The USA’s Food and Drug Administration (FDA) has provided a final guidance for industry on its current thinking in relation to the development of cannabis and cannabis-derived human drugs.
Following on from draft guidance issued on July 22, 2020, this final version has been released to support clinical research. The three main topics covered concern:
- sourcing of cannabis for clinical research
- general quality considerations for developing human drugs
- calculation of percent delta-9 THC in various forms/preparations of cannabis to determine their status as a controlled substance.
The FDA notes the final guidance:
“.. does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.”
The recommendations in the guidance are intended for products that meet the legal definition of a drug under the Federal Food, Drug, and Cosmetic Act (FD&C Act).
The guidance acknowledges the National Institute on Drug Abuse (NIDA) Drug Supply Program was once the only show in town for domestic, federally legal sourced cannabis for clinical research, which was grown under contract by the University of Mississippi at the National Center for Natural Products Research. This was a rather thorny issue for some years as the quality of cannabis produced was reportedly quite low at times.
However, given the 2018 Farm Bill legalizing hemp and the DEA allowing other players in, the FDA has adjusted its thinking on sources of cannabis for clinical research, stating other sources authorized by DEA to provide Schedule I cannabis materials for research are fine to use.
The document, titled Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research, can be viewed here.
While the updated guidance will no doubt be welcomed by researchers, FDA regulations for industry concerning cannabidiol specifically are still yet to materialise. But perhaps 2023 will be the year they finally will after some further prodding. We recently reported the FDA commissioner is to be questioned by the U.S. House Oversight Committee over the lack of action on hemp-derived CBD regulation.