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On March 23, 2020, the U.S. Drug Enforcement Administration published a proposed rule for approving additional growing licenses for research-grade cannabis. As of today, the only cultivator approved for a growing license in the United States is at the University of Mississippi, authorized through contract with the National Institute on Drug Abuse (NIDA). The new rule would end the four-year pause by the Department of Justice on approving any additional licenses.
Under the proposed rule, the DEA would have complete and sole ownership of all cannabis produced by federally licensed entities. The DEA has begun a formal review of the current 35 institutions awaiting approval to grow research-grade cannabis. Of those 35 applicants, the DEA would choose between five and 13 for approval. The applicants are grouped into three license types: growers or bulk manufacturers of cannabis that would conduct their own research; growers that would supply DEA-registered researchers with cannabis; and growers that would supply the Drug Supply Program of NIDA, as the University of Mississippi does now.
The proposed rule’s public comment period ends May 22, 2020.
Food and Drug Administration Endorses Increased Research on Cannabidiol
This proposed rule follows a March 5 Food and Drug Administration report to Congress, acknowledging an increased interest in drug development from cannabidiol (CBD) and other compounds found in cannabis. The report, required by Congress, was an update on the FDA’s progress to address data gaps. The report addressed FDA activities to encourage, facilitate and initiate more research on CBD. In addition, the report calls for industry and researchers to share new data with FDA and identify opportunities to further collaborate with the Centers for Disease Control and Prevention, the Substance Abuse and Mental Health Services Administration and NIDA.
As of March 11, 2020, FDA reopened a docket from 2019 seeking scientific data and information about products containing cannabis or cannabis-derived compounds such as CBD. The public docket was reopened in light of the continued interest and increased research activity in this space, as well as the need for additional scientific data on this topic.