The DEA announced last week that it is placing certain drug products that have been approved by the FDA and which contain cannabidiol (CBD) in schedule V of the Controlled Substances Act. The action places FDA-approved drugs that contain CBD derived from cannabis and no more than 0.1 percent tetrahydrocannabinols in Schedule V.
Schedule V drugs are those considered to have lower potential for abuse than drugs in Schedules I – IV. For reference, cannabis and heroin are Schedule I, cocaine and Ritalin are Schedule II, Tylenol with codeine is Schedule III, and Xanax and Ambien are Schedule IV.
Importantly, this does not render all CBD in the Schedule V category. DEA expressly limited the classification to FDA-approved drugs, which currently consists of just one product – Epidiolex. Cannabis remains a Schedule I substance and cannabis-based CBD generally remains scheduled as a derivative of cannabis.
DEA’s move provides certainty for drug makers seeking to introduce a CBD drug similar to Epidiolex, but would not apply to products with greater than .1 percent tetrahydrocannabinols.