DEA Reschedules Epidiolex

Today, the Drug Enforcement Administration (DEA) announced that it is scheduling Epidiolex, a seizure medication developed by GW Pharmaceuticals, in Schedule V of the Controlled Substances Act (CSA). This is the least restrictive of the five schedules and is reserved for drugs that have a low potential for abuse relative to the drugs in schedule 4; have a currently accepted medical use in treatment in the United States; and consist primarily of preparations containing limited quantities of certain narcotics.

This is an important development. First of all, Epidiolex is a preparation of cannabidiol (CBD) derived from marijuana. As such, and according to the Source Rule, it was Schedule I (the most restrictive) until rescheduled today.

Second, and related, the DEA did not schedule CBD itself. CBD is not listed in the CSA. It is only unlawful if derived from marijuana. There has been speculation that the DEA would “reschedule” CBD; however, since CBD is not independently scheduled in the CSA this would make no sense. Epidiolex had to be rescheduled since it is derived from marijuana. The DEA did not schedule (or “reschedule”) CBD.

Third, this is the first time that the DEA has acknowledged that marijuana has a “currently accepted medical use” . Since the CSA was created, and despite a sordid history of thwarting attempts to reschedule it in the light of mounting evidence, the DEA has held onto the notion that marijuana is a dangerous drug with no medical utility. In that context, this is an enormous sea-change. We can expect much more of this in the coming years.

Finally, I think it is important to note that the DEA has adopted the Source Rule in its press release. Rather than improperly assert or imply that all CBD is schedule 1 as it has in the past, the DEA was careful to refer only to marijuana-derived CBD as a controlled substance:

“Marijuana and CBD derived from marijuana remain against the law, except for the limited circumstances that it has been determined there is a medically approved benefit. In those instances, such as here, the drug will be made appropriately available to the public for medical use.”

Stay tuned. This is not the last we’ll hear about Epidiolex or GW Pharmaceuticals.

Posted September 27, 2018. (Revised September 28, 2018.)

Rod Kight is a lawyer based in Asheville, NC. He is licensed in North Carolina and Oregon and represents legal cannabis businesses. You can contact him by clicking here.