NAC: CHAPTER 453B - PRESCRIPTION DRUG DONATION PROGRAM

[Rev. 8/26/2026 9:41:05 AM]

CHAPTER 453B - PRESCRIPTION DRUG DONATION PROGRAM

[NAC-453B Revised Date: 8-26]

GENERAL PROVISIONS

453B.010 Definitions.

453B.020 “Cancer drug” defined. [Replaced in revision by NAC 453B.032.]

453B.030 “Distribute” defined.

453B.032 “Donated prescription drug” defined.

453B.035 “Health clinic” defined.

453B.070 Eligibility of person to receive donated prescription drug.

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 Executive Secretary; appeal of denial.

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 donated prescription drugs.

453B.110 Restrictions on donated prescription drugs.

453B.120 Handling fee.

GENERAL PROVISIONS

NAC 453B.010 Definitions. (NRS 453B.080, 453B.120) As used in this chapter, unless the context otherwise requires, the words and terms defined in NAC 453B.030, 453B.032 and 453B.035 have the meanings ascribed to them in those sections.

(Added to NAC by Bd. of Pharmacy by R211-09, eff. 7-22-2010; A by R007-22, 12-29-2022)—(Substituted in revision for NAC 457.500)

NAC 453B.020 “Cancer drug” defined. [Replaced in revision by NAC 453B.032.]

NAC 453B.030 “Distribute” defined. (NRS 453B.080, 453B.120) “Distribute” means to deliver, other than by administering or dispensing, a donated prescription drug.

(Added to NAC by Bd. of Pharmacy by R211-09, eff. 7-22-2010; A by R007-22, 12-29-2022)—(Substituted in revision for NAC 457.520)

NAC 453B.032 “Donated prescription drug” defined. (NRS 453B.080, 453B.120) “Donated prescription drug” means a drug that has been donated to the Program.

(Added to NAC by Bd. of Pharmacy by R211-09, eff. 7-22-2010; A by R007-22, 12-29-2022)—(Substituted in revision for NAC 453B.020 and 457.510)

NAC 453B.035 “Health clinic” defined. (NRS 453B.080, 453B.120) “Health clinic” means a facility which provides, as a regular course of practice, medical services and goods 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; A by R007-22, 12-29-2022)—(Substituted in revision for NAC 457.525)

NAC 453B.070 Eligibility of person to receive donated prescription drug. (NRS 453B.080, 453B.120) A person who wishes to receive a donated prescription drug dispensed pursuant to the Program must be a resident of this State.

(Added to NAC by Bd. of Pharmacy by R211-09, eff. 7-22-2010; A by R007-22, 12-29-2022)—(Substituted in revision for NAC 457.555)

PARTICIPATION OF PHARMACISTS, MEDICAL FACILITIES, HEALTH CLINICS AND PROVIDERS OF HEALTH CARE IN PROGRAM

NAC 453B.080 Eligibility for participation in Program. (NRS 453B.080, 453B.120)

1. To be eligible to participate in the Program:

(a) A pharmacy must:

(1) Be licensed in this State;

(2) Have established the procedures required by subsection 2;

(3) Be approved to participate in the Program pursuant to NAC 453B.085; and

(4) Be in good standing with the Board.

(b) A medical facility must:

(1) Be licensed in this State;

(2) Have established the procedures required by subsection 2; and

(3) Be approved to participate in the Program pursuant to NAC 453B.085.

(1) Have established the procedures required by subsection 2; and

(2) Be approved to participate in the Program pursuant to NAC 453B.085.

(d) A provider of health care must:

(1) Be licensed in this State;

(2) Provide, as a regular course of practice, medical services and goods;

(3) Have established the procedures required by subsection 2; and

(4) Be approved to participate in the Program pursuant to NAC 453B.085.

2. To be eligible to participate in the Program, a pharmacy, medical facility, health clinic or provider of health care must have established procedures for:

(a) Receiving, inspecting and storing donated prescription drugs in accordance with NAC 453B.105.

(b) Keeping the records required by NRS 453B.090.

(1) Meets the requirements of NAC 453B.070;

(2) Has been issued a prescription as required by NRS 453B.100; and

(3) Has signed the waiver of liability required by NRS 453B.130.

(d) Disposing of donated prescription drugs.

(Added to NAC by Bd. of Pharmacy by R211-09, eff. 7-22-2010; A by R007-22, 12-29-2022)—(Substituted in revision for NAC 457.565)

NAC 453B.085 Submission of application to participate; written notice of approval or denial by Executive Secretary; appeal of denial. (NRS 453B.080, 453B.120)

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 Executive Secretary of the Board shall 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 Executive Secretary approves a pharmacy, medical facility, health clinic or provider of health care for participation in the Program, the Executive Secretary shall provide written notice of his or her approval of the application to the pharmacy, medical facility, health clinic or provider of health care not later than 30 days after his or her decision.

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

5. A pharmacy, medical facility, health clinic or provider of health care that is aggrieved by a decision of the Executive Secretary to deny participation in the Program may appeal that decision by submitting a written notice of appeal to the Board not later than 30 days after receiving notice of the decision pursuant to subsection 4.

(Added to NAC by Bd. of Pharmacy by R211-09, eff. 7-22-2010; A by R007-22, 12-29-2022)—(Substituted in revision for NAC 457.570)

NAC 453B.090 Compliance with federal and state laws and regulations required. (NRS 453B.080, 453B.110, 453B.120) A pharmacy, medical facility, health clinic or provider of health care that participates in the Program shall comply with all applicable federal and state laws and regulations when accepting, distributing and dispensing a donated prescription drug pursuant to the Program.

(Added to NAC by Bd. of Pharmacy by R211-09, eff. 7-22-2010; A by R007-22, 12-29-2022)—(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 donated prescription drugs. (NRS 453B.080, 453B.100, 453B.120)

1. A pharmacy, medical facility, health clinic or provider of health care that participates in the Program is not required to accept a prescription drug for donation.

2. In addition to the requirements of NRS 453B.100 and 453B.130 and NAC 453B.110, a pharmacist may dispense a donated prescription drug to a person if:

(a) The pharmacist has inspected the packaging of the donated prescription drug to determine if the donated prescription drug meets the requirements of subsection 6 of NRS 453B.080; and

(b) The person requesting the donated prescription drug presents to the pharmacist:

(1) Proof that the person meets the requirements of NAC 453B.070; and

(2) 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 donated prescription drug:

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

(b) Separately from all other drugs; and

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

(Added to NAC by Bd. of Pharmacy by R211-09, eff. 7-22-2010; A by R007-22, 12-29-2022)—(Substituted in revision for NAC 457.585)

NAC 453B.110 Restrictions on donated prescription drugs. (NRS 453B.080, 453B.120)

1. In addition to the requirements of NRS 453B.080, a donated prescription drug:

(a) Must not be a controlled substance.

(b) Must not be a compounded drug product.

(c) Must not be dispensed by a pharmacist if the pharmacist suspects that the prescription drug is adulterated or misbranded.

(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 prescription drug.

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

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

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

(h) Must be a prescription drug that was originally dispensed pursuant to a 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; A by R007-22, 12-29-2022)—(Substituted in revision for NAC 457.587)

NAC 453B.120 Handling fee. (NRS 453B.080, 453B.120) 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 donated prescription drug.

(Added to NAC by Bd. of Pharmacy by R211-09, eff. 7-22-2010; A by R007-22, 12-29-2022)—(Substituted in revision for NAC 457.595)