The US FDA has issued final guidance for industry on developing drugs containing cannabis or cannabis compounds.
The need for the guidance grew out of the 2018 Farm Bill, which removed hemp as a Schedule I substance and also clarified the FDA's authority in regulating products containing cannabis or cannabis-derived compounds. Hemp is considered cannabis below 0.3% delta-9 THC by dry weight.
The guidance noted that companies no longer need to rely on the National Institute on Drug Abuse Drug Supply Program, which was the only federally legal source of marijuana for research purposes. It notes that a list of DEA-approved growers of cannabis is available online.
The guidance also provides resources for quality considerations so sponsors can demonstrate the quality, purity, and potency or strength of an investigational drug.
In addition, it recommends that sponsors figure the delta-9 THC content early in development to determine potential abuse liability and control status.
The FDA has approved only one cannabis-derived drug, Epidiolex (cannabidiol), from Jazz Pharmaceuticals (NASDAQ:JAZZ) for a rare epilepsy disorder. The drug contains cannabidiol, or CBD, the non-psychoactive compound found in cannabis.
Other companies with cannabidiol therapies in the pipeline include Tetra Bio-Pharma (OTCQB:TBPMF), 180 Life Sciences (NASDAQ:ATNF), Artelo Biosciences (NASDAQ:ARTL), and Enveric Biosciences (NASDAQ:ENVB).