By LeeWEpstein

April 8, 2020


GW Pharmaceuticals announced Monday that Epidiolex, cannabidiol (CBD) drug used in the treatment of epilepsy, has been removed from Schedule V of the U.S. Drug Enforcement Administration’s (DEA) Controlled Substances Act.

People who could benefit from it will now be able to obtain it more easily. GW stated in its press release that it “will now begin the process of implementing these changes at the state level and through the EPIDIOLEX distribution network.

As with many uncontrolled drugs, patients or their legal representatives will still need to obtain a prescription from a doctor, but these prescriptions will be valid for up to one year and can be transferred between pharmacies.

“This DEA notification fully establishes that EPIDIOLEX, the only CBD drug approved by the FDA, is no longer a controlled substance under the Federal Controlled Substances Act,” said Justin Gover, CEO of GW Pharmaceuticals, in a statement. “We would like to thank the DEA for confirming the uncontrolled status of this drug. ┬╗

“It is important to note that the declassification of EPIDIOLEX will facilitate patient access to this important therapy for patients living with Lennox-Gastaut syndrome and Dravet’s syndrome, two of the most incapacitating forms of epilepsy,” he said.

The Food and Drug Administration (FDA) approved Epidiolex for use in 2018. The DEA had classified Epidiolex in Schedule V of the list of controlled substances, unlike cannabis and its derivatives listed in Schedule I, the most restrictive.

The FDA then strongly urged the DEA to remove Epidiolex from the controlled substances list, arguing that CBD carries minimal risk, has established health benefits and should not be controlled at all. The DEA responded that international treaty obligations justified its control, albeit in the least restrictive category, in Schedule V. At that time, the FDA felt that if the international status of the CBD changed, the DEA should “expeditiously” reconsider its status as a controlled substance.

Last year, the World Health Organization (WHO) clarified that preparations containing CBD, with no more than 0.2% THC, should not be “under international control”.

In the meantime, the FDA has been working on its regulations for hemp products following its legalization at the federal level under the Farm Bill 2018. CBD should soon be considered as a dietary supplement, which would open a regulatory path for all CBD products already on the US market.

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