The statutory requirement in Minnesota’s medical marijuana statute states “the Commissioner shall require each medical cannabis manufacturer to contract with an independent laboratory to test medical cannabis produced by the manufacturer.” The purposes for testing each batch of product is for safety to ensure that the product is free from harmful contaminants, gauge dosage and assess cannabinoid profile to maximize patient benefit to ensure potency, ensure consistency and quality of product, and help guide development of industry standards.
Stability testing of the marijuana product is also required under the statute. The marijuana product must be tested at time intervals to assess stability characteristics. Stability testing is used to establish appropriate storage conditions and expiration dates. Accelerated studies may be used to establish tentative expiration dates and they can collect actual shelf life data until a tentative expiration date is verified or an appropriate date determined.
Stability testing is used to determine analyte categories such as a cannabinoid profile (THC, CBD, CBN, etc.), metals (arsenic, cadmium, lead, mercury) pesticides and plant growth regulators (abamectin, pyrthrins, bifenazate, daminozide, paclubtrazol), microbial contaminants in mycotoxins (viable aerobic bacteria, total coliforms, total yeast and mold), residual solvents (acetone, butane, IPA, MeOH, EtOH, and many more). The Commissioner will maintain and publish a detailed list of analytes available for approval. This allows for flexibility to add and remove analytes in the Commissioner shall review the list at least every six months. Any changes will be published in the state register and post it on the program’s website.
Minnesota’s medical marijuana statute states “the Commissioner shall approve the laboratory chosen by each manufacturer and require that the laboratory report testing results to the manufacturer in a manner determined by the Commissioner.” A laboratory may request to be approved by the Commissioner to test the eligible product types and analytes. Laboratory are encouraged to operate formal management systems in accordance to International Organization for Standardization (ISO) 17025 General Requirements for the Competency of Testing and Calibration Laboratories.
For the proposed application process, labs should submit application forms and require documentations, such as quality manuals and SOPs, the Commissioner will review documentation will determine award approval if the laboratory’s application meets quality system requirements. Inspections, announced or unannounced, of laboratories requesting approval or already approved laboratories may be conducted. Finally, approved laboratories will receive a letter of compliance.
There are also ongoing accreditation requirements. There are third-party accreditation bodies available for certification of cannabis testing laboratories (A2ALA, ACLASS). It is proposed that the laboratory shall receive ISO 17025 certification by December 31, 2016.