.  Performing any other functions which require the professional judgment of a pharmacist.

     [Bd. of Pharmacy, § 639.305, eff. 6-26-80]—(NAC A 11-15-93)

      NAC 639.701  Acts not required to be performed by pharmaceutical professionals. (NRS 639.070)  The following acts are not required to be performed by a pharmacist, intern pharmacist, pharmaceutical technician or pharmaceutical technician in training:

     1.  Entering information into the pharmacy’s computer other than information contained in a new prescription concerning the prescription drug and the directions for its use.

     2.  Processing sales, including the operation of a cash register.

     3.  Stocking shelves.

     4.  Delivering medication to a patient or to areas of a hospital where patients are cared for.

     (Added to NAC by Bd. of Pharmacy, eff. 11-15-93; A by R037-07, 1-30-2008)

      NAC 639.702  Responsibility for acts and omissions of personnel who are not pharmacists. (NRS 639.070)  The owner of a pharmacy, the managing pharmacist of the pharmacy and the registered pharmacist on duty at the pharmacy are responsible for the acts and omissions of pharmaceutical technicians and other personnel who are not pharmacists working in or for the pharmacy, including, but not limited to, any errors committed or unauthorized work performed by such personnel, if the owner, managing pharmacist or registered pharmacist knew or reasonably should have known of the act or omission.

     (Added to NAC by Bd. of Pharmacy, eff. 11-15-93)

      NAC 639.704  Check of license or certification required before employment by pharmacy or wholesaler. (NRS 639.070)

     1.  Before employing a pharmacist, intern pharmacist, pharmaceutical technician or pharmaceutical technician in training, a pharmacy or wholesaler licensed by the Board shall contact the Board to inquire whether the applicant has had his or her license or certification suspended or revoked by the Board or by a similar board in another state.

     2.  If the applicant has had his or her license or certification suspended or revoked, the pharmacy or wholesaler shall not employ the applicant to work in the pharmacy unless authorized by the Board.

     (Added to NAC by Bd. of Pharmacy by R216-99, eff. 3-13-2000)

      NAC 639.706  Marking of prescriptions with serial numbers; maintenance of files of prescriptions. (NRS 639.070, 639.0745, 639.236)

     1.  A pharmacist who receives a prescription to fill, including a prescription that is written, transcribed from an oral order or transferred to the pharmacy, shall mark on the prescription a unique serial number issued for that prescription.

     2.  A pharmacist shall maintain files of prescriptions in a manner that ensures that every serial number is accounted for pursuant to NAC 453.480. If the prescriptions are not filed in numerical order, the pharmacist shall file the prescriptions in such a manner that any prescription can be readily retrieved.

     3.  A pharmacist shall maintain a physical record in the files of prescriptions that accurately explains or accounts for any serial number issued for a prescription that is not filled, including a serial number issued in error or for a prescription that is later rendered void.

     (Added to NAC by Bd. of Pharmacy, eff. 10-1-93; A by R120-02, 10-24-2002)

      NAC 639.707  Counseling of patients: Duties of pharmacist or intern pharmacist; documentation. (NRS 639.070, 639.266)

     1.  Except as otherwise provided in this section, a pharmacist or an intern pharmacist under the supervision of a pharmacist shall verbally provide a patient or a person caring for the patient with information about each prescription drug or device dispensed to the patient that:

     (a) Has not been previously dispensed to the patient from that pharmacy; or

     (b) Has been previously dispensed to the patient from that pharmacy, including, without limitation, a prescription drug or a device that is being refilled, if, in the professional judgment of the pharmacist or intern pharmacist:

          (1) The information would further or improve the drug therapy of the patient; or

          (2) A reasonable concern relating to the safety or efficacy of the drug therapy of the patient was raised by the review of the patient’s record that the pharmacist or intern pharmacist conducted pursuant to subsection 4.

     2.  The information provided by the pharmacist or intern pharmacist pursuant to subsection 1 may include, without limitation:

     (a) The name and a description of the drug;

     (b) The form of dosage, dose, route of administration and duration of drug therapy;

     (c) The intended use of the drug or device and expected responses from that use;

     (d) Any special directions and precautions for the preparation, administration and use of the drug or device by the patient;

     (e) Any common severe side effects, interactions and contraindications that may occur, recommendations to avoid these side effects, interactions or contraindications, and the action required if they occur;

     (f) Techniques for the patient or the person caring for the patient to monitor the drug therapy;

     (g) Proper storage of the drug or device;

     (h) Information about refilling the prescription;

     (i) Actions to be taken in the event of a missed dose;

     (j) Any relevant information contained in the record of medication of the patient; and

     (k) Any other information which, in the professional judgment of the pharmacist or intern pharmacist, is necessary to ensure the safe and effective use of the drug or device by the patient.

     3.  The pharmacist or intern pharmacist shall provide the information required pursuant to subsections 1 and 2 in written form to the patient if a drug or device will be distributed to the patient outside the confines of the pharmacy by mail or any other delivery service. A pharmacist or intern pharmacist is not required to provide written information pursuant to this subsection if the drug or device is being delivered to a patient who is in a licensed medical facility where other licensed health care professionals are authorized to administer drugs.

     4.  The pharmacist or intern pharmacist shall review a patient’s record before dispensing a prescription to determine its therapeutic appropriateness and, in making that determination, may consider, without limitation:

     (a) Overutilization of the drug and drug abuse;

     (b) Underutilization of the drug;

     (c) Therapeutic duplications, contraindications and any warning labels or other information included with the drug;

     (d) Interactions between the drug and any:

          (1) Other drugs which the patient is taking or has recently taken;

          (2) Diseases which the patient has, including any stages of that disease; and

          (3) Allergies that the patient may have; and

     (e) Incorrect dosage or duration of treatment.

     5.  A pharmacist or intern pharmacist is not required to counsel a patient pursuant to this section if the patient or a person caring for the patient refuses to accept the counseling.

     6.  Except as otherwise provided in subsection 7, the pharmacist or intern pharmacist shall, at the time that counseling is provided or refused:

     (a) Initial a written document that is maintained at the pharmacy to record whether counseling was provided to or refused by a patient or the person caring for the patient; or

     (b) Enter, pursuant to NAC 639.751, initials onto a record in a computerized system used by the pharmacy for recording information concerning prescriptions to indicate whether counseling was provided to or refused by a patient or the person caring for the patient.

     7.  The pharmacist or intern pharmacist is not required to comply with the provisions of subsection 6 if the prescription drug or device dispensed to the patient is being refilled.

     (Added to NAC by Bd. of Pharmacy, eff. 11-15-93; A 9-6-96; R016-03, 10-21-2003; R050-07, 12-17-2008; R034-09, 10-27-2009)

      NAC 639.708  Counseling of patients: Duties of pharmacy. (NRS 639.070, 639.266)  To facilitate counseling regarding a prescription, a pharmacy shall:

     1.  Maintain a record of medication for each patient to whom a prescription has been dispensed by that pharmacy. The record must:

     (a) Be retrievable for use by the pharmacist;

     (b) Be maintained for at least 2 years after the most recent entry;

     (c) List all prescriptions dispensed to the patient at that pharmacy; and

     (d) Include all data required to be placed on the prescription.

     2.  Make a reasonable effort to obtain and retain in the record of medication the:

     (a) Telephone number or numbers, if any, of the patient;

     (b) Gender of the patient;

     (c) Age or date of birth of the patient;

     (d) History of the patient, including allergies, reactions to particular drugs and any medications or medical devices used by the patient; and

     (e) Any comments relevant to the drug therapy of the patient, including any other information which is specific to the patient or drug.

     3.  Ensure that a pharmacist is available by telephone during business hours and, if the pharmacy routinely delivers prescriptions outside of the trade area covered by local telephone service, provide a toll-free telephone number.

     4.  Include with each prescription container delivered or distributed by a public carrier:

     (a) The local, and if applicable toll-free, telephone numbers of the pharmacy;

     (b) The hours during which the patient may contact the pharmacy by telephone; and

     (c) A written notice in substantially the following form:

 

Written information about this prescription has been provided for you. Please read this information before you take this medication. If you have questions concerning this prescription, a pharmacist is available between the hours of ..... and ..... to answer your questions.

 

     5.  Maintain the confidentiality of each patient’s records, including prescriptions, pursuant to NRS 639.238. A pharmacist shall not divulge the contents of a patient’s records, except as authorized by NRS 639.238.

     6.  Make available to a practitioner, upon request, all information relating to a prescription that is provided to a patient of that practitioner by the pharmacist or an intern pharmacist.

     7.  Ensure that counseling is conducted in a confidential manner to prevent disclosure of information to any person other than the patient or the person caring for the patient.

