A regulatory framework review of Schedule I psychedelics in the United States

Psilocybin and MDMA are being studied for psychiatric conditions like major depressive disorder and PTSD. Although the FDA has designated both as Breakthrough Therapies, they remain Schedule I substances under the Controlled Substances Act, meaning they are legally considered to have no accepted medical use and high abuse potential. Programs like Expanded Access and federal Right-to-Try legislation offer limited pathways for patient access, but these are constrained for Schedule I drugs. Clinicians need to understand the administrative procedures, court cases, and legislative initiatives related to these substances to make informed decisions and participate in shaping policy.

Study at a glance

Abstract

Abstract Psychoactive substances such as psilocybin and 3,4‐methylenedioxy‐methamphetamine (MDMA) are currently being investigated for a variety of psychiatric indications including major depressive disorder and post‐traumatic stress disorder. It is critical that clinicians working in the mental health field understand the regulatory framework that balances access and control for such substances. While both psilocybin and MDMA are designated as “Breakthrough Therapy” by the Food and Drug Administration (FDA), they remain classified as Schedule I substances under the Controlled Substances Act (CSA) of 1970. There are programs such as Expanded Access (EA) and federal Right‐to‐Try (RTT) legislation that can accommodate patient access to investigational drugs under certain circumstances, but these programs are not without their limits—particularly for Schedule I substances that do not currently have an accepted medical use per the CSA. It is in the clinical community's best interest to understand the administrative procedures, key court cases, and federal legislative initiatives related to these substances in order to make well‐informed decisions for themselves and their patients. Furthermore, understanding the administrative proceedings related to controlled substances will also allow subject matter experts to participate in and shape the policies governing such substances.