Mont. Admin. r. 42.39.312 - MARIJUANA ITEM RECALLS

(1) For purposes of this rule, the following definitions apply:

(a) "affected licensee" means a licensee whose marijuana or marijuana products are subject to a recall. More than one licensee may be an affected licensee in a recall;

(b) "affected product" means marijuana or a marijuana product subject to a recall.

(2) A recall is required when marijuana or marijuana products pose a risk to public health and safety. A recall shall be based on evidence that marijuana or a marijuana product is contaminated or otherwise unfit for human use, consumption, or application.

(3) A licensee must develop a recall plan that establishes the procedures the licensee will follow in the event of a recall of its product or products. A recall plan must, at a minimum:

(a) designate a member of the licensee's staff who serves as the licensee's recall coordinator;

(b) establish procedures for identifying and isolating product to prevent or minimize its distribution to customers;

(c) establish procedures to retrieve and destroy product; and

(d) establish a communications plan to notify those affected by the recall, including:

(i) how the affected licensee will notify registered cardholders and other licensees in possession of affected product; and

(ii) the use of a press release and other appropriate notifications to ensure customers are notified of the recall and affected product information.

(4) If the department or the Department of Public Health and Human Services determines that a recall is required, an affected licensee shall:

(a) immediately notify registered cardholders and other licensees that received the affected product;

(b) immediately issue a press release or other appropriate public notification to inform customers of the recall and identifying information about the affected product recalled;

(c) provide the department with a copy of the press release or other appropriate public notification in (4)(b);

(d) post on its website, if applicable, information about the recall and the affected product; and

(e) perform a causation analysis to determine the issue or issues leading to the recall and provide to the department a corrective action report and preventative action report, as both are defined by the Department of Public Health and Human Services, which details how the affected licensee plans to correct and prevent future recalls

(5) An affected licensee must coordinate with the department for destruction of the affected product and allow the department to oversee the destruction.

(6) An affected licensee must track the total amount of affected product and the amount of affected product returned to the affected licensee as part of the recall effort. The affected licensee must periodically report to the department on the progress of the recall efforts.

(7) If an affected licensee determines that a recall is required, it must immediately notify the department. The affected licensee must then follow the procedures established in (4) through (6).

(8) If the department determines that a recall is successful, and the risk to public health and safety is no longer present, the department shall notify the affected licensee and close the recall.

(9) The department shall maintain a marijuana recall page on its website of all current recalls.

Notes

Mont. Admin. r. 42.39.312

TRANS, from 37.107.420, 2021 MAR p. 765, Eff.7/2/2021; AMD, 2021 MAR p. 1971, Eff. 1/1/2022

AUTH: 16-12-112, MCA; IMP: 16-12-105, 16-12-112, 16-12-209, MCA