     (Added to NAC by Bd. of Pharmacy, eff. 11-15-93)

      NAC 639.709  Persons to whom pharmacy may furnish certain restricted products. (NRS 639.070, 639.595)

     1.  A pharmacy may furnish drugs, controlled substances, poisons, chemicals, devices or appliances restricted by federal law to sale by or on the order of a physician only to:

     (a) The ultimate user;

     (b) A licensed practitioner;

     (c) Another pharmacy to alleviate a temporary shortage; or

     (d) A wholesaler only for the purposes of, and subject to the conditions set forth in, NAC 639.5975.

     2.  Drugs, controlled substances, poisons, chemicals, devices or appliances that are returned by a person for credit, in an amount equal to or less than the actual purchase price, to a wholesaler or manufacturer pursuant to subsections 2, 3 and 4 of NAC 639.5975 are not subject to the provisions of this section.

     3.  As used in this section, “ultimate user” means a person who lawfully possesses a drug, controlled substance, poison, chemical, device or appliance restricted by federal law to sale by or on the order of a physician for his or her own use, the use of a member of the person’s household or the use of any person for whom he or she is caring, or for administering to any animal owned by the person or by a member of his or her household.

     (Added to NAC by Bd. of Pharmacy, eff. 10-1-93; A 5-22-96; R118-98, 9-10-98; R049-04, 2-28-2005)

      NAC 639.7102  Use of computer system for issuance and transmission of prescription. (NRS 639.070, 639.0745)

     1.  A practitioner may:

     (a) Issue a prescription using a computer system approved by the Board; and

     (b) Transmit the prescription using that computer system to a pharmacy specified by the patient for whom the practitioner issues the prescription.

     2.  The Board will approve the computer system of a practitioner if the computer system:

     (a) Requires a fingerprint scan, retinal scan, personal identification number or other unique identification of the practitioner to activate the computer system by which a prescription will be entered and to reactivate the computer system if the computer system has not been in use for 15 minutes or longer;

     (b) Maintains a record of:

          (1) Each prescription that the practitioner issues using the computer system; and

          (2) Each pharmacy to which the practitioner submits the prescription;

     (c) Is able to print a written prescription that complies with NRS 639.2353 and NAC 453.440;

     (d) Places on the face of the prescription, if it is printed from the computer system of the practitioner or the pharmacy to which the practitioner transmits the prescription, or if it is displayed on the monitor of the computer of the pharmacy, a mark that uniquely identifies the practitioner, including, without limitation, the practitioner’s signature or a security code which is known to or verifiable by the pharmacy;

     (e) Requires the practitioner, before the computer system places the words “Dispense As Written” on the face of the prescription, to make a specific entry into the computer system for the prescription; and

     (f) Except as otherwise provided in subsection 3, transmits to the pharmacy specified by the patient the prescription and any other confidential information relating to the patient in a manner that ensures that the prescription or other confidential information may not be altered by a person other than the pharmacist.

     3.  The provisions of paragraph (f) of subsection 2 do not prohibit a practitioner from using a routing company to transmit a prescription pursuant to this section. A routing company:

     (a) May, for the purpose of verifying an audit conducted of the routing company, store any prescription or other confidential information it receives or transmits pursuant to this subsection in a form that is secure and ensures the confidentiality of the information.

     (b) May not add a provision to, delete a provision from or otherwise modify a prescription or any other confidential information that it receives or transmits pursuant to this subsection.

     4.  A pharmacy that receives a prescription from a practitioner using a computer system which is approved by the Board may fill that prescription if:

     (a) The pharmacy prints a copy of the prescription and files the copy in the same manner in which the pharmacy files any other prescription maintained by it; or

     (b) The computer system of the pharmacy:

          (1) Maintains the prescription in a manner that ensures that the prescription is numbered consecutively in accordance with NAC 639.914;

          (2) Is able to print a copy of the prescription; and

          (3) Prohibits the modification of the prescription unless the computer system:

               (I) Automatically prepares a notation within the records of the computer system indicating that the pharmacy has modified the prescription and automatically records the modification; and

               (II) Requires the pharmacy to prepare a record indicating the identity of the person who modified the prescription.

     5.  If a pharmacy fills a prescription pursuant to paragraph (b) of subsection 4, a pharmacist employed by the pharmacy shall, each day:

     (a) Store the prescription or cause the prescription to be stored on a tape, disc or other device that is used for the storage of information by a computer; and

     (b) Store the tape, disc or device:

          (1) At a location other than the pharmacy; or

          (2) In any other manner that:

               (I) Protects the tape, disc or device from loss or damage; and

               (II) Ensures that any confidential information included in the tape, disc or device remains confidential.

     6.  If a practitioner prints a prescription using a computer system that is approved pursuant to this section, the practitioner shall:

     (a) Except as otherwise provided in paragraph (b), manually sign the printed prescription; or

     (b) If the prescription includes a mark that uniquely identifies the practitioner in accordance with paragraph (d) of subsection 2, print the prescription on security paper.

     7.  A practitioner may transmit a prescription or any other confidential information relating to a patient to an insurer or any entity other than a pharmacy pursuant to this section if, before transmitting the prescription or confidential information:

     (a) The practitioner submits a written notice to the patient:

          (1) Identifying the insurer or entity; and

          (2) Indicating that the practitioner intends to transmit the prescription or confidential information to the insurer or entity; and

     (b) The patient consents in writing to the transmission of the prescription or confidential information to:

          (1) The insurer or entity; and

          (2) The pharmacy specified by the patient pursuant to this section.

     8.  The provisions of this section do not prohibit a computer system that is approved pursuant to this section from being used to transmit:

     (a) The ICD code set forth in the most recent revision of the International Classification of Diseases; or

     (b) Any other information that is not related to the issuance, filling or transmission of a prescription for a patient or the transmission of any confidential information relating to the patient pursuant to this section.

     9.  As used in this section:

     (a) “Routing company” means any business that:

          (1) Receives a prescription or any other confidential information from a practitioner in accordance with a contract between:

               (I) The routing company and the practitioner or a company that provides computer software for the management of the practitioner’s practice; or

               (II) A patient of the practitioner and a third-party payor; and

          (2) Transmits the prescription or confidential information:

               (I) Directly to the pharmacy specified by the patient; or

               (II) Through the company that provides computer software for the management of the business operations of the pharmacy.

     (b) “Security paper” means any paper that is approved by the staff of the Board and that includes features which ensure that the paper:

          (1) May not be duplicated without creating an indication on the paper that the paper has been duplicated; and

          (2) May be authenticated as having been issued by a practitioner or the office of the practitioner.

     (Added to NAC by Bd. of Pharmacy by R067-02, eff. 10-22-2003; A by R037-06, 5-4-2006; R176-12, 12-20-2012)

      NAC 639.7105  Electronic transmission of prescription. (NRS 639.070, 639.0745)  Except as otherwise provided in NAC 639.711:

     1.  A prescription for a dangerous drug or a controlled substance listed in schedule II, III, IV or V may be transmitted electronically by a practitioner to a pharmacy.

     2.  A practitioner shall not transmit a prescription electronically to a pharmacy unless:

     (a) The practitioner is the only person who will have access to the prescription until it is received by the pharmacy;

     (b) The patient:

          (1) Consents to the transmission of the prescription electronically; and

          (2) Approves the pharmacy where the prescription will be transmitted; and

     (c) All requirements of 21 C.F.R. Part 1311 are satisfied.

     3.  In addition to the requirements set forth in NRS 639.2353 and 639.2589, a prescription that is transmitted electronically to a pharmacy must include:

     (a) The telephone number of the prescribing practitioner;

     (b) The time and date of the transmission; and

     (c) The name of the pharmacy to which the prescription is sent.

     4.  In addition to the requirements set forth in subsection 3 and NRS 639.2353 and 639.2589, a prescription for a controlled substance that is transmitted electronically to a pharmacy must include:

     (a) The registration number from the Drug Enforcement Administration of the prescribing practitioner; and

     (b) If the technological capability exists to require such information to be transmitted electronically:

          (1) The Nevada controlled substance registration number of the prescribing practitioner;

          (2) The indication for use or the diagnosis code; and

          (3) The date of the last physical examination of the patient.

     5.  A pharmacist who receives a prescription that is transmitted electronically shall:

     (a) Print a copy of the prescription on paper that is of sufficient quality to last for at least 2 years; and

     (b) Keep a copy of the prescription for at least 2 years after the pharmacist receives the prescription.

     6.  A pharmacist shall not dispense a prescription that is transmitted electronically until the pharmacist determines that the prescription complies with the requirements of state and federal law.

     7.  A prescription that is transmitted electronically and complies with the provisions of this section shall be deemed an original prescription.

     8.  The Board may suspend the privilege of a practitioner to transmit prescriptions electronically if the Board reasonably suspects that the practitioner has transmitted a prescription electronically that is:

     (a) Unlawful;

     (b) Fraudulent; or

     (c) Not for a legitimate medical purpose.

