Chapter 333-333

333-333-2020 General Manufacturer Requirements (1) A manufacturer must: (a) Use equipment, counters and surfaces for post-harvest processing that are food-grade and do not react adversely with any solvent being used. (b) Construct and maintain floors, walls, ceilings, counters an…

333-333-2030 Manufacturer Endorsements (1) A manufacturer may only produce, transfer, and sell psilocybin products if the manufacturer has received an endorsement from the Oregon Health Authority (Authority) for that type of product. Endorsement types are: (a) Fungi cultivation; …

333-333-2040 Pesticides Manufacturers are prohibited from applying pesticides to fungi or growing medium. Statutory/Other Authority: ORS 475A.235 Statutes/Other Implemented: ORS 475A.235 & ORS 475A.290 History: PH 74-2022, adopt filed 05/19/2022, effective 05/20/2022

333-333-2050 Adulterants (1) A licensee may not add to psilocybin products, substrates, growing medium or client packaging any chemical, drug, plant, or substance that has the effect of altering potency, intoxicating effect, duration of effect, toxicity or potential for excessive…

333-333-2060 Psilocybin Extract Manufacturing Requirements (1) A manufacturer with a psilocybin extraction endorsement may use only water, vegetable glycerin, acetic acid, ethanol and methanol as solvents in extraction. All other solvents are prohibited. (2) A manufacturer with a…

333-333-2070 Psilocybin Extract Manufacturing Safety Procedures (1) A manufacturer with an extraction endorsement must: (a) Work in an environment with proper ventilation, controlling all sources of ignition where flammable vapors may be present; (b) Use only potable water in pro…

333-333-2080 Psilocybin Edible Manufacturing Requirements (1) A manufacturer premises with an edible endorsement must be licensed by the Oregon Department of Agriculture (ODA) as a food establishment and must comply with the applicable provisions of OAR chapter 603, division 21, …

333-333-2100 Psilocybin Manufacturing Records A manufacturer with a psilocybin extraction, or edible psilocybin production endorsement must create and maintain standard policies and procedures that include but are not limited to: (1) Instructions and ingredients for making each p…

333-333-2110 Allowable Psilocybin Product Types (1) A manufacturer with a fungi cultivation endorsement may produce and dry whole fungi, mycelium and homogenized fungi. A manufacturer with a fungi cultivation endorsement may produce fungi in aquatic environments in addition to an…

333-333-2120 Psilocybin Product Delivery Methods (1) A manufacturer must design and manufacture all psilocybin products to be consumed by a client orally or delivered via another enteral method (2) A manufacturer is prohibited from designing or manufacturing psilocybin products t…

333-333-2200 Psilocybin Product Quantity Limits (1) Quantities of psilocybin products shall be measured in total grams of psilocybin analyte contained in a product that has been tested for potency as required by OAR 333-333-7040. (2) A manufacturer must ensure that potency tests …

333-333-2300 Packaging for Sale to Client (1) Client packaging must protect the packaged psilocybin product from contamination and excessive moisture and must not impart any toxic or harmful substance to the packaged item. (2) All psilocybin products must be transferred to a serv…

333-333-2310 Packaging and Serving Size (1) A serving of a psilocybin product may not contain more than 25 mg of psilocybin analyte. (2) Client packaging may not contain more than one serving of a psilocybin product. Statutory/Other Authority: ORS 475A.235 & ORS 475A.642 Statutes…

333-333-2400 Labeling for Sale to Client (1) A label required by these rules must: (a) Be printed or attached to client packaging containing psilocybin products. (b) Contain all required information in a legible font at least eight points large. (c) Be in English, though it may a…

333-333-2410 Product Information Document (1) Manufacturers must provide a product information document with all products transferred to a service center that lists the following information in English on a printed or electronic document in 12-point font or larger. (a) The manufa…

333-333-3010 Psilocybin Training Program Curriculum Approval Process (1) A training program applicant must submit the following to the Oregon Health Authority (Authority) to be considered for curriculum approval to train psilocybin facilitators: (a) A completed application packag…

333-333-3020 Psilocybin Training Program Application Requirements For curriculum to be approved, training program applicants must: (1) Demonstrate that its proposed course modules contain the content required by OAR 333-333-3060; (2) Demonstrate that its proposed hours of instruc…

333-333-3030 Psilocybin Training Instructor Qualifications and Program Performance (1) In order for curriculum to be approved or reapproved, a training program must demonstrate that each lead educator, instructor and person who trains instructors at a training program has suffici…

333-333-3035 Psilocybin Training Program Curriculum Approval Renewal (1) A training program that applies for renewal of curriculum approval must submit a complete renewal application, including proof that the program has received and continues to hold any approvals required from …

333-333-3040 Psilocybin Training Program Record Keeping (1) Training programs shall maintain records for each class, including course syllabi, location, date and student attendance for every online and in-person class. These records must be maintained for five years. Training pro…

333-333-3050 Psilocybin Training Program Core Requirements (1) For new applications and renewals received on or after January 1, 2025, training programs shall provide core training that consists of at least 128 hours of instruction. (2) For training that is not conducted in perso…

333-333-3060 Psilocybin Training Curriculum Modules (1) "Historical, Traditional, and Contemporary Practices and Applications" module shall include: (a) Current and historical use of plant and fungal medicines in indigenous and western cultures; (b) The Controlled Substances Act …

333-333-3070 Psilocybin Facilitator Practicum Requirements (1) Training programs must have curriculum that requires students to complete practicum training that provides an opportunity to observe the facilitation of non-ordinary states of consciousness. (2) After January 1, 2026,…

