DEA approves Schedule V for first ever plant-derived cannabidiol prescription formulation


In Washington, D.C., the U.S. Drug Enforcement Administration transferred EPIDIOLEX, which was already approved by the Food and Drug Administration, to Schedule V, the lowest restriction classification.

EPIDIOLEX, which was approved for the treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients two years of age or older, is the first prescription pharmaceutical formulation of highly-purified, plant-derived cannabidiol, a cannabinoid lacking the high associated with marijuana, and the first in a new category of anti-epileptic drugs.

Medicines in Schedule V have a proven medical use and low potential for abuse. DEA’s decision to move EPIDIOLEX to Schedule V was based on non-clinical and clinical data that evaluated the medicine’s potential for abuse and applies only to CBD products approved by the FDA. Other, non-FDA-approved CBD preparations remain in Schedule I. Some examples of Schedule V drugs are cough preparations and a number of commonly prescribed anti-epilepsy drugs.