     (Added to NAC by Bd. of Pharmacy, eff. 11-14-97; A by R164-01, 12-17-2001; R160-10, 5-5-2011; R176-12, 12-20-2012)

      NAC 639.711  Transmission of prescription by facsimile machine. (NRS 639.070, 639.0745)

     1.  A prescription for a controlled substance listed in schedule II must not be transmitted by a practitioner or the designated agent of the practitioner by a facsimile machine to a pharmacy unless the prescription is:

     (a) For a controlled substance that will be compounded for the direct administration to a patient by parenteral, intravenous, intramuscular, subcutaneous or intraspinal infusion;

     (b) For issuance to a resident of a facility for long-term care; or

     (c) For issuance to a patient enrolled in a program that provides hospice care which has been licensed by this State or certified by Medicare pursuant to Title XVIII of the Social Security Act. Such a prescription must state that the patient receives hospice care.

     2.  A dangerous drug or a controlled substance listed in schedule III, IV or V may be transmitted by a practitioner or the designated agent of the practitioner by a facsimile machine to a pharmacy.

     3.  A practitioner or the designated agent of the practitioner shall not transmit a prescription by a facsimile machine to a pharmacy unless the patient:

     (a) Consents to the use of the facsimile machine; and

     (b) Approves the pharmacy where the facsimile prescription will be transmitted.

     4.  A pharmacist shall not dispense a facsimile prescription unless it is signed by a practitioner and transmitted to a pharmacy by the practitioner or the designated agent of the practitioner.

     5.  A facsimile prescription must be kept by the pharmacist for at least 2 years after it is received by the pharmacist. If the paper is not of sufficient quality to last for at least 2 years, the facsimile prescription must be reproduced on permanent paper or the pharmacist must reduce the prescription to writing and attach the original transmission of the prescription to the reproduced copy or the prescription reduced to writing.

     6.  A facsimile prescription which complies with the provisions of this section shall be deemed an original prescription.

     7.  A pharmacist may act as the designated agent of a practitioner for the purposes of this section if:

     (a) The pharmacist, pursuant to a contract entered into with a health maintenance organization or other third-party payor, reviews the records of practitioners or patients to optimize the patients’ drug therapy; and

     (b) The document that serves as a prescription or by which the patient’s drug therapy is modified:

          (1) Is signed by the practitioner;

          (2) Contains an acknowledgment by the practitioner that the pharmacist is acting as the practitioner’s designated agent; and

          (3) Indicates the name of at least one person to whom questions regarding the validity of the prescription or the modification of the patient’s drug therapy are to be directed.

     8.  As used in this section:

     (a) “Facsimile machine” means a device which transmits or receives a reproduction or facsimile of a document or photograph which is transmitted electronically or telephonically by telecommunications lines, including, without limitation, a computer that has a facsimile modem through which documents can be sent and received.

     (b) “Facsimile prescription” means an electronically produced image of a written prescription which is transmitted by a facsimile machine.

     (Added to NAC by Bd. of Pharmacy, eff. 7-1-92; A 10-1-93; 11-14-97; R026-98, 4-17-98; R112-99, 11-3-99; R164-01, 12-17-2001; R121-02, 10-24-2002; R070-03, 10-21-2003)

      NAC 639.712  Transcribing prescription transmitted by oral order. (NRS 639.070, 639.0745)

     1.  A pharmacist who transcribes a prescription transmitted by an oral order of a practitioner or the practitioner’s agent shall sign or initial the prescription and specify on the prescription:

     (a) The date the prescription was orally transmitted to the pharmacy; and

     (b) The name of the person who orally transmitted the prescription.

     2.  This section does not apply to chart orders.

     (Added to NAC by Bd. of Pharmacy, eff. 10-17-86; A 11-15-93)

      NAC 639.7125  Use of fulfillment pharmacy by dispensing pharmacy. (NRS 639.070, 639.0745)

     1.  Except as otherwise provided in subsection 2, a prescription may be filled or refilled by a fulfillment pharmacy for a dispensing pharmacy if:

     (a) The fulfillment pharmacy enters the data concerning the prescription into its computer system directly or the dispensing pharmacy enters the data concerning the prescription into its computer system and transfers that data to the computer system of the fulfillment pharmacy in a secure and confidential manner;

     (b) The computer system of the dispensing pharmacy:

          (1) Transmits to the computer system of the fulfillment pharmacy the National Drug Code number of the drug that the fulfillment pharmacy must use to fill or refill the prescription;

          (2) Makes and retains a record documenting the date and time that the prescription is transmitted to the fulfillment pharmacy and the identity of the fulfillment pharmacy; and

          (3) If applicable, automatically reduces the number of refills of the prescription;

     (c) The computer systems of the dispensing pharmacy and the fulfillment pharmacy are operated in compliance with the applicable provisions of this chapter and chapter 639 of NRS;

     (d) The fulfillment pharmacy labels the container in which the prescription will be dispensed in compliance with NRS 639.2801 using a label from the dispensing pharmacy or a label that contains the same information as the dispensing pharmacy would have been required to place on the label if the dispensing pharmacy had filled or refilled the prescription;

     (e) For each prescription that is being filled for the first time:

          (1) A pharmacist employed by the dispensing pharmacy or a pharmacist employed by the fulfillment pharmacy verifies the correctness of the data in the computer system of the dispensing pharmacy concerning the prescription before the prescription is filled by the fulfillment pharmacy, and:

               (I) If the computer system of the dispensing pharmacy is capable of recording the identification of the pharmacist and the date and time when the pharmacist performed the verification, the pharmacist properly records in the computer system of the dispensing pharmacy the verification of the data; or

               (II) Makes a written notation of the verification of the data directly on the prescription; or

          (2) If the dispensing pharmacy receives the prescription drug from the fulfillment pharmacy, a pharmacist employed by the dispensing pharmacy verifies the correctness of the prescription drug ordered by the prescription when it is received from the fulfillment pharmacy and the pharmacist makes a written notation on the prescription or in the record of the prescription in the computer system of the dispensing pharmacy that includes the name of the pharmacist and the date on which the pharmacist performed the verification;

     (f) For each prescription that is being refilled by the fulfillment pharmacy, a pharmacist or any other person employed by the dispensing pharmacy makes a record, by hand on a written document or in the record of the prescription in the computer system of the dispensing pharmacy, that includes:

          (1) The date that the request to refill the prescription was sent to the fulfillment pharmacy; and

          (2) The date that the prescription drug ordered to refill the prescription was received by the dispensing pharmacy from the fulfillment pharmacy; and

     (g) A pharmacist employed by the dispensing pharmacy verifies the correctness of the prescription drug ordered to refill the prescription if the prescription drug is received from the fulfillment pharmacy and if, in his or her professional judgment, the pharmacist determines such verification is necessary.

     2.  If the drug identified by the National Drug Code number which is transmitted to a fulfillment pharmacy pursuant to subparagraph (1) of paragraph (b) of subsection 1 is not available to the fulfillment pharmacy, the fulfillment pharmacy:

     (a) Shall not fill or refill the prescription; and

     (b) Shall transmit the prescription back to the dispensing pharmacy to be filled or refilled.

     3.  If a dispensing pharmacy:

     (a) Does not include prescription drugs ordered by prescriptions that are filled or refilled by a fulfillment pharmacy in the inventory of the dispensing pharmacy, the dispensing pharmacy shall, not later than 30 days after receipt of a prescription drug ordered by a prescription that was filled or refilled by a fulfillment pharmacy:

          (1) Return the prescription drug to the fulfillment pharmacy that filled or refilled the prescription if the prescription drug has not been dispensed to a patient or an agent of a patient; and

          (2) Ensure that a pharmacist employed by the dispensing pharmacy records the date that the prescription drug was returned to the fulfillment pharmacy on a written document that is maintained at the dispensing pharmacy or in the record of the prescription in the computer system of the dispensing pharmacy.

     (b) Includes prescription drugs ordered by prescriptions that are filled or refilled by a fulfillment pharmacy in the inventory of the dispensing pharmacy, the dispensing pharmacy shall:

          (1) Not take possession of a prescription drug ordered by a prescription that was filled or refilled by a fulfillment pharmacy unless the prescription drug is accompanied by a written or electronic record;

          (2) File and process an invoice for each prescription drug that it receives from a fulfillment pharmacy in the same manner as the dispensing pharmacy files and processes invoices for prescription drugs that it receives from a wholesaler; and

          (3) Process and treat each prescription drug ordered by a prescription that is filled or refilled by a fulfillment pharmacy in the same manner as the dispensing pharmacy processes and treats prescription drugs that originate from the inventory of the dispensing pharmacy.

