NAC: CHAPTER 453B - CANCER DRUG DONATION PROGRAM

[Rev. 5/25/2022 11:30:28 AM]

[NAC-453B Revised Date: 8-15]

CHAPTER 453B - CANCER DRUG DONATION PROGRAM

General Provisions

453B.010 Definitions.

453B.015 “Board” defined.

453B.020 “Cancer drug” defined.

453B.025 “Dispense” defined.

453B.030 “Distribute” defined.

453B.035 “Health clinic” defined.

453B.040 “Medical facility” defined.

453B.045 “Pharmacy” defined.

453B.050 “Program” defined.

453B.055 “Provider of health care” defined.

Participation of Persons in Program

453B.070 Eligibility for participation in Program to receive cancer drug.

453B.075 Submission of application to participate; written notice of approval or denial by Board.

Participation of Pharmacists, Medical Facilities, Health Clinics and Providers of Health Care in Program

453B.080 Eligibility for participation in Program.

453B.085 Submission of application to participate; written notice of approval or denial by Board.

453B.090 Compliance with federal and state laws and regulations required.

Administration of Program; Fees

453B.100 Board to establish and maintain registry of participants; notification to Board of certain changes in information or status.

453B.105 Donating, dispensing and storage of cancer drugs.

453B.110 Restrictions on donated cancer drugs.

453B.115 Maintenance of records by pharmacy, medical facility, health clinic or provider of health care that participates in Program.

453B.120 Handling fee.

General Provisions

NAC 453B.010 Definitions. (NRS 453B.230) As used in this chapter, unless the context otherwise requires, the words and terms defined in NAC 453B.015 to 453B.055, inclusive, have the meanings ascribed to them in those sections.

(Added to NAC by Bd. of Pharmacy by R211-09, eff. 7-22-2010)—(Substituted in revision for NAC 457.500)

NAC 453B.015 “Board” defined. (NRS 453B.230) “Board” means the State Board of Pharmacy.

(Added to NAC by Bd. of Pharmacy by R211-09, eff. 7-22-2010)—(Substituted in revision for NAC 457.505)

NAC 453B.020 “Cancer drug” defined. (NRS 453B.230) “Cancer drug” has the meaning ascribed to it in NRS 453B.160.

(Added to NAC by Bd. of Pharmacy by R211-09, eff. 7-22-2010)—(Substituted in revision for NAC 457.510)

NAC 453B.025 “Dispense” defined. (NRS 453B.230) “Dispense” has the meaning ascribed to it in NRS 639.0065.

(Added to NAC by Bd. of Pharmacy by R211-09, eff. 7-22-2010)—(Substituted in revision for NAC 457.515)

NAC 453B.030 “Distribute” defined. (NRS 453B.230) “Distribute” means to deliver, other than by administering or dispensing, a cancer drug.

(Added to NAC by Bd. of Pharmacy by R211-09, eff. 7-22-2010)—(Substituted in revision for NAC 457.520)

NAC 453B.035 “Health clinic” defined. (NRS 453B.230) “Health clinic” means a facility which provides, as a regular course of practice, medical services and goods to persons with cancer and is operated by a physician who is licensed pursuant to chapter 630 or 633 of NRS.

(Added to NAC by Bd. of Pharmacy by R211-09, eff. 7-22-2010)—(Substituted in revision for NAC 457.525)

NAC 453B.040 “Medical facility” defined. (NRS 453B.230) “Medical facility” has the meaning ascribed to it in NRS 449.0151.

(Added to NAC by Bd. of Pharmacy by R211-09, eff. 7-22-2010)—(Substituted in revision for NAC 457.530)

NAC 453B.045 “Pharmacy” defined. (NRS 453B.230) “Pharmacy” has the meaning ascribed to it in NRS 639.012.

(Added to NAC by Bd. of Pharmacy by R211-09, eff. 7-22-2010)—(Substituted in revision for NAC 457.535)

NAC 453B.050 “Program” defined. (NRS 453B.230) “Program” has the meaning ascribed to it in NRS 453B.180.

(Added to NAC by Bd. of Pharmacy by R211-09, eff. 7-22-2010)—(Substituted in revision for NAC 457.540)

NAC 453B.055 “Provider of health care” defined. (NRS 453B.230) “Provider of health care” has the meaning ascribed to it in NRS 629.031.

