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Epidiolex is No Longer a Schedule I Drug

Epidiolex is No Longer a Schedule I Drug

September 27, 2018
Attorneys

After decades of advocates asking for cannabis to be removed as a Schedule I drug, on September 28, 2018, the DEA recognized that cannabis can have medicinal value and therefore the cannabis drug Epidiolex cannot be a Schedule I drug. Schedule I is reserved for drugs that have “no medicinal value” and have the potential to be highly addictive.

Specifically the DEA concluded that “Epidiolex no longer meets the criteria for placement in schedule I of the CSA.”

On June 25, 2018 the FDA had approved Epidiolex “for the treatment of seizures associated with two rare and severe forms of epilepsy”. Epidolex contains cannabidiol (CBD) extracted from the cannabis plant. Prior to reaching its conclusion, the DEA solicited input from the Department of Health and Human Services which advised that Epidiolex had little potential for abuse.

The DEA’s action is specifically limited to Epidiolex and future generic versions that are approved by the FDA or that meet this definition: A drug product in finished dosage formulation that has been approved by the U.S. Food and Drug Administration that contains cannabidiol (2-[1R-3-methyl-6R-(1- methylethenyl)-2-cyclohexen-1-yl]-5-pentyl-1,3-benzenediol) derived from cannabis and no more than 0.1 percent (w/w) residual tetrahydrocannabinols.

The DEA announcement made clear that all other forms of cannabis remain on schedule I. This is a significant change in DEA policy in recognizing what until now has been a Schedule I substance -- the most dangerous type of drug—and now recognizing that it can be listed on Schedule V.

Pashman Stein Walder Hayden is carefully monitoring developments in New Jersey and federally with respect to marijuana legislation and will be available to help its clients navigate the sure-to-be complex regulatory framework of this potential business frontier.

Please contact Sean Mack at smack@pashmanstein.com or 201.270.4919 for further information.