     4.  The transmission of a prescription by a dispensing pharmacy to a fulfillment pharmacy pursuant to this section is not a transfer of a prescription.

     5.  A dispensing pharmacy shall ensure that a patient has been counseled in compliance with NRS 639.266 and NAC 639.707 and 639.708.

     6.  If a prescription is transmitted to and filled or refilled by a fulfillment pharmacy pursuant to this section, both the dispensing pharmacy and the fulfillment pharmacy are individually responsible for ensuring that their respective portions of the prescription have been filled or refilled correctly.

     7.  A dispensing pharmacy shall not transmit, and a fulfillment pharmacy shall not fill or refill, a prescription pursuant to this section for any controlled substance listed in schedule II.

     8.  This section does not prohibit a fulfillment pharmacy from communicating with a patient concerning a prescription which is filled or refilled by the fulfillment pharmacy.

     9.  As used in this section:

     (a) “Dispensing pharmacy” means a pharmacy licensed by the Board that sends a prescription to a fulfillment pharmacy to be filled or refilled by the fulfillment pharmacy.

     (b) “Fulfillment pharmacy” means a pharmacy licensed by the Board that fills or refills prescriptions on behalf of a dispensing pharmacy.

     (c) “Wholesaler” has the meaning ascribed to it in NRS 639.016.

     (Added to NAC by Bd. of Pharmacy by R035-02, eff. 10-15-2002; A by R020-03, 10-21-2003; R035-09, 8-13-2010)

      NAC 639.713  Transfer of information between pharmacies: Conditions; prohibitions. (NRS 639.070, 639.0745)

     1.  Except as otherwise provided in subsection 4, a transfer of information between pharmacies relating to a prescription for a dangerous drug or controlled substance for the purpose of filling and dispensing that prescription is subject to the following conditions:

     (a) Information relating to a prescription and any remaining number of refills may be transferred orally, by a facsimile machine in accordance with NAC 639.7145 or by computer.

     (b) An oral transfer must be communicated directly between two registered pharmacists.

     (c) The original and the transferred prescriptions must be maintained for 2 years after the date on which the prescription was filled.

     (d) Information relating to a prescription may be transferred by a computer if:

          (1) The computer that transfers the information reduces, at the time the information is transferred, the number of refills authorized by the original prescription; and

          (2) The computer that receives the information allows the transfer of the prescription for a controlled substance only once.

     2.  A pharmacist who receives a prescription for a controlled substance which has been transferred by a computer shall inform the patient that the prescription may be transferred only once.

     3.  A pharmacy shall not, without first notifying the Board:

     (a) Sell, give or otherwise transfer all its prescription files, including information relating to patients and practitioners, to another pharmacy, including a pharmacy under its control or ownership; or

     (b) Receive all the prescription files, including information relating to patients and practitioners, from another pharmacy, including a pharmacy under its control or ownership.

Ê A file transferred pursuant to this subsection is not a transfer of information between pharmacies for the purposes of subsection 1, regardless of whether the transfer occurs before or after the prescription is filled.

     4.  A prescription for a controlled substance listed in schedule II must not be transferred pursuant to the provisions of this section.

     (Added to NAC by Bd. of Pharmacy, eff. 12-3-91; A 7-17-96; 10-24-97; R155-04, 12-20-2004)

      NAC 639.714  Transfer of information between pharmacies: Procedure for oral transfers. (NRS 639.070, 639.0745)

     1.  Except as otherwise provided in subsection 3, a pharmacist who orally transfers the information relating to a prescription pursuant to NAC 639.713 shall:

     (a) Write the word “void” on the face of the prescription; and

     (b) Record on the reverse side of the invalidated prescription the following information:

          (1) The name of the pharmacist who transfers the information relating to the prescription;

          (2) The date of the transfer;

          (3) The name and address of the pharmacy to which the prescription is transferred; and

          (4) The name of the pharmacist who receives the information relating to the prescription.

     2.  The pharmacist who receives the information relating to the prescription that was transferred orally shall:

     (a) Reduce the transferred information to a written prescription;

     (b) Write the word “transfer” on the face of the transferred prescription;

     (c) If the prescription is for a controlled substance, inform the patient that the prescription may be transferred only once; and

     (d) Record the following information on the transferred prescription:

          (1) The name and address of the pharmacy from which the prescription was transferred;

          (2) The name of the pharmacist who transferred the information relating to the prescription;

          (3) The serial number of the original prescription;

          (4) The date the original prescription was issued and the most recent date of dispensing, if different; and

          (5) The number of refills authorized by the original prescription, the date the prescription was most recently refilled and the number of refills remaining.

     3.  A pharmacy which maintains its records of prescriptions on a computer system shall invalidate in its system a prescription which has been orally transferred to another pharmacy. If the computer has the capability to maintain the information described in paragraph (b) of subsection 1, the pharmacy:

     (a) Shall maintain that information on its computer; and

     (b) Is not required to record that information on the original transferred prescription.

     (Added to NAC by Bd. of Pharmacy, eff. 12-3-91; A 10-24-97)

      NAC 639.7145  Transfer of information between pharmacies: Requirements for transfer by facsimile machine. (NRS 639.070, 639.0745)

     1.  Information relating to a prescription may be transferred from a pharmacy to another pharmacy by a facsimile machine pursuant to NAC 639.713 if:

     (a) The transmission from the transferring pharmacy:

          (1) Includes the information required by subsection 2 of NRS 639.2353, which may be provided in the form of an accurate printout of the pharmacy’s computerized record of the prescription; and

          (2) Except as otherwise provided in subsection 2, includes:

               (I) A copy of the original prescription maintained in the records of the transferring pharmacy on which the pharmacist at the transferring pharmacy has signed the copy and written his or her license number; or

               (II) The signature and handwritten license number of the pharmacist at the transferring pharmacy and a notation that specifically indicates that the pharmacist intends to transfer the prescription.

     (b) The transmission is prepared and transmitted by a pharmaceutical technician or pharmacist at the transferring pharmacy.

     (c) Except as otherwise provided in subsection 3, the pharmacist at the transferring pharmacy processes the original prescription in the manner prescribed in paragraph (a) and subparagraphs (1), (2) and (3) of paragraph (b) of subsection 1 of NAC 639.714.

     2.  A pharmacy may transfer prescriptions by facsimile machine to another pharmacy without complying with the provisions of subparagraph (2) of paragraph (a) of subsection 1 only upon application to and authorization by the Board. The Board may grant that authority to a pharmacy if the Board is satisfied that:

     (a) The pharmacy’s computer system will accurately represent the identity of the pharmacist responsible for the transfer; and

     (b) The identity of the pharmacist responsible for the transfer cannot be falsified, modified, added or otherwise provided without the knowledge and assent of that pharmacist.

     3.  A pharmacy which maintains its records of prescriptions in a computer system shall invalidate in its system a prescription transferred by a facsimile machine to another pharmacy. A pharmacy which transfers a prescription by a facsimile machine is not required to process the original prescription in the manner prescribed in paragraph (c) of subsection 1 if the pharmacy cancels the prescription stored in its computer system in a manner which ensures that the prescription cannot be refilled by that pharmacy.

     (Added to NAC by Bd. of Pharmacy by R155-04, eff. 12-20-2004)

      NAC 639.715  Mechanical devices: Restrictions on use. (NRS 639.070, 639.2655)  No drug, controlled substance, medicine, chemical or poison, as those terms are defined in chapters 453, 454 and 639 of NRS, may be sold or offered for sale or dispensed by means of any mechanical device except as otherwise provided in NAC 639.718 and 639.720.

     [Bd. of Pharmacy, § 639.315, eff. 6-26-80]—(NAC A by R038-07, 10-31-2007)

      NAC 639.718  Mechanical devices: Use by pharmacy to furnish prescription drugs to patients. (NRS 639.070, 639.2655)

     1.  Except as otherwise provided in this section, a pharmacy may use a mechanical device to furnish a prescription drug to a patient. The device must conform to all of the following provisions:

     (a) The device must contain only prescription drugs:

          (1) For which counseling is not required pursuant to NAC 639.707; and

          (2) For which the prescriptions have been processed, verified and completed in the same manner as prescriptions for drugs that are delivered manually by the pharmacy, including the provision of printed medication guides and any other information required pursuant to NAC 639.707.

     (b) The device must not contain controlled substances included in schedule II.

     (c) The device must be designed to ensure that the device:

          (1) Is located such that access to the device:

               (I) For stocking, cleaning, maintenance or any other purpose can be obtained only by a pharmacist or a member of the staff of the pharmacy from within a secured area of the pharmacy; and

               (II) Is secure from unauthorized access to and removal of prescription drugs from the device.

          (2) Records the name of each person at the pharmacy who authorizes access to the device.

          (3) Cannot be used by a patient:

               (I) Outside the physical location of the pharmacy.

