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On Tuesday, July 21, 2020, the U.S. Food and Drug Administration (FDA) released a new draft guidance, Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research. The draft guidance is intended to support the development of human drugs containing cannabis or cannabis-derived compounds, and reflects FDA’s current thinking on several relevant topics. Of particular interest are FDA’s recommendations on the sourcing of cannabis and cannabis-derived compounds, as well as how to calculate delta-9 tetrahydrocannabinol (THC) content in raw materials, intermediate steps, and finished products.

Changes to federal law made by the 2018 Farm Bill allow “hemp” to serve as a source for cannabis and cannabis-derived compounds, provided they do not contain delta-9 THC at more than 0.3 percent by dry weight. This change has been a long time coming — for decades, the only federally legal source of cannabis for clinical research was the National Institute on Drug Abuse (NIDA) Drug Supply Program (DSP). The NIDA DSP remains the only federally legal source of cannabis containing more than 0.3 percent delta-9 THC for use in clinical research, as such compounds remain Schedule I controlled substances under the Controlled Substances Act (CSA).

The draft guidance also notes that dry weight calculations have “limited utility” for manufacturing intermediates (which occur between raw materials and final products), solutions, and final products, and provides additional calculations to use for solution-based and solid oral dosage forms. The Agency points out that intermediates and drug products may contain greater than 0.3% delta-9 THC by dry weight, and that such materials may be considered a Schedule 1 controlled substance — even if the starting materials met the definition of hemp. FDA recommends that anyone who may be transporting intermediates or by-products exceeding 0.3% delta-9 THC contact DEA for recommendations.

Note that the draft guidance explicitly does not address fully synthetic versions of substances that may be found in cannabis, as such compounds are already regulated like other fully synthetic drugs. The document also does not address non-drug products, such as dietary supplements containing CBD.

Comments on FDA’s draft guidance can be submitted to the public docket here until Sept. 21, 2020.

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