[Rev. 11/21/2013 11:51:04 AM--2013]

CHAPTER 453B - DRUG DONATION PROGRAMS

HIV/AIDS DRUG DONATION PROGRAM

NRS 453B.010        Definitions. [Effective October 1, 2014.]

NRS 453B.020        “Board” defined. [Effective October 1, 2014.]

NRS 453B.030        “HIV/AIDS drug” defined. [Effective October 1, 2014.]

NRS 453B.040        “Medical facility” defined. [Effective October 1, 2014.]

NRS 453B.050        “Pharmacy” defined. [Effective October 1, 2014.]

NRS 453B.060        “Program” defined. [Effective October 1, 2014.]

NRS 453B.070        “Provider of health care” defined. [Effective October 1, 2014.]

NRS 453B.080        Establishment of Program; handling fee; conditions for acceptance, distribution and dispensing of donated drugs; certain restrictions. [Effective October 1, 2014.]

NRS 453B.090        Maintenance and content of records; storage of HIV/AIDS drugs. [Effective October 1, 2014.]

NRS 453B.100        Dispensing of donated drug. [Effective October 1, 2014.]

NRS 453B.110        Compliance with applicable laws; authority to distribute donated drug to another participant in Program. [Effective October 1, 2014.]

NRS 453B.120        Regulations. [Effective October 1, 2014.]

NRS 453B.130        Limitation on civil and criminal liability; limitation on disciplinary action by professional licensing board; waiver of liability. [Effective October 1, 2014.]

CANCER DRUG DONATION PROGRAM

NRS 453B.150        Definitions.

NRS 453B.160        “Cancer drug” defined.

NRS 453B.170        “Medical facility” defined.

NRS 453B.180        “Program” defined.

NRS 453B.190        “Provider of health care” defined.

NRS 453B.200        Establishment of Program; handling fee; conditions for acceptance, distribution and dispensing of donated drugs; certain restrictions.

NRS 453B.210        Dispensing of donated drug.

NRS 453B.220        Compliance with applicable laws; authority to distribute donated drug to another participant in Program.

NRS 453B.230        Regulations.

NRS 453B.240        Limitation on civil and criminal liability; limitation on disciplinary action by professional licensing board.

_________

HIV/AIDS DRUG DONATION PROGRAM

      NRS 453B.010  Definitions. [Effective October 1, 2014.]  As used in NRS 453B.010 to 453B.130, inclusive, unless the context otherwise requires, the words and terms defined in NRS 453B.020 to 453B.070, inclusive, have the meanings ascribed to them in those sections.

      (Added to NRS by 2013, 2257, effective October 1, 2014)

      NRS 453B.020  “Board” defined. [Effective October 1, 2014.]  “Board” means the State Board of Pharmacy.

      (Added to NRS by 2013, 2257, effective October 1, 2014)

      NRS 453B.030  “HIV/AIDS drug” defined. [Effective October 1, 2014.]  “HIV/AIDS drug” means a prescription drug that is used to treat the human immunodeficiency virus or acquired immunodeficiency syndrome.

      (Added to NRS by 2013, 2257, effective October 1, 2014)

      NRS 453B.040  “Medical facility” defined. [Effective October 1, 2014.]  “Medical facility” has the meaning ascribed to it in NRS 449.0151.

      (Added to NRS by 2013, 2257, effective October 1, 2014)

      NRS 453B.050  “Pharmacy” defined. [Effective October 1, 2014.]  “Pharmacy” has the meaning ascribed to it in NRS 639.012.

      (Added to NRS by 2013, 2257, effective October 1, 2014)

      NRS 453B.060  “Program” defined. [Effective October 1, 2014.]  “Program” means the HIV/AIDS Drug Donation Program established pursuant to NRS 453B.080.

      (Added to NRS by 2013, 2257, effective October 1, 2014)

      NRS 453B.070  “Provider of health care” defined. [Effective October 1, 2014.]  “Provider of health care” has the meaning ascribed to it in NRS 629.031.

      (Added to NRS by 2013, 2257, effective October 1, 2014)

      NRS 453B.080  Establishment of Program; handling fee; conditions for acceptance, distribution and dispensing of donated drugs; certain restrictions. [Effective October 1, 2014.]

      1.  The Board shall establish and maintain the HIV/AIDS Drug Donation Program to accept, distribute and dispense HIV/AIDS drugs donated to the Program.

