On September 27, 2018, the Drug Enforcement Agency (DEA) scheduled EPIDIOLEX® as a Schedule V regulated drug under the Controlled Substance Act (CSA). In doing so, the DEA has expressly scheduled a drug wholly-containing cannabis compounds as an active ingredient. Epidiolex was recently approved by the Food & Drug Administration (FDA) for market as a treatment of seizures related to epilepsy, Lennox-Gastaut syndrome, and Dravet syndrome, which was discussed earlier on this blog. Epidiolex is a product of cannabis pharmaceutical company, GW Pharmaceuticals plc, based in the United Kingdom.
The larger question which has caused confusion among many in the cannabis industry, is whether the scheduling of Epidiolex means a rescheduling of cannabidiol (CBD), which is the active ingredient of Epidiolex. The answer is “No,” at least not at this time. The DEA, acting under its authority, schedules all drugs according to their abuse potential, as noted with their most recent scheduling list. All parts of the cannabis plant are listed in Schedule I as “marihuana” or “marihuana extract”; CBD, or any other cannabis compound, is not listed separately. Because the drugs are scheduled based on their basic or parent chemical, and not necessarily the derivative salts, isomers, or esters, in order for CBD to be rescheduled lower than its current Schedule I (i.e., drugs with the highest abuse potential) would be if the entire cannabis plant were rescheduled. This is not anticipated to happen anytime soon.
However, there are more companies investing heavily into medical and scientific research on various compounds of the Cannabaceae plant. As more drugs make it through the FDA approval process, it may force the DEA (absent congressional action) to rethink cannabis rescheduling on the CSA schedule list.