justicedao/ipfs_state_laws huggingface dataset:
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 county that authorizes land use in the city or county where the premises proposed to be licensed is located prior to acting on an application for a new manufacturer or service center license. (3) The Authority may verify any information submitted by the applicant, including but not limited to contacting any individual or legal entity identified in the application to request additional documents or information. (4) The Authority may require an inspection of the premises proposed to be licensed prior to issuing a license. There is no fee for inspections performed under this section. (5) If the Authority determines that the applicant is not in compliance with these rules following an inspection described in section (4) of this rule, the Authority will provide a notice of the failed inspection identifying the requirements that have not been met. (6) An applicant that fails an inspection described in section (4) of this rule will have 90 calendar days from the date the notice was sent to submit a written response that demonstrates the noted deficiencies have been corrected. (7) If the applicant’s response under section (6) of this rule appears to correct the noted deficiencies, the Authority may schedule another inspection. (8) If the applicant fails a second inspection, the Authority will deny the application unless the applicant shows good cause for the Authority to perform additional inspections. Statutory/Other Authority: ORS 475A.235, ORS 475A.250 & ORS 475A.290 Statutes/Other Implemented: ORS 475A.235, ORS 475A.250 & ORS 475A.290 History: PH 206-2022, adopt filed 12/27/2022, effective 12/27/2022
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 request license fee payment . An applicant may not exercise any license privileges until they receive proof of licensure issued under section (4) of this rule. (2) If an applicant for a manufacturer, service center or laboratory license fails to pay the license fee or payment fails to clear within 60 calendar days of the notice described in section (1) of this rule, the Authority may require re-inspection of the premises proposed to be licensed. Any re-inspections that take place pursuant to this rule will be subject to the change fee described in OAR 333-333-4060(7). (3) If an applicant for any license type fails to pay the license fee or payment fails to clear within 180 calendar days of the notice described in section (1) of this rule, the application will be considered incomplete. (4) The Authority will not approve the license until it has confirmed that payment of the license fee has cleared and processing the application is complete. When the license is approved, the Authority will notify the applicant in writing and will provide the applicant proof of licensure, that includes a unique license number, the licensee name(s), the operational name, the effective date of the license, and address of the licensed premises. Licenses issued under ORS chapter 475A may be held by multiple licensees. (5) A licensee may not exercise license privileges until the effective date of licensure identified on the proof of licensure issued under section (4) of this rule. (6) Manufacturer, service center and laboratory licensees must display a proof of licensure in a prominent place on the licensed premises. (7) Facilitator licensees must be able to provide proof of licensure when performing preparation, administration or integration sessions. (8) Manufacturer, service center and laboratory licenses are only valid for the licensed premises and are only issued to the individuals or entities listed on the application or subsequently approved by the Authority. (9) Facilitator licenses are only issued to the individual listed on the application. (10) A license may not be transferred except as provided in OAR 333-333-4270. Statutory/Other Authority: ORS 475A.235 Statutes/Other Implemented: ORS 475A.235 History: PH 21-2025, amend filed 10/24/2025, effective 01/01/2026 PH 58-2023, amend filed 12/21/2023, effective 01/01/2024 PH 206-2022, adopt filed 12/27/2022, effective 12/27/2022
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 reason to reject the application the Authority may refuse to accept the withdrawal and may issue a proposed denial of the application in accordance with OAR 333-333-4130. Statutory/Other Authority: ORS 475A.235 & ORS 475A.250 Statutes/Other Implemented: ORS 475A.235 & ORS 475A.250 History: PH 82-2024, amend filed 11/22/2024, effective 01/01/2025 PH 206-2022, adopt filed 12/27/2022, effective 12/27/2022
