New Year, New Rules: Updated Oregon Psilocybin Services Regulations Now in Effect
By Yolanda Clarke
Feb 27, 2024
As we usher in 2024, licensees and interested stakeholders in Oregon’s psilocybin services program have updated regulations to inform their operations. This step marks yet another accomplishment for Oregon Psilocybin Services (OPS), the regulatory authority tasked with the development and implementation of the first state-regulated natural medicine program in the nation, and which successfully issued the first licenses for the program in 2023.
Rulemaking Process: Ensuring Transparency and Stakeholder Input
To ensure a transparent process and robust stakeholder involvement, OPS’ Rules Advisory Committees (RAC) held multiple meetings in Fall 2023, where the public was encouraged to provide input on the proposed changes. Informed by the RAC, suggestions from the Oregon Psilocybin Advisory Board, and public comment periods, these updated regulations went into effect as of January 1, 2024. Regulatory changes focused on technical fixes to the initial rules promulgated during OPS’ implementation phase, implementing Senate Bill 303, a data reporting bill for service centers, and requirements regarding approval of facilitator training programs.
Key Updates: Clarifying Existing Rules and Addressing New Areas
The most novel updates to the rules relate to the promulgation of regulations for SB 303. While the requirements for SB 303 do not go into effect until 2025, OPS has started the implementation process. With these rules, OPS has clarified and created a distinction between the aggregate, de-identified data collected by service centers to be provided to OPS to assist with evaluating safety risks and the personally identifiable information collected directly from clients, which clients have the option to disclose, but are not required to do so.
Other changes serve to clarify or modify existing requirements. To become a licensed facilitator, applicants must complete training at a psilocybin facilitator program approved by the OPS. In Oregon, the Higher Education Coordinating Commission (HECC) licenses career training schools and degree-granting programs. The new rules clarify that to receive and maintain OPS approval, training programs must either be licensed by HECC or qualify for an exemption. Also revised was the definition of “nondirective facilitation,” which clarifies that clients must make the decisions regarding their participation in psilocybin services, and facilitators should not give direct advice or interpretations of a client’s experiences (unless needed for health and safety reasons). Facilitators may, however, provide resources, referrals, and health and safety support within their scope of practice. This nondirective facilitation should occur at each stage in the process: preparation, administration, and integration. Adverse event reporting requirements were also altered, clarifying that reporting is only necessary in those instances where a client required medical care to be provided or had to be transported to a medical facility.
Looking Ahead: Future Considerations for the Psilocybin Program
Stakeholders can anticipate an annual rulemaking session each fall. While the needs of the program will dictate those future changes, updates to legislation and public comments and feedback received in the 2023 rulemaking session will likely arise again. OPS mentioned several topics that may be revisited in later rulemaking, including the need for speciation testing, required labeling of psilocin potencies, and limitations on the monetization of client data.
Oregon continues to lead the nation in state-regulated psilocybin services. If you are interested in participating in this exciting emerging market, please get in touch with Yolanda Clarke for assistance in making your business plans a reality.