               (II) Unless the patient previously has indicated to the pharmacy that the patient desires that his or her prescription drugs be furnished by the mechanical device.

          (4) Provides a method to identify the patient and furnishes a prescription drug only to the patient or to an authorized agent of the patient.

          (5) Can furnish one, any combination or all of the prescription drugs available to a patient at the option of the patient at the time that the patient removes the prescription drugs from the device.

          (6) Records the date and time that the patient removes the prescription drugs from the device.

          (7) Informs a patient:

               (I) That a prescription drug is not available to be furnished by the device if the pharmacist wishes to counsel the patient regarding the prescription drug.

               (II) If the patient is using the device at the time that the pharmacy is open, that the patient may discuss questions and concerns regarding the prescription drug with a pharmacist at the pharmacy.

               (III) If the patient is using the device at the time that the pharmacy is closed, that the patient may discuss questions and concerns regarding the prescription drug using a toll-free telephone number at which a pharmacist at a pharmacy licensed by the Board will respond at all hours when the pharmacy at which the device is located is closed. A pharmacist who responds to questions or concerns pursuant to this sub-subparagraph must have access by computer to the same information regarding the patient that a pharmacist would have using the computer system of the pharmacy at which the device is located.

     2.  A pharmacy shall not use a mechanical device to furnish a prescription drug to a patient until the pharmacy has notified the Board in writing of:

     (a) The type of device that will be used; and

     (b) The anticipated date that the device will first be used.

     3.  The Board may prohibit a pharmacy from using a mechanical device to furnish a prescription drug to a patient if the Board determines that the device or the pharmacy’s use of the device does not comply with this section.

     4.  The provisions of this section do not prohibit the use of a mechanical device to furnish a drug or device that is approved by the Food and Drug Administration for sale over the counter without a prescription if the pharmacy using the mechanical device is otherwise authorized to use the mechanical device pursuant to this section.

     (Added to NAC by Bd. of Pharmacy by R038-07, eff. 10-31-2007)

      NAC 639.720  Mechanical devices: Use to furnish drugs and medicines for administration to registered patients in medical facility and to patients receiving treatment in emergency room of hospital. (NRS 639.070, 639.2655)

     1.  Except as otherwise provided in subsections 4 and 6, a mechanical device may be used to furnish drugs and medicines for administration to registered patients in a medical facility. The device must conform to all the following provisions:

     (a) All drugs and medicines stocked in the device must be approved for use in the device by a registered pharmacist employed by the:

          (1) Medical facility in which the drug or medicine is administered; or

          (2) Pharmacy that supplies the medical facility in which the drug or medicine is administered.

     (b) Access to the device must be:

          (1) Limited to pharmaceutical technicians, pharmaceutical technicians in training, intern pharmacists, registered pharmacists, licensed practical nurses, registered nurses or other practitioners who are:

               (I) Authorized by law to prescribe or administer controlled substances, poisons, or dangerous drugs and devices; and

               (II) Employed by the medical facility or pharmacy that supplies the medical facility.

          (2) Monitored and controlled by the pharmacy which supplies the medical facility or the registered pharmacist who is employed by the medical facility.

     (c) Each container of a drug or medicine stored in the device must be labeled in a manner which includes the information required pursuant to subsection 2 of NAC 639.476.

     (d) The device must be designed in such a manner that:

          (1) Each time a person obtains access to the device, the device automatically prepares a record which is readily retrievable and which includes:

               (I) The name, strength, quantity and form of dosage of the drug or medicine which is stocked, inventoried or removed for administration to a patient;

               (II) The day and time access to the device is obtained;

               (III) If a drug or medicine is removed for administration to a patient, the name of the patient;

               (IV) An inventory of the drugs and medicines stored in the device; and

               (V) The name of the person who obtained access to the device.

          (2) Access to the device may be obtained only by a person with the use of a code which identifies that person.

     2.  A pharmacy which supplies drugs and medicines to a medical facility which are furnished by a mechanical device pursuant to subsection 1 shall maintain a written policy which sets forth:

     (a) The duties of all persons who are authorized to obtain access to the device; and

     (b) The procedure for:

          (1) Maintaining the security of the drugs and medicines stored in the device during the maintenance and repair of the device;

          (2) The preparation of an inventory of the drugs and medicines stored in the device; and

          (3) Stocking the device with drugs and medicines.

     3.  A pharmacy which supplies drugs or medicines to a medical facility which uses a mechanical device to furnish drugs or medicines for administration to patients pursuant to subsection 1 shall provide written notice to the Board. The notice must include:

     (a) A description of each mechanical device used by the medical facility to furnish drugs or medicines for administration to patients, including, without limitation, the name of the manufacturer of the device; and

     (b) The address of the medical facility at which the mechanical device is located.

     4.  A pharmacy shall not stock a mechanical device with drugs or medicines and a mechanical device must not be used to furnish drugs or medicines for administration to patients until:

     (a) The pharmacy has notified the Board as required by subsection 3; and

     (b) The Board has issued a certificate to the pharmacy that authorizes the use of the mechanical device at the medical facility at which the mechanical device is located.

     5.  Each medical facility that uses a mechanical device pursuant to subsection 1 must make and maintain a record of any waste of a controlled substance in the manner provided in NAC 639.486. The record of any waste of a controlled substance may be prepared:

     (a) By the mechanical device if the mechanical device is capable of making and maintaining such a record and documenting the record of the waste being witnessed by another person as provided in paragraph (g) of subsection 1 of NAC 639.486; or

     (b) As a written record.

     6.  A mechanical device may be used to furnish drugs and medicines for a patient receiving treatment in the emergency room of a hospital. The device must conform to all the following provisions:

     (a) All drugs and medicines stocked in the device must be approved for use in the device by a registered pharmacist employed by or contracted with the:

          (1) Hospital in which the drug or medicine is furnished; or

          (2) Pharmacy that supplies the hospital in which the drug or medicine is furnished.

     (b) Access to the device for the purposes of stocking, inventory and monitoring must be limited to pharmaceutical technicians, pharmaceutical technicians in training, intern pharmacists or registered pharmacists employed by the hospital or the pharmacy that supplies the hospital.

     (c) Use of the device to furnish a drug or medicine to a patient must be:

          (1) By a practitioner who:

               (I) Is authorized by law to prescribe controlled substances or dangerous drugs;

               (II) Is employed by or who has privileges at the hospital;

               (III) Prescribed the drug or medicine that is furnished to the patient;

               (IV) Personally verifies the correctness of the prescription for the drug or medicine before he or she furnishes it to the patient; and

               (V) Has offered to the patient the choice of being provided a prescription that may be filled at a pharmacy, which offer first must be declined by the patient before the prescription is transmitted to the mechanical device to fill and furnish the prescription; or

          (2) By the patient where:

               (I) The device requires from the patient a unique code known only to the patient to allow the patient to access the device; and

               (II) The patient is notified by the device that he or she may choose not to purchase the drug or medicine from the device at any time before the device furnishes the drug or medicine.

     (d) Each container of a drug or medicine dispensed by the device is labeled pursuant to NRS 639.2801.

     (e) The device must be designed in such a manner that:

          (1) Each time a person obtains access to the device, the device automatically prepares a record which is readily retrievable and which includes:

               (I) The name, strength, quantity and form of dosage of the drug or medicine which is stocked, inventoried or removed for dispensing to a patient;

               (II) The day and time access to the device is obtained;

               (III) If a drug or medicine is removed for dispensing to a patient, the name of the patient;

               (IV) An inventory of the drugs and medicines stored in the device; and

               (V) The name of the person who obtained access to the device.

          (2) Access to the device may be obtained only by a person with the use of a unique code which identifies that person.

     (f) The device must be located in such a place and manner that a person is unable to remove it from the hospital, and that attempts to obtain access to the device without authorization are visible to employees of the hospital.

     (g) Before the device is used to furnish a drug or medicine directly to a patient pursuant to paragraph (c), the manufacturer of the device must appear before the Board for its approval of that use of the device and submit evidence satisfactory to the Board that the device:

          (1) Furnishes drugs and medicines accurately; and

          (2) Otherwise satisfies the provisions of this subsection.