      2.  Any person or governmental entity may donate an HIV/AIDS drug to the Program. An HIV/AIDS drug may be donated at a pharmacy, medical facility, health clinic or provider of health care that participates in the Program.

      3.  A pharmacy, medical facility, health clinic or provider of health care that participates in the Program may charge a patient who receives an HIV/AIDS drug a handling fee in accordance with the regulations adopted by the Board pursuant to NRS 453B.120.

      4.  A pharmacy, medical facility, health clinic or provider of health care that participates in the Program must establish written procedures for receiving and inspecting donated HIV/AIDS drugs which are approved by the Board.

      5.  An HIV/AIDS drug may be accepted, distributed or dispensed pursuant to the Program only if the HIV/AIDS drug:

      (a) Is in its original, unopened, sealed and tamper-evident unit dose packaging or, if packaged in single-unit doses, the single-unit dose packaging is unopened;

      (b) Is not adulterated or misbranded; and

      (c) Bears an expiration date that is 180 days or more after the date on which the drug is donated.

      6.  An HIV/AIDS drug donated to the Program may not be:

      (a) Resold; or

      (b) Designated by the donor for a specific person.

      7.  The provisions of this section do not require a pharmacy, medical facility, health clinic or provider of health care to participate in the Program.

      (Added to NRS by 2013, 2257, effective October 1, 2014)

      NRS 453B.090  Maintenance and content of records; storage of HIV/AIDS drugs. [Effective October 1, 2014.]  A pharmacy, medical facility, health clinic or provider of health care that participates in the Program shall:

      1.  Maintain the records for any HIV/AIDS drug that is donated to the Program separate from all other records kept by the pharmacy, medical facility, health clinic or provider of health care. Records for any HIV/AIDS drug donated to the Program must include, without limitation:

      (a) The date the pharmacy, medical facility, health clinic or provider of health care received the drug;

      (b) The date the drug was dispensed pursuant to the original prescription;

      (c) The original prescription number of the drug;

      (d) The name of the drug;

      (e) The dosage of the drug;

      (f) The quantity of the drug that is donated;

      (g) The date of expiration of the drug;

      (h) The name, address and telephone number of the person who originally dispensed the drug;

      (i) The name, address and telephone number of the person who donated the drug; and

      (j) The lot number of the drug.

      2.  Maintain the record of an HIV/AIDS drug that is distributed to another pharmacy, medical facility, health clinic or provider of health care which is participating in the Program separate from all other records kept by the pharmacy, medical facility, health clinic or provider of health care. The records for any HIV/AIDS drug distributed to another pharmacy, medical facility, health clinic or provider of health care must include, without limitation:

      (a) The information required by subsection 1;

      (b) The name, address and telephone number of the pharmacy, medical facility, health clinic or provider of health care that is distributing the drug;

      (c) The quantity of the drug that is being distributed; and

      (d) The name, address and telephone number of the pharmacy, medical facility, health clinic or provider of health care to which the drug is distributed.

      3.  Record and retain the name and telephone number of any person to whom a donated HIV/AIDS drug is dispensed.

      4.  Store an HIV/AIDS drug that is donated to the Program:

      (a) Pursuant to the recommendations of the manufacturer of the drug concerning the storage conditions;

      (b) Separate from all other drugs; and

      (c) In a locked storage area.

      (Added to NRS by 2013, 2258, effective October 1, 2014)

      NRS 453B.100  Dispensing of donated drug. [Effective October 1, 2014.]  An HIV/AIDS drug donated for use in the Program may only be dispensed:

      1.  By a pharmacist who is registered pursuant to chapter 639 of NRS; and

      2.  To a person who is eligible to receive HIV/AIDS drugs dispensed pursuant to the Program.

      (Added to NRS by 2013, 2259, effective October 1, 2014)

      NRS 453B.110  Compliance with applicable laws; authority to distribute donated drug to another participant in Program. [Effective October 1, 2014.]  A pharmacy, medical facility, health clinic or provider of health care that participates in the Program:

      1.  Shall comply with all applicable state and federal laws concerning the storage, distribution and dispensing of any HIV/AIDS drugs donated to the Program; and

      2.  May distribute an HIV/AIDS drug donated to the Program to another pharmacy, medical facility, health clinic or provider of health care for use in the Program.

