The Kentucky Office of Medical Cannabis (“OMC”) released Technical Advisory 2025-002, “Guidance re Determining and Documenting Measurement Uncertainty in Medical Cannabis Testing,” on February 3, 2025. This guidance addresses required reporting of measurement uncertainty by safety compliance (testing) facility licensees.
Specifically, safety compliance facility licensees are directed to take the following actions:
- Determine the measurement uncertainty of each test they conduct;
- Document the methods used to determine measurement uncertainty in their respective standard operating procedures; and
- Report measurement uncertainty on all Certificates of Analysis provided to other licensed medical cannabis businesses.
OMC referenced the certification of accreditation required to be provided by safety compliance facility licensees, 915 KAR 1:060(1)(6)(g), which in turn requires compliance with International Organization for Standardization (ISO) Standard 17025: “General requirements for the competence of testing and calibration laboratories.” Among other guidance, Section 7.6 of ISO 17025 requires:
- Identification of all significant contributions to uncertainty in their measurements;
- Evaluation of uncertainty contributions as part of all instrument calibrations; and
- Evaluation and estimation of measurement uncertainty of all performed testing.
Safety compliance facility licensees should carefully review and follow the requirements of ISO 17025 when preparing for, performing and reporting testing of medical cannabis products.
Kentucky’s medical cannabis market continues to develop following the initial period of licensee awards to cultivators, processors and dispensaries, as well as safety compliance facilities. Compliance with regulatory requirements will be a key concern for all cannabis businesses moving forward, as well as understanding the effects of compliance by one cannabis business in the chain from plant to consumer.
Medical cannabis business owners should carefully review all regulations and requirements under Kentucky law as they continue to develop their business and operations, and continue to check for additional guidance and updates from OMC. If you have any questions about remaining compliant with the ever-changing landscape of cannabis laws and regulations, our team is available to assist.
