The following is an edited version of the document published in the Federal Register.
The FDA has announced the availability of a guidance for industry entitled ‘‘Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research.’’ This guidance outlines FDA’s current thinking on several topics relevant to the development of human drugs containing cannabis and cannabis-derived compounds, including the source of cannabis for clinical research; general quality considerations for developing human drugs that contain cannabis and cannabis-derived compounds; and calculation of percent delta-9 THC in botanical raw materials, intermediates, drug substances, and drug products to determine their status as a controlled substance.
This guidance has been issued to support clinical research for the development of human drugs containing cannabis and cannabis-derived compounds. It finalizes the draft guidance entitled ‘‘Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research’’ issued on July 22, 2020 (85 FR 44305).
Changes from the draft to the final guidance include clarifying sources of cannabis for clinical research (including Schedule I sources), adding resources that explain expectations for investigational new drugs (INDs) in various stages of drug development, and providing guidance on quality considerations for INDs. The final guidance also lists applicable U.S. Pharmacopeia chapters on quality testing, including the assessment of leachables from packaging and delivery systems. Further, the guidance addresses the calculation of delta-9 THC content, which is relevant to determine control status for cannabis and cannabis-derived compounds.
In addition, editorial changes were made to improve clarity, including better explaining FDA’s authority to regulate human drugs and renaming subsection III.C to emphasize that this section relates to control status considerations under the CSA.