DEA Reschedules FDA-Approved CBD Medicines
[dropcap class=”kp-dropcap”]I[/dropcap]n an unpublished Sept. 28 document, The U.S. Drug Enforcement Administration announced that it has moved approved cannabidiol (CBD) medicines from Schedule I to Schedule V, a much less restrictive category and one that recognizes medicinal value.
“With the issuance of this final order, the Acting Administrator of the Drug Enforcement Administration places certain drug products that have been approved by the Food and Drug Administration (FDA) and which contain cannabidiol in schedule V of the Controlled Substances Act,” the document reads.
Since 1972 all cannabis derivatives—including CBD—have been federally classified under the most restrictive category of drugs alongside heroin and LSD. Cannabis is restricted more than Schedule II drugs like cocaine or PCP. Schedule V is a loosely regulated category. Robitussin AC, for instance, is an example of a Schedule V drug.
Rescheduling means drugs that contain CBD and tetrahydrocannabinol (THC) content below 0.1 percent are now classified as Schedule V drugs if they have been approved by the U.S. Food and Drug Administration (FDA).
The implications are enormous—Epidiolex can now be distributed like a typical drug via pharmaceutical supply chains. Epidiolex was approved by the FDA last June, which may have reignited efforts within the DEA to reschedule CBD products. Others have speculated that CBD medical research will begin to skyrocket.
While synthetic drugs that mimic cannabis, such as Dronabinol have been moved to Schedule II, all cannabis derivatives have remained on Schedule I, until now.
While nothing may change for smaller CBD manufacturers, the DEA’s willingness to reschedule any type of cannabis-derived medicine is an enormous step.
Stocks soared for larger corporations such as GW Pharma and Tilray, as investors caught wind of the rescheduling announcement. GW Pharma’s Epidiolex is approved for children ages two and older who suffer from Dravet Syndrome and Lennox-Gastaut Syndrome, but its cost is much too high for most patients to pay without insurance.
