The FDA has finalized guidance on trials of human drugs containing cannabis and cannabis-derived compounds, offering updated direction on federally authorized sources for cannabis and providing references to relevant quality considerations.

The National Institute on Drug Abuse’s (NIDA) Drug Supply Program (DSP), which provides cannabis grown under contract by the University of Mississippi, was formerly the only domestic, federally legal source for cannabis containing more than 0.3 percent delta-9 THC for use in clinical research. But this has changed since the agency’s 2020 draft guidance, and sponsors and investigators now have multiple sourcing options beyond the program.

According to the final guidance, researchers may now use non-NIDA DSP sources of cannabis that contain more than 0.3 percent delta-9 THC on a dry weight basis (a THC level that renders the cannabis a Schedule I controlled substance), as well as non-NIDA DSP sources for cannabis at or under the 0.3 percent threshold, so long as FDA deems the source(s) to be of adequate quality during its IND review. They may also still use the NIDA DSP for sourcing cannabis stronger than the 0.3 percent delta-9 THC threshold, the guidance says.

A list of Drug Enforcement Administration (DEA)-cleared growers of Schedule I cannabis is located online and can be accessed through the guidance. The FDA advises that sponsors and investigators with questions about cannabis production and sources for research direct their inquiries to the DEA.

The guidance also includes a section with resources for quality considerations that are especially relevant to trials of drugs containing cannabis and cannabis-derived compounds.

The third and final section, “considerations of control status under the Controlled Substances Act (CSA),” addresses loosened regulatory requirements for cannabis and cannabis-derived compounds following passage of the 2018 Farm Bill, which created the definition of “hemp,” cannabis that does not exceed 0.3 percent delta-9 THC by dry weight.

“If the cannabis does not meet the definition of hemp … activities related to growing and manufacturing cannabis for use as an investigational drug for research must still comply with applicable CSA and DEA requirements,” the guidance notes. “Sponsors and investigators proposing drug development activities involving controlled substances should consult DEA about the applicable requirements.”

This section contains information on how to calculate delta-9 THC content early on in the development process “to gain insight into … potential abuse liability and control status” and how this information should be included in an IND.

Access the final guidance here: https://bit.ly/3iUIvns.