NRS: CHAPTER 453B - HIV/AIDS DRUG DONATION PROGRAM

[Rev. 6/29/2024 4:11:09 PM--2023]

CHAPTER 453B - HIV/AIDS DRUG DONATION PROGRAM

NRS 453B.020 “Board” defined.

NRS 453B.040 “Medical facility” defined.

NRS 453B.050 “Pharmacy” defined.

NRS 453B.060 “Program” defined.

NRS 453B.070 “Provider of health care” defined.

NRS 453B.080 Establishment of Program; handling fee; conditions for acceptance, distribution and dispensing of donated drugs; certain restrictions; prescription drug without lot number deemed recalled.

NRS 453B.090 Maintenance and content of records; storage of drugs.

NRS 453B.100 Dispensing of donated drug.

NRS 453B.110 Compliance with applicable laws; authority to distribute donated drug to another participant in Program.

NRS 453B.120 Regulations.

NRS 453B.130 Limitation on civil and criminal liability; limitation on disciplinary action by professional licensing board; waiver of liability.

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NRS 453B.010 Definitions. 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)

NRS 453B.020 “Board” defined. “Board” means the State Board of Pharmacy.

(Added to NRS by 2013, 2257)

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

(Added to NRS by 2013, 2257)

NRS 453B.050 “Pharmacy” defined. “Pharmacy” has the meaning ascribed to it in NRS 639.012.

(Added to NRS by 2013, 2257)

NRS 453B.060 “Program” defined. “Program” means the Prescription Drug Donation Program established pursuant to NRS 453B.080.

(Added to NRS by 2013, 2257; A 2017, 685)

NRS 453B.070 “Provider of health care” defined. “Provider of health care” has the meaning ascribed to it in NRS 629.031.

(Added to NRS by 2013, 2257)

1. The Board shall establish and maintain the Prescription Drug Donation Program to accept, distribute and dispense prescription drugs donated to the Program.

2. Except as otherwise provided in this section, a person or governmental entity may donate any prescription drug to the Program.

3. A prescription drug may be donated to the Program at a pharmacy, medical facility, health clinic or provider of health care that participates in the Program.

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

5. 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 prescription drugs.

6. A prescription drug may be accepted, distributed or dispensed pursuant to the Program only if the 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

7. A prescription drug donated to the Program may not be:

(a) Resold; or

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

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

9. Marijuana, as defined in NRS 453.096, or any drug that may only be dispensed to a patient registered with the manufacturer of the drug pursuant to requirements of the United States Food and Drug Administration may not be donated, accepted, distributed or dispensed pursuant to the Program.

10. A prescription drug donated to the Program that does not include a lot number shall be deemed to have been recalled if the prescription drug has the same National Drug Code assigned by the United States Food and Drug Administration as a recalled prescription drug.

(Added to NRS by 2013, 2257; A 2017, 685)

NRS 453B.090 Maintenance and content of records; storage of drugs. A pharmacy, medical facility, health clinic or provider of health care that participates in the Program shall:

1. Maintain the records for any prescription 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 prescription 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) If donated by the person for whom the drug was prescribed, the date the drug was dispensed pursuant to the original prescription;

(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) If donated by the person for whom the drug was prescribed, 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 a donated prescription 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 donated prescription 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;

(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 prescription drug is dispensed.

4. Store a prescription 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

(Added to NRS by 2013, 2258; A 2017, 686)

NRS 453B.100 Dispensing of donated drug. A prescription drug donated for use in the Program may only be dispensed:

1. By a pharmacist who is registered pursuant to chapter 639 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 prescription drugs dispensed pursuant to the Program.

(Added to NRS by 2013, 2259; A 2017, 687)

NRS 453B.110 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 any prescription drugs donated to the Program; and

2. May distribute a prescription 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; A 2017, 687)

NRS 453B.120 Regulations. 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. For medical facilities or providers of health care who participate in the Program by accepting, distributing or dispensing a prescription drug used to treat cancer, the requirements prescribed pursuant to this subsection must include a requirement that any such medical facility or provider of health care 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 prescription drugs dispensed pursuant to the Program.

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

4. The requirements for the written procedures established by a pharmacy, medical facility, health clinic or provider of health care for receiving and inspecting prescription drugs donated to the Program and the manner in which a pharmacy, medical facility, health clinic or provider of health care must submit such procedures for approval, including, without limitation, a requirement that a pharmacy, medical facility, health clinic or provider of health care that dispenses prescription drugs donated to the Program verify and record the eligibility of persons to receive such prescription drugs in the manner set forth in regulations adopted pursuant to subsection 2.

(Added to NRS by 2013, 2259; A 2017, 687)

NRS 453B.130 Limitation on civil and criminal liability; limitation on disciplinary action by professional licensing board; waiver of liability.

1. A person who exercises reasonable care in the donation of a prescription 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 prescription 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 prescription drug donated to the Program 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 prescription drug.

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

4. A prescription 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 prescription drug.

(Added to NRS by 2013, 2259; A 2017, 688)