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 wishes to make any material or substantial changes to the licensed premises must submit a form prescribed by the Authority, and submit any information identified in the form. (3) For the purposes of this rule a material or substantial change includes, but is not limited to: (a) Any change to the footprint of the licensed premises. (b) Any change to ingress and egress of the licensed premises. (c) Any change that would require installation of additional videorecording cameras or a change to the security system. (d) Any change to the premises plan that alters limited access areas or client administration areas on the licensed premises. (4) Emergency repairs to the licensed premises made to ensure safety and security do not require prior approval under section (1) of this rule. A licensee must provide notice of emergency repairs in a form and manner prescribed by the Authority within five business days of making repairs. Statutory/Other Authority: ORS 475A.235 Statutes/Other Implemented: ORS 475A.235 History: PH 58-2023, amend filed 12/21/2023, effective 01/01/2024 PH 206-2022, adopt filed 12/27/2022, effective 12/27/2022
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 bankrupt licensee, the personal representative of a deceased licensee, or a person holding a security interest in the licensed entity for a reasonable period of time to allow orderly disposition of the licensed entity. (a) The trustee, receiver or personal representative must provide the Authority with the following information: (A) Proof that the person is the legal trustee, receiver or personal representative for the legal entity; and (B) A written request for a certificate of authority to operate as a trustee, receiver or personal representative of the licensee, listing the address and telephone number of the trustee, receiver or personal representative. (b) The secured party must provide the Authority with the following information: (A) Proof of a security interest in the licensed entity; (B) Proof of the licensee’s default on the secured debt; (C) Proof of legal access to the real property; and (D) A written request for authority to operate as a secured party listing the secured party’s address and telephone number. (2) The Authority may revoke or refuse to issue or extend a certificate of authority for the trustee, receiver, personal representative, or secured party to operate: (a) If the trustee, receiver, personal representative or secured party does not propose to exercise licensed privileges immediately or does not begin exercising licensed privileges immediately upon receiving the temporary certificate of authority; (b) For any of the reasons that the Authority may revoke or refuse to issue or renew a license; (c) If the trustee, receiver, personal representative or secured party operates in violation of ORS 475A, or these rules; or (d) If a reasonable time for disposition of the legal entity has elapsed. (3) No person or entity described in section (1) of this rule may operate the licensed entity until a certificate of authority has been issued under this rule, except that the personal representative of a deceased licensee may operate the licensed entity for up to 10 days after the death provided that the personal representative submits the information required in subsection (1)(a) of this rule and obtains a certificate of authority within that time period. (4) A certificate of authority under this rule is initially issued for a 60-day period and may be extended as reasonably necessary to allow for the disposition of the licensed entity. Statutory/Other Authority: ORS 475A.235 Statutes/Other Implemented: ORS 475A.235 & ORS 475A.243 History: PH 206-2022, adopt filed 12/27/2022, effective 12/27/2022
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 products left by a deceased, insolvent or bankrupt licensee, or subject to a security interest, may be transferred or destroyed pursuant to an order issued by the Authority. (b) The licensed entity of a deceased, insolvent or bankrupt licensee may be operated for a reasonable period, as specified in the order issued under this rule or OAR 333-333-4260, following the death, insolvency or bankruptcy. (3) If a license is revoked, the Authority may address in its order the manner and condition under which psilocybin products held by the licensee may be transferred or sold to other licensees or must be otherwise disposed. (4) If a license is surrendered or expires the Authority may address by order the manner and condition under which psilocybin products held by the licensee may be transferred or sold to other licensees or must be otherwise disposed of. Statutory/Other Authority: ORS 475A.235 Statutes/Other Implemented: ORS 475A.235 & ORS 475A.243 History: PH 206-2022, adopt filed 12/27/2022, effective 12/27/2022