      (Added to NRS by 2013, 2259, effective October 1, 2014)

      NRS 453B.120  Regulations. [Effective October 1, 2014.]  The Board shall adopt regulations to carry out the provisions of this chapter. The regulations must prescribe, without limitation:

      1.  The requirements for the participation of pharmacies, medical facilities, health clinics and providers of health care in the Program;

      2.  The criteria for determining the eligibility of persons to receive HIV/AIDS drugs dispensed pursuant to the Program, including, without limitation, a requirement that a person apply to the Board on a form prescribed by the Board for eligibility to receive HIV/AIDS drugs dispensed or distributed pursuant to the Program;

      3.  The categories of HIV/AIDS drugs that may be accepted for distribution or dispensing pursuant to the Program;

      4.  The maximum fee that a pharmacy, medical facility, health clinic or provider of health care may charge to distribute or dispense HIV/AIDS drugs pursuant to the Program; and

      5.  The requirements for the written procedures established by a pharmacy, medical facility, health clinic or provider of health care for receiving and inspecting donated HIV/AIDS drugs and the manner in which a pharmacy, medical facility, health clinic or provider of health care must submit such procedures for approval.

      (Added to NRS by 2013, 2259, effective October 1, 2014)

      NRS 453B.130  Limitation on civil and criminal liability; limitation on disciplinary action by professional licensing board; waiver of liability. [Effective October 1, 2014.]

      1.  A person who exercises reasonable care in the donation of an HIV/AIDS drug in accordance with the provisions of this chapter and the regulations adopted pursuant thereto is not subject to any civil or criminal liability or disciplinary action by a professional licensing board for any loss, injury or death that results from the donation of the HIV/AIDS drug.

      2.  A pharmacy, medical facility, health clinic or provider of health care which participates in the Program and which exercises reasonable care in the acceptance, distribution or dispensation of an HIV/AIDS drug is not subject to civil or criminal liability or disciplinary action by a professional licensing board for any loss, injury or death that results from the acceptance, distribution or dispensation of the HIV/AIDS drug.

      3.  A manufacturer of an HIV/AIDS drug is not subject to civil or criminal liability for any claim or injury arising from the donation, acceptance, distribution or dispensation of the HIV/AIDS drug pursuant to this chapter and the regulations adopted pursuant thereto.

      4.  An HIV/AIDS drug may not be dispensed pursuant to the Program unless the person to whom the drug is dispensed has signed a waiver of liability for any action described in this section performed by any person, pharmacy, medical facility, health clinic, provider of health care or manufacturer of the HIV/AIDS drug.

      (Added to NRS by 2013, 2259, effective October 1, 2014)

CANCER DRUG DONATION PROGRAM

      NRS 453B.150  Definitions.  As used in NRS 453B.150 to 453B.240, inclusive, unless the context otherwise requires, the words and terms defined in NRS 453B.160 to 453B.190, inclusive, have the meanings ascribed to them in those sections.

      (Added to NRS by 2009, 454)—(Substituted in revision for NRS 457.400)

      NRS 453B.160  “Cancer drug” defined.  “Cancer drug” means a prescription drug that is used to treat cancer.

      (Added to NRS by 2009, 454)—(Substituted in revision for NRS 457.410)

      NRS 453B.170  “Medical facility” defined.  “Medical facility” has the meaning ascribed to it in NRS 449.0151.

      (Added to NRS by 2009, 454)—(Substituted in revision for NRS 457.420)

      NRS 453B.180  “Program” defined.  “Program” means the Cancer Drug Donation Program established pursuant to NRS 453B.200.

      (Added to NRS by 2009, 454)—(Substituted in revision for NRS 457.430)

      NRS 453B.190  “Provider of health care” defined.  “Provider of health care” has the meaning ascribed to it in NRS 629.031.

      (Added to NRS by 2009, 455)—(Substituted in revision for NRS 457.440)

      NRS 453B.200  Establishment of Program; handling fee; conditions for acceptance, distribution and dispensing of donated drugs; certain restrictions.

      1.  The State Board of Pharmacy shall establish and maintain the Cancer Drug Donation Program to accept, distribute and dispense cancer drugs donated to the Program.

      2.  Any person may donate a cancer drug to the Program. A cancer drug may be donated at a pharmacy, medical facility, health clinic or provider of health care that participates in the Program.

