Ch 19 P 34 Prescription Drug Donation

Question 1

Board

Answer 1

The NM Board of pharmacy

Question 2

Clinic

Answer 2

A facility licensed pursuant to Section 61-22-14 NMSA 1978 in which one or more licensed practitioners diagnose and treat patients and in which drugs are stored, dispensed or administered for the diagnosis and treatment of the facility’s patients; provided that “clinic” does not include the privately owned practice of a licensed practitioner or group of licensed practitioners exempt under Section 61-11-11 NMSA 1978.

Question 3

Donor

Answer 3

An individual who donates an unused prescription drug to a clinic or participating practitioner, who originally prescribed that prescription drug for their patient, for the purpose of redistribution of established patients of that clinic or practitioner.

Question 4

Eligible drug

Answer 4

An unused prescription drug stored in a tamper-evident container, or by a tamper-evident process preventing unauthorized access, and has an expiration date of six months or greater listed on the packaging. No drug shall be re-dispensed more than one time.

Question 5

Ineligible drug

Answer 5

Any controlled substances or any prescription drug within the risk evaluation and mitigation strategies (REMS) requirements as set forth by Section 505-1[21 USC355-1] of the Food Drug and Cosmetic Act (FD&C Act), with the exception of a medication guide (MedGuide) as set forth in Title 34, CFR, Subsection 208, patient package insert (PPI) or a communication plan, without prior board approval.

Question 6

Participating practitioner

Answer 6

A licensed practitioner who is authorized to prescribe drugs, who registers with the board and is subject to rules promulgated by the board to participate in the collection of donated drugs prescribed for use by established patients of that practitioner, and donated for the purpose of redistribution to established patients of that practitioner.

Question 7

Prescription drug

Answer 7

For the purposes of this rule means any drug required by federal or state law or regulation to be dispensed only by a prescription, including finished dosage forms and active ingredients subject to Section 503(b) of the Federal Food, Drug and Cosmetic Act.

Question 8

Recipient

Answer 8

An individual who voluntarily receives donated prescription drugs.

Question 9

Tamper-evident

Answer 9

A device or process that makes unauthorized access to protected pharmaceutical packaging easily detected.

Question 10

REMS

Answer 10

Risk evaluation and mitigation strategy as required by the Food and Drug Administration Amendments Act of 2007.