Pharma Grade CBD Products to be Rescheduled to Schedule V
Pharma Grade CBD Products such as Epidiolex will be Schedule V – comparable to codeine-containing cough syrups – indicating a low potential for abuse and effectiveness as a therapeutic drug.
The Drug Enforcement Agency published a notification on the FDA CBD rescheduling in the Federal Register.
“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 (CBD) in schedule V of the Controlled Substances Act (CSA). Specifically, this order places FDA-approved drugs that contain CBD derived from cannabis and no more than 0.1 percent tetrahydrocannabinols in schedule V. This action is required to satisfy the responsibility of the Acting Administrator under the CSA to place a drug in the schedule he deems most appropriate to carry out United States obligations under the Single Convention on Narcotic Drugs, 1961. Also consistent therewith, DEA is adding such drugs to the list of substances that may only be imported or exported pursuant to a permit.”
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 (CBD) in schedule V of the Controlled Substances Act (CSA). Specifically, this order places FDA-approved drugs that contain CBD derived from cannabis and no more than 0.1 percent tetrahydrocannabinols in schedule V. This action is required to satisfy the responsibility of the Acting Administrator under the CSA to place a drug in the schedule he deems most appropriate to carry out United States obligations under the Single Convention on Narcotic Drugs, 1961. Also consistent therewith, DEA is adding such drugs to the list of substances that may only be imported or exported pursuant to a permit.
The announcement indicates a major shift in federal policy toward cannabis-derived drugs, as until now all cannabis derived medicines were considered Schedule 1 – indicating a high potential for abuse on no agreed medical value. The admission that CBD has medical use undermine’s cannabis’ inclusion in Schedule I.
The new ruling will apply only to pharma grade CBD medicines manufactured under cGMP, not to CBD or hemp extracts generally.
At this stage that only includes GW Pharma’s CBD Isolate drug Epidolex which is used in the treatment of epilepsy.
“Any material, compound, mixture or preparation other than Epidiolex that falls within the CSA definition of marijuana, including any non-FDA-approved CBD extract that falls within such definition, remains a Schedule I controlled substance under the CSA.”
The situation with hemp oil products is more confusing. The DEA has previously ruled that hemp oil products are not part of schedule 1, but it’s statements or often contradictory.
The future of the hemp industry is still uncertain pending passage of the 2018 Farm Bill which could The new remove hemp and hemp products like CBD from the purview of the Controlled Substances Act,
