1. A. Controls for Processing of Cannabis Concentrates and Cannabis-Infused Products.

   1. (1) A licensed processor of cannabis concentrates and cannabis-infused products shall:

      1. (a) Develop standard operating procedures in accordance with COMAR 14.17.11.19, good manufacturing practices, and a training plan before producing cannabis concentrates and cannabis-infused products;

      2. (b) Require that any person involved in processing cannabis concentrates and cannabis-infused products:

         1. (i) Is appropriately trained in accordance with their job description to safely operate and maintain the system used for processing;
         2. (ii) Has direct access to applicable material safety sheets and labels; and
         3. (iii) Follows OSHA protocols for handling and storage of all chemicals;
      3. (c) Assign a unique lot number to each lot of cannabis concentrate or cannabis-infused product;
      4. (d) If using a solvent-based extraction method, ensure solvents are at least 99 percent pure;

      5. (e) Require:

         1. (i) The use of solvents in a professional grade, closed-loop extraction system designed to recover the solvents;
         2. (ii) Work in a spark-free environment with proper ventilation; and
         3. (iii) Following all applicable OSHA regulations, and local fire, safety, and building codes in the processing and storage of the solvents; and

      6. (f) If using carbon dioxide gas extraction, ensure:

         1. (i) Every vessel is rated to a minimum of 900 pounds per square inch;
         2. (ii) The use of a professional grade, closed-loop system; and
         3. (iii) The use of carbon dioxide that is at least 99 percent pure.
   2. (2) A licensed processor may use heat, screens, presses, steam distillation, ice water, and other methods to produce cannabis concentrates.
2. B. Upon successful completion of a validation process, the licensed processor shall use an Administration-registered independent testing laboratory to test each unique lot of cannabis concentrate or cannabis-infused product and obtain a certificate of analysis.

3. C. Batch Release Controls.

   1. (1) If a licensed processor, upon review of the certificate of analysis, determines that a lot meets the specification for the product, the licensed processor may:

      1. (a) Assign an expiration date to the lot;
      2. (b) Release the lot for distribution; and
      3. (c) Revise the status of the lot in the seed-to-sale tracking system.

   2. (2) If a licensed processor receives test results that the lot falls outside action limits, the licensed processor:

      1. (a) May rework or reprocess the lot according to their standard operating procedure; and
      2. (b) If applicable, shall ensure the reworked or reprocessed lot is resampled and retested by the independent testing laboratory to meet all required specifications.
   3. (3) A licensed processor shall retain every certificate of analysis.
   4. (4) All cannabis products shall have a certificate of analysis, as specified in COMAR 14.17.08.05A(5), prior to transfer to a licensed dispensary.

4. D. Stability Testing and Retention Sampling.

   1. (1) A processor shall provide a sample from each unique lot to an independent testing laboratory sufficient to perform stability testing at 6-month intervals to:

      1. (a) Ensure product potency and purity; and
      2. (b) Provide support for expiration dating.

   2. (2) Retention samples retained from each released lot shall be:

      1. (a) Tested by the State Cannabis Testing Laboratory following an adverse event reported to the Administration;
      2. (b) Properly stored by the licensed processor; and
      3. (c) Properly discarded 6 months after the expiration date of the lot.

5. E. Correction and Prevention Action.

   1. (1) If a processor’s test results indicate the confirmed presence of a pathogen more than once in a 60-day period, the processor shall:

      1. (a) Conduct environmental swab testing as required by the Administration’s Technical Authority;
      2. (b) Conduct an investigation to determine the root cause of contamination;
      3. (c) Decontaminate all areas, including rooms, equipment, and surfaces used for cannabis product processing;

      4. (d) Provide, in the manner designated by the Administration:

         1. (i) A report of the investigation; and
         2. (ii) The licensee’s corrective action plan; and
      5. (e) If applicable, update and implement standard operating procedures needed to ensure passing samples in the future.

   2. (2) The Administration may require a processor to:

      1. (a) Conduct further investigation; and
      2. (b) Implement additional procedures to prevent future contamination.

Authority: Alcoholic Beverages and Cannabis Article, §§36-202, 36-203, and 36-401, Annotated Code of Maryland

Effective date:

Regulations .01—.07 adopted as an emergency provision effective July 1, 2023 (50:14 Md. R. 559); emergency status expired June 30, 2024

Regulations .01—.19 adopted as an emergency provision effective June 7, 2024 (51:14 Md. R. 676)

Regulations .01—.19 adopted effective July 22, 2024 (51:14 Md. R. 678)

Regulation .03B amended effective March 16, 2026 (53:5 Md. R. 244)

Regulation .04C amended effective April 14, 2025 (52:7 Md. R. 324)

Regulation .04E adopted effective March 16, 2026 (53:5 Md. R. 244)

Regulation .17D adopted effective March 16, 2026 (53:5 Md. R. 244)

Regulation .18B amended effective April 14, 2025 (52:7 Md. R. 324)

Regulation .19A amended effective May 26, 2025 (52:10 Md. R. 436); March 16, 2026 (53:5 Md. R. 244)