In developing the medical cannabis edibles regulations, the Commission made approval of an edible cannabis product exemption contingent, in part, on the licensee seeking the exemption demonstrating it was certified by an accredited third-party certification body “in an alternative pharmaceutical or dietary supplement certification approved by the Commission.” The regulations do not specify the type of pharmaceutical or dietary supplement certification required, but current Good Manufacturing Practices (cGMP) certification is the standard that the U.S. Food and Drug Administration adopted to ensure safe and effective food, drugs, dietary supplements, and medical devices. In addition, cGMP certifications in drug or dietary supplement manufacturing were discussed while drafting the edible cannabis product exemption regulations and in public meetings as potentially meeting this regulatory requirement. This is because the edible cannabis regulations had the same primary focus as FDAs cGMP regulations: the safe and sanitary receipt, storage, manufacture, transport, use, and disposal of products.
Audit to CSQ Code: Manufacturing of Cannabis Dietary Supplements with 21 CFR 111 Addendum