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.21 Medical Cannabis Products and Components Not Subject to This Chapter.
C. The Commission may approve a request to exempt a dosage form from Regulations .01—.19 under the following conditions if the licensed processor submits:
(1) A completed application in a form prescribed by the Commission;
(2) Standard operating procedures for all aspects of the receipt, processing, storage, packaging, labeling, handling, tracking, and shipping of products in the dosage form;
(3) The dosage form is recognized by the United States Pharmacopeia, the National Formulary, or the Food and Drug Administration; and
(4) The licensed processor is certified by an accredited third-party certification body in an alternative pharmaceutical or dietary supplement certification approved by the Commission.
Licensees seeking an edible cannabis product exemption under COMAR 10.62.37.21 need to follow this process for each product they wish to be exempt from the edibles dosage limits.
Name of Licensee
Upload documentation demonstrating that the proposed dosage form is recognized by the U.S. Pharmacopeia, the National Formulary, or the Food and Drug Administration.
Upload Standard Operating Procedures (SOPs) for all aspects of the receipt, processing, storage, packaging, labeling, handling, tracking, and shipping of products in the proposed dosage form.
Upload File(s) detailing a complete ingredient list for the proposed dosage form.
Upload images of the product packaging, including any product labeling. Include multiple images to ensure all sides of the packaging are displayed.
Upload images of the product in the proposed dosage form.
Upload a copy of the cGMP certification issued to the licensee.
cGMP Support Documentation (Please upload your facility's cGMP final audit, corrective action plan, and the certification body's accreditation certificate)
I attest that the information reported on this form is accurate and complete as of this date: (Click on the box to select a date from the calendar)