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Pα+ Library: Bifurcated Scheduling

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Given that drugs placed in Schedule I of the Controlled Substances Act (CSA) are deemed (among other things) to have “no accepted medical use”, one might think that an FDA approval of a medicine containing such a drug—the de facto recognition that a drug has an accepted medical use in the U.S.—might necessitate its rescheduling.

It is true that once approved by the FDA, the DEA generally has up to 90 days to make a rescheduling decision regarding the drug product.

However, the DEA may opt to only reschedule (or deschedule) the drug product, as opposed to the substance itself, essentially carving out a new scheduling position only for specific forms or uses of a substance.

This is the crux of bifurcated scheduling: where a drug product is placed in a different schedule to the substance itself.

As Matt Zorn points out in On Drugs, bifurcated scheduling is not predestined (indeed, such actions weren’t anticipated by the Controlled Substances Act and appear to have been taken in an ad hoc basis).

However, we—along with others—believe it is very likely to be the case with psychedelics.

Below, we first look at examples of bifurcated scheduling of other drugs (and drug products) as well as psychedelics, before sharing what bifurcated scheduling might look like in the case that psychedelic-based treatments are approved.

We then discuss the potential repercussions of such a move, some of which are more obvious than others.

In this Library entry:

  • Examples of Bifurcated Scheduling
    • GHB and Cannabis-Based Medicines
    • MDMA and Psilocybin in Australia
  • Looking Ahead to Potential Approvals of Psychedelics
    • MDMA
    • Psilocybin
  • Potential Repercussions
    • Criminalisation Continues
    • Taxes
    • Entrenching Barriers to Research for Non-Approved Drug Forms?

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Through our years of reporting we have covered many of the topics we believe to be important to the present and future of the psychedelics space, broadly defined. However, much of this commentary is scattered across Bulletins, deep dives, special reports and year-end reviews.

The Pα+ Library provides digestible explainers on salient topics across psychedelic drug development, policy and business: from basic explainers such as “what is psychedelic-assisted therapy?” through to more complex matters such as REMS programs and bifurcated scheduling.

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