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 applicable. The license remains in effect until the Authority accepts the surrender. The Authority may request additional information and require additional site inspections prior to accepting the surrender. (2) A service center, manufacturer or laboratory license that requests to surrender its license must submit a products plan, in a form and manner prescribed by the Authority, in order to complete its surrender request. An identical products plan must be signed by every individual person identified as a licensee and must describe the licensees’ plan to dispose of psilocybin products in inventory by destroying the products or transferring psilocybin products to another license in compliance with these rules. All psilocybin products designated as waste or transferred to another license must be recorded in the product tracking system. (3) A service center that requests to surrender its license must submit a client records plan, in a form and manner prescribed by the Authority, for approval in order to complete is surrender request. An identical client records plan must be signed by every individual licensee affiliated with the licensed premises and must describe the service center’s plan to: (a) Destroy client records; or (b) Obtain client’s written consent as described in OAR 333-333-4810 and transfer client records to another service center. (4) The Authority will review product plans and client record plans and may require revisions to plans prior to accepting a surrender request. If the Authority accepts a surrender request, the Authority will notify the licensee in writing of the date of acceptance. The licensee must cease all license privileges on this date through the remainder of the licensing period. The licensee must receive a new license before engaging in any licensed activities. (5) A training program may request to surrender approval of its curriculum in a form and manner prescribed by the Authority. The training program’s curriculum approval remains in effect until the Authority accepts the surrender. If the Authority accepts the surrender, the Authority will notify the training programs in writing of the date of acceptance. On or before the date of their surrender, the training program must notify any enrolled students that their curriculum is no longer approved by the Authority. Statutory/Other Authority: ORS 475A.235 Statutes/Other Implemented: ORS 475A.235 History: PH 82-2024, amend filed 11/22/2024, effective 01/01/2025 PH 206-2022, adopt filed 12/27/2022, effective 12/27/2022
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 unsafe due to unforeseen circumstances such as fire or a power outage. (b) Documents general procedures for emergency response when a client experiences a medical or other emergency while receiving psilocybin services. (c) Documents procedures for addressing disruptive conduct and difficult client reactions that do not rise to the level of requiring an emergency response. (d) Documents procedures for clients who attempt to leave an administration session prior to the minimum duration for the session specified in OAR 333-333-5250, including but not limited to contacting the person the client has identified as required by OAR 333-333-5080(2). (e) Documents procedures for safely monitoring clients in case of unforeseen circumstances that prevent a facilitator from completing a client administration session. (2) The emergency plan described in section (1) of this rule must be provided to every facilitator who will offer psilocybin services at the service center prior to the facilitator providing psilocybin services at that location. Statutory/Other Authority: ORS 475A.235 & ORS 475A.305 Statutes/Other Implemented: ORS 475A.235 & ORS 475A.305 History: PH 82-2024, amend filed 11/22/2024, effective 01/01/2025 PH 206-2022, adopt filed 12/27/2022, effective 12/27/2022
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 an administration area. (2) In addition to a restroom described in section (1) of this rule, a service center may identify alternate restrooms that are located in unlicensed areas of the same structure where the licensed premises is located. Service center applicants and licensees must identify alternate restrooms on the floor plan required by OAR 333-333-4000(3)(e). (3) Clients may use alternate restrooms described in section (2) of this rule when restrooms within the licensed premises are occupied, subject to the following conditions: (a) A facilitator must escort a client to and from the alternate restroom location. (b) A facilitator must remain at the restroom door to ensure that no other people are present in the alternate restroom during the time the client is using the restroom. Statutory/Other Authority: ORS 475A.235 & ORS 475A.305 Statutes/Other Implemented: ORS 475A.235 & ORS 475A.305 History: PH 206-2022, adopt filed 12/27/2022, effective 12/27/2022