      3.  A pharmacy, medical facility, health clinic or provider of health care that participates in the Program may charge a patient who receives a cancer drug a handling fee in accordance with the regulations adopted by the State Board of Pharmacy pursuant to NRS 453B.230.

      4.  A cancer drug may be accepted, distributed or dispensed pursuant to the Program only if the cancer drug:

      (a) Is in its original, unopened, sealed and tamper-evident unit dose packaging or, if packaged in single-unit doses, the single-unit dose packaging is unopened;

      (b) Is not adulterated or misbranded; and

      (c) Bears an expiration date that is later than 30 days after the drug is donated.

      5.  A cancer drug donated to the Program may not be:

      (a) Resold; or

      (b) Designated by the donor for a specific person.

      6.  The provisions of this section do not require a pharmacy, medical facility, health clinic or provider of health care to participate in the Program.

      (Added to NRS by 2009, 455)—(Substituted in revision for NRS 457.450)

      NRS 453B.210  Dispensing of donated drug.  A cancer drug donated for use in the Program may only be dispensed:

      1.  By a pharmacist who is registered pursuant to chapter 639 of NRS or by a physician who is licensed pursuant to chapter 630 or 633 of NRS;

      2.  Pursuant to a prescription written by a person who is authorized to write prescriptions; and

      3.  To a person who is eligible to receive cancer drugs dispensed pursuant to the Program.

      (Added to NRS by 2009, 455; A 2013, 153)—(Substituted in revision for NRS 457.460)

      NRS 453B.220  Compliance with applicable laws; authority to distribute donated drug to another participant in Program.  A pharmacy, medical facility, health clinic or provider of health care that participates in the Program:

      1.  Shall comply with all applicable state and federal laws concerning the storage, distribution and dispensing of the cancer drugs; and

      2.  May distribute a cancer drug donated to the Program to another pharmacy, medical facility, health clinic or provider of health care for use in the Program.

      (Added to NRS by 2009, 455)—(Substituted in revision for NRS 457.470)

      NRS 453B.230  Regulations.  The State Board of Pharmacy shall adopt regulations to carry out the provisions of NRS 453B.150 to 453B.240, inclusive. The regulations must prescribe, without limitation:

      1.  The requirements for the participation of pharmacies, medical facilities, health clinics and providers of health care in the Program, including, without limitation:

      (a) A requirement that each provider of health care who participates in the Program provide, as a regular course of practice, medical services and goods to persons with cancer; and

      (b) A requirement that each medical facility that participates in the Program provide, as a regular course of practice, medical services and goods to persons with cancer;

      2.  The criteria for determining the eligibility of persons to receive cancer drugs dispensed pursuant to the Program, including, without limitation, a requirement that a person sign up with the State Board of Pharmacy on a form prescribed by the Board to be eligible to receive cancer drugs dispensed pursuant to the Program;

      3.  The categories of cancer drugs that may be accepted for distribution or dispensing pursuant to the Program; and

      4.  The maximum fee that a pharmacy, medical facility, health clinic or provider of health care may charge to distribute or dispense cancer drugs pursuant to the Program.

      (Added to NRS by 2009, 455)—(Substituted in revision for NRS 457.480)

      NRS 453B.240  Limitation on civil and criminal liability; limitation on disciplinary action by professional licensing board.

      1.  A person who exercises reasonable care in the donation of a cancer drug in accordance with the provisions of NRS 453B.150 to 453B.240, inclusive, and the regulations adopted pursuant thereto, is not subject to any civil or criminal liability or disciplinary action by a professional licensing board for any loss, injury or death that results from the donation of the cancer drug.

      2.  A pharmacy, medical facility, health clinic or provider of health care which participates in the Program and which exercises reasonable care in the acceptance, distribution or dispensation of a cancer drug is not subject to civil or criminal liability or disciplinary action by a professional licensing board for any loss, injury or death that results from the acceptance, distribution or dispensation of the cancer drug.

      3.  A manufacturer of a cancer drug is not subject to civil or criminal liability for any claim or injury arising from the donation, acceptance, distribution or dispensation of the cancer drug pursuant to NRS 453B.150 to 453B.240, inclusive, and the regulations adopted pursuant thereto.

      (Added to NRS by 2009, 456)—(Substituted in revision for NRS 457.490)