Rule 351-4-.12 - Product Recall Procedures(1) If the Commission receives information demonstrating that a recall is necessary to protect patients or to protect public health and safety, and a production licensee does not initiate a recall, then the Commission may order such recall until the risk to such health and safety is no longer present.(2) A production 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) Factors that necessitate a recall;(b) Employees responsible for implementing the recall procedures;(c) Notifications to patients, caregivers, the public, and the Commission and its employees;(d) The collection and transport of such recalled product from a dispensing licensee or pharmacy to the originating production licensee; and(e) Factors determining when a licensee-initiated recall may be terminated.(3) Prior to a licensee-initiated recall, a production licensee shall provide notice to the Commission and its employees, with such notice including, at a minimum, the following:(a) Information that necessitates a recall, including a summary of any adverse events and symptoms experienced by patients;(b) Details of the product in final packaged form subject to the recall, including the brand name(s), unique identifying manufactured batch number(s), and the expiration date(s) of such product;(c) The total number of product in final packaged form that are subject to the recall, including the locations of dispensaries and pharmacies which may be dispensing such product; and(d) A detailed plan for the recall and the recalled product, including whether the licensee plans to quarantine, remediate, retest, or dispose of such product in accordance with the rules of the Commission.(4) When a recall is initiated, whether by the production licensee or ordered by the Commission, then such licensee shall post a notice of such recall within twenty-four (24) hours of initiating a recall in a prominent location on the licensee's website and social media until the recall is terminated. Copies of such notice shall be provided to dispensaries and pharmacies that dispensed such recalled product. Such notice shall include, at a minimum, the following: (a) The brand name(s), unique identifying manufactured batch number(s), and the expiration date(s) of the recalled product in final packaged form.(b) The contact information of such licensee, including the designated phone number, electronic mail address, and website for information about such recall and recalled product; and(c) Readily accessible information regarding patient health, safety, treatment, disposal, poison control, or overdose, which may be made available.(5) During a recall, whether initiated by the licensee or ordered by the Commission, a production licensee shall submit a report to the Commission and its employees, on a weekly basis, with the following information:(a) The number of patients contacted who may be impacted by the recall;(b) Summary of adverse events, including symptoms, experienced by patients;(c) Efforts to retrieve the recalled product from dispensing licensees and pharmacies;(d) The amount of recalled product in final packaged form that have been returned;(e) The amount of recalled product in final packaged form outstanding; and(f) The progress of implementing such licensee's plan for the recall and the recalled product.(6) At the conclusion of a recall, whether initiated by the licensee or ordered by the Commission, the production licensee shall:(a) Complete an internal investigation to determine the cause(s) and issue(s) leading to the recall;(b) Submit a summary of findings from such investigation to the Commission;(c) Submit a plan to address the causes and issues, including prevention efforts, to the Commission; and(d) Inform the impacted dispensaries and pharmacies of the termination of such recall by providing them with written notice.Ga. Comp. R. & Regs. R. 351-4-.12
O.C.G.A. §§ 16-12-203, 16-12-206, 16-12-210, 16-12-211, 16-12-212, 16-12-213.
Original Rule entitled "Product Recall Procedures" adopted. F. Mar. 16, 2023; eff. Apr. 5, 2023.Amended: F. Nov. 9, 2023; eff. Nov. 29, 2023.