Rule 511-5-12-.03. Eligible drugs

1. (1) Drugs shall only be dispensed pursuant to the program if:

   1. (a) For prescription drugs, with an expiration date that does not expire before the completion of the medication by the eligible patient based on the prescribing health care professional's directions for use and, for over-the-counter drugs, with an expiration date that does not expire before use by the eligible patient based on the directions for use on the manufacturer's label; and
   2. (b) The drugs were donated in unopened tamper-evident packaging as defined by United States Pharmacopeia General Chapter 659, Packaging and Storage Requirements, including but not limited to unopened unit-dose and multiple-dose packaging.

2. (2) The following drugs shall not be donated to the program:

   1. (a) Controlled substances;
   2. (b) Drugs subject to a federal Food and Drug Administration managed risk evaluation and mitigation strategy pursuant to 21 U.S.C. Section 355-1 if inventory transfer is prohibited by such strategy; or
   3. (c) Drugs that there is reason to believe are adulterated pursuant to Code Section 26-3-7.

Authority: §§ 31-2A-6, 31-8-304.

History. Original Rule was filed as Emergency Rule 511-5-12-0.1-.03 on January 3, 2017; effective January 1, 2017, to remain in effect for a period of 120 days or until the effective date of a permanent Rule covering the same subject matter superseding this Emergency Rule is adopted, as specified by the Agency.

Adopted: Permanent Rule entitled "Eligible drugs." F. Feb. 14, 2017; eff. Mar. 6, 2017.

Amended: F. Oct. 8, 2025; eff. Nov. 7, 2025, as specified by the Agency.