DEA reschedules approved CBD drugs to schedule V

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As of October 2018, the DEA has rescheduled approved cannabis-derived drugs from schedule I to schedule V. The DEA’s foregoing classification of cannabis as schedule I has meant that CBD, a cannabis derivative, was categorized as having a high potential for abuse and no currently accepted medical use. However, the DEA’s reclassification was a forgone conclusion after the June 2018 FDA approval of Epidiolex, a CBD-based drug currently used to treat two forms of epilepsy. The FDA had previously recommended this re-scheduling of CBD to the DEA in May of 2018 noting its efficacy in treating epilepsy, and its negligible potential for abuse. Epidiolex, approved as a schedule I drug, had its classification revised to a schedule V drug in September 2018.

The rescheduling represents a first in terms of cannabis derivatives appearing outside of a schedule I classification. However, it is a potential scope of cannabis derived drugs that have the possibility of becoming available under a schedule V classification is limited by the following three conditions: first, the DEA requires that any possible schedule V cannabis-derived drugs receive FDA approval. Second, the drug must be derived from cannabis, and finally, the cannabis derivative can contain no more than 0.1% tetrahydrocannabinols (THC).

Hemp-derived CBD falls outside of these considerations owing to its inclusion in the 2014 Farm Bill that green-lighted the agricultural development of industrial hemp.