Regulation .04 Cannabis Product Processing.
Regulation .04 Cannabis Product Processing.LinkCopy Citation
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.