FDA finalizes guidance on cannabis clinical research

When Congress passed the Agriculture Improvement Act of 2018, also known as the 2018 Farm Bill, it defined hemp as including cannabis and derivatives or extracts of cannabis with “a delta-9 tetrahydrocannabinol (THC) concentration of not more than 0.3% on a dry weight basis.”  That means low cannabis-concentration hemp is no longer considered marijuana and is no longer an illegal substance under the Controlled Substances Act (CSA). It also means such products are no longer under the purview of the Drug Enforcement Agency, which regulates controlled substances.

That change led the FDA to publish a draft guidance in 2020 that outlined its thinking on what drug developers need to do to stay in compliance with federal law while also meeting the agency’s requirements to prove cannabis or cannabis-derived compounds can be used in clinical research (RELATED: Cannabis clinical research clarified in draft guidance, Regulatory Focus, 22 July 2020).