How to report stability study results in Metrc

Minnesota’s Office of Cannabis Management (OCM) is providing testing facility instruction on how to report stability testing results for the lab sample batch evaluated at each stability timepoint.

Note: A stability study is defined in the Cannabis Technical Authority (Section IX, Page 14).

Stability testing is required for all products. Product stability must be evaluated in the final packaged form to establish an expiration (or best-if-used-by) date for the product. Product stability must be established on the first batch for each cultivation or manufacturing process. If the cultivation or manufacturing process changes, stability must be demonstrated for the new cultivation or manufacturing process.

For each stability test timepoint, the lab will document storage of a portion of a sample from one batch in the final packaged form. The sample must be stored at the conditions specified on the product label or, if none are indicated, at room temperature and not in direct sunlight until the stability test timepoint. The manufacturer must provide the licensed testing laboratory with an adequate sample volume in the final packaged form to generate a sufficiently sized composite of the samples at each stability test timepoint. The testing facility is not required to analyze the minimum sample volume at each timepoint. The manufacturer may test at whatever time increments are appropriate for the material. The manufacturer and testing facility will agree on a stability testing timeline for each product.

At the stability test timepoint, the sample will be analyzed for microbial content (as specified in Section I), cannabinoid profile (as specified in Section VII), and any contaminant category that could leach from the packaging. For example, solutions stored in vape devices should be tested for heavy metals. Each manufacturer should evaluate if additional contaminant categories are relevant for stability timepoint analysis.

To meet the stability requirements for each timepoint, the microbial content must meet those specified in Section I and the concentration of the cannabinoid present at the highest concentration must vary by less than 15% of the label claim, as compared to the potency determined at T0 or, if there is no label claim, from the amount determined at T0.

Until data have been collected establishing evidence-based expiration (or best-if-used-by) dates, a cannabis product will have a six-month expiration date. If a license holder has data to support a longer expiration date on the first batch, they can submit those data to the office for evaluation on a case-by-case basis. Stability testing must be initiated within three months for any new products. Failure to demonstrate six-month stability will result in an assigned expiration date according to the last demonstrated passing results for that product.

Metrc actions to report stability study data

T0 timepoint: To initiate a stability study, a business should contact a testing facility and request the stability testing schedule that will meet their needs. Product stability should be evaluated on the first batch of a cultivation or manufacturing process; the business will submit the representative lab test sample to the testing facility with sufficient material for the batch compliance testing and all stability testing timepoints. The business should select the lab test batches for compliance testing and “Stability Study T0 (and the corresponding product type)." The stability study test material will be in addition to or part of the representative sample material that is evaluated for batch compliance testing. The testing facility will perform the batch compliance testing and report the results for potency and microbial testing as both the compliance batch testing and “Stability Study T0 (and the corresponding product type).”

T1 timepoint: The testing facility will retain the remaining lab sample from T0 and the compliance batch testing and hold it at their facility as agreed upon between the business and testing facility. At the agreed upon time point, the testing facility will pull sufficient material for the stability analysis. The results from this analysis will be reported for the same Metrc ID as the initial lab sample as “Stability Study T1 (and the corresponding product type).” Note: the business will NOT request testing for “Stability Study T1” through Metrc. The results can be reported without the test being requested by uploading the appropriate set of results from the Lab Test Batch upload guide. If the business requests “Stability Study T1 (etc.)” testing, their entire batch will be on hold for the entirety of the stability analysis.

Tn timepoints: The testing facility will continue to retain the lab sample and report additional testing timepoints in sequential order as agreed upon with the business. If the testing facility generates failing results, they will report the failing results which will indicate that the product stability was demonstrated as the Tn-1 timepoint. If a product demonstrates passing results at the last tested timepoint, additional stability studies are not required and the product may be assigned a stability of the last timepoint with passing results.

Lab Test Batch upload guide

OCM will provide the templates for reporting results in a .csv file for all lab test results. The reporting guide has the lab test batch configurations that will be used to report each stability testing timepoint. T0 is reported along with the compliance testing results for the batch, and a testing facility will upload the sequential timepoints: T1, T2, at the agreed upon schedule as determined with the laboratory. The testing results uploaded for the stability timepoint will not override the initial test results as long as the testing facility ensures that it uploads the next sequential stability timepoint. The testing facility should ensure that the appropriate product category is used to report the stability study results.