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 and identify any training program affiliated with the practicum at least 10 business days prior to practicum taking place at their location. A practicum site may use a single written notice to provide advance notice of multiple instances of practicum taking place at their location. (3) If a practicum site supervisor is affiliated with a practicum site rather than affiliated with a training program, the service center must share the name of the practicum site supervisor with the Authority, in a form and manner prescribed by the Authority, prior to students participating in practicum at the practicum site. (4) A practicum site must comply with all applicable requirements of these rules, including but not limited to OAR 333-333-5200. (5) Students who consume psilocybin during practicum are considered clients for the purpose of these rules and licensees must comply with ORS 475A.210 to ORS 475A.722 and these rules when selling psilocybin products and providing psilocybin services to clients who are also students. Statutory/Other Authority: ORS 475A.235 & ORS 475A.305 Statutes/Other Implemented: ORS 475A.235 & ORS 475A.305 History: PH 82-2024, amend filed 11/22/2024, effective 01/01/2025 PH 206-2022, adopt filed 12/27/2022, effective 12/27/2022
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 and must verify that the client is 21 years of age or older by viewing the client’s: (1) Passport; (2) Driver license, whether issued by the State of Oregon or by another state of the United States; (3) Identification card issued under ORS 807.400; (4) United States military identification card; (5) An identification card issued by a federally recognized Indian tribe with photo, name and date of birth; or (6) Any other identification card issued by a state or territory that bears a picture of the person, the name of the person, the person’s date of birth and a physical description of the person. Statutory/Other Authority: ORS 475A.235 & ORS 475A.445 Statutes/Other Implemented: ORS 475A.235 & ORS 475A.445 History: PH 206-2022, adopt filed 12/27/2022, effective 12/27/2022
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 competition of any kind. (c) Sell, give, or otherwise make available any psilocybin products to any person who is visibly intoxicated. (d) Participate in preparation or integration sessions with any person who is visibly intoxicated. (e) Make false representations or statements to the Oregon Health Authority (Authority) in order to induce or prevent action by the Authority. (f) Misrepresent any psilocybin product to a client or to the public. (g) Deliver or transfer psilocybin products to or from an unlicensed location, or aid or assist in any manner in the delivery or transfer of psilocybin products to or from an unlicensed location. (h) Allow any client to leave the licensed premises with psilocybin products. (i) Sell or offer to sell a psilocybin product that does not comply with the minimum standards prescribed by the statutory laws of this state. (2) No licensee or licensee representative may be under the influence of intoxicants while present on a licensed premises. The requirements of this section to do not apply to licensees and licensee representatives who are off duty and consume psilocybin products while receiving psilocybin services as a client. Statutory/Other Authority: ORS 475A.235 Statutes/Other Implemented: ORS 475A.235 History: PH 82-2024, amend filed 11/22/2024, effective 01/01/2025 PH 206-2022, adopt filed 12/27/2022, effective 12/27/2022
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 on all sides with permanent walls and secured with at a minimum, a properly installed steel door with a steel frame, and a commercial grade, non-residential lock; or (b) A locked safe located within a limited access area of the licensed premises that is not located within an area that meets the requirements of subsection (2)(a). (3) Products that require refrigeration may be stored within a locked refrigerator or freezer located within a limited access area of the licensed premises that is not located within an area that meets the requirements of subsection (2)(a). (4) The requirements of sections (2) and (3) of this rule do not prevent a licensee from designating the entirety of a limited access area as an area for product storage if doing so is consistent with other requirements of these rules. (5) The requirements of section (2) of this rule do not apply to fungi and mycelium stored at a manufacturer’s licensed premises that has not been harvested or is undergoing a drying process. (6) The requirements of section (2) of this rule do not apply to secondary doses of psilocybin products that have been purchased by a client and are stored pursuant to OAR 333-333-5240. (7) Psilocybin products that require refrigeration must be stored in appropriate, temperature-controlled environments. (8) Psilocybin products offered for sale by a service center must be stored in such a manner that the items are only accessible to licensee representatives until such time as the sale to the client is completed. Clients who wish to examine psilocybin products prior to purchase may do so only under the direct supervision of a licensee representative. Statutory/Other Authority: ORS 475A.235 Statutes/Other Implemented: ORS 475A.235 History: PH 82-2024, amend filed 11/22/2024, effective 01/01/2025 PH 58-2023, amend filed 12/21/2023, effective 01/01/2024 PH 206-2022, adopt filed 12/27/2022, effective 12/27/2022