Md. Code Regs. 10.62.37.21

Current through Register Vol. 51, No. 8, April 19, 2024

Section 10.62.37.21 - Medical Cannabis Products and Components Not Subject to This Chapter

A. Regulations .01-.19 of this chapter do not apply to the following:

(1) Dried leaves and flowers of the cannabis plant;

(2) Medical cannabis concentrates; and

(3) Medical cannabis-infused products as defined in COMAR 10.62.23.01B(3)(c).

B. A licensed processor may submit a request to the Commission to exempt a medical cannabis product intended for human consumption by oral ingestion, in whole or part, from Regulations .01-.19 of this chapter if the dosage form is recognized by the United States Pharmacopeia, the National Formulary, or the Food and Drug Administration.

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.

Md. Code Regs. 10.62.37.21

Regulation .21 adopted effective 48:8 Md. R. 309, eff. 4/19/2021