A regulatory framework review of Schedule I psychedelics in the United States
JACCP JOURNAL OF THE AMERICAN COLLEGE OF CLINICAL PHARMACY June 12, 2023 Kevin Herkenham 5 citations
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.