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Proposed Medical Cannabis Manufacturing Regulations: New License "Type P"

 

The California Department of Public Health, Office of Manufactured Cannabis Safety, released proposed regulations on April 28, 2017 that would create a new license type, the “Type P” license, for “entities that only package or repackage medical cannabis products or label or relabel the cannabis product container.”  Entities that package and label their own products are not required to hold a Type P license.

 

§40118. Manufacturing License Classifications.

The following license types are available from the Department:

(a) “Type P,” for entities that only package or repackage medical cannabis products or label or relabel the cannabis product container. Entities that engage in packaging or labeling of their own product as part of the manufacturing process do not need to hold a separate Type P license. For purposes of section 19328 of the Business and Professions Code, a Type P license shall be subject to the same restrictions as a Type 6 license.

The ISOR for Section 40118 explains the reasoning behind the new “Type P” license.

“Manufacturing License Classifications. The Act establishes two license types for manufacturers – Type 6 for manufacturers using nonvolatile solvents and Type 7 for manufacturers using volatile solvents. (Bus. & Prof. Code §19300.7 subd. (k) and (l).) However, Business and Professions Code section 19302.1(f) allows the Department to create additional license types as needed. This section is necessary to make specific the Department’s licensing authority.

 Subsection (a) creates a new license category of “Type P” for manufacturers that only engage in the packaging of cannabis products. Packing operations offer numerous opportunities for contamination of a product if not conducted in accordance with GMPs. In order to mitigate the risk of contamination, it is necessary for packaging operations to be under the oversight of the Department. During the pre-regulatory stakeholder meetings, the Department heard from numerous individuals who expressed an interest in only the packaging or labeling of products. This provision is necessary to for the Department to fulfill its mandate under the Act to license and regulate manufacturers. Subsection (a) also clarifies that entities that package and label their own products are not required to hold a Type P license. This provision is necessary in order to prevent confusion to the regulated public. This subsection also establishes that holders of a Type P license are subject to the same additional license restrictions as a Type 6 license. Business and Professions Code section 19328 restricts the types of additional licenses that a licensee may hold. Type 6 and 7 licensees can only hold a cultivation, transporting, or “producing dispensary” license. In keeping with the intent of the Act to restrict the number and types of additional licenses can hold, the Department is imposing the same restrictions on the license types created by this proposal.

The above information is provided for informational purposes only and is not intended as legal advice.  Please contact a lawyer for legal counsel.

If you would like legal assistance in advocating for changes to the proposed regulations, please get in touch with us.  If you are interested in a legal consultation about the “Type P” license, the Medical Marijuana Regulation and Safety Act (MCRSA), or compliance with California’s cannabis laws, please contact the Law Offices of Omar Figueroa at (707) 829-0215 or at (415) 489-0420.