(Added to NAC by Bd. of Pharmacy by R211-09, eff. 7-22-2010)—(Substituted in revision for NAC 457.545)

Participation of Persons in Program

NAC 453B.070 Eligibility for participation in Program to receive cancer drug. (NRS 453B.230) A person who wishes to receive a cancer drug dispensed pursuant to the Program must be:

1. A resident of this State;

2. Diagnosed as having cancer; and

3. Approved to participate in the Program pursuant to NAC 453B.075.

(Added to NAC by Bd. of Pharmacy by R211-09, eff. 7-22-2010)—(Substituted in revision for NAC 457.555)

NAC 453B.075 Submission of application to participate; written notice of approval or denial by Board. (NRS 453B.230)

1. A person who wishes to participate in the Program must submit an application to the Board on a form prescribed by the Board.

2. The Board will review the application and determine if the person is qualified to participate in the Program.

3. If the Board approves a person to participate in the Program, the Board will provide written notice of its approval of the application to the person not later than 30 days after its decision.

4. If the Board denies a person from participating in the Program, the Board will provide written notice of its denial of the application to the person not later than 30 days after its decision.

(Added to NAC by Bd. of Pharmacy by R211-09, eff. 7-22-2010)—(Substituted in revision for NAC 457.560)

Participation of Pharmacists, Medical Facilities, Health Clinics and Providers of Health Care in Program

NAC 453B.080 Eligibility for participation in Program. (NRS 453B.230) To be eligible to participate in the Program:

1. A pharmacy must be:

(a) Licensed in this State; and

(b) Approved to participate in the Program pursuant to NAC 453B.085.

2. A medical facility must:

(a) Be licensed in this State;

(b) Provide, as a regular course of practice, medical services and goods to persons with cancer; and

3. A health clinic must be approved to participate in the Program pursuant to NAC 453B.085.

4. A provider of health care must:

(a) Be licensed in this State;

(b) Provide, as a regular course of practice, medical services and goods to persons with cancer; and

(Added to NAC by Bd. of Pharmacy by R211-09, eff. 7-22-2010)—(Substituted in revision for NAC 457.565)

NAC 453B.085 Submission of application to participate; written notice of approval or denial by Board. (NRS 453B.230)

1. A pharmacy, medical facility, health clinic or provider of health care that wishes to participate in the Program must submit an application to the Board on a form prescribed by the Board.

2. The Board will review the application and determine if the pharmacy, medical facility, health clinic or provider of health care is qualified to participate in the Program.

3. If the Board approves a pharmacy, medical facility, health clinic or provider of health care for participation in the Program, the Board will provide written notice of its approval of the application to the pharmacy, medical facility, health clinic or provider of health care not later than 30 days after its decision.

4. If the Board denies a pharmacy, medical facility, health clinic or provider of health care from participating in the Program, the Board will provide written notice of its denial of the application to the pharmacy, medical facility, health clinic or provider of health care not later than 30 days after its decision.

(Added to NAC by Bd. of Pharmacy by R211-09, eff. 7-22-2010)—(Substituted in revision for NAC 457.570)

NAC 453B.090 Compliance with federal and state laws and regulations required. (NRS 453B.200, 453B.230) A pharmacy, medical facility, health clinic or provider of health care that participates in the Program must comply with all applicable federal and state laws and regulations when accepting, distributing and dispensing a cancer drug pursuant to the Program.

(Added to NAC by Bd. of Pharmacy by R211-09, eff. 7-22-2010)—(Substituted in revision for NAC 457.575)

Administration of Program; Fees

NAC 453B.100 Board to establish and maintain registry of participants; notification to Board of certain changes in information or status. (NRS 453B.230)

1. The Board will establish and maintain a registry of pharmacies, medical facilities, health clinics and providers of health care that participate in the Program, which must include, without limitation, the name, address and telephone number of each pharmacy, medical facility, health clinic and provider of health care that is authorized by the Board to participate in the Program.

