Researchers working on cannabis-based medicines finally have a rulebook. The Food and Drug Administration (FDA) has issued guidance covering how these drugs should be developed and what makes hemp and marijuana different from a regulatory standpoint. Titled “Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research,” it was announced in a notice set to be published in the Federal Register on Tuesday, following a draft version that underwent a White House review in 2020.
What the FDA Guidance Actually Covers
The purpose is to support clinical research for the development of cannabis and cannabis-derived human drugs. Nothing in it is binding; the FDA made several non-binding recommendations for researchers interested in developing cannabis drugs that could go to market. The advice is “intended to address the legal definitions and regulatory controls related to cannabis, and to address certain questions raised about drugs containing cannabis.”
The reason a separate document was needed at all traces back to the federal legalization of hemp in the 2018 Farm Bill, which makes the drug development protocol different for that version of the cannabis crop than it is for marijuana, which remains in Schedule I of the Controlled Substances Act (CSA).
The dividing line is potency. Cannabis containing no more than 0.3 percent THC by dry weight meets the federal definition of hemp and is not considered a controlled substance like marijuana, which continues to fall under the purview of the Drug Enforcement Administration (DEA). Sourcing is correspondingly looser for hemp: those products do not need to come from the limited number of National Institute on Drug Abuse- (NIDA) contracted suppliers for marijuana as long as they are “deemed to be of adequate quality by FDA.”
More Places to Source Research Material
That flexibility is new. The agency points out that for “many years,” scientists could only get marijuana from one NIDA-approved farm at the University of Mississippi. DEA has since accepted more manufacturers, giving researchers “new sourcing options” as they pursue cannabis research.
A newer section deals with the arithmetic that separates hemp from marijuana. FDA largely defers to DEA on the matter, but it also advises researchers to “calculate the delta-9 THC content in their proposed cannabis or cannabis-derived investigational drug product early in the development process to gain insight into their product’s potential abuse liability and control status.”
Beyond definitions, the document is a walkthrough of FDA’s regulatory mechanisms and how investigational new drugs work, plus the practical details: basic standards for clinical studies, how combustible drug products differ from oral preparations, storage requirements for researchers, and more.
One large question stays open. Advocates, lawmakers and stakeholders are still waiting to see what actions, if any, FDA will take to allow for the marketing of hemp-based products like CBD oil in the food supply or as dietary supplements.
