A regulatory framework review of Schedule I psychedelics in the United States
Kevin Herkenham
JACCP JOURNAL OF THE AMERICAN COLLEGE OF CLINICAL PHARMACY June 12, 2023 DOI: 10.1002/jac5.1841 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Review Peer reviewed |
|---|---|
| Topics | MDMA Psilocybin |
| Keywords | Legislation Schedule Hallucinogen |
| Citations | 5 |
| Key findings | Psilocybin and MDMA are FDA Breakthrough Therapies but remain Schedule I substances, and existing access programs are limited for such drugs. |
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.
Comparable studies
Other narrative reviews on MDMA, most cited first.
| Study | Year | Design | Participants |
|---|---|---|---|
| Human Pharmacology of MDMA | 2004 | Review | |
| Human psychopharmacology of Ecstasy (MDMA): a review of 15 years of empirical research | 2001 | Review | |
| 3,4‐Methylenedioxymethamphetamine (MDMA, “Ecstasy”): pharmacology and toxicology in animals and humans | 1994 | Review | |
| (±)3,4-Methylenedioxymethamphetamine (‘Ecstasy’)-Induced Serotonin Neurotoxicity: Studies in Animals | 2000 | Review | |
| Amphetamine toxicities | 2010 | Review |
Citations in the library
Cited by 5
- Role of selective serotonin reuptake inhibitors, serotonin-norepinephrine reuptake inhibitors and psychedelics in the treatment of major depressive disorder: A perspective on mechanistic insight and current status. European Journal of Pharmacology August 15, 2025
- Emerging drugs in phase II and III clinical development for the treatment of alcohol use disorder. Expert Opinion on Emerging Drugs September 1, 2024
- Classic Psychedelics for Chronic Pain: A Critical Review of the Literature and Practical Advice for Clinicians. Drugs June 4, 2026
- Psilocybin as a psychophysical adaptogen in chronic pain rehabilitation. Journal of Pain July 21, 2025
- Mixed-Methods Study of Use and Attitudes About Psychedelics for Therapeutic Purposes Among Low-Income U.S. Veterans Nationally. Journal of Psychoactive Drugs March 24, 2025
Cites 4
- Effects of Psilocybin-Assisted Therapy on Major Depressive Disorder JAMA Psychiatry November 4, 2020
- Efficacy and safety of psilocybin-assisted treatment for major depressive disorder: Prospective 12-month follow-up Journal of Psychopharmacology February 1, 2022
- Psychedelics: Where we are now, why we got here, what we must do Neuropharmacology February 21, 2018
- The Past and Future of Psychedelic Science: An Introduction to This Issue Journal of Psychoactive Drugs March 15, 2019