Rule 351-6-.09. Recall Procedures

1. (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:

   1. (a) Notifications to patients, caregivers, and the public;
   2. (b) Reporting adverse events and symptoms experienced by patients to the originating production licensee and the Commission and its employees;
   3. (c) The collection of such recalled product;
   4. (d) The quarantine and storage of such recalled product that have not been dispensed;
   5. (e) The quarantine and storage of such recalled product that would be returned; and
   6. (f) The return of such recalled product to the originating production licensee.

2. (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:

   1. (a) Received from the originating production licensee responsible for the recall;
   2. (b) Posted within twenty-four (24) hours of the recall being initiated;
   3. (c) Displayed in a conspicuous location, unobstructed, and easily viewable for patients and caregivers; and
   4. (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. (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:

   1. (a) Removed from availability for retail purchase or transfer; and
   2. (b) Quarantined and stored from all other product in final packaged form that is not part of the recall.

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.