A handful of entities are in various stages of the FDA approval process for MDMA and psilocybin drugs (see here and here for some of our prior analysis of the issues). FDA approval could happen in the next few years.

But there’s a catch: psilocybin and MDMA are both schedule I drugs under the Controlled Substances Act (CSA). And schedule I narcotics are essentially off limits for prescription. So, how will this new system work?

In order for physicians and medical professionals to prescribe and administer FDA approved MDMA and psilocybin formulations, the federal government has to reschedule them. One question I get frequently is whether this would mean a categorical rescheduling of MDMA and psilocybin. In other words, would the government move psilocybin and MDMA, as a whole, to a lower schedule.

The answer to this question is almost certainly no. In all likelihood, the federal government will reschedule the FDA approved drug formulations and leave MDMA and psilocybin on schedule I. There is precedent for this. Gamma-hydroxybutyric acid (or GHB) is a schedule I depressant under the CSA. Drug manufacturers have gotten FDA approval for drugs that contain formulations of GHB – for example, XYWAV®, and according to that link:

XYWAV is a Schedule III controlled substance. The active moiety of XYWAV is oxybate, also known as gamma-hydroxybutyrate (GHB), a Schedule I controlled substance. Abuse of illicit GHB, either alone or in combination with other CNS depressants, is associated with CNS adverse reactions, including seizure, respiratory depression, decreases in the level of consciousness, coma, and death. The rapid onset of sedation, coupled with the amnestic features of GHB particularly when combined with alcohol, has proven to be dangerous for the voluntary and involuntary user (eg, assault victim). Physicians should carefully evaluate patients for a history of drug abuse and follow such patients closely.

Indeed, if you take a look at the DEA’s CSA regulations, you’ll see right there under schedule III: “Any drug product containing gamma hydroxybutyric acid, including its salts, isomers, and salts of isomers, for which an application is approved under section 505 of the Federal Food, Drug, and Cosmetic Act”. Translated into English: if a drug containing GHB gets FDA approval, it is a schedule III drug.

All signs point to something similar happening for both MDMA and psilocybin. There’s virtually no way the federal government will loosen up CSA restrictions for non-approved formulations, so we’ll likely see carveouts for those FDA approved drugs on schedule II or III. That will allow a regulated medical market while giving the DEA wide enforcement powers for everyone else.

I should also point out here that the expected rescheduling won’t effect the service center market in places like Oregon or Colorado. Those service centers will use psilocybin produced in state-regulated manners, not FDA approved formulations. So none of the benefits of, say, moving a drug to schedule III and getting rid of 280E risks, are going to happen.

Make sure to stay tuned to the Psychedelics Law Blog for more updates on the psychedelics industry.

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