2. A pharmacy, medical facility, health clinic or provider of health care must notify the Board, on a form prescribed by the Board, if the pharmacy, medical facility, health clinic or provider of health care:

(a) Has a change in its name, address or telephone number; or

(b) No longer wishes to participate in the Program.

3. The Board will post the registry on the Internet website maintained by the Board.

(Added to NAC by Bd. of Pharmacy by R211-09, eff. 7-22-2010)—(Substituted in revision for NAC 457.580)

NAC 453B.105 Donating, dispensing and storage of cancer drugs. (NRS 453B.230)

1. Except as otherwise required for the storage of cancer drugs pursuant to subsection 3, a pharmacy, medical facility, health clinic or provider of health care shall not limit the amount of cancer drugs that a person may donate to the Program.

2. In addition to the requirements of NRS 453B.210, a pharmacist may dispense a cancer drug to a person who is participating in the Program if:

(a) The pharmacist has inspected the packaging of the cancer drug to determine if the cancer drug meets the requirements of subsection 4 of NRS 453B.200;

(b) The person requesting the cancer drug presents to the pharmacist the written notice of approval from the Board which states that the person is approved to participate in the Program; and

(c) The person requesting the cancer drug presents to the pharmacist a prescription written by a person who is authorized to write prescriptions.

3. A pharmacy, medical facility, health clinic or provider of health care shall store a cancer drug that is donated to the Program:

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

(b) Separately from all other drugs; and

4. If a cancer drug that is donated to the Program expires before it is dispensed, the pharmacy, medical facility, health clinic or provider of health care shall destroy the cancer drug.

(Added to NAC by Bd. of Pharmacy by R211-09, eff. 7-22-2010)—(Substituted in revision for NAC 457.585)

NAC 453B.110 Restrictions on donated cancer drugs. (NRS 453B.230)

1. In addition to the requirements of NRS 453B.200, a cancer drug that is donated to the Program:

(a) Must not be a controlled substance.

(b) Must not be a compounded drug product.

(d) Must not be dispensed by a pharmacist if, in the professional judgment of the pharmacist, there is a reasonable concern relating to the safety or efficacy of the cancer drug.

(e) Must not require refrigeration or freezing or other temperature requirements that are not a controlled room temperature.

(f) Must not be a cancer drug for which a program of restrictive distribution has been established by the manufacturer of the cancer drug.

(g) Must not be a cancer drug for which an ongoing clinical trial or study is being conducted.

(h) Must be a cancer drug that was dispensed pursuant to an original prescription by a pharmacy licensed pursuant to chapter 639 of NRS.

2. As used in this section, “program of restrictive distribution” means a program that is developed in collaboration with the United States Food and Drug Administration by a manufacturer of a drug to reduce the risks associated with that drug by limiting the persons who can prescribe the drug and who can receive the drug.

(Added to NAC by Bd. of Pharmacy by R211-09, eff. 7-22-2010)—(Substituted in revision for NAC 457.587)

NAC 453B.115 Maintenance of records by pharmacy, medical facility, health clinic or provider of health care that participates in Program. (NRS 453B.230)

1. In addition to the requirements of NRS 639.2801 and NAC 639.708, a pharmacy, medical facility, health clinic or provider of health care that participates in the Program shall maintain records for a cancer drug that is donated to the Program. The records must include, without limitation:

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

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

(d) The name of the cancer drug;

(e) The dosage of the cancer drug;

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

(g) The date of expiration of the cancer drug;

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

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

(j) The lot number of the cancer drug.

2. A pharmacy, medical facility, health clinic or provider of health care shall maintain records of a cancer drug that is distributed to another pharmacy, medical facility, health clinic or provider of health care that is participating in the Program. The records must include, without limitation:

(a) The information required pursuant to 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 cancer drug;

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

(Added to NAC by Bd. of Pharmacy by R211-09, eff. 7-22-2010)—(Substituted in revision for NAC 457.590)

NAC 453B.120 Handling fee. (NRS 453B.200, 453B.230) A pharmacy, medical facility, health clinic or provider of health care may charge a handling fee of not more than $10 for distributing or dispensing a cancer drug that is donated to the Program.

(Added to NAC by Bd. of Pharmacy by R211-09, eff. 7-22-2010)—(Substituted in revision for NAC 457.595)