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.Ga. Comp. R. & Regs. R. 351-6-.09
O.C.G.A. §§ 16-12-203, 16-12-206, 16-12-210.
Original Rule entitled "Recall Procedures" adopted. F. Mar. 16, 2023; eff. Apr. 5, 2023.Amended: F. Nov. 9, 2023; eff. Nov. 29, 2023.