Regulation & Enforcement

The American Psychiatric Association is the national medical specialty society for psychiatry in the United States, with headquarters in Washington, DC and a membership base of psychiatric physicians. It serves psychiatrists and the broader mental health field through official position statements, clinical guidance, journals, and public policy communications. Its core activity is to represent psychiatry in clinical, professional, and policy discussions affecting mental health care. APA has an explicit, cautious stance on psychedelics and empathogens in mental health care. Its 2022 position statement says there is not yet adequate scientific evidence to endorse use outside approved investigational studies, while supporting continued research under strong scientific and regulatory standards. In 2024 APA also submitted comments to FDA on MDMA and in 2026 it publicly welcomed federal investment in psychedelic research while reiterating the need for controlled studies and patient protections.

Pharmaceutical company responsible for LUMRYZ REMS implementation in the U.S., including prescriber and pharmacy certification and controlled distribution safeguards.

Biopharmaceutical company responsible for BRIXADI REMS implementation in the U.S., with certified provider and pharmacy requirements and controlled outpatient distribution pathways.

Colorado Division of Professions and Occupations program overseeing facilitator licensing, renewals, complaints, and rule/policy resources for natural medicine services.

Colorado Department of Revenue division responsible for licensing and regulating natural medicine businesses, including healing centers, cultivations, product manufacturers, and testing facilities.

The Colorado Natural Medicine Advisory Board is a statutorily created state board within Colorado’s Division of Professions and Occupations that advises the state licensing authority on implementing Colorado’s natural medicine regulatory program. It operates in Colorado and serves statewide public interests, with board membership drawn to reflect expertise in natural medicine, research, cultivation, public health, insurance, behavioral health, veterans, Indigenous use, and criminal justice reform. Its core work is to make recommendations on rules, public education, training, facilitator qualifications, data collection, and access considerations. In Colorado’s regulated natural medicine system, the board functions as an implementation and oversight working group rather than a direct service provider or advocacy nonprofit. Documented current activity includes recommending state action on ibogaine sourcing and cultural protocols, including alignment with the Nagoya Protocol and a federal Controlled Substances Act waiver request for import pathways. Its role in the field is to shape how regulated access is designed, safer use information is communicated, and whether additional natural medicines or insurance coverage considerations should be evaluated over time.

EU medicines regulator for scientific review and pharmacovigilance, including psychiatric products with psychedelic relevance.

EU public drugs observatory and surveillance body publishing trend and risk evidence including hallucinogen/psychedelic monitoring.

Canadian federal health regulator administering controlled access and oversight pathways relevant to psychedelic therapies.

Pharmaceutical company responsible for the U.S. SUBLOCADE REMS program, including enrollment, certified healthcare setting controls, and controlled dispensing requirements.

Pharmaceutical sponsor operating SPRAVATO REMS restricted-distribution controls for supervised administration, site certification, and patient enrollment in the US market.

Biopharmaceutical company that administers the U.S. XYWAV and XYREM REMS restricted distribution program, including certification, dispensing controls, and program reporting requirements.

Oregon state health authority administering Oregon Psilocybin Services licensing and implementation oversight.

The Oregon Psilocybin Advisory Board is a state advisory body within the Oregon Health Authority that operates in Oregon. It was established under Oregon law to make recommendations on scientific evidence, safety and efficacy, and the requirements, specifications, and guidelines for psilocybin services in the state. Its work is oriented toward public meetings, advisory recommendations, and related subcommittee and workgroup processes. In Oregon's regulated psilocybin system, the board functions as an implementation and policy guidance group rather than a direct service provider. Source materials show it has produced evidence reviews and has supported ongoing advisory and workgroup activity tied to psilocybin service rules, product issues, and public comment opportunities. Potential collaboration areas include regulatory implementation, evidence review, clinical and facilitator standards, public health safeguards, and access-oriented policy feedback from researchers, clinicians, funders, and patient or community stakeholders.

Regional psychiatric college issuing clinical memoranda and implementation guidance on psychedelic-assisted therapy, including MDMA and psilocybin use in regulated psychiatric contexts.

Swiss federal authority issuing exceptional licences for otherwise prohibited narcotics, including controlled pathways relevant to psychedelic substances under medical/scientific exceptions.

U.S. shared-system REMS program for transmucosal immediate-release fentanyl products, maintaining restricted prescriber, pharmacy, and patient enrollment controls.

Australian national regulator for scheduling, prescribing pathways, and safety oversight including MDMA/psilocybin psychiatry contexts.

US federal regulator for drug development and safety oversight, including psychedelic clinical-investigation pathways.

U.S. REMS program for isotretinoin products that enforces pregnancy-prevention controls through prescriber, pharmacy, and patient workflow requirements.