Md. Code Regs. 14.17.14.01

Current through Register Vol. 51, No. 24, December 2, 2024

Section 14.17.14.01 - Complaints, Adverse Events, and Recall

A. The Administration, licensees, and certifying providers shall establish a procedure to receive, organize, store, and respond to all oral, written, electronic, or other complaints regarding any cannabis product and severe adverse events.

B. In the event a licensee or certifying provider receives a complaint regarding the quality or safety of a product, including a report of a serious adverse event, the licensee or certifying provider shall report the complaint within 24 hours to:

(1) The Administration;

(2) If applicable, the licensed grower or processor from which the cannabis originated; and

(3) If applicable, the licensed dispensary that dispensed the cannabis.

C. Complaint Investigation Process.

(1) After notifying the Administration about a complaint as required in §B of this regulation, a licensee or certifying provider shall:

(a) Promptly identify the batch number or lot number of the cannabis or cannabis product, or any other product that is the subject of the complaint;

(b) Investigate the production of the batch or lot to determine if there was a deviation from the standard operating procedure in the production of the batch or lot;

(c) Send part of the retention sample of the batch or lot to an independent testing laboratory to determine if it meets quality and safety standards; and

(d) If there is reasonable cause to suspect communicable disease transmission from or by an agent, collect morbidity history from any suspected agents.

(2) If the sample analysis conducted under §C(1) of this regulation reveals that the batch or lot fails to meet quality and safety standards, the licensee shall:

(a) Order a recall of all products derived from or included in the batch or lot;

(b) To the extent possible, notify all adult-use consumers, patients, caregivers, and dispensaries who may have obtained cannabis products from such a batch or lot of the recall; and

(c) Pay reimbursement for any returned cannabis.

(3) In the case of a report of a serious adverse event, if the investigation reveals a deviation from the standard operating procedure in the production of the batch or lot, the licensee shall:

(a) Order a recall of all products derived from or included in the batch or lot;

(b) Notify all adult-use consumers, patients, caregivers, and dispensaries who may have obtained cannabis from such a batch or lot of the recall; and

(c) Pay reimbursement for any returned cannabis.

(4) If the licensee's investigation reveals there is reasonable cause to suspect communicable disease transmission from or by an agent, the licensee shall ensure that appropriate follow-up action is taken, whenever applicable, including but not limited to:

(a) Immediately excluding any indicated agent from the licensed facility;

(b) Issuing an order to recall all products derived from, or included in, any affected batch or lot;

(c) To the extent possible, notifying all adult-use consumers, patients, caregivers, and dispensaries who may have obtained cannabis from any affected batch or lot of the recall;

(d) Reimbursing for any returned cannabis;

(e) Immediately closing the licensed premises until medical and epidemiological evidence shows that the likelihood of further disease transmission is low; and

(f) In accordance with COMAR 10.06.01, conducting an investigation, a report, and control of a communicable disease outbreak.

D. Custody of Returned Recalled Cannabis Products.

(1) The licensee shall develop a procedure to ensure cannabis that is recalled is stored and segregated until disposal of recalled material is authorized by the Administration.

(2) Within 24 hours of the receipt of notice from the Administration that the disposal of recalled cannabis is authorized, the licensee shall dispose of the recalled cannabis according to its standard operating procedure.

Md. Code Regs. 14.17.14.01

Regulation .01 adopted effective 50:14 Md. R. 559, eff. 7/1/2023 (EMERGENCY); adopted effective 51:14 Md. R. 676, eff. 6/7/2024, exp. 8/31/2024 (Emergency); adopted effective 51:14 Md. R. 678, eff. 7/22/2024.