Today, the Bureau of Cannabis Control released a new fact sheet containing important information on cannabis laboratory testing requirements. This new document summarizes the requirements for a cannabis goods batch that fails regulatory compliance testing, including requirements for completing and submitting Certificates of Analysis (COAs) to the Bureau.

The fact sheet is now accessible on California’s Cannabis Portal:

https://cannabis.ca.gov/wp-content/uploads/sites/13/2018/08/Laboratory-Testing-Fact-Sheet.pdf

Requirements for a Cannabis Goods Batch That Fails Regulatory Compliance Testing:

A cannabis goods batch that fails any test performed by a licensed testing laboratory fails regulatory compliance testing and may not be transported to any retailer for sale. If a cannabis goods batch fails regulatory compliance testing, the laboratory may not retest the batch and must issue a Certificate of Analysis (COA) based on the initial testing. Cannabis goods that have received a failing COA due exclusively to label claims may be relabeled to match the results on the COA.

A licensed testing laboratory shall not amend any COA after issuance. Cannabis goods that fail regulatory compliance testing must be quarantined at the distribution premises with a clearly identifiable batch number. Retesting is not a form of remediation. Any retesting performed without remediation will not supersede the original test results performed by the licensed testing laboratory.

A failed cannabis goods batch may be remediated or destroyed if the licensed manufacturer or licensed microbusiness complies with the following: Prior to any remediation, the licensed manufacturer or licensed microbusiness must submit a corrective action plan to the California Department of Public Health (CDPH) at RP.MCSB@cdph.ca.gov. CDPH will review and ultimately approve or deny remediation plans.  Once the cannabis goods have been remediated and returned to the distributor’s premises, the cannabis goods batch must pass all required regulatory compliance testing before being transported to a retailer for sale.

Requirements for Certificates of Analysis (COAs):

All COAs issued by a licensed laboratory must be sent to BCC.Labs@dca.ca.gov within one business day of completing the analyses of the sample. The laboratory shall test each sample for each of the required analytes and shall report the results of each analysis performed by the laboratory on the COA. Once a sample has been collected by the laboratory, the laboratory must test it for each analyte and must report the results on the regulatory compliance COA. (There is no process for the licensee requesting testing to cancel the testing once a sample has been collected from the distributor’s premises.)

The COA must accurately reflect all testing that is conducted, even if one or more tests were not requested by the licensee or required by the bureau’s regulations. A licensed testing laboratory shall not amend any COA after issuance.

A unique lot/batch number must be used to identify each cannabis goods batch. The same batch number may NOT be used for multiple batches. The bureau’s regulations do not permit the reporting of any results prior to the completion of analyses, nor prior to the release of the regulatory compliance COA. Laboratories are not permitted to release results as they become available via an online portal or any other type of notification. (For example, it is not permitted to allow the requester to access or notify them of results upon completion of each individual analysis— cannabinoid, pesticide, microbial testing, etc.)

 

Laboratory-Testing-Fact-Sheet