Rule 511-5-12-.06 - Dispensing and distribution of donated drugs(1) An eligible recipient may only dispense or administer prescription drugs if otherwise permitted by law.(2) Donation and the brokering or other facilitation of a donation of a drug pursuant to this program shall not be considered wholesale distribution and shall not require licensure as a wholesaler.(3) Donated prescription drugs may only be dispensed to eligible patients pursuant to a valid prescription drug order in accordance with Title 26, Chapter 4. That patient shall be provided with appropriate counseling on the use of the prescription drug, including any potential side effects and the fact that the drug was donated.(4) An eligible recipient may further donate unused prescription drugs to or receive unused prescription drugs from another eligible recipient in the program when one has the need for a drug and another has it available. An inventory of such donations shall be created in accordance with DPH Rule 511-5-12-.05(8) unless both eligible recipients are under common ownership or common control.(5) An eligible recipient shall dispose of any drug that does not meet all of the requirements of Code Section 31-8-301 in one of the following ways: (a) Return the drug to the donor;(b) Destroy the drug through an incinerator licensed with the Environmental Protection Agency or other lawful method; or(c) Transfer the drug to a reverse distributor.(6) All such donated drugs to be disposed shall be quarantined in a separately designated area(7) An eligible recipient shall maintain a written of electronic record of disposal, including: (a) The disposal method as described in paragraph (5) of this Rule;(b) The date of disposal or quarantine; and(c) The name, strength, and quantity of each drug disposed.(8) No record of disposal other than as described in paragraph (7) of this Rule shall be required.(9) Donated drugs shall not be resold and shall be considered nonsaleable; provided, however, that reimbursement for any handling fee authorized pursuant to this Chapter shall not constitute reselling.(10) Before dispensing a donated drug, an eligible recipient shall inspect the drug to determine that it has not adulterated. The drug must be repackaged into a new container or all previous patient information and pharmacy labeling must be redacted or removed from the donated container.(11) Dispensed drugs must clearly indicate the final dispenser's information and current patient information, and shall be properly labeled in accordance with the regulations of the Georgia Board of Pharmacy.(12) An eligible recipient that provides donated drugs to an eligible patient shall maintain patient-specific written or electronic records in accordance with Georgia law and the regulations of the Board of Pharmacy. If also providing patients with purchased drugs, the eligible recipient shall also note, either on the face of a written prescription or in the electronic record of prescription, that a donated drug was dispensed to the patient.(13) An expiration date is required on all donated drugs dispensed. The expiration date shall be brought forward to the filled prescription. If multiple packaged donated drugs are used to fill a single prescription with varied expiration dates, the shortest expiration date shall be used for the dispensed prescription.(14) Dispensed drugs shall not expire before the use by the patient based on the prescribing practitioner's directions for use or, for over-the-counter medicine not dispensed pursuant to a prescription, the directions for use on the package's label.(15) Dispensed drugs subject to a United States Food and Drug Administration managed risk evaluation and mitigation strategy pursuant to 21 U.S.C. Section 355-1 shall be managed and dispensed according to the requirements of that strategy.Ga. Comp. R. & Regs. R. 511-5-12-.06
§§ 31-2A-6, 31-8-304.
Original Rule was filed as Emergency Rule 511-5-12-0.1-.06 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 "Dispensing and distribution of donated drugs." F. Feb. 14, 2017; eff. Mar. 6, 2017.