DEA Classifies FDA-Approved CBD Drugs in Schedule V of CSA

The Drug Enforcement Administration is classifying FDA-approved drugs that contain cannabidiol (CBD) derived from cannabis and no more than 0.1 percent tetrahydrocannabinols in schedule V of the Controlled Substances Act. As a result of the order, Epidiolex, which had previously been classified in schedule I, is now placed in Schedule V, along with any generic versions of the same formulation that might be approved by the FDA in the future. DEA is also adding such drugs to the list of schedule III, IV and V drugs that require a permit for importation or exportation. Any material, compound, mixture or preparation other than Epidiolex that falls within the CSA definition of marijuana, including any non-FDA-approved CBD extract that falls within such definition, remains a schedule I controlled substance under the CSA, the agency said.