15.03.270 Samples for Lab Analysis

(a) For each lot of medical marijuana product produced, the registered entity shall submit a predetermined number of final medical marijuana products (e.g., sealed vials or capsules; with the number of samples submitted, based on statistical analysis, determined to be representative of the lot) to an independent laboratory/laboratory approved by the Authority. The laboratory verifying the cannabinoid content shall be approved for the analysis of medical marijuana product by the Authority. Such laboratory, or approved laboratories cumulatively, shall certify the medical marijuana product lot as passing all contaminant testing and verify that the content is consistent with the brand prior to the medical marijuana product being released from the manufacturer to any dispensing facility.

(1) Any lot not meeting the minimum standards or specifications for safety shall be rejected and destroyed by the registered entity in accordance with Chapter of this Part.

(2) Any lot not meeting the minimum standards or specifications for brand consistency shall be reported to the Authority and not dispensed by a registered entity without prior written approval from the Authority.

(3) The registered entity shall keep and maintain records documenting submission of medical marijuana products to approved laboratories as required herein, and the results of the laboratory testing. The registered entity shall provide the Authority with such records upon request.

(b) The registered entity shall demonstrate the stability of each approved medical marijuana product produced (each brand in each form) by testing both the unopened and opened product at an approved laboratory under Subchapter 10.

(1) The stability of opened products shall be validated under the conditions (light,

temperature and humidity), specified for storage of the product and an expiration date for opened product shall be determined;

(2) The stability of unopened products (e.g., sealed packages or vials) shall be validated by ongoing stability testing and an expiration date for unopened products shall be determined.

(3) Specifications regarding storage conditions must address storage at the manufacturing facility once the package is sealed, during transport, at the dispensing facility, in the patient's home and for samples retained for future testing.

(c) No synthetic marijuana additives nor any cannabinoid preparation not produced by a registered entity in an approved manufacturing facility shall be used in the production of any medical marijuana product.

(d) The registered entity's approved standard operating procedure for the aforementioned activities must be followed, unless otherwise approved by the Authority.