The prescription CBD drug Epidiolex has been been taken off the list of federally controlled substances by the U.S. Drug Enforcement Administration (DEA).
Epidiolex, which is the only approved pharmaceutical containing CBD, has been effective in treating two rare forms of epilepsy in young children.
GW Pharmaceuticals, the drug’s maker, said the de-listing means patients will be able to more easily obtain Epidiolex. Patients must still get a doctor’s prescription to obtain the drug, which will no longer be subject to state-level monitoring requirements. Under the changes, prescriptions are now valid for up to a year and can be transferred among pharmacies.
“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,” Justin Gover, CEO of GW, said in a statement.
FDA will set rules
The company said it will “begin the process of implementing these changes at the state level and through the Epidiolex distribution network.”
There are no FDA-approved over-the-counter CBD products, but producers and re-sellers of those products as food and food supplements continue to skirmish with government officials amid an unclear federal regulatory scheme. Non-Epidiolex CBD products currently being sold in the U.S. are considered to be illegal by the FDA, which says the compound’s safety profile has not been established.
FDA said it is in the process of setting a regulatory framework for CBD as a food and dietary supplement, and is setting up enforcement guidance for CBD.