# COMAR Title 14 — Independent Agencies

## Subtitle 17 — Maryland Cannabis Administration

### Chapter 11 — Cannabis Processor Operations

#### Regulation .04 Cannabis Product Processing.

*COMAR 14.17.11.04*

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

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

    (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;

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

      (i) Is appropriately trained in accordance with their job description to safely operate and maintain the system used for processing;

      (ii) Has direct access to applicable material safety sheets and labels; and

      (iii) Follows OSHA protocols for handling and storage of all chemicals;

    (c) Assign a unique lot number to each lot of cannabis concentrate or cannabis-infused product;

    (d) If using a solvent-based extraction method, ensure solvents are at least 99 percent pure;

    (e) Require:

      (i) The use of solvents in a professional grade, closed-loop extraction system designed to recover the solvents;

      (ii) Work in a spark-free environment with proper ventilation; and

      (iii) Following all applicable OSHA regulations, and local fire, safety, and building codes in the processing and storage of the solvents; and

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

      (i) Every vessel is rated to a minimum of 900 pounds per square inch;

      (ii) The use of a professional grade, closed-loop system; and

      (iii) The use of carbon dioxide that is at least 99 percent pure.

  (2) A licensed processor may use heat, screens, presses, steam distillation, ice water, and other methods to produce cannabis concentrates.

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.

C. Batch Release Controls.

  (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:

    (a) Assign an expiration date to the lot;

    (b) Release the lot for distribution; and

    (c) Revise the status of the lot in the seed-to-sale tracking system.

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

    (a) May rework or reprocess the lot according to their standard operating procedure; and

    (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) A licensed processor shall retain every certificate of analysis.

  (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.

D. Stability Testing and Retention Sampling.

  (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:

    (a) Ensure product potency and purity; and

    (b) Provide support for expiration dating.

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

    (a) Tested by the State Cannabis Testing Laboratory following an adverse event reported to the Administration;

    (b) Properly stored by the licensed processor; and

    (c) Properly discarded 6 months after the expiration date of the lot.

E. Correction and Prevention Action.

  (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:

    (a) Conduct environmental swab testing as required by the Administration’s Technical Authority;

    (b) Conduct an investigation to determine the root cause of contamination;

    (c) Decontaminate all areas, including rooms, equipment, and surfaces used for cannabis product processing;

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

      (i) A report of the investigation; and

      (ii) The licensee’s corrective action plan; and

    (e) If applicable, update and implement standard operating procedures needed to ensure passing samples in the future.

  (2) The Administration may require a processor to:

    (a) Conduct further investigation; and

    (b) Implement additional procedures to prevent future contamination.