Chapter 333-333

333-333-4400 Licensed Premises Operating Requirements (1) A licensee or permittee may not permit: (a) A person under 21 years of age to work or be present on a licensed premises except for persons temporarily at the premises to make a service, maintenance, or repair call or for o…

333-333-4450 Client Administration Areas (1) Client administration areas must be designed to create an appropriate and comfortable setting for experiencing the effects of consuming psilocybin products. Client administration areas must offer clients options for sitting or reclinin…

333-333-4460 Service Center Safety and Emergency Plan (1) Every service center shall create and maintain a service center safety and emergency plan which: (a) Documents procedures for evacuating and relocating clients to a safe location when the client administration areas become…

333-333-4465 Client Restrooms (1) Service centers must make at least one accessible single occupancy restroom located within the licensed premises available for clients’ use during an administration session. The rest room required by this rule is not required to be located within…

333-333-4470 Practicum Site (1) Any service center may function as a practicum site under OAR 333-333-3070. (2) A practicum site must notify the Oregon Health Authority (Authority) in a form and manner prescribed by the Authority that practicum will be offered at their location a…

333-333-4480 Service Center Privileges and Prohibitions (1) A service center may: (a) Between the hours of 6:00 AM and 11:59 PM local time, sell psilocybin products and provide psilocybin services to clients 21 years of age or older. (b) Purchase, possess or receive psilocybin pr…

333-333-4490 Verification of Age Prior to completing the sale of a psilocybin product or providing psilocybin services to a client, a service center licensee representative and a facilitator must verify that the client has a valid, unexpired government-issued photo identification…

333-333-4500 Licensee Prohibitions (1) A licensee or permittee may not: (a) Import into this state or export from this state any psilocybin products. (b) Give psilocybin products as a prize, premium or consideration for a lottery, contest, game of chance or game of skill, or comp…

333-333-4510 Storage (1) All psilocybin products must be stored within a limited access area on a licensed premises. (2) All psilocybin products stored on a licensed premises must be kept within: (a) An area within a limited access area of the licensed premises that is enclosed o…

333-333-4520 Client Bill of Rights (1) A service center must post the following “Client Bill of Rights” in a prominent location within the licensed premises and must provide every client with a copy during their preparation session: “Clients receiving psilocybin services in Orego…

333-333-4550 Security Requirements (1) A service center, manufacturer or laboratory licensee is responsible for the security of all psilocybin products on the licensed premises or in transit from the licensed premises, including providing adequate safeguards against theft or dive…

333-333-4600 Alarm System (1) A service center, manufacturer or laboratory must have a fully operational security alarm system on the licensed premises, activated at all times when the licensed premises is closed for business. (2) The security alarm system for the licensed premis…

333-333-4620 Required Security Video Recording Equipment (1) A licensed premises must have a fully operational video recording system to ensure security of the licensed premises. (2) Required video recording equipment must, at a minimum: (a) Consist of: (A) Digital or network vid…

333-333-4630 Required Security Camera Coverage and Camera Placement (1) A licensed premises is required to have camera coverage, if applicable, for: (a) All points of ingress and egress to and from indoor areas of the licensed premises, unless those points are located within a cl…

333-333-4640 Video Recordings of Administration Sessions (1) A service center licensee may not install video recording equipment in client administration areas. Service centers may make video and audio recordings of administration, preparation and integration sessions using porta…

333-333-4650 Security Video Recording Requirements for Licensed Facilities (1) To ensure security of the licensed premises, a service center, manufacturer or laboratory licensee is required to have cameras that continuously record, 24 hours a day: (a) In all areas where psilocybi…

333-333-4660 Location and Maintenance of Required Security Video Equipment (1) Except as provided in OAR 333-333 4620(3), a service center, manufacturer or laboratory licensee must house the required recording equipment in a designated, locked, and secured room or other enclosure…

333-333-4700 Duty to Contact Emergency Services (1) Facilitators and service center licensee representatives are required to make reasonable efforts to resolve any activity or conditions on the licensed premises that endangers the safety of any person present on the premises. (2)…

333-333-4810 Client Confidentiality (1) A service center or facilitator may not disclose any information that may be used to identify a client, or disclose any communication made by a client related to psilocybin services or selling psilocybin products to a client to any person i…

333-333-4820 Record Retention (1) Licensees shall store, maintain and destroy records, including client records, in a manner that prevents unauthorized access, protects client confidentiality and prevents alteration of client records. (a) All client records and copies of client r…

333-333-4830 Financial and Business Records In addition to any other recordkeeping requirements in these rules, a licensee must have and maintain records that clearly reflect all financial transactions and the financial condition of the licensed entity. The following records may …

333-333-4900 Collection and Maintenance of 303 Client Data (1) On and after January 1, 2025, service centers must collect 303 client data in a manner prescribed by the Oregon Health Authority (Authority), consistent with OAR chapter 950, division 30, by using the form published b…

333-333-4910 Required Reporting of Data (1) All data required to be submitted under this rule must be submitted in a form and manner prescribed by the Oregon Health Authority (Authority) on a quarterly basis no later than the 25th calendar day following the last day of the quarte…

333-333-4920 Sale of Records Licensees may not sell, monetize, or otherwise profit from client records, 303 client data or 303 service center data. Statutory/Other Authority: ORS 475A.235 & ORS 475A.372 Statutes/Other Implemented: ORS 475A.235 & ORS 475A.372 History: PH 73-2024, …

333-333-4930 Reporting of Licensee and Applicant Data (1) Every individual licensee and applicant associated with a psilocybin license or application must provide information regarding their race, ethnicity, preferred spoken and written languages, sexual orientation and gender id…

