Epidiolex Removed From Controlled Substance List

The Drug Enforcement Administration has removed Epidiolex medication from the list of federally controlled substances. The medication, manufactured by GW Pharma, is made from isolated, single-molecule CBD. Epiodiolex is used in the treatment of epilepsy and is administered orally.

Epidiolex was approved by the FDA in June 2018. The DEA classified Epidiolex as a Schedule V controlled substance in September 2018.

The removal of Epidiolex from the Federal Controlled Substances list comes following the World Health Organization’s 2019 announcement that CBD containing less than 0.2% THC would no longer be under international control. As well, the FDA sent a letter to the DEA containing proven benefits of CBD and demonstrating that CBD does not fit the bill for a controlled substance.

“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,” Justin Gover, CEO of GW, said in a press release. “We would like to thank DEA for confirming the non-controlled status of this medicine.”

GW Pharma stated in the notice that it will “begin the process of implementing these changes at the state level and through the EPIDIOLEX distribution network.”