Regulation & Enforcement

US professional psychiatric body that publishes position statements and guidance relevant to evidence standards and clinical policy considerations for psychedelic and empathogenic therapies.

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.

Statutorily created Colorado advisory board providing implementation recommendations for natural medicine regulation, safety standards, licensing architecture, and program oversight priorities.

EU medicines regulator coordinating scientific and policy dialogue on psychedelic medicinal products, including multi-stakeholder work toward regulatory framework design in the European context.

EU-level drug monitoring authority publishing surveillance and risk intelligence on hallucinogens, including LSD-related trends and associated policy-relevant evidence streams.

Canadian federal health regulator administering Special Access Program pathways for restricted drugs, including psychedelic substances under case-by-case clinical access conditions.

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 public health authority operating Oregon Psilocybin Services (OPS), with statutory responsibilities for licensing, regulation, and oversight of psilocybin service delivery under ORS 475A.

State advisory board charged with issuing recommendations to Oregon Health Authority on psilocybin services implementation, professional standards, public health safeguards, and operational controls.

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 implementing schedule controls and authorised-prescriber pathways relevant to MDMA and psilocybin use in tightly regulated psychiatric indications.

US federal regulator with statutory authority to require and enforce Risk Evaluation and Mitigation Strategies (REMS) for drug products where additional safety controls are needed.

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