Md. Code Regs. 10.62.37.15

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

Section 10.62.37.15 - Limited Testing for Research and Development Purposes

A. A licensed processor may process edible cannabis products for research and development purposes to facilitate safe edible cannabis product development and innovation.

B. The research and development of the edible cannabis products under this regulation may not include testing of any type on human or animal subjects.

C. Edible Cannabis Product Development. A licensed processor who processes edible cannabis products for research and development shall:

(1) Track the medical cannabis used for research and development in the perpetual inventory control system;

(2) Quarantine each batch or lot in a quarantine area and label each batch or lot with a distinctive label;

(3) Process the medical cannabis for research and development during a time that does not overlap with the processing of any medical cannabis that will be intended for human consumption; and

(4) Establish standard operating procedures for cleaning and sanitation that:

(a) Include protocols for adequately cleaning processing areas, cookware, and equipment in between processing edible cannabis products for research and development purposes and processing products intended for human consumption; and

(b) Are approved by the Commission.

D. Research and Development Testing.

(1) A licensed processor may conduct the research and development testing on the processor's premises or through an independent testing laboratory.

(2) If an independent testing laboratory conducts the research and development testing on the edible cannabis product, the laboratory shall clearly mark any certificate of analysis or reporting of test results with "R&D TESTING ONLY" on the header and footer of the report in 20-point white font and a red background.

E. Any edible cannabis product transferred from the licensed premises for research and development testing shall:

(1) Be packaged in accordance with Regulation .13C of this chapter;

(2) Be labeled with the statements:

(a) "CAUTION: NOT FOR HUMAN OR ANIMAL CONSUMPTION."; and

(b) "This product has not been approved by the Maryland Medical Cannabis Commission and is intended for research and development purposes only.";

(3) Identify the name and telephone number of the licensed processor who manufactured the product; and

(4) Include a unique identifying number.

F. A batch or lot of medical cannabis originally used or processed for research and development purposes:

(1) May not be used in the processing of medical cannabis sold to a licensed dispensary; and

(2) Shall be destroyed and logged as green waste.

G. A licensed processor shall maintain a record of all research and development tests for at least 2 years and provide copies of the test results to the Commission, upon request.

Md. Code Regs. 10.62.37.15

Regulation .15 adopted effective 48:8 Md. R. 309, eff. 4/19/2021