justicedao/ipfs_state_laws huggingface dataset:
333-275-0180 Hemodialysis Technician Certification Fees (1) Initial certification (based on months between initial certification until renewal): (a) 19-24 months - $150. (b) 13-18 months - $112.50. (c) 7-12 months - $75. (d) 1-6 months - $37.50. (2) Provisional certification: (a) Initial – valid for 6 months - $37.50. (b) Renewal – valid for additional 6 months (one time only) - $37.50. (3) Certification renewal - $150. (4) Criminal conviction petition for determination - $50. (5) Delinquent (late fee) - $25. (6) Duplicate or replacement certificate fee - $25. (7) As authorized by ORS 688.645, an application for certification renewal submitted or postmarked after May 31st of the renewal year must include a $25 delinquent fee in addition to the certification renewal fee. (8) Fees established in this rule are non-refundable. Statutory/Other Authority: ORS 688.640, ORS 688.665 & ORS 670.280 Statutes/Other Implemented: ORS 688.645 & ORS 670.280 History: PH 13-2026, amend filed 01/07/2026, effective 01/07/2026 PH 13-2023, amend filed 03/13/2023, effective 07/01/2023 OHD 2-2001, f. & cert. ef. 1-18-01
333-275-1000 Provisional Certification During Declared Emergency During a declared emergency, the following provisions apply: (1) A provisional certificate issued under OAR 333-275-0080 that was valid three months prior to an emergency declaration shall continue to be valid for a period determined by the Authority, not to exceed six months or until the state of emergency is terminated, whichever is earlier. If the emergency still exists after six months, the Authority may renew or continue the certification for a time period determined by the Authority or until the state of emergency is terminated, whichever is earlier. (2) A provisional certificate that expired 90 calendar days or less prior to an emergency declaration may be renewed under OAR 333-275-0080 except that: (a) The applicant must complete and submit documentation of completion of an Authority-approved abbreviated training program consisting of a minimum of 16 hours of theory and 16 hours of supervised clinical learning experiences related to hemodialysis as it is performed in a particular facility or dialysis facility or center. (b) The applicant must be endorsed and submit an endorsement letter from the medical director of the sponsoring dialysis facility or center that intends to immediately employ the individual, in a paid or volunteer capacity. (c) A certificate renewed under this section shall be valid for a period determined by the Authority, not to exceed six months or until the state of emergency is terminated, whichever is earlier. If the emergency still exists after six months, the Authority may renew or continue the certification for an additional time period determined by the Authority or until the state of emergency is terminated, which is earlier. (3) The Authority may deny, suspend, or revoke a certificate issued or renewed under this rule for any reason that it may deny, suspend, or revoke a certificate in ORS 688.625 through 688.665 or these rules. (4) This rule is not in effect when the state of emergency or public health emergency is terminated. Statutory/Other Authority: ORS 401.165, 401.168, 401.990, 413.042, 431A.005, 431A.010, 431A.015, 433.441, 688.635, 688.640 & 688.650 Statutes/Other Implemented: ORS 688.640 & 688.650 History: PH 13-2023, amend filed 03/13/2023, effective 07/01/2023 PH 20-2021, temporary amend filed 05/13/2021, effective 05/13/2021 through 11/08/2021 PH 70-2020, adopt filed 10/06/2020, effective 10/06/2020 PH 22-2020, temporary adopt filed 04/10/2020, effective 04/10/2020 through 10/06/2020
333-333-2015 Allowable Species A manufacturer may only cultivate, manufacture or possess fruiting bodies of the fungi species Psilocybe cubensis and psilocybin products derived from Psilocybe Cubensis on the licensed premises . Statutory/Other Authority: ORS 475A.235 Statutes/Other Implemented: ORS 475A.235 History: PH 72-2024, minor correction filed 08/24/2024, effective 08/24/2024 PH 206-2022, adopt filed 12/27/2022, effective 12/27/2022
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 and surface areas in a manner that reduces the potential development of microbials, molds and unintended fungi. (c) Maintain the licensed premise in a manner that is free from