     7.  As used in this section, “medical facility” has the meaning ascribed to it in NRS 449.0151.

     [Bd. of Pharmacy, § 639.320, eff. 6-26-80]—(NAC A 12-21-95; 5-20-96; R017-03, 10-21-2003; R043-07, 10-31-2007)

      NAC 639.725  Use of mechanical counting device for dispensing medication to be taken orally. (NRS 639.070, 639.2655, 639.2801)

     1.  A mechanical counting device that is used by a pharmacy for dispensing medication to be taken orally must use one of the following methods to identify the contents of the device:

     (a) The following information must be affixed to the front of each cell of the device:

          (1) The generic name or trade name of the medication;

          (2) The manufacturer of the medication;

          (3) The strength of the medication;

          (4) The expiration date of the medication;

          (5) The lot number of the medication;

          (6) The date on which the pharmacist last placed the medication into the device; and

          (7) The initials of the pharmacist who:

               (I) Placed the medication into the device; or

               (II) Verified the correctness of the drug placed into the device when the drug was placed by a pharmaceutical technician, a pharmaceutical technician in training or an intern pharmacist; or

     (b) A label that shows the generic name or trade name and the strength of the medication must be affixed to each cell of the device and a log must be kept for each cell which contains:

          (1) An identification of the cell by the name of the medication or the number of the cell;

          (2) The name of the manufacturer of the medication;

          (3) The expiration date of the medication;

          (4) The lot number of the medication;

          (5) The amount of the medication placed in the device;

          (6) The date on which the pharmacist last placed the medication into the device; and

          (7) The initials of the pharmacist who:

               (I) Placed the medication into the device; or

               (II) Verified the correctness of the drug placed into the device when the drug was placed by a pharmaceutical technician, a pharmaceutical technician in training or an intern pharmacist.

     2.  A record of any drug placed into a mechanical counting device must be maintained either electronically or manually for not less than 2 years and must include, without limitation, the information listed in paragraph (b) of subsection 1.

     3.  The Board may prohibit a pharmacy from using a mechanical counting device for dispensing medication to be taken orally if the pharmacy does not identify the contents of the device in accordance with the provisions of subsection 1.

     (Added to NAC by Bd. of Pharmacy, eff. 3-17-92; A by R039-06, 5-4-2006; R186-12, 2-20-2013)

      NAC 639.730  Inspection of damaged pharmaceuticals. (NRS 639.070)  After a fire or other catastrophe in which pharmaceutical preparations, devices or appliances are damaged, the owner, operator or manager of the pharmacy shall not dispose of the damaged merchandise to any other person, until it has first been inspected and declared safe by the Board. If, in the opinion of the Board, such preparations, appliances or devices are unsafe or unfit for use, they must be destroyed.

     [Bd. of Pharmacy, § 639.310, eff. 6-26-80]

      NAC 639.740  Container for dispensing prescribed medicine. (NRS 639.070)  Except for a hospital pharmacy for inpatients or in a facility for skilled nursing or a facility for extended care, all prescribed medicine must be dispensed in a container which is designed to prevent a child from opening it, if commercially available, unless the person to whom the medication is dispensed:

     1.  Is at least 18 years of age;

     2.  Specifically requests a container which is not so designed; and

     3.  Signs a document verifying that he or she made such a request.

     (Added to NAC by Bd. of Pharmacy, eff. 10-17-86)

      NAC 639.742  Dispensing of controlled substances or dangerous drugs: Application by practitioner for certificate of registration; application by facility required under certain circumstances; duties of dispensing practitioner and facility relating to drugs; authority of dispensing practitioner and technician. (NRS 639.070, 639.0727)

     1.  A practitioner who wishes to dispense controlled substances or dangerous drugs must apply to the Board on an application provided by the Board for a certificate of registration to dispense controlled substances or dangerous drugs. A practitioner must submit a separate application for each site of practice, including, without limitation, a remote site, from which the practitioner wishes to dispense controlled substances or dangerous drugs. A certificate of registration to dispense controlled substances or dangerous drugs is a revocable privilege, and no holder of such a certificate of registration acquires any vested right therein or thereunder.

     2.  If a facility from which the practitioner intends to dispense dangerous drugs or controlled substances is not wholly owned and operated by the practitioner, the owner or owners of the facility must also submit an application to the Board on a form provided by the Board.

     3.  Except as otherwise provided in NRS 639.23277 and NAC 639.395, the dispensing practitioner and, if applicable, the owner or owners of the facility, shall ensure that:

     (a) All drugs are ordered by the dispensing practitioner;

     (b) All drugs are received and accounted for by the dispensing practitioner;

     (c) All drugs are stored in a secure, locked room or cabinet to which the dispensing practitioner has the only key or lock combination;

     (d) All drugs are dispensed in accordance with NAC 639.745;

     (e) No prescription is dispensed to a patient unless the dispensing practitioner is on-site at the facility;

     (f) All drugs are dispensed only to the patient personally at the facility;

     (g) The price of each drug dispensed to a patient is separately itemized on any bill or statement provided to the patient;

     (h) All drugs are dispensed only for medically necessary purposes and according to prevailing standards of care for practitioners practicing in the specialty claimed or practiced by the dispensing practitioner; and

     (i) The certificate for each dispensing technician employed at the facility is displayed in the room or cabinet in which drugs are stored.

     4.  With regard to the filling and dispensing of a prescription at a facility, only the dispensing practitioner or a dispensing technician may:

     (a) Enter the room or cabinet in which drugs are stored;

     (b) Remove drugs from stock;

     (c) Count, pour or reconstitute drugs;

     (d) Place drugs into containers;

     (e) Produce and affix appropriate labels to containers that contain or will contain drugs;

     (f) Fill containers for later use in dispensing drugs; or

     (g) Package or repackage drugs.

     5.  A dispensing practitioner may compound drug products if he or she complies with the provisions of NAC 639.661 to 639.690, inclusive, as if:

     (a) He or she were a pharmacist;

     (b) His or her practice site was a pharmacy; and

     (c) Any dispensing technician involved in the compounding was a pharmaceutical technician.

     (Added to NAC by Bd. of Pharmacy by R034-02, eff. 5-30-2003; A by R035-06, 9-18-2008; R037-10, 10-15-2010)

      NAC 639.7425  Dispensing technician: Requirements; application and fee for registration; provisional registration; issuance of certificate of registration. (NRS 639.070)

     1.  No person may act as a dispensing technician unless the person is:

     (a) A registered pharmaceutical technician; or

     (b) Employed at a facility to which a certificate of registration has been issued pursuant to NAC 639.742 and the dispensing practitioner at that facility has registered the person as a dispensing technician.

     2.  A dispensing practitioner may apply to the Board to register a person as a dispensing technician by submitting to the Board the fee required by NAC 639.744 and proof satisfactory to the Board that the person:

     (a) Is 18 years of age or older;

     (b) Has received a high school diploma or its equivalent;

     (c) Has not been convicted of any felony or misdemeanor involving moral turpitude, dishonesty or the unlawful possession, sale or use of drugs; and

     (d) Does not have a history of drug abuse.

     3.  Upon determining that a person for whom application for registration as a dispensing technician has been made by a dispensing practitioner satisfies the requirements of subsection 2, the Board will issue to the person a provisional registration as a dispensing technician for that practitioner.

     4.  A person acting as a dispensing technician pursuant to a provisional registration must complete at least 500 hours of training and experience provided by the dispensing practitioner relating to the skills that the person will be performing as a dispensing technician for that dispensing practitioner. Only that training and experience received by the person after the provisional registration is issued may be applied to satisfy the 500-hour requirement. In providing the training and experience, the dispensing practitioner shall supervise the training and experience of the person by observing the work of the person on a random basis at least three times each day during which the person is receiving training and experience.

     5.  A provisional registration issued to a person acting as a dispensing technician expires 12 months after it is issued or upon the expiration of the certificate of registration of the dispensing practitioner to whom the dispensing technician is registered, whichever is earlier. If a person acting as a dispensing technician pursuant to a provisional registration:

     (a) Fails to complete the required 500 hours of training and experience before the expiration of the provisional registration, the person shall not act as a dispensing technician unless he or she is issued a new provisional registration pursuant to this section. Any hours of training and experience completed by the person while acting as a dispensing technician pursuant to a provisional registration that has expired may not be used to satisfy the 500-hour requirement for a new provisional registration.

     (b) Completes the required 500 hours of training and experience before the expiration of the provisional registration, the dispensing practitioner shall file with the Board a signed affidavit certifying:

          (1) The number of hours of training and experience successfully completed by the person.

          (2) The specific training and experience received by the person.

          (3) That the person is, in the opinion of the dispensing practitioner, competent to perform the duties of a dispensing technician.

     6.  The Board, upon receiving the affidavit of the dispensing practitioner pursuant to subsection 5, will issue to the person a certificate of registration as a dispensing technician for that practitioner.

     (Added to NAC by Bd. of Pharmacy by R034-02, eff. 5-30-2003; A by R048-07, 12-4-2007)

      NAC 639.743  Dispensing technician: Access to drugs; performance of functions. (NRS 639.070, 639.0727)

     1.  Except as otherwise provided in NRS 639.23277 and NAC 639.395, a person to whom a dispensing practitioner is providing training and experience pursuant to subsection 4 of NAC 639.7425 must not be allowed access to the room or cabinet in which drugs are stored unless accompanied by the dispensing practitioner. After the person has completed his or her training and experience and the Board has received an affidavit from the dispensing practitioner pursuant to subsection 5 of NAC 639.7425:

     (a) The person may access the room or cabinet in which drugs are stored without being accompanied by the dispensing practitioner, so long as the dispensing practitioner is on-site at the facility; and

     (b) The dispensing practitioner is not required to observe the work of the person.

