Md. Code Regs. 14.17.19.02

Current through Register Vol. 51, No. 26, December 27, 2024

Section 14.17.19.02 - Research and Development

A. The Administration may register an entity to grow, process, test, or transfer cannabis for the purposes of research and development.

B. An entity under §A of this regulation shall conduct research and development only for the purposes under Alcoholic Beverages and Cannabis Article, §36-702, Annotated Code of Maryland.

C. Registration.

(1) An entity shall submit an application to the Administration that includes:

(a) The name of the primary researcher or entity;

(b) The address the research will be primarily taking place;

(c) The research purpose; and

(d) An application fee as specified in COMAR 14.17.21.

(2) Registrations under this regulation shall be valid for 2 years and may be renewed for additional 2 year terms in a manner determined by the Administration.

D. Research and development entities under this regulation shall otherwise comply with Alcoholic Beverages and Cannabis Article, §36-702, Annotated Code of Maryland, and the following requirements:

(1) The study shall be conducted in conformity with study protocols provided and any additional Administration guidance;

(2) The entity shall notify the Administration of any adverse events reported by study participants within 48 hours of the study's primary researcher being made aware of the adverse event;

(3) Within 30 days, the entity or primary researcher shall update the Administration with any changes to the study protocols, including but not limited to:

(a) Scope;

(b) Researcher;

(c) Number of participants;

(d) Study duration; and

(e) Products used;

(4) The entity may continue to conduct research under this regulation while awaiting Administration approval of any changes to the study protocols;

(5) The entity or primary researcher shall provide documentation of Institutional Review Board or Institutional Animal Care and Use Committee, whichever is applicable, approval prior to the beginning of the study;

(6) An entity shall track the cannabis used for research and development in the seed-to-sale tracking system;

(7) A batch or lot of cannabis originally used or processed for research and development purposes:

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

(b) Shall be destroyed and logged as green waste; and

(8) An entity shall maintain a record of all research and development tests for at least 2 years and provide copies of the test results to the Administration, upon request.

E. Edible Cannabis Product Development. An entity that processes edible cannabis products for research and development shall:

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

(2) Process the cannabis for research and development during a time that does not overlap with the processing of any cannabis that will be intended for distribution.

F. Limited Testing for Edible Cannabis Product Development.

(1) An entity may conduct the research and development testing on the entity'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.

(3) The cannabis product shall be categorized as "Work in Process" in the seed-to-sale tracking system.

(4) Any edible cannabis product transferred from the premises for research and development testing shall:

(a) Be packaged in accordance with COMAR 14.17.18.05;

(b) Be labeled with the statements:

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

(ii) "This product has not been approved by the Administration and is intended for research and development purposes only.";

(c) Identify the name and telephone number of the entity who manufactured the product; and

(d) Include a unique identifying number.

Md. Code Regs. 14.17.19.02

Regulation .02 adopted effective 50:14 Md. R. 559, eff. 7/1/2023 (EMERGENCY); adopted effective 51:14 Md. R. 676, eff. 6/7/2024, exp. 8/31/2024 (Emergency); adopted effective 51:14 Md. R. 678, eff. 7/22/2024.