Oregon Psilocybin – Administrative Rules

Background on the Rulemaking Process

The Oregon Health Authority, Public Health Division, Oregon Psilocybin Services (OPS) section is required to adopt administrative rules to implement ORS chapter 475A, the Oregon Psilocybin Services Act. The rulemaking process is informed by recommendations from the Oregon Psilocybin Advisory Board (OPAB), input from Rules Advisory Committees (RACs) and comments received during public comment periods.

The Oregon Health Authority (OHA) adopted the first subset of rules related to psilocybin products, testing and training programs in May 2022. The remainder of rules needed to regulate the production of psilocybin products and the provision of psilocybin services in Oregon will be adopted by December 30, 2022.

Proposed Rules and the November 2022 Public Comment Period.

Below is a copy of the proposed rules for the November public comment period. The public comment period ran from November 1, 2022 to November 21, 2022 (and closed at 5:00 P.M. Pacific Time). The public comment period is now closed. The Oregon Health Authority is reviewing and considering all written comments and comments provided during the public hearings.

Once finalized in late December, the Hearing Officer Report and final rules will be linked to this webpage and sent out through the Oregon Psilocybin Services mailing list .

Proposed Rules - November 1, 2022

Exhibit 1 - Proposed (333-333-6200)

Notice to Interested Parties

Notice of Proposed Rulemaking

OHA Thank You Letter to RAC members - November 2, 2022

November 2022 Public Hearings

The Oregon Health Authority held three virtual public hearings in November. Simultaneous interpretation in Spanish and American Sign Language (ASL) was provided, as well as live closed caption transcription. Recordings of the hearings can be found below.

September 2022 Rules Advisory Committees (RACs)

Oregon Psilocybin Services (OPS) convened three Rules Advisory Committees (RACs) in September 2022 to discuss proposed rules on (1) Packaging, labeling and product transportation, (2) Licensing, facilities, and operations, and (3) Facilitator conduct, preparation, administration, and integration sessions.

Rules Advisory Committees (RACs) are an important part of the rulemaking process. RAC members provide input on draft administrative rules before they become effective. RACs are comprised of individuals who have subject matter expertise, lived experience and who are likely to be affected by the proposed rules. The RAC process is designed to include a diversity of opinions and viewpoints. In addition to providing recommendations, RACs evaluate fiscal and racial impact of the proposed rules. Draft rules are updated based on RAC input, and the next version of proposed rules is then made available for public comment.

The September RAC meetings were recorded and posted to this webpage. The draft rules were updated based on RAC input and the next version of proposed rules were posted to this webpage for public comment on November 1, 2022. Please keep in mind that a subset of rules pertaining to psilocybin services were already adopted in May 2022 and can be found on this page under "Adopted Rules".

Draft Rules for September 2022 RACs

September 2022 RAC Meeting Materials and Recordings

Adopted Rules

The Oregon Health Authority (OHA) adopted the first subset of rules related to psilocybin products, testing and training programs in May 2022. These rules are needed to implement ORS chapter 475A, the Oregon Psilocybin Services Act.

The rules specify curriculum requirements for programs planning to train people interested in facilitating psilocybin services in Oregon, as well as initial requirements related to psilocybin products and testing. Please keep in mind that this is only a sub-section of the rules. A second rulemaking process for the remainder of the rules is taking place this Fall.

To read the final text of the rules, go to: Chapter 333, Division 333
To read a letter to the public from the Oregon Psilocybin Services Section (OPS), go to: Letter to the Public
To read the Hearings Officer Report, go to: Hearing Officer Report