In an interesting twist, a firm petitioned the FDA/DEA to request that a synthetic version of Cannabidiol (CBD) oil be placed in Schedule V of the Controlled Substances Act in order for the firm to submit an ANDA for a generic version of Epidiolex (a treatment for seizures associated with Lennox-Gastaut syndrome or Dravet syndrome) which contains CBD oil derived from the Cannabis sativa L. plant.
The scheduling order by DEA of the CBD oil cites the derivation of the plant material specifically and that it contains less than 0.1% tetrahydrocannabinols (THC). The petitioner argues that the synthetic version would contain a reduced level of THC and thus it should appear in the same scheduling order.
The FDA points out that the DEA scheduling determination is specific to derivation from the plant cited in the order, and any scheduling decision for a synthetic version would fall under the purview of the DEA, not the FDA. The FDA notes that it does not make scheduling decisions, and thus the firm should petition the DEA for the proposed scheduling action. A similar issue arose when generic dronabinol products were being considered by the FDA.
The petition and the FDA denial letter in docket number FDA-2018-P-4590, can be found here .