333-333-3080 Accelerated Training Hours (1) Programs may grant qualified students accelerated training hours not to exceed 40 percent of the total number of core training hours required by OAR 333-333-3050. (2) Accelerated training hours may be awarded based on students’ professi…

333-333-3085 Transfer of Training Hours Due to Training Program Closure (1) Training programs may accept transfer core training hours for students who were previously enrolled in another approved training program that on or after January 1, 2026: (a) Effectively surrendered its c…

333-333-3090 Training Program Completion and Exams (1) Training programs shall maintain a level of training for students such that students who successfully complete the program’s training could reasonably expect to possess the knowledge and skills required to practice as a facil…

333-333-3200 Facilitator Exam (1) Every applicant for a facilitator license must take the exam required by ORS 475A.330 and receive a passing score prior to being issued a facilitator license. (2) A passing score on the exam is 75 percent correct. After the applicant takes the ex…

333-333-3300 Continuing Facilitator Education (1) For renewal applications received on or after January 1, 2026, facilitator licensees must have completed four hours of continuing facilitator education during their annual license period in order to be eligible for license renewal…

333-333-4000 Application Process (1) Applications must be submitted to the Oregon Health Authority (Authority) in the form and manner prescribed by the Authority. (2) The application fee specified in OAR 333-333-4060(1) must be submitted at the time of application in the form and…

333-333-4010 Communication with the Oregon Health Authority (1) If an applicant or licensee is required to or elects to submit anything in writing to the Oregon Health Authority (Authority), unless otherwise prescribed by the Authority, the applicant or licensee may submit the wr…

333-333-4020 Social Equity Plans (1) In addition to the requirements of OAR 333-333-4000 applicants for a manufacturer, service center, facilitator or laboratory license must submit a social equity plan for their initial application to be considered complete. (2) Social equity pl…

333-333-4030 True Name on Application (1) An application for a service center, manufacturing or laboratory license must specify the legal names of all individuals and legal entities who qualify as applicants. (2) An application for a facilitator license must identify the legal na…

333-333-4040 Financial Interests (1) Applicants and licensees must create and maintain complete lists of all individuals and legal entities that hold a financial interest in the entity, including contact information for each individual or entity and a description of their financi…

333-333-4060 License Fees (1) At the time of initial license application: (a) An applicant for a service center, manufacturer or laboratory license must pay a US$500 non-refundable application fee. (b) An applicant for a facilitator license must pay a US$150 non-refundable applic…

333-333-4070 Worker Permit Term and Fees (1) An individual who is a licensee representative must have a valid worker permit if the individual participates in: (a) The provision of psilocybin services at a licensed premises. (b) The possession, manufacturing, securing or selling o…

333-333-4100 Criminal Records Checks (1) The Oregon Health Authority (Authority) may require any individual person identified as a licensee, a worker permit holder or applicant on a worker permit or license application to undergo a criminal records check and fitness determination…

333-333-4110 Application Review (1) Once the Authority has determined that an application is complete, it must review the application to determine compliance with ORS chapter 475A and these rules. (2) The Authority must receive a land use compatibility statement from the city or …

333-333-4120 Approval and Issuance (1) If upon review of an application the Oregon Health Authority (Authority) determines the application meets all licensing requirements, the Authority will notify the applicant in writing that the application is pending approval and will reques…

333-333-4130 Application Denial (1) The Oregon Health Authority (Authority) shall deny an application if: (a) An applicant is under the age of 21. (b) The applicant for a facilitator license is not an individual person. (c) The applicant’s land use compatibility statement shows t…

333-333-4140 Application Withdrawal An applicant for a license or worker permit may request to withdraw an initial or renewal application at any time prior to the Oregon Health Authority (Authority) acting on the application. If the Authority reasonably believes that there is a r…

333-333-4200 Notification of Changes (1) An applicant or licensee must notify the Oregon Health Authority (Authority) in writing in a form and manner prescribed by the Authority and receive written approval from the Authority prior to the following: (a) Adding or removing an indi…

333-333-4210 Modifying Licensed Premises (1) A licensee may not make any changes that materially or substantially alter the licensed premises or the usage of the licensed premises without the Oregon Health Authority’s (Authority’s) prior written approval. (2) A licensee who wishe…

333-333-4250 License Renewal (1) Renewal Applications: (a) A renewal application must be submitted in a form and manner prescribed by the Oregon Health Authority (Authority) and must include documents, and information required by the Authority to be complete. (b) For facilitator …

333-333-4260 Standards for Authority to Operate a Licensed Business as a Trustee, a Receiver, a Personal Representative, or a Secured Party (1) The Authority may issue a temporary certificate of authority to operate a licensed entity to a trustee, the receiver of an insolvent or …

333-333-4270 Closure of Licensed Entity (1) License privileges cease upon death of a licensee unless the Authority issues an order as described in section (2) of this rule. (2) The Authority may issue an order providing for the manner and condition under which: (a) Psilocybin pro…

333-333-4280 Surrender (1) A licensee may request to surrender a license in a form and manner prescribed by the Oregon Health Authority (Authority). Each individual person identified as a licensee must submit a separate request, including a product plan and client record plan if …

333-333-4300 Licensed Premises Location Requirements (1) A licensed premises may not be located on state or federally owned land. (2) The interior and exterior areas of a licensed premises may not overlap with: (a) An area that is licensed or certified or otherwise approved by th…