The Legal Status of Psilocybin Therapy in the United States

Updated
June 29, 2023
Edited by Ben Smith
Last Updated:
May 2, 2024
Fashionable woman holding a stylized scale, depicting the balance of justice and mental health in a psychedelic context.

Psilocybin is a naturally occurring psychedelic compound found in certain types of mushrooms. In recent years, there has been an increasing interest in the therapeutic potential of psilocybin for various mental health issues, such as depression and anxiety. However, due to its classification as a Schedule I substance under U.S. federal law, the legal status of psilocybin therapy is complex and varies from state to state. This article will explore the current legal status of psilocybin therapy in the United States and discuss the role that advocacy organizations have played in advocating for access to this treatment option. 

The Federal Legal Status of Psilocybin 

Psilocybin is classified as a Schedule I controlled substance at the federal level in the United States. According to the U.S. Drug Enforcement Administration (DEA), Schedule I substances have a high potential for abuse and no currently accepted medical use. This classification means that possession, sale, and distribution of psilocybin are illegal under federal law.

However, despite its Schedule I classification, research into the therapeutic potential of psilocybin is allowed with approval from the Food and Drug Administration (FDA) or DEA [1]. Researchers seeking to study psilocybin must obtain a Schedule I research registration from the DEA, which allows for the possession, use, and distribution of the substance for research purposes. In addition, researchers must also obtain approval from the FDA for their research protocol and any investigational drug product they plan to use.

While psilocybin remains illegal for any use at the federal level, there is growing interest in studying its potential therapeutic benefits for conditions such as depression, anxiety, and substance use disorders. Currently, a number of clinical trials are underway to evaluate the safety and effectiveness of psilocybin-assisted therapy for these and other conditions.

State-Level Variations in the Legal Status of Psilocybin

In addition to its federal status, the legal status of psilocybin varies from state to state within the United States. While psilocybin is currently a Schedule I controlled substance at the federal level, some states have taken steps to decriminalize or legalize psilocybin for certain purposes.

Decriminalization of the possession of psilocybin for personal use means that individuals caught with small amounts of psilocybin may not face criminal charges. In other states, psilocybin has been legalized for recreational use, meaning possession and use are no longer criminal offenses.

However, in many states, psilocybin possession and sale are still considered criminal offenses punishable by fines or imprisonment. Additionally, some states allow for limited medical use or research into the therapeutic applications of psilocybin with approval from state authorities. For example, in Oregon, voters approved a measure in 2020 that legalized psilocybin for certain therapeutic uses, such as the treatment of depression and anxiety, with the guidance of a licensed provider [2].

The Legal Status of Psilocybin Therapy Clinics in the United States

It is currently not legal to operate a psilocybin therapy clinic in any U.S. state. As such, clinics that offer psilocybin therapy are not legally sanctioned and are not regulated by the government. However, despite the legal restrictions, there are private clinics that offer unapproved treatments using psilocybin without FDA approval or DEA registration. These clinics typically operate on a fee-for-service basis and often require patients to have a referral from a healthcare provider before receiving treatment.

Furthemore, The Johns Hopkins Center for Psychedelic & Consciousness Research is conducting clinical trials to evaluate the safety and effectiveness of psilocybin therapy for a variety of conditions, including treatment-resistant depression, anxiety, and substance use disorders [3]

While the availability of psilocybin therapy is currently limited, this research is a promising step toward making this treatment option more widely available in the future.

The Role of Advocacy Organizations in Legalizing Psilocybin Therapy

Advocacy organizations such as MAPS, Multidisciplinary Association for Psychedelic Studies (MAPS), Heffter Research Institute (HRI), and Usona Institute are working towards making psilocybin therapy more widely available through legislative efforts at both the state and federal levels. These organizations are also supporting research into therapeutic applications of psychedelics through clinical trials and public education campaigns aimed at raising awareness about their potential benefits. 

Through these efforts, we can hope for a future where access to psilocybin therapy will be more widely available and its benefits more widely understood. The support and advocacy of these organizations can play a significant role in making this possible.

The Future of Psilocybin's Legal Status in the United States

Given its increasing popularity among mental health professionals as well as growing public support for its therapeutic potential, it is likely that more states will legalize access to psilocybin-assisted therapy over time. 

Several cities across the country have already passed ordinances decriminalizing personal possession or small amounts of these substances; while this does not necessarily make them legal per se, it does reduce enforcement penalties related to their use. 

Ultimately, only Congress can reclassify these substances under federal law; until then, their legal status remains uncertain but promising. 

At Psychly, we are committed to upholding the highest standards in our content creation process. We strive to ensure that all statements presented in our articles are supported by reliable, high-quality sources, such as peer-reviewed studies and reputable academic journals.

- The Psychly Team

  1. Psilocybin therapy: FDA Breakthrough Therapy designation received. (2018). COMPASS Pathways. https://compasspathways.com/compass-pathways-receives-fda-breakthrough-therapy-designation-for-psilocybin-therapy-for-treatment-resistant-depression/
  2. Oregon Health Authority : Oregon Psilocybin Services : Prevention and Wellness : State of Oregon. (2016). Oregon.gov; Oregon Psilocybin Services : Oregon Health Authority. https://www.oregon.gov/oha/ph/preventionwellness/pages/oregon-psilocybin-services.aspx
  3. ‌Center. (2023). Center for Psychedelic & Consciousness Research. Center for Psychedelic & Consciousness Research. https://hopkinspsychedelic.org/

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