Code of Maryland Regulations (Last Updated: April 6, 2021) |
Title 10. Maryland Department of Health |
Part 5. |
Subtitle 62. NATALIE LAPRADE MEDICAL CANNABIS COMMISSION |
Chapter 10.62.17. Complaints, Adverse Events, and Recall |
Sec. 10.62.17.03. Complaint Investigation by Grower or Dispensary
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A. Whenever a complaint regarding the quality or safety of medical cannabis is received by a licensed grower, licensed processor or licensed dispensary, a licensee shall, within 24 hours, review the complaint to determine if it is substantive or reports a serious adverse event.
B. If a licensee determines that the complaint is substantive or reports a serious adverse event, a licensee shall:
(1) Promptly determine the batch number or lot number of the medical cannabis, the medical cannabis finished product, and medical cannabis concentrate that is the subject of the complaint; and
(2) Investigate the record and circumstances of the production of the batch and lot to determine:
(a) If there was a deviation from the standard operating procedure in the production of the medical cannabis by reviewing production logs; and
(b) If the sample meets specification by submitting parts of the retention samples of the batch and lot to an independent testing laboratory.
C. If sample analysis of the batch or lot reveals that the batch or lot fails to meet specification, the licensee shall:
(1) Order a recall of all products derived from or included in the batch or lot;
(2) Notify all patients, caregivers, and dispensaries who may have obtained medical cannabis products from such a batch or lot of the recall; and
(3) Offer and pay reimbursement for any returned medical cannabis.
D. In a case of a report of a serious adverse event or a substantive complaint, if the investigation reveals a deviation from the standard operating procedure in the production of the batch or lot, the licensee may:
(1) Order a recall of all products derived from or included in the batch or lot;
(2) Notify all patients, caregivers, and dispensaries who may have obtained medical cannabis products from such a batch or lot of the recall; and
(3) Offer and pay reimbursement for any returned medical cannabis.