FDA Releases Final Guidance for Cannabis Pharmaceutical Research

The federal Food and Drug Administration (FDA) on Tuesday released its proposed final guidance on research related to the development of human drugs containing cannabis or cannabis-derived compounds. The guidance would allow researchers to use hemp products derived from any source if deemed “of adequate quality” by the FDA but would not allow THC-rich cannabis from any source, requiring only products from sources authorized by the Drug Enforcement Administration (DEA). 

Under federal law, hemp products must contain less than 0.3% THC. 

After decades of allowing cannabis for research purposes to be grown at only one site – the University of Mississippi’s National Center for Natural Products Research – the DEA opened up applications for new growers in 2020. In all, there are now seven “Bulk Manufacturer Marihuana Growers” approved by the DEA.  

According to the guidance document, cannabis and cannabis-derived compounds would be held to the “same regulatory standards as any other botanical raw material, botanical drug substance, or botanical drug product” and researchers would have to follow the agency’s 2016 guidance for Botanical Drug Development. 

The FDA notes the guidance “does not address development of fully synthetic versions of substances that occur in cannabis, sometimes known as cannabis-related compounds (e.g., dronabinol), which are regulated like other fully synthetic drugs.” 

The guidance is still in the public comment period and must complete that process before becoming policy.