Md. Code Regs. 14.17.11.04

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

Section 14.17.11.04 - Cannabis Product Processing

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 does not meet specifications, the licensed processor:

(a) Shall notify the Administration of the determination within 24 hours of the receiving the test results;

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

(c) 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.

Md. Code Regs. 14.17.11.04

Regulation .04 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.