The US Food and Drug Administration has finalized a 2020 draft guidance outlining how sponsors and investigators can conduct clinical trials for certain drugs containing cannabis or cannabis-derived compounds without running afoul of federal law.
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…
