FDA provides recommendations on sources of cannabis in clinical research, resources for information on quality, and control status considerations under the Controlled Substances Act.

Key Points:

..The Food and Drug Administration (FDA) highlighted recommendations and applicable resources for sponsors intending to use cannabis and cannabis-derived compounds in investigational clinical drug research.

..Although the 2018 Farm Bill removed “hemp” as a controlled substance, sponsors growing and manufacturing cannabis or cannabis-derived compounds with a higher than 0.3% delta-9 tetrahydrocannabinol (THC) by dry weight must still comply with the Drug Enforcement Administration’s (DEA’s) rules regarding controlled substances.