HF4577

Purpose

Create a regulated program in Minnesota to allow psilocybin to be used therapeutically for adults 21 and older. Individuals must have a licensed facilitator, a qualifying medical condition, and meet enrollment requirements. The bill sets up rules, licensing, data collection, and protections to guide how psilocybin can be used in medical treatment.

Key Provisions

• 152.40–152.53: Psilocybin Therapeutic Use Program

  • Establishes a state program to authorize therapeutic use of psilocybin for eligible adults.
  • Requires rulemaking to govern the program, including: qualifying medical conditions, dosing and safety standards, health screening, risk assessment, and procedures to prevent diversion.
  • Creates roles and credentials: registered patients, registered facilitators, registered suppliers (cultivators), and testing facilities.
  • Allows treatment facilities and program-approved locations for administering psilocybin, with safety requirements and supervision.

• 152.41: Program Operations

  • The Department of Health administers the program.
  • Rules must address who qualifies, how testing is done, how dosing is determined, and how health screenings and risk assessments are performed.
  • Establishes a process to register facilitators and cultivators, including competency requirements and collaboration with a program research institution and an advisory committee.

• 152.42: Eligibility and Enrollment

  • To enroll: be 21+, obtain health care practitioner certifications confirming a qualifying medical condition, pass health screenings, and submit an enrollment application.
  • Enrollment opens January 1, 2027.
  • Health screenings screen for contraindications; if contraindications exist, they may be reevaluated with a formal risk assessment before enrollment is allowed.

• 152.43: Cultivation

  • Cultivation of psilocybin is allowed for the program when done by registered suppliers at approved facilities.
  • Cultivators must register with the commissioner, and cultivation must occur in secure locations with on-site testing for quality and potency.
  • Testing facilities verify quality and dosage.

• 152.44: Location and Facilitator Administration Sessions

  • Psilocybin administration sessions must occur only at approved locations (private residence with owner permission or licensed treatment facility).
  • A registered facilitator must be physically present to supervise sessions and assist with emergencies.
  • Informed consent must be obtained, including information on effects and interactions with other drugs.
  • A chain-of-custody process is required for psilocybin doses, with documentation of the exact dose used in each session.

• 152.45: Registered Facilitator

  • Facilitators must be at least 21, hold a licensed mental health professional credential, and demonstrate competency in ethics, safe use of psilocybin, and duties during sessions.
  • Facilitators must apply for registration and renew every 12 months; complaints can affect renewal.
  • A public list of registered facilitators will be posted on the Department of Health website.
  • Individuals may begin applying for facilitator registration on October 1, 2026.

• 152.46: Limitations

  • Several activities are prohibited, including giving psilocybin to non-patients, creating treatment centers on school grounds, or having facilitators provide psilocybin to non-patients.
  • Also prohibits certain conduct that would undermine the program’s integrity.

• 152.47: Criminal and Civil Protections

  • Public employees and program participants have protections related to the program, including restrictions on certain civil or criminal liability when acting within the program’s scope.
  • Certain data in the patient registry is protected (not freely accessible without warrant); information cannot be used as evidence in criminal proceedings unless independently obtained.
  • Families and individuals involved in the program receive certain protections against searches or penalties related to program participation.

• 152.48: Violations and Penalties

  • Diversion (selling or transferring psilocybin to nonpatients) is a felony with penalties up to two years in prison or a fine up to $3,000, or both.

• Interagency and Oversight

  • The Department of Health will work with the Office of Cannabis Management to coordinate oversight of patient registries, licensing, cultivation, and testing.

• Program Start and Evaluation

  • The initial program phase is limited: 20–50 facilitators, at least three testing facilities, and up to 1,000 patients over the first three years.
  • A formal evaluation is required at the end of the three-year period to assess outcomes and make recommendations.

Significant Changes to Existing Law

• Creates a new, regulated psilocybin therapeutic use framework in Minnesota Statutes (new sections in the 152.xx range) with defined terms and roles (registered patient, registered facilitator, registered supplier, testing facility).
• Establishes a formal, government-supervised program rather than an informal or unregulated use.
• Requires formal health screenings, risk assessments, and informed consent prior to enrollment and administration.
• Introduces licensing and oversight for facilitators, cultivators, and testing facilities; mandates collaboration with a program research institution and an advisory committee.
• Sets up a data collection and monitoring system using deidentified data to evaluate program outcomes and safety.
• Creates civil and criminal protections for participants and program staff, while instituting penalties for diversion of psilocybin.
• Requires coordination with the Office of Cannabis Management for certain program functions (registries, licensing, cultivation/testing oversight).

How This Affects the Public

• Provides a legally regulated path for eligible adults to access psilocybin therapy under medical supervision.
• Establishes safety nets (screenings, risk assessments, informed consent) and prevents improper use and diversion.
• Protects participants from certain employment, housing, education, and custody consequences when actions are limited to lawful program participation, with some federal-law-related exceptions.
• Introduces strict controls to prevent access by minors and to prevent distribution outside the program.

Potential Implications to Monitor

• Availability and accessibility: phased rollout with a capped number of facilitators, facilities, and patients.
• Privacy and data use: deidentified data collection for monitoring and research.
• Enforcement: penalties for diversion and remedies for violations, plus civil actions for damages in certain cases.
• Interagency cooperation: how the Department of Health and the Office of Cannabis Management share oversight responsibilities.

Relevant Terms

• psilocybin, psilocybin therapeutic use program, registered patient, registered facilitator, registered supplier, treatment facility, cultivation, testing facility, program research institution, advisory committee, qualifying medical condition, health care practitioner, risk assessment tool, informed consent, administration session, preparation session, integration session, dosing limit, chain of custody, withdrawal/recall of psilocybin, deidentified data, rulemaking, expedited rulemaking, cross-agency interagency agreement, Office of Cannabis Management, screening, contraindications, cardiovascular disease, psychosis, bipolar disorders, MAOIs, ketamine (contextual reference as related to psychedelic therapies), diversion, felony, civil protections, employment protections, housing protections, education protections, custody and parenting time protections, complaints, program initiation, evaluation, and 21 years of age restriction.