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Psychedelic drugs1 like MDMA, psilocybin ("magic mushrooms"), LSD, and DMT are substances that have psychoactive properties. Their widespread use during the counterculture movement of the 1960s invoked harsh criticism and, ultimately, backlash from the government, earning these substances Schedule I designation as drugs that have "no currently accepted medical use." However, studies have found many psychedelics administered in a clinical setting with a trained therapist to be effective at treating post-traumatic stress disorder (PTSD), depression, anxiety, and substance abuse disorders.2 Increased societal focus on the importance of mental health and wellbeing in recent years has led to a renaissance of scientific and commercial interest in psychedelics and their potential as valuable and effective therapies. With the recognition that there is a significant need for effective therapies to address these mental health issues to which psychedelics may address, this emerging drug market is projected to grow to $10.75 billion by 2027.3
Efforts are advancing across the United States to reschedule (from Schedule I to lessrestrictive schedules), decriminalize, and (in some instances) legalize the use of psychedelics in a therapeutic setting. This article provides a brief overview of the regulatory framework restricting the production, sale, and use of psychedelics; discusses psychedelic drugs which have been approved for limited use; and addresses recent legislative developments in the movement to decriminalize and/or legalize the use of psychedelics.
The Regulatory Framework for Psychedelics: A Brief Introduction
All psychedelic drugs discussed in this article, other than ketamine, are considered Schedule I drugs under the federal Controlled Substances Act (CSA).4 They are illegal to produce, possess, distribute, or consume. This does not mean that progress toward legitimization is not occurring.
The U.S. Drug Enforcement Administration's (DEA) Diversion Control Division manages the registration of applicants seeking to study or otherwise handle Schedule I controlled substances for medical and scientific purposes, clinical research, and religious/indigenous use. A big issue with research of Schedule I drugs is that it can disqualify the facility - like a university - from receiving federal funding even for unrelated projects.5 However, in late 2021 the DEA significantly increased the production quota in the manufacturing of the Schedule I substances psilocybin, psilocin, cannabis, and cannabis extract6 in the recognition of the need to fulfill research and development requirements and as...