     2.  A dispensing practitioner who allows a dispensing technician to perform any function described in subsection 4 or 5 of NAC 639.742 is responsible for the performance of that function by the dispensing technician. All such functions performed by a dispensing technician must be performed at the express direction and delegation of the dispensing practitioner. Each prescription with respect to which a dispensing technician performed such a function:

     (a) Must be checked by the dispensing practitioner, and the dispensing practitioner shall indicate on the label of the prescription and in his or her record regarding the prescription that the dispensing practitioner has checked the work performed by the dispensing technician; and

     (b) Must not be dispensed to the patient without the initials of the dispensing practitioner thereon. A prescription which has been so initialed must be handed to the patient only by the dispensing practitioner or an employee authorized by the dispensing practitioner.

     (Added to NAC by Bd. of Pharmacy by R034-02, eff. 5-30-2003; A by R048-07, 12-4-2007; R035-06, 9-18-2008; R037-10, 10-15-2010)

      NAC 639.7435  Dispensing technician: Transferability, expiration and termination of registration; notice of change of address of employment; subsequent employment. (NRS 639.070, 639.0727)

     1.  The registration of a dispensing technician is nontransferable and limited to the dispensing practitioner to whom the dispensing technician is registered. The registration of a dispensing technician expires at the same time that the certificate of registration of the dispensing practitioner expires. If a dispensing practitioner and the dispensing technician registered to that practitioner leave the facility at which they are registered, and the dispensing technician continues his or her employment with that practitioner at a different site, the dispensing practitioner shall, as soon as practicable, notify the Board of the change of address of employment of the dispensing technician.

     2.  If a dispensing technician no longer works as a dispensing technician for the dispensing practitioner to whom the dispensing technician is registered, the registration of the dispensing technician terminates. If that person is subsequently employed by another dispensing practitioner to work as a dispensing technician, the employing dispensing practitioner must, before the person may act as a dispensing technician for that practitioner:

     (a) Register the person with the Board, showing the site of employment and the name of the dispensing practitioner; and

     (b) Ensure that the person receives an additional 200 hours of training and experience provided by the dispensing practitioner. The additional training and experience must be provided in accordance with subsection 4 of NAC 639.7425. Except as otherwise provided in NRS 639.23277 and NAC 639.395, the dispensing practitioner shall not allow the person to be registered as a dispensing technician to enter the room or cabinet in which drugs are stored or perform any function described in subsection 4 or 5 of NAC 639.742 without the dispensing practitioner observing the act by the person to be registered as a dispensing technician until that person has completed the 200 additional hours of training and experience.

     (Added to NAC by Bd. of Pharmacy by R034-02, eff. 5-30-2003; A by R048-07, 12-4-2007; R035-06, 9-18-2008; R037-10, 10-15-2010)

      NAC 639.744  Dispensing practitioner: Fee for initial registration and renewal; registration of multiple dispensing technicians. (NRS 639.070, 639.0727)

     1.  A dispensing practitioner shall pay to the Board a fee of $40 for each dispensing technician whom that practitioner registers:

     (a) At the time of application by the dispensing practitioner for initial registration of the person as a dispensing technician; and

     (b) With the practitioner’s renewal thereafter as a part of and in addition to the practitioner’s renewal of his or her registration as a dispensing practitioner.

     2.  A dispensing practitioner may register more than one dispensing technician at a time, except that only one of those dispensing technicians, including, without limitation, a dispensing technician staffing a remote site, may be designated and allowed to perform the functions described in subsection 4 or 5 of NAC 639.742 at one time. A dispensing practitioner shall make and maintain a document on which must be recorded for each day the name of the dispensing technician so designated and allowed to perform the functions described in subsection 4 or 5 of NAC 639.742, and maintain the record for not less than 2 years.

     (Added to NAC by Bd. of Pharmacy by R034-02, eff. 5-30-2003; A by R035-06, 9-18-2008; R037-10, 10-15-2010)

      NAC 639.7445  Dispensing practitioner: Disciplinary action for violation of NAC 639.742 to 639.7445, inclusive. (NRS 639.070)  If a dispensing practitioner allows any person to perform any act in violation of NAC 639.742 to 639.7445, inclusive, the dispensing practitioner is subject to discipline relating to his or her registration as a dispensing practitioner, including, without limitation, the temporary and immediate suspension of his or her registration as a dispensing practitioner until:

     1.  The violation is remedied; or

     2.  If an accusation has been made pursuant to NRS 639.241, the Board holds a hearing.

     (Added to NAC by Bd. of Pharmacy by R034-02, eff. 5-30-2003)

      NAC 639.745  Duties of certain practitioners concerning dispensing of controlled substances and dangerous drugs. (NRS 639.070, 639.0727)

     1.  Each practitioner who is registered with the Board to dispense controlled substances and dangerous drugs, including, without limitation, a dispensing practitioner, and who dispenses such products for use by the practitioner’s patients outside his or her presence shall:

     (a) Keep complete, accurate and readily retrievable records of each controlled substance and dangerous drug purchased and dispensed. The record for each such product dispensed to a patient must include:

          (1) The name of the patient and, if not readily available from the practitioner’s records, the patient’s address;

          (2) The name, strength and quantity of the prescribed controlled substance or dangerous drug;

          (3) The directions for use;

          (4) The date the prescription was issued; and

          (5) A unique identifying number.

     (b) Maintain a separate file for the records concerning the purchase of each controlled substance listed in schedule II and a separate file for the records concerning the dispensing of each controlled substance listed in schedule II. Each prescription for a controlled substance or dangerous drug must be maintained in a separate file pursuant to the requirements set forth in NAC 453.480.

     (c) Keep all controlled substances and dangerous drugs in a locked storage area. Access to the storage area must be restricted to the persons described in NRS 453.375.

     (d) Ensure that each package or container in which a controlled substance is dispensed, except samples in the manufacturer’s packages, is clearly labeled pursuant to the requirements set forth in NRS 639.2801.

     (e) Ensure that the package or container in which a controlled substance or dangerous drug is dispensed complies with all state and federal packaging requirements.

     (f) Be deemed to be a pharmacy as that term is used in NAC 639.926 and shall comply with that section.

     2.  A practitioner may dispense dangerous drugs or controlled substances only after the patient has been informed by the practitioner that the patient may request a written prescription and have it filled at another location of the patient’s choosing.

     3.  A record regarding the dispensing of a controlled substance or dangerous drug made and kept pursuant to this section must be maintained on paper or in a computer. If the record is:

     (a) Maintained on paper, the record must:

          (1) Include all the information required to be on the prescription pursuant to NRS 639.2353 and NAC 453.440;

          (2) Set forth on the front of the prescription a certification initialed and dated by the patient that the patient has been informed by the practitioner in accordance with subsection 2 and that the patient has agreed to have the practitioner dispense the controlled substance or dangerous drug; and

          (3) Be serially numbered and kept in numerical order in a single file for all dispensing practitioners, including, without limitation, physician assistants and advanced practitioners of nursing, practicing at the same location.

     (b) Maintained in a computer, the record must:

          (1) Include all the information required to be on the prescription pursuant to NRS 639.2353 and NAC 453.440;

          (2) Contain a certification, either in the computer or a separate paper document, initialed and dated by the patient that the patient has been informed by the practitioner in accordance with subsection 2 and that the patient has agreed to have the practitioner dispense the controlled substance or dangerous drug; and

          (3) Be searchable for any item required by paragraph (a) of subsection 1 to be included in the record.

     (Added to NAC by Bd. of Pharmacy, eff. 2-6-90; A by R034-02, 5-30-2003; R157-04, 10-22-2004; R037-10, 10-15-2010)

      NAC 639.748  Identification of person to whom controlled substance is dispensed. (NRS 639.070)

     1.  Except as otherwise provided in this section, an employee of a pharmacy who is authorized to dispense controlled substances shall, before dispensing a controlled substance pursuant to a lawful prescription, request the person to whom the controlled substance will be dispensed to present a current form of identification issued by a federal, state or local governmental agency that contains a photograph of the person. The employee shall not dispense the controlled substance if:

     (a) That person does not present such identification; or

     (b) The employee reasonably believes that the identification presented has been altered or is false or otherwise invalid.

     2.  The provisions of subsection 1 do not apply if:

     (a) The prescription is paid for, in whole or in part, by an insurer;

     (b) The prescription is for a patient who has had a prescription for the same controlled substance previously filled by the pharmacy; or

     (c) The pharmacy is a part of the health care facility where the patient is being treated.

