DEA Reclassifies Cannabis-Derived Epilepsy Treatment from Schedule I to 5

DEA notes that status change is specific only to Epidiolex and does not amend schedule of whole-plant cannabis and CBD.

Epidiolex, a prescription medicine made from a formulation of plant-derived cannabidiol (CBD), has been reclassified by the DEA from Schedule 1 to Schedule V - the lowest restriction classification available under federal law.

A spokesperson for the DEA noted that this change of status is specific only to Epidiolex and does not amend the schedule I status of either whole-plant cannabis or CBD.

“As of right now, any other CBD product other than Epidiolex remains a Schedule I Controlled Substance, so it’s still illegal under federal law.”

A Schedule V substance under the Controlled Substances Act are medicines deemed to possess a “low potential for abuse” and are non-addictive. A Schedule I substance is viewed by the DEA as having no medical use and a high potential for abuse. Among Schedule I drugs are heroin, LSD, meth, and cannabis.

Epidiolex, approved by the FDA in June 2018, has has been shown effective in significantly reducing seizures caused by two rare forms of epilepsy that begin in childhood: Dravet Syndrome (DS) and Lennox-Gastaut Syndrome (LGS).

Commenting on the scheduling change, NORML’s Deputy Director Paul Armentano said:

“The DEA’s rescheduling of this plant-derived medicine provides an additional option to patients seeking the therapeutic benefits of cannabis. However, it remains to be seen to what degree physicians will be comfortable prescribing this new agent, and whether most patients can feasibly afford it.”

Epidiolex is expected to cost roughly $32,500 per year, according to a spokesperson for the drug maker, United Kingdom-based GW Pharmaceuticals.

“We anticipated that Epidiolex will be the first of many potential FDA-approved medicines based on the cannabis plant,” continued Armentano. “These are welcome alternatives. But these products should not be regulated in such a manner that patients no longer have ready access to herbal cannabis - a product that humans have used safely and effectively as a medicine for thousands of years and is approved today by statute in 31 states.”

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