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(1) If the results of quality assurance testing for any analyte/method exceed the action limits defined in ARM 37.107.316, then the sample and related lot or test batch has "failed" quality assurance testing.

(2) When a marijuana testing laboratory performs quality assurance testing, the laboratory must verify that the following quality control criteria are within acceptable limits based upon the laboratory's method specific standard operating procedures, the laboratory quality assurance plan, and the manufacturer's instructions for use, if applicable:

(a) standard curves;

(b) method blank;

(c) laboratory control sample(s);

(d) positive and negative controls;

(e) laboratory replicate values;

(f) matrix spike sample(s);

(g) continuing calibration verification sample;

(h) sample preparation controls; and

(i) crossing thresholds.

(3) If the quality control criteria for initial quality assurance testing are within acceptable limits, then the results of all individual samples within the analytical batch are considered valid, including "failed" samples and must be reported.

(4) A provider may request that the laboratory resample the failed batch or lot for repeat testing within seven calendar days of receiving notice from the laboratory of any failed testing and resampled analyses must be completed by the laboratory within 30 days of receiving the request from the provider.

(5) Quality assurance testing on resampled batches or lots must include all of the analytes defined in ARM 37.107.316.

(6) The results of resample quality assurance tests are considered valid and must be reported if the quality control criteria are within the acceptable limits.

(7) The provider is responsible for the costs of resampling and retesting.

(8) If the quality control criteria for initial quality assurance testing are not within acceptable limits, then the results of all individual samples within an analytical batch are considered invalid (failed run) and the entire run must be repeated with new controls and not reported.

(9) The laboratory should document and investigate failed runs, as part of the laboratory's quality assurance plan, to determine the root cause of the failure and whether corrective and preventative action measures are warranted.

(10) A provider is not permitted to sell or transfer to a registered cardholder, marijuana items that have a failed quality assurance test.

(11) Failed harvest lots or test batches may be remediated as long as the remediation method does not impart any substance or effect to the usable marijuana, marijuana concentrates, or marijuana-infused products that may have a toxic or deleterious effect on the health of the consumer.

(12) Remediation methods used on specific lots or batches of marijuana or marijuana-infused products that have failed initial quality assurance testing must be disclosed to the state laboratory and to the Medical Marijuana Program prior to remediation.

(13) No remediated harvest lots or test batches may be sold or transferred until the completion and successful passage of all quality assurance testing, and the results certified in a certificate of analysis, as required in these rules and Montana statute.

(14) With the exception of moisture analysis or residual solvent screening, a remediated sample from a failed harvest lot or test batch that fails quality assurance testing cannot be remediated again and the harvest lot or test batch must be destroyed. Harvest lots or test batches that fail initial quality assurance testing for moisture analysis or residual solvent screening may be remediated and retested a maximum of two times.

(15) A laboratory licensee must document all sampling, testing, retesting, remediation, and destruction that are a result of failing a test under this subchapter.


History: 50-46-344, MCA; IMP, 50-46-304, 50-46-311, 50-46-326, 50-46-329, 50-46-344, MCA; NEW, 2019 MAR p. 1868, Eff. 10/19/19.

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