Rule 351-6-.09. Recall Procedures

(1) A dispensing licensee shall establish, maintain, and follow standard operating procedures for licensee-initiated or Commission-ordered recalls of product in final packaged form. Such procedures shall address, at a minimum, the following: (a) Notifications to patients, caregivers, and the public; (b) Reporting adverse events and symptoms experienced by patients to the originating production licensee and the Commission and its employees; (c) The collection of such recalled product; (d) The quarantine and storage of such recalled product that have not been dispensed; (e) The quarantine and storage of such recalled product that would be returned; and (f) The return of such recalled product to the originating production licensee. (2) The dispensing licensee shall display a public notice of a licensee-initiated or Commission-ordered recall until the termination of the recall. Such notice shall be: (a) Received from the originating production licensee responsible for the recall; (b) Posted within twenty-four (24) hours of the recall being initiated; (c) Displayed in a conspicuous location, unobstructed, and easily viewable for patients and caregivers; and (d) Posted in a prominent location of the dispensing licensee's website and social media, if the dispensary impacted by the recall has a website separate from the originating production licensee. (3) Upon receipt of a written notice for a recall, a dispensing licensee shall ensure product in final packaged form subject to the recall is: (a) Removed from availability for retail purchase or transfer; and (b) Quarantined and stored from all other product in final packaged form that is not part of the recall. Cite as Ga. Comp. R. & Regs. R. 351-6-.09
Authority: O.C.G.A. §§ 16-12-203, 16-12-206, 16-12-210.
History. Original Rule entitled "Recall Procedures" adopted. F. Mar. 16, 2023; eff. Apr. 5, 2023.
Amended: F. Nov. 9, 2023; eff. Nov. 29, 2023.