Newly licensed cultivators and processors will be subject to a myriad of regulatory requirements built into the program to protect public health and safety, including mandatory testing requirements.
So far, Kentucky has licensed three safety compliance facilities to test medical cannabis and medical cannabis products from across the state. The Office of Medical Cannabis also opened a new application period for this category of license through November 30, 2024. It is critical that enough safety compliance facilities are both licensed and operational when the program launches, in order to prevent a backlog in testing that could prevent a sufficient supply to meet patient demand.
Licensees must have samples from each harvest and production batch tested by safety compliance facilities to ensure the quality of medicinal cannabis through each stage of processing. Testing is performed to identify psychoactive compounds (THC and other cannabinoids along with terpene types and concentrations), production residuals (residual pesticides, processing chemicals, residual solvents, heavy metals, vitamin E acetate), and impurities/contaminants (microbial impurities, mycotoxins, water activity, yeast, and mold).
Kentucky law also imposes caps on the amount of delta-9 THC that can be present in medical cannabis and medical cannabis products. Raw plant material that tests over 35% delta-9 THC potency is considered cannabis waste and must be destroyed. Medical cannabis products intended for oral consumption as an edible, oil, or tincture cannot contain more than ten milligrams of delta-9 THC per serving, and concentrates containing a delta-9 THC content of more than 70% are prohibited.
A harvest batch or production batch sample that fails any initial testing may be reanalyzed by the safety compliance facility using the reserve sample for that harvest or production batch. In some cases, medical cannabis and medical cannabis products can be remediated or sterilized if they cannot pass testing requirements, subject to parameters outlined in the regulations for various scenarios.
For example, if a harvest batch or production batch sample fails microbial impurities testing, the harvest batch or production batch may be further processed if the processing method effectively remediates the batch and does not impart any toxic or deleterious substance to the medical cannabis in the batch. If a harvest batch sample fails water activity testing, the harvest batch may be further dried and cured by the cultivator or producer.
Where remediation is allowed, a harvest or production batch may only be remediated twice. If the harvest or production batch fails testing after a second remediation attempt and the second retesting, the harvest or production batch is deemed medical cannabis waste and destroyed by the cultivator, processor, or producer in accordance with the applicable regulations.
Prior to initiating any efforts to remediate a harvest or production batch, cultivators, processors, and producers must create and maintain detailed written procedures for each remediation process. Those procedures must be made available to the regulators upon request within three business days of receiving such a request or during an inspection. The licensees must document all remediation, sterilization, resampling, retesting, and disposal of medicinal cannabis that fails testing.
If your business has questions about testing requirements or how to develop effective and compliant plans for remediation of cannabis or cannabis products that fail testing, please reach out.
