Oregon Administrative Code

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 …

333-333-6110 Advertising Media, Coupons, and Promotions (1) A licensee may not utilize television, radio, billboards, print media or internet advertising unless the licensee has reliable evidence that no more than 30 percent of the audience for the program, publication or Interne…

333-333-6120 Removal of Objectionable and Non-Conforming Advertising (1) A licensee must remove any sign, display, or advertisement if the Authority determines it violates these rules. (2) The Authority will notify the licensee to identify any non-conforming advertising and provi…

333-333-6150 Inspections (1) The Oregon Health Authority (Authority) may conduct: (a) An inspection of a licensed premises at any time to ensure that a licensee or permittee is in compliance with ORS 475A.210 to 475A.722. and these rules. (b) Compliance transactions in order to d…

333-333-6160 Investigations (1) For purposes of this rule and OAR 333-333-6040, “evidence” includes but is not limited to, physical objects, documents, records, video recordings and interviews with an Oregon Health Authority (Authority) authorized representative. (2) An applicant…

333-333-6200 Suspension, Cancellation, Civil Penalties, Sanction Schedule (1) The Oregon Health Authority (Authority) may suspend or revoke: (a) A license issued under ORS chapter 475A for violation of a provision of ORS chapter 475A or these rules, in accordance with section (4)…

333-333-6210 Licensee Responsibility (1) A licensee is responsible for: (a) The violation of any of these rules and any provision of ORS 475A.210 to 475A.722. (b) Any act or omission of a licensee representative in violation of these rules or of ORS 475A.210 to 475A.722. (2) If a…

333-333-6220 Suspended Licenses: Posting of Suspension Notice Sign, Activities Allowed During Suspension (1) Before 6:00 AM on the date a license suspension goes into effect, and until the suspension is completed, Authority staff must ensure that a suspension notice sign is poste…

333-333-7010 Psilocybin Testing: Purpose (1) The purpose of OAR 333-333-7010 to OAR 333-333-7150 is to establish minimum compliance testing standards for psilocybin products. (2) A person licensed under ORS 475A.290 or 475A.305may not transfer, accept or provide a psilocybin prod…

333-333-7020 Ordering Tests (1) A manufacturer must provide to a laboratory, prior to the laboratory taking samples, the following information: (a) The manufacturer’s license number and endorsement type; (b) The manufacturer’s name, address and contact information; (c) Type of ps…

333-333-7030 Speciation Testing (1) A manufacturer must order a test for a batch taken from the first harvest lot recorded in a calendar year to ensure that the lot contains Psilocybe cubensis. This test must be performed prior to transferring the harvest lot to another licensee …

333-333-7040 Potency Testing (1) A manufacturer must order tests for every batch of finished psilocybin product from a harvest lot or process lot to determine the concentration (potency) of psilocybin and psilocin in the product. (2) A process lot of homogenized fungi, psilocybin…

333-333-7050 Solvent Testing (1) If methanol or acetic acid are used to manufacture psilocybin extract, a manufacturer must order tests for methanol or acetic acid for every process lot of psilocybin extract prior to selling or transferring the psilocybin extract or converting to…

333-333-7060 Pesticide Testing (1) A licensee must submit one or more batches from a harvest lot or process lot for pesticide testing upon written request by the Oregon Health Authority. (2) A batch fails pesticide testing if the test detects the presence of a pesticide above act…

333-333-7070 Contaminant Testing (1) A licensee must submit one or more batches from a harvest lot or process lot for contaminant testing upon written request by the Oregon Health Authority. (2) A psilocybin product required to be tested for contaminants under these rules must be…

333-333-7080 Heavy Metals Testing (1) A licensee must submit one or more batches from a harvest lot or process lot for heavy metal testing upon written request by the Oregon Health Authority. (2) A harvest lot or process lot required to be tested for heavy metals may be tested fo…

333-333-7090 Psilocybin Batch Requirements (1) A manufacturer must separate each harvest lot of dried whole fungi into batches no larger than one kilogram. (2) A process lot for psilocybin extracts, homogenized fungi or edible psilocybin products is considered a batch. (3) A manu…

333-333-7100 Psilocybin Product Sampling Requirements (1) Whole fungi. (a) Whole fungi may only be sampled after it is dried, regardless of whether the whole fungi will be processed into another product type. (b) Sufficient sample increments must be taken to perform required test…

333-333-7110 Requirements for Pre-Tested Psilocybin Products (1) Following samples being taken from a harvest or process lot a manufacturer must: (a) Label the batch with the following information: (A) The harvest or process lot unique identification number; (B) The name of the l…

333-333-7120 Failed Test Samples (1) If a sample or a field duplicate sample (collectively referred to as "sample" for purposes of this rule) fails any initial test, the laboratory that did the testing may reanalyze the sample. The laboratory that did the initial test may not sub…

333-333-7150 Quality Control Testing (1) A manufacturer may request that a laboratory conduct testing for the purpose of assuring quality control for psilocybin products that are manufactured in compliance with these rules, except as provided in section (2) of this rule. (2) A ma…

333-333-8000 Waste Management (1) A manufacturer, service center or laboratory licensee must store, manage and dispose of solid and liquid wastes generated during production and processing of psilocybin products in accordance with applicable state and local laws and regulations w…

