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FDA Approves CBD Marijuana Drug; Will Reclassification Follow?

By George Khoury, Esq. on June 27, 2018 | Last updated on March 21, 2019

In national news this week, London-based GW Pharmaceuticals has just secured the nation's first ever FDA approval of a marijuana-based prescription medication.

While a synthetic form of THC (the active psychoactive ingredient in marijuana) has been available for decades for chemo patients, and others with debilitating conditions, the new drug actually is derived from CBD, a chemical found in both marijuana and hemp and has no psychoactive effects. The new drug, Epidiolex, is meant to treat children ages two and up who suffer from two different rare medical conditions that cause severe seizures (that are often resistant to other drug treatments).

Reclassification Imminent

Despite the lack of a psychoactive side-effect, CBD is also considered a Schedule I drug under federal law. But that may soon be changing, according to GW and the FDA.

The FDA explained in the announcement of the approval of the CBD drug that it advises and informs the DEA on scheduling. And since Schedule I drugs have no acceptable medical uses, it has advised the DEA to reclassify CBD since the new CBD-based drug clearly belies that classification.

However, when the reclassification will actually occur is another issue entirely. GW, for its part, is hoping that it will be within the next few months as it cannot currently market the drug without violating federal law.

Not So Fast Smokey the Lawyer

If you were hoping that this potential breakthrough would be the spark that lights up your pathway into a marijuana law practice, go grab a bag of Funyuns and think about it after you've come back down from magical Christmas land.

This breakthrough isn't likely to make too much of a difference anytime soon for most marijuana practices simply because most of the producers of marijuana derivatives aren't going to be able to put together an application for FDA approval, let alone pay for the studies and clinical trials required to get FDA approval. However, down the road some years, some marijuana practices may be able to carve out a niche of seeking FDA approval for biosimilars or generics of FDA approved marijuana-based drugs and supplements.

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