The United States Drug Enforcement Administration (DEA) has classified Epidiolex, a prescription medicine made from cannabis-derived cannabidiol (CBD), as a Schedule V controlled substance, which is the lowest classification under U.S. law.
The Food and Drug Administration (FDA) gave approval to the medicine in June for the treatment of two rare forms of severe epilepsy: Lennox-Gastaut syndrome and Dravet syndrome. It is the first botanically-derived medicine from cannabis to receive US market approval.
A spokesperson for the DEA affirmed that the change is only specific to Epidiolex, and does not amend the schedule I status of either whole-plant cannabis or CBD – stating: “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.”
The drug’s manufacturer estimates that physicians will be able to begin prescribing the medicine within six weeks. An annual prescription is anticipated to cost patients $32,500.
Schedule V substances, as defined by the US Controlled Substances Act, are medicines deemed to possess a “low potential for abuse,” and are associated with “limited physical dependence or psychological dependence.”