Or. Admin. Code § 333-333-5000

Current through Register Vol. 63, No. 12, December 1, 2024

Section 333-333-5000 - [Effective 1/1/2025] 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 session with the facilitator. All required forms and prior written consent described in this rule must be signed and completed prior to a client participating in an administration session. If different facilitators will conduct a client's preparation session, administration session or integration session, the client must provide written consent as described in subsection (8)(g) of this rule. A client must have an opportunity to approve and meet any facilitator who will provide psilocybin services prior to receiving services from that facilitator. Any facilitator who was not present for a client's preparation session must review the forms and documents required by this rule before providing psilocybin services to a client.

(2) Preparation sessions required under this rule must be conducted privately with each individual client to allow clients to share personal information.

(3) For every client who will participate in an administration session, a facilitator must receive a completed client information form as described in OAR 333-333-5050.

(4) On or after January 1, 2025, for every client who will participate in an administration session, a service center must receive written confirmation, in a form and manner prescribed by the Oregon Health Authority (Authority), that the client has had an opportunity to request that 303 data related to their receipt of psilocybin services be withheld from data submitted to the Authority.

(5) For every client who will participate in an administration session, a facilitator must complete a transportation plan as described in OAR 333-333-5150 in coordination with the client. The transportation plan may not approve a client to operate a motor vehicle, bicycle, or other form of self-operated transportation following the administration session.

(6) For every client who will participate in an administration session, a facilitator must coordinate with the client to complete a safety and support plan as described in OAR 333-333-5080.

(7) A facilitator must review each of the following documents with a client during a preparation session:

(a) Informed consent document as described in OAR 333-333-5040.

(b) Client Bill of Rights as described in OAR 333-333-4520.

(c) Product information document as described in OAR 333-333-2410 for any products that may be consumed during an administration session, except as provided in OAR 333-333-2410(2).

(d) Documentation of the fees charged for provision of psilocybin services prepared in coordination with the service center. This documentation must indicate whether fees for services will be paid to the service center or directly to the facilitator. This documentation must describe applicable refund policies for psilocybin services and any additional fees, including but not limited to cancellation fees, that could be charged to the client. Documentation required by this subsection must be provided to a client prior to collecting any money from the client for psilocybin services.

(e) Documentation of the price charged for sale of psilocybin products prepared in coordination with the service center. This documentation must list product prices separately from taxes as required by OAR 333-333-5180. Documentation required by this subsection must be provided to a client prior to collecting any money from a client for psilocybin products.

(f) Applicable sections of the service center emergency plan required by OAR 333-333-4460.

(g) The service center's policy on possession of firearms and weapons required by OAR 333-333-4480(4).

(8) In addition to the documents required by sections (3), (4), (5), (6) and (7) of this rule, a facilitator must obtain prior written consent from a client for the following activities and circumstances:

(a) Participation in a group administration session, including the opportunity to meet other clients and facilitators participating in the group session as described in OAR 333-333-5020.

(b) Use of supportive touch during an administration session, if any, as described in OAR 333-333-5120(7).

(c) Participation in a training practicum, including information regarding training program students and instructors who will be present during the client's administration session. The client must have an opportunity to meet any students or instructors who will be present during their administration session prior to the commencement of an administration session.

(d) Video or audio recording of an administration session pursuant to requirements of OAR 333-333-4640.

(e) Presence of an interpreter or client support person allowed by OAR 333-333-5070, in the administration area during an administration session.

(f) Sharing of identifiable client data as described in OAR 333-333-4810(2).

(g) The use of different facilitators to conduct a client's preparation, administration sessions or integration session.

(h) Consuming secondary doses of psilocybin products after the administration session has begun, including the maximum amount of psilocybin analyte that a client has agreed to consume, not to exceed 50 mg of psilocybin analyte.

(i) Participating in an administration session where licensee representatives of a service center will be present pursuant to OAR 333-333-5200(9).

(j) Disclosure form for de-identified client data required by OAR 333-333-4810(5).

(9) If a facilitator or service center intends to share de-identified data related to the client's receipt of psilocybin product or services, a facilitator or service center must provide a disclosure form required by OAR 333-333-4810(5) during the client's preparation session.

(10) During a preparation session, facilitators must provide clients an opportunity to discuss internal and external factors that could impact a psilocybin experience including but not limited to the client's intention and expectations. If the client will participate in an outdoor administration session, the facilitator must provide an opportunity to discuss the client's specific concerns that may be relevant to participating in an outdoor administration session, including but not limited to allergies and sensitivity to sun exposure.

(11) Preparation sessions may be completed in person or virtually using video conferencing technology.

(12) The requirements of this rule may be satisfied by conducting multiple preparation sessions.

(13) A facilitator must complete an initial preparation session with every client before conducting an administration session with that client for the first time. After a client completes an initial preparation session at a service center, the client is not required to complete additional preparation sessions prior to participating in an administration session at the same service center for a period of 12 months.

(14) If a facilitator does not complete additional preparation sessions as allowed by section (13) of this rule, the facilitator must confirm that the information contained in the client's previously completed client information form remains accurate prior to conducting an administration session. If the previously completed client information form is no longer accurate on the date of the client's proposed administration session, a facilitator must conduct an additional preparation session to complete an updated client information prior to conducting administration sessions.

(15) A facilitator must discuss the process for verification of license status and process for making complaints to the Authority during a preparation session.

(16) The documents described in sections (7), (8) and (9) of this rule must be provided to a client prior to a preparation session upon the client's request.

(17) All client records, including any copies of client records, described by this rule must be stored at the service center where the client participates or intends to participate in an administration session as required by OAR 333-333-4820.

(18) If different facilitators will conduct preparation and administration sessions, the facilitator conducting the administration session must receive and review all forms and documents required to be completed during a preparation session prior to beginning the administration session.

(19) Except for practicum site supervisors, lead educators and students participating in a practicum with the client's prior written consent, only the client, and any facilitators and client support persons who will be present during the client's administration session may be present during a preparation session.

Or. Admin. Code § 333-333-5000

PH 206-2022, adopt filed 12/27/2022, effective 12/27/2022; PH 58-2023, amend filed 12/21/2023, effective 1/1/2024; PH 82-2024, amend filed 11/22/2024, effective 1/1/2025

Statutory/Other Authority: ORS 475A.235 & ORS 475A.340

Statutes/Other Implemented: ORS 475A.340 & OL 2023, ch. 150