333-333-8100 Product Transportation (1) Psilocybin products transferred by licensees. (a) Psilocybin products transferred between licensed premises may only be transported by a licensee or licensee representative of the originating or receiving licensee. (b) Samples of psilocybin…

333-333-8200 Product Tracking — General Requirements (1) A service center, manufacturer or laboratory licensee must use the product tracking system as an inventory and recordkeeping system to record and maintain an accurate inventory of psilocybin products as specified in OAR 333…

333-333-8210 Product Tracking - Reconciliation of Inventory (1) Each service center, manufacturer and laboratory licensee must: (a) Use the product tracking system for all inventory tracking activities, as required by these rules. (b) By 11:59 AM local time of the next calendar d…

333-333-8220 Product Tracking - Unique Identification Numbers (1) A service center, manufacturer or laboratory licensee must use unique identification numbers generated by the product tracking system for inventory tracking activities required by these rules. (2) A manufacturer li…

333-333-8230 Product Tracking — Cultivation Batches (1) Within 72 hours of beginning a production process, a manufacturer must create a cultivation batch that will contain all fruiting bodies and mycelium produced by that production process. (2) A manufacturer must create a batch…

333-333-8240 Product Tracking — Inventory Audits (1) The Oregon Health Authority may perform a physical audit of the inventory of any service center, manufacturer or laboratory licensee at the agency’s discretion and with reasonable notice to the licensee. (2) A variance between …

333-333-8250 Product Tracking - User Requirements (1) A service center, manufacturer or laboratory licensee and any product tracking system user shall enter data into the product tracking system that fully and transparently accounts for all inventory tracking activities. (2) A se…

333-500-0005 Applicability Unless a specific rule provides otherwise, OAR chapter 333, divisions 500 through 535 apply to a hospital classified as general, low occupancy acute care, or psychiatric or mental and do not apply to a hospital classified as a special inpatient care fac…

333-500-0010 Definitions As used in OAR chapter 333, divisions 500 through 535, unless the context requires otherwise, the following definitions apply: (1) "Assessment" means a complete nursing assessment, including: (a) The systematic and ongoing collection of information to det…

333-500-0020 Application for Hospital License (1) An applicant wishing to apply for a license to operate a hospital shall submit an application on a form prescribed by the Oregon Health Authority (Authority) and pay the applicable fee as specified in OAR 333-500-0030. (2) A singl…

333-500-0025 Endorsement of Satellite Operations (1) The Oregon Health Authority (Authority) may endorse, under a hospital’s license, a satellite or mobile satellite of a hospital. (2) In order for a satellite to be endorsed under a hospital’s license, the applicant or licensee s…

333-500-0027 Emergency Medical Services Satellites (1) A facility indorsed as a satellite under a hospital license for the provision of emergency medical services must, in addition to any requirements in OAR 333-500-0025: (a) Operate 24 hours a day, seven days a week, 365 days a …

333-500-0030 Annual License Fee/Late Fee (1) The annual license fee for a hospital is as specified in ORS 441.020. (2) If a hospital license covers a satellite or mobile satellite approved by the Oregon Health Authority (Authority) under OAR 333-500-0025, the applicable license f…

333-500-0032 Classification (1) A hospital shall be classified as one of the following: (a) General Hospital; (b) Low Occupancy Acute Care Hospital; or (c) Mental or Psychiatric Hospital. (2) A hospital’s classification shall be determined by the type of services it provides, as …

333-500-0034 Application Review (1) In reviewing an application for a new hospital, the Oregon Health Authority (Authority) shall: (a) Verify compliance with the applicable sections of ORS chapters 441 and 476, and OAR 333-500 through 535, 675, and chapter 837; (b) Determine whet…

333-500-0036 Approval of License Application (1) The Oregon Health Authority (Authority) shall notify an applicant in writing if a license application is approved, and shall include the license with the appropriate classification. (2) A license shall be issued only for the premis…

333-500-0038 Denial of License Application If the Oregon Health Authority intends to deny a license application, it shall issue a Notice of Proposed Denial of License Application in accordance with ORS 183.411 through 183.470. Statutory/Other Authority: ORS 441.025 Statutes/Other…

333-500-0040 Expiration and Renewal of License (1) Each license to operate a hospital shall expire on December 31 following the date of issue, and if a renewal is desired, the licensee shall make application and pay the appropriate fee at least 30 days prior to the expiration dat…

333-500-0045 Submission of Plans (1) A hospital proposing to make alterations or additions to an existing facility or to construct a new facility shall, before commencing such alteration, addition or new construction, submit plans and specifications to the Oregon Health Authority…

333-500-0055 Discontinuance and Recommencement of Operation of Hospitals (1) If a hospital wishes to temporarily discontinue operation but retain its license to operate, the hospital shall notify the Oregon Health Authority (Authority) of the fact at least 14 days prior to the te…

333-500-0060 Return of Hospital License and Hospital Closure (1) If a hospital’s license is suspended, revoked, expires, or if a hospital decides to permanently close, the license certificate in the licensee’s possession shall be returned to the Oregon Health Authority (Authority…

333-500-0065 Waivers (1) While all hospitals are required to maintain continuous compliance with the Oregon Health Authority (Authority)’s rules, these requirements do not prohibit the use of alternative concepts, methods, procedures, techniques, equipment, facilities, personnel …