DEA Reschedules CBD-Based Drug to Schedule V

Sep 27, 2018

According to a report from CNBC.com (1), the U.S. Drug Enforcement Administration (DEA) has rescheduled GW Pharmaceuticals’ cannabidiol (CBD)-based drug, Epidiolex, to schedule V.

The U.S. Food and Drug Administration (FDA) approved Epidiolex in June 2018, as an oral solution for the treatment of seizures associated with two rare and severe forms of epilepsy—Lennox-Gastaut syndrome and Dravet syndrome—in patients two years of age and older (2,3). The FDA’s approval of Epidiolex forced the DEA to consider how to classify it since cannabis is considered a schedule I drug, which is defined as having no currently accepted medical use and a high potential for abuse. Epidiolex will be classified as a schedule V controlled substance, which is the lowest level, defined as those with a proven medical use and low potential for abuse.

According to the CNBC report, the rescheduling applies to CBD containing no more than 0.1% tetrahydrocannabinol (THC), in FDA-approved drug products. This allows GW Pharmaceuticals to sell Epidiolex, but it does not broadly apply to all CBD products.

For more information on the descheduling, please read the full report from CNBC (1).