Purpose

This bill creates a legal, regulated system for the therapeutic use of psilocybin for adults aged 21 and older who have a qualifying medical condition and meet program requirements. The goal is to provide safe access to psilocybin through a structured framework that includes trained facilitators, licensed facilities, and ongoing oversight, research, and data collection.

Key Definitions (select terms)

• psilocybin: the psychoactive compound found in certain mushrooms.
• registered patient: a Minnesota resident enrolled in the program and certified by a health care practitioner.
• registered facilitator: a trained, licensed individual who conducts preparation sessions, administers psilocybin, and leads integration sessions.
• treatment facility: a licensed clinic or center equipped for psilocybin sessions.
• registered supplier: a state-licensed cultivator of psilocybin for the program.
• testing facility: a licensed entity that tests psilocybin for quality and dosing.
• program research institution: a Minnesota nonprofit or academic group that helps with data collection, training, and ethical oversight.
• administration session: a session where a registered patient consumes psilocybin under supervision.
• preparation session: a meeting before an administration session.
• integration session: a meeting after an administration session.
• health care practitioner: a Minnesota-licensed physician.
• qualifying medical condition: medical conditions designated by the commissioner where psilocybin shows therapeutic potential (examples include PTSD, depression, anxiety, substance use disorders, chronic pain).

How the Program Works (Overview)

• Establishment and control: The commissioner of health must establish and run the psilocybin therapeutic use program, with rules to govern every aspect.
• Rulemaking and oversight: The program will have rulemaking authority, guidance from an advisory committee, and collaboration with a program research institution. The Office of Cannabis Management will oversee certain program functions.
• Safety and standards: Rules will cover which medical conditions qualify, safety testing standards, proper dosing, and mechanisms to prevent diversion.
• Data and research: The program will collect deidentified data on use, outcomes, and adverse effects to evaluate and improve the program, and may support related research.
• Pilot scope: The initial program is designed as a controlled start with specific limits (see below) and a plan to evaluate after a set period.

Eligibility and Enrollment

• Age and diagnosis: To enroll, a person must be 21 or older and have a qualifying medical condition confirmed by health care practitioners.
• Health screening and risk assessment: A detailed health screening is required to identify contraindications. If contraindications exist, a formal risk assessment tool is used to determine whether enrollment can proceed.
• Informed consent: Applicants must be given information about psilocybin use, possible adverse effects, drug interactions, and must sign an informed consent form.
• Enrollment timing: Eligible individuals may apply beginning January 1, 2027. Enrolled patients receive a program card after enrollment.
• Renewal: Registrations last 12 months and can be renewed with updated certifications and a renewal fee.

Where and How Psilocybin Is Used

• Location: Administered only at an approved treatment facility or at a private residence if allowed by the property owner and with proper oversight.
• Facilitator presence: A registered facilitator must be physically present during administration sessions to supervise use and contact emergency services if needed.
• Preparation and integration: The facilitator may require attendance at preparation and integration sessions as part of supervision.
• Informed consent and records: Patients must sign a consent form and receive information prior to sessions; the facilitator keeps a signed record for two years.

Roles and Licensing

• Facilitators: Must be at least 21, hold a relevant license, and demonstrate competency in ethics, safe psilocybin use, and duties during sessions. Facilitators’ renewals can be denied for safety/ethical concerns.
• Registered facilitators: May be added to a public list on the Department of Health website.
• Registered suppliers and testing facilities: Must register with the commissioner and operate under program rules, ensuring quality and dosing controls.
• Training and standards: The program will establish required competencies for facilitators and cultivators in collaboration with the program research institution.

Cultivation, Testing, and Dosing

• Cultivation: Licensed cultivators must grow psilocybin for the program at approved locations under secure conditions.
• Limits: The total amount cultivated and possessed must stay within program-designated limits.
• Testing: Testing facilities are required to ensure quality and potency before psilocybin is released for treatment.
• Chain of custody: A formal process tracks psilocybin from supplier to facilitator/patient, with documented dose specifics recorded at exchanges.

Locations and Administration Details

• Administration sessions: A patient may only use psilocybin during an administration session at an approved site or home (if allowed) with supervision.
• Preparation and integration: The same registered facilitator may require or perform preparation and integration sessions.
• Dosing and consent: Treatment involves a prescribed dosing limit, and patients must sign an informed consent form before sessions.

Protections, Compliance, and Penalties

• Civil and criminal protections: Several protections exist for patients, suppliers, and facilitators in the course of program activities; penalties apply for improper distribution or diversion.
• Privacy and records: Information in the patient registry is protected; access by authorities requires a valid search warrant, and registry data generally cannot be used as evidence in criminal cases unless independently obtained.
• Employment, housing, and education: Protections prevent discrimination in employment, housing, and education for participants, with limited exceptions tied to federal law or safety concerns.
• Custody and damages: Courts can award damages to individuals harmed by violations of program protections.

Program Initiation and Evaluation

• Pilot caps: The initial program is designed to start with 20 to 50 facilitators, at least three testing facilities, and no more than 1,000 patients over the first three years.
• Evaluation: A formal evaluation is planned at the end of the three-year period, with input from the advisory committee and the program research institution. The program may also explore related psilocybin research.

Oversight and Interagency Coordination

• Oversight: The commissioner of health leads the program with rules and safety standards; the Office of Cannabis Management oversees certain functions (registries, licensing, cultivation, and testing).
• Data and research funding: The bill contemplates data collection and potential funding to support program operations and research.

Timeline and Next Steps

• Facilitator registration: Eligible individuals may apply to be registered facilitators starting October 1, 2026.
• Enrollment start: Enrollment and access to the program are set to begin January 1, 2027.
• Rulemaking timeline: Rulemaking guidance and deadlines are set to develop standards for medical conditions, testing, risk assessment, and competency demonstration, with expedited rulemaking possible for certain rules if notices are published timely.

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Relevant Terms psilocybin; psilocybin therapeutic use program; registered patient; registered facilitator; treatment facility; registered supplier; testing facility; program research institution; advisory committee; Psychedelic Medicine Advisory Committee; commissioner of health; Office of Cannabis Management; health care practitioner; qualifying medical condition; administration session; preparation session; integration session; informed consent; health screening; contraindications; formal risk assessment tool; dosing limit; deidentified data; data collection; chain of custody; cultivation; testing; access and enrollment; eligibility; renewal; registrant list; supervision; emergency cooperation; sheltering protections; civil protections; employment protections; housing protections; custody and visitation protections; violations; diversion; penalties; program initiation; pilot caps; evaluation.