Ga. Comp. R. & Regs. 511-5-12-.03

Current through Rules and Regulations filed through December 24, 2024
Rule 511-5-12-.03 - Eligible drugs
(1) Drugs shall only be dispensed pursuant to the program if:
(a) For prescription drugs, they do 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, they do not expire before use by the eligible patient based on the directions for use on the manufacturer's label; and
(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) The following drugs shall not be donated to the program:
(a) Controlled substances;
(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
(c) Drugs that there is reason to believe are adulterated pursuant to Code Section 26-3-7.

Ga. Comp. R. & Regs. R. 511-5-12-.03

§§ 31-2A-6, 31-8-304.

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.