Definitions

As used in this article, the term: (1) ‘‘Controlled substance’’ means a drug, substance, or immediate precursor in Schedules I through V of Code Sections 16-13-25 through 16-13-29 and Schedules I through V of 21 C.F.R. Part 1308. (2) ‘‘Eligible patient’’ means an individual who is indigent, uninsured, underinsured, or enrolled in a public assistance health benefits program, in accordance with criteria established by the Department of Public Health pursuant to Code Section 31-8-304. Other individuals may be considered eligible patients if the need for donated drugs for indigent, uninsured, underinsured, and public assistance health benefits program patients is less than the supply of donated drugs. (3) ‘‘Eligible recipient’’ means a pharmacy, hospital, federally qualified health center, nonprofit clinic, or other entity meeting the criteria established by the Department of Public Health pursuant to Code Section 31-8-304. (4) ‘‘Health care facility’’ means a: (A) Nursing home licensed pursuant to Article 1 of Chapter 7 of this title; (B) Personal care home licensed pursuant to Code Section 31-7-12; (C) Assisted living community licensed pursuant to Code Section 31-7-12.2; (D) Hospice licensed pursuant to Article 9 of Chapter 7 of this title; and (E) Home health agency licensed pursuant to Article 7 of Chapter 7 of this title. (5) ‘‘Health care professional’’ means any of the following who provide medical, dental, or other health related diagnosis, care, or treatment: (A) Physicians licensed to practice medicine under Chapter 34 of Title 43; (B) Registered nurses and licensed practical nurses licensed under Chapter 26 of Title 43; (C) Physician assistants licensed under Chapter 34 of Title 43; 536 31-8-301 (D) Dentists and dental hygienists licensed under Chapter 11 of Title 43; (E) Optometrists licensed under Chapter 30 of Title 43; and (F) Pharmacists licensed under Chapter 4 of Title 26. (6) ‘‘Hospital’’ means a facility licensed pursuant to Chapter 7 of this title. (7) ‘‘Program’’ means the drug repository program established pursuant to Code Section 31-8-301. History. — Code 1981, § 31-8-300, enacted by Ga. L. 2016, p. 524, § 1/HB 897. 31-8-301. Drug repository program established; criteria and requirements for unused over-the-counter and prescription drugs. (a) The Department of Public Health shall establish a drug repository program to accept and dispense over-the-counter and prescription drugs donated for the purpose of being dispensed to eligible patients. (b) Drugs shall only be dispensed pursuant to the program if: (1) 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 (2) 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. (c) The following drugs shall not be donated to the program: (1) Controlled substances; (2) Drugs subject to a federal Food and Drug Administration managed risk evaluation and mitigation strategy pursuant to Section 355-1 of Title 21 of the United States Code if inventory transfer is prohibited by such strategy; or (3) Drugs that there is reason to believe are adulterated pursuant to Code Section 26-3-7. History. — Code 1981, § 31-8-301, enacted by Ga. L. 2016, p. 524, § 1/HB 897. 537 31-8-302 31-8-302. Procedures for donation and dispensing of unused over-the-counter and prescription drugs. (a) Any person, including a drug manufacturer, wholesaler, reverse distributor pharmacy, third-party logistics provider, government entity, hospital, or health care facility, may donate over-the-counter and prescription drugs to the program. The drugs shall be donated to an eligible recipient that voluntarily elects to participate in the program. Nothing in this or any other Code section shall require an eligible recipient to participate in the program. (b) An eligible recipient may do any of the following: (1) Accept and dispense donated drugs to eligible patients. Prescription drugs shall only be dispensed pursuant to a valid prescription drug order. Eligible patients who are indigent, uninsured, underinsured, or enrolled in a public assistance health benefits program in accordance with criteria established by the Department of Public Health pursuant to Code Section 31-8-304 shall be prioritized over other individuals; (2) Transfer donated drugs to another eligible recipient participating in the program or to a drug repository program operated by another state; (3) Repackage donated drugs as necessary for dispensing, administration, or transfers; and (4) Replenish drugs previously dispensed or administered to eligible patients. (c) An eligible recipient that accepts donated drugs shall comply with all applicable federal laws and laws of this state dealing with storage and distribution of dangerous drugs and shall inspect all drugs prior to dispensing them to determine that they are not adulterated. (d) An eligible recipient may charge a handling fee established in accordance with rules and regulations adopted by the Department of Public Health pursuant to Code Section 31-8-304; provided, however, that any such fee shall not exceed the reasonable costs of participating in the program. (e) Drugs donated to the program shall not be resold; provided, however, that reimbursement for any fee charged as authorized pursuant to this article by a health plan or pharmacy benefits manager for donated drugs shall not constitute reselling. Nothing in this article shall require a health plan or pharmacy benefits manager to be reimbursed for donated drugs. 538 31-8-304 History. — Code 1981, § 31-8-302, enacted by Ga. L. 2016, p. 524, § 1/HB 897. 31-8-303. Limited liability.