For the first time in history, the United States Drug Enforcement Administration (DEA) has descheduled a marijuana-derived drug from the federal Controlled Substances Act (the CSA).
On April 6, the GW Pharmaceuticals plc (GW) announced that it received notification from DEA confirming that GW’s anti-epileptic cannabidiol (CBD) oral solution branded as Epidiolex is no longer classified as a Schedule V drug under the CSA. According to the GW, this change was effective immediately.
Epidiolex had been listed as a federal controlled substance because the CBD in the drug was derived from marijuana, not hemp. Hemp was descheduled in the 2018 Farm Bill, but Marijuana remains a Schedule I drug under DEA jurisdiction.
In a statement, GW’s CEO, Justin Glover, was quoted in a press release saying,
“This notification from DEA fully establishes that Epidiolex, the only CBD medicine approved by FDA, is no longer a controlled substance under the federal Controlled Substances Act. We would like to thank DEA for confirming the non-controlled status of this medicine. Importantly, the descheduling of Epidiolex has the potential to further ease patient access to this important therapy for patients living with Lennox-Gastaut Syndrome and Dravet syndrome, two of the most debilitating forms of epilepsy.”
The descheduling of Epidiolex makes it easier for patients living with epilepsy to access the drug because doctors who prescribe the drug no longer have to be in the DEA’s drug-monitoring program. Although the descheduling of Epidiolex will not have an immediate effect on the legal status of CBD or related products, it does signify a positive move for what it foretells for CBD products in general.