Remediation: Recovering After Failed Testing

What’s the What on Cannabis Remediation

All cannabis products must be tested before retail sale, but what happens if your product doesn’t pass required testing? You may have to destroy your product if it doesn’t pass. However, to avoid destruction, you must complete the process of remediation. Remediation is where a business remedies or corrects something undesirable or deficient in their product.

First, and unfortunately, there is no path to remediation for cultivators.  Only those licensed to manufacture cannabis may perform remediation on a cannabis product batch or a harvest batch. We highly recommend pursuing R&D testing as a cultivator if you have any doubts.

Second, it should be noted that re-testing is not allowed and is NOT a form of remediation. Licensed laboratories are not permitted to re-test the batch after a batch fails regulatory compliance testing and are required to issue a Certificate of Analysis based on initial testing. Furthermore, any re-testing performed without remediation will not supersede the original tests.

Remediation Steps

In order for a manufacturer or microbusiness to appropriately remediate a batch, the following steps must be taken:

  1. Upon being notified of failure, the licensed distributor or microbusiness authorized to engage in distribution must have the cannabis goods quarantined and stored separately and distinctly from others with a clear identifiable batch number.
  2. If the product was produced by a Microbusiness authorized to engage in manufacturing, the microbusiness must submit a corrective action plan to the Bureau of Cannabis Control (BCC) at Labs@dca.ca.gov within 30 calendar days of issuance of the COA.
  3. If the product was produced by a Manufacturer, the manufacturer must submit a corrective action plan to the California Department of Public Health (CDPH) at MCSB@cdph.ca.gov within 30 calendar days of issuance of the COA
  4. The licensed distributor must hold the failed cannabis goods batches in quarantine until the corrective action plan is approved.
  5. If the corrective action plan is approved, microbusiness or manufacturer may now reclaim the product to perform remediation and re-testing after remediation.

Failed cannabis goods batches for which a corrective action plan is not approved cannot be remediated and must be destroyed by the licensed distributor or microbusiness authorized to engage in distribution. If the batch has gone through the remediation process twice and fails testing it also must be destroyed.

Lastly, edible cannabis products cannot be remediated unless they failed required testing because 1) the per package limit of THC was exceeded and therefore the edible can be repackaged; or 2) there was a discrepancy in cannabinoid or terpenoid content and therefore can be relabeled with the correct information provided THC limits are not exceeded.

 

Remediation is the key to salvage cannabis and cannabis products that do not pass regulatory compliance testing. If you are having trouble navigating the remediation process or need assistance adding remediation clauses to a distribution contract give us a call.

 

For more details on what California state regulatory compliance testing is see the full BCC published laboratory testing fact sheet HERE

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