1. A. In this regulation, “novel product” means a cannabis product that is:

   1. (1) Not presently authorized in Maryland; and
   2. (2) Lawfully produced in another jurisdiction.
2. B. A licensed processor may submit a request to the Administration in a manner prescribed by the Administration to approve a novel product.

3. C. A valid novel product request shall include:

   1. (1) A detailed product description;
   2. (2) An explanation of how the product deviates from current regulations;
   3. (3) Evidence that the same product type is permitted in at least one other state’s regulated cannabis market; and

   4. (4) Health and safety information, including but not limited to:

      1. (a) Available information or studies regarding any beneficial or adverse effects from the use of the product; and
      2. (b) Packaging and labeling strategies to minimize risk to patients, consumers, and children.

4. D. The Administration may:

   1. (1) Make its own determination to approve or deny the request; or
   2. (2) Defer the request to the Public Health Advisory Council.
5. E. The Administration reserves the right to make a final determination on the request

Authority: Alcoholic Beverages and Cannabis Article, §§36-202, 36-203, and 36-203.1, Annotated Code of Maryland

Effective date:

Regulations .01—.11 adopted as an emergency provision effective July 1, 2023 (50:14 Md. R. 559); emergency status expired June 30, 2024

Regulations .01—.11 adopted as an emergency provision effective June 7, 2024 (51:14 Md. R. 676)

Regulations .01—.11 adopted effective July 22, 2024 (51:14 Md. R. 678)

Regulation .05G amended effective March 16, 2026 (53:5 Md. R. 244)

Regulation .08C amended effective April 14, 2025 (52:7 Md. R. 324)

Regulation .12 adopted effective April 14, 2025 (52:7 Md. R. 324)