According to Administrative Rule 61(2), processed marijuana-infused products must be homogenous. The allowable variation for weight and delta-9 tetrahydrocannabinol (THC) potency between the actual results and the intended dose is to be +/- 15%. This is the Marijuana Regulatory Agency’s (MRA) guidelines for a processor to follow to verify the marijuana-infused product is homogeneous.
Ensuring that delta-9 THC concentration and weight are distributed uniformly throughout a batch of a marijuana-infused product provides patients with the assurance that the dose of medication is accurate and consistent. A patient who is accustomed to a gummy containing a specific amount of delta-9 THC knows what effect to expect from that dose. When products are not homogenous, the delta-9 THC concentration varies and could result in the patient being either underdosed or overdosed.
A packaged unit of marijuana-infused product cannot contain more than the published THC Limit and must be divided into distinct and easily identifiable dosages. Each dose must not contain more than the maximum published THC Limit.
Testing for homogeneity is not required on every batch of marijuana-infused product. The testing is required on the initial batch and every six months, as verification, if the manufacturing process does not change. The processor should attest that there are no changes to the manufacturing process prior to the Safety Compliance Facility (SCF) taking a sample. The SCF should include this attestation on the chain of custody form.
To perform homogeneity testing, each dose shall be treated as a separate sample. The weight and concentration of delta-9 THC must be recorded and the variation must only be +/- 15% amongst all samples.