     3.  The employee shall:

     (a) Make a photocopy of the identification presented to the employee; or

     (b) Record the full name of the person to whom the controlled substance is dispensed and the identification number indicated on his or her identification, if any, on the prescription, the refill log, the counseling log, a computer record related to the patient or any other document that is readily retrievable.

     4.  If a photocopy of the identification is made pursuant to paragraph (a) of subsection 3, it must be filed with the copy of the prescription that is maintained by the pharmacy.

     (Added to NAC by Bd. of Pharmacy by R146-03, eff. 4-8-2004)

      NAC 639.750  Dispensing of medication at certain locations when local retail pharmacy is closed. (NRS 639.070)

     1.  If the services of a local retail pharmacy are not available, the practitioner in charge of the emergency room of a hospital or of a surgical center for ambulatory patients may dispense medication in an amount adequate to treat patients in the emergency room or surgical center for ambulatory patients during the hours that the local retail pharmacy is closed.

     2.  If a practitioner dispenses medication at the emergency room of a hospital or at a surgical center for ambulatory patients:

     (a) The following information must be maintained for each medication dispensed:

          (1) The name of the patient and, if not readily available from the records of the hospital, the address of the patient;

          (2) The name, strength and quantity of the medication;

          (3) The name of the prescribing practitioner and the classification of his or her license;

          (4) The registration number of the prescribing practitioner that is issued by the Drug Enforcement Administration of the United States Department of Justice, if the medication is a controlled substance;

          (5) The signature of the practitioner who dispenses the medication;

          (6) The directions for using the medication;

          (7) The date the medication is dispensed; and

          (8) The signature of the prescribing practitioner.

     (b) The medication must be dispensed in a container in accordance with NAC 639.740.

     (c) A label that contains the following information must be affixed to the container:

          (1) The date;

          (2) The name of the prescribing practitioner;

          (3) The name of the patient;

          (4) The number of dosage units;

          (5) Specific directions for use;

          (6) The expiration date of the medication;

          (7) The proprietary or generic name of the medication;

          (8) The strength of the medication;

          (9) The initials of the practitioner who dispenses the medication; and

          (10) The following warning:

 

Caution: Do not use with alcohol or nonprescription drugs without consulting the prescribing practitioner.

 

     (Added to NAC by Bd. of Pharmacy, eff. 3-17-92; A 10-24-97)

      NAC 639.751  Requirements concerning signatures or initials to be placed on prescription. (NRS 639.070)

     1.  Except as otherwise provided in subsection 4, if the signature or initials of a pharmacist or pharmaceutical technician are required to be placed on a prescription by a provision of chapter 453 or 639 of NRS or any regulations adopted pursuant thereto, the signature or initials must be:

     (a) Handwritten:

          (1) In nonerasable ink;

          (2) Personally by the pharmacist or pharmaceutical technician who is identified by the signature or initials;

          (3) Contemporaneously with the act for which the signature or initials are required; and

          (4) On the document on which the signature or initials are required; or

     (b) Entered into a record in a computer system used by the pharmacy if the computer system:

          (1) Makes and retains a record which:

               (I) Documents the date and time at which the signature or initials are entered; and

               (II) Cannot be modified or deleted; and

          (2) Uses a method which ensures that the signature or initials accurately depict the identity of the person entering the signature or initials, including, without limitation:

               (I) Biometric identification;

               (II) A bar code, magnetic strip, radio frequency chip or other similar technology; or

               (III) A personal identification number, password or other similar type of unique code.

     2.  Any signature or initials entered into a record in a computer system relating to the processing, filling or refilling of a prescription that are not required to be entered by a provision of chapter 453 or 639 of NRS or any regulations adopted pursuant thereto must comply with the requirements of subsection 1.

     3.  A written record of a refill of a prescription pursuant to NAC 639.918 is not required for a prescription refilled by a pharmacist who enters his or her signature or initials onto a record of the refill in a computer system pursuant to subsection 1. The provisions of this subsection must not be construed to exempt a pharmacy from the recordkeeping requirements of NRS 639.2392.

     4.  A signature or initials required for the following acts must be handwritten:

     (a) The sale of any Schedule “A” poison, as defined in NRS 454.010;

     (b) The dispensing or selling of procaine hydrochloride with preservatives and stabilizers (Gerovital H3) pursuant to NRS 639.2845;

     (c) The receipt of in-service training as a pharmaceutical technician pursuant to NAC 639.254; and

     (d) The changing of the written policies and procedures relating to the operation of a pharmacy by the managing pharmacist pursuant to NAC 639.941.

     (Added to NAC by Bd. of Pharmacy by R050-07, eff. 12-17-2008)

      NAC 639.752  Restrictions on filling or dispensing certain prescriptions. (NRS 639.070)

     1.  Except as otherwise provided in this section and NRS 639.235, a pharmacist shall not fill a prescription for, or dispense, a dangerous drug or a controlled substance if the prescription is:

     (a) Written by a practitioner who is not licensed to practice in this State, but is authorized by the laws of another state to prescribe;

     (b) For a patient who resides in a state other than the state in which the prescribing practitioner’s practice is located;

     (c) Requested to be furnished in a manner other than by dispensing directly to the patient, or an agent of the patient, in person; and

     (d) To be paid for in full, in cash or cash equivalent, at the time the prescription is dispensed,

Ê unless the pharmacist first verifies the prescription as set forth in subsection 2.

     2.  A pharmacist who verifies a prescription pursuant to this section must:

     (a) Speak with the patient or the prescribing practitioner;

     (b) Establish that:

          (1) The prescription is authentic; and

          (2) A bona fide relationship between the patient and the prescribing practitioner did exist when the prescription was written; and

     (c) Record on the prescription or in the prescription record in the pharmacy’s computer:

          (1) The name of the person with whom the pharmacist spoke concerning the prescription;

          (2) The date and time of the conversation; and

          (3) The date and time the patient was examined by the prescribing practitioner.

     3.  Subsection 1 does not apply to a pharmacist who refills a prescription he or she has previously filled if the pharmacist verified the prescription before filling it the first time.

     4.  For the purposes of this section, a bona fide relationship between the patient and the prescribing practitioner shall be deemed to exist:

     (a) If the patient was physically examined by the practitioner within the 6 months immediately preceding the date the prescription was issued; or

     (b) If the patient is incarcerated in a local correctional institution or a facility or institution operated by the Department of Corrections and was examined through the use of a telephone or a videoconferencing system by a practitioner who is a physician licensed pursuant to chapter 630 or 633 of NRS and:

          (1) The medical history of the patient is available to the physician;

          (2) A nurse or an advanced practitioner of nursing licensed pursuant to chapter 632 of NRS or a physician assistant licensed pursuant to chapter 630 or 633 of NRS is physically present with the patient when the physician examines the patient and that nurse, advanced practitioner of nursing or physician assistant is trained in the use of the telephone or videoconferencing system; and

          (3) The physician enters the results of the examination into the medical chart of the patient that is maintained by the local correctional institution or the facility or institution operated by the Department of Corrections.

     5.  As used in this section:

     (a) “Cash equivalent” includes, without limitation:

          (1) A check;

          (2) A credit card;

          (3) A draft;

          (4) An electronic funds transfer; and

          (5) A prescription drug discount card or other device obtained pursuant to the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, Public Law 108-173, or any regulations adopted pursuant thereto.

     (b) “Local correctional institution” has the meaning ascribed to it in NAC 211.070.

     (Added to NAC by Bd. of Pharmacy by R112-99, eff. 11-3-99; A by R156-04, 10-22-2004; R212-09, 8-13-2010)

      NAC 639.753  Declination of pharmacist to fill prescription. (NRS 639.070)

     1.  A pharmacist may decline to fill a prescription that satisfies the requirements of this chapter and chapter 639 of NRS only if the pharmacist reasonably believes, in his or her professional judgment, that:

     (a) The filling of the prescription would be unlawful;

     (b) The filling of the prescription would be imminently harmful to the medical health of the patient;

     (c) The prescription is fraudulent; or

     (d) The prescription is not for a legitimate medical purpose.

     2.  If a pharmacist declines to fill a prescription pursuant to this section, the pharmacist shall speak with the prescribing practitioner in a timely manner to discuss and resolve the concerns of the pharmacist regarding the prescription. Before the pharmacist speaks with the prescribing practitioner, the pharmacist may, based on his or her professional judgment:

     (a) Retain the prescription and not return the prescription to the patient;

     (b) Return the prescription to the patient;

     (c) Make a photocopy of the prescription and return the prescription to the patient; and

     (d) Unless the prescription is for a controlled substance that is listed in schedule II, dispense a quantity of the drug