333-333-5000 Preparation Session Requirements (1) A facilitator must complete a preparation session with every client who will participate in an administration session at least 24 hours but no more than 90 days prior to the commencement of the client’s first administration sessio…

333-333-5020 Group Preparation Sessions (1) In addition to the requirements of OAR 333-333-5000 facilitators must inform clients who will participate in a group session of additional considerations for participating in group administration sessions including: (a) Safety considera…

333-333-5040 Informed Consent (1) A facilitator or service center must provide every client a copy of the following informed consent document during the client’s preparation session or prior to the preparation session upon a client’s request: Introduction: In the State of Oregon,…

333-333-5050 Client Information Form (1) A client must review and complete a client information form in coordination with a facilitator prior to participating in an administration session. This requirement must be satisfied by using the designated form published by the Oregon Hea…

333-333-5070 Interpreters and Client Support Persons (1) If an interpreter or client support person will be present during receipt of psilocybin services, a client and facilitator must meet with the interpreter or client support person prior to beginning the administration sessio…

333-333-5075 Culturally and Linguistically Responsive Services (1) Service centers and facilitators must create and maintain: (a) Documentation of culturally and linguistically responsive services, if any, offered to clients that support client safety and access to services. (b) …

333-333-5080 Safety and Support Plans (1) A facilitator must work with every client who will participate in an administration session to draft a safety and support plan in a form and manner prescribed by the Oregon Health Authority. Safety and support plans must identify risks an…

333-333-5100 Facilitator Record Keeping and Confidentiality (1) A facilitator shall work with service centers as needed to create the following records for every client to whom they provide psilocybin services in a form and manner prescribed by the Oregon Health Authority. All ph…

333-333-5120 Facilitator Conduct (1) Facilitators have a duty to put clients’ interest above their own and to use a standard of care that other reasonable facilitators would use under similar circumstances. (2) A facilitator shall not make any misrepresentations to clients regard…

333-333-5130 Facilitator Scope of Practice (1) A facilitator shall not engage in any conduct that requires additional professional licensure while providing psilocybin services to clients, including but not limited to diagnosing and treating physical or mental health conditions. …

333-333-5140 Duty to Report Misconduct (1) Any licensee, licensee representative or permittee who witnesses or becomes aware of licensee or permitted worker conduct involving a client or the manufacturing, testing, storage or transfer of psilocybin products that violates ORS chap…

333-333-5150 Transportation Plans (1) A facilitator must create and record a transportation plan in a form and manner prescribed by the Oregon Health Authority for every client who will participate in an administration session. (2) Transportation plans must be signed by the clien…

333-333-5160 Sale of Psilocybin Services A facilitator must list fees for psilocybin products separately from fees for preparation, administration and integration sessions and must specify whether those fees will be paid directly to the facilitator or to the service center where …

333-333-5170 Sale and Transfer of Psilocybin Products to Clients (1) Psilocybin products may only be sold and transferred to clients by licensee representatives of a service center. Licensee representatives of a service center may only sell and transfer products to clients consis…

333-333-5180 Collection of Taxes (1) A service center must collect from clients, at the point of sale, the tax imposed on psilocybin products under ORS 475A.662 and ORS 475A.666. (2) A service center must hold the tax described in section (1) of this rule in trust for the State o…

333-333-5200 Administration Session Requirements (1) Administration sessions must be conducted by a facilitator and may only take place within a service center’s designated administration area. (2) The requirements of OAR 333-333-5000 and OAR 333-333-5020, if applicable, must be …

333-333-5210 Outdoor Administration Sessions (1) Facilitators may conduct outdoor administration sessions within designated outdoor administration areas at a service center. (2) Outdoor administration areas must be free of falling hazards, drowning hazards and any other condition…

333-333-5230 Group Administration Sessions (1) Group administration sessions may be conducted pursuant to the requirements of OAR 333-333-5020 and this rule. (2) Client to Facilitator Ratio. The minimum facilitator to client ratio depends on the amount of psilocybin product clien…

333-333-5240 Consumption Limits (1) A service center licensee or licensee representative may not allow a client to consume more than a total of 50 mg of psilocybin analyte, including initial and secondary doses, during an administration session or during a 24- hour period. Both i…

333-333-5250 Duration of Administration Session (1) The minimum duration of an administration session shall be dependent on the total amount of psilocybin analyte a client consumes during that session, including any secondary dose consumed. (a) For clients consuming less than 2.5…

333-333-5260 Integration Session (1) A facilitator shall offer clients the opportunity to participate in one or more integration sessions following participation in an administration session. (2) A facilitator must use a nondirective facilitation approach to an integration sessio…

333-333-6000 Prohibited Conduct (1) Sale to a person under 21 years of age. A licensee or permittee may not sell, deliver, transfer or make available any psilocybin product to a person under 21 years of age. (2) Services to a person under 21 years of age. A facilitator may not pr…

333-333-6030 Laboratory Licensee Prohibited Conduct (1) In addition to the prohibitions set forth in OAR 333-333-6000, a laboratory licensee may not: (a) Perform any required psilocybin sampling or testing using any sampling or testing methods or equipment not permitted under the…

333-333-6040 Dishonest Conduct (1) False Statements. A licensee or permittee may not make a false statement or representation to the Oregon Health Authority (Authority) in order to induce or prevent action or investigation by the Authority. (2) Psilocybin Product Misrepresentatio…

333-333-6100 Advertising Restrictions (1) Advertising for psilocybin products and services may not: (a) Contain statements that are deceptive, false, or misleading. (b) Contain any content that can reasonably be considered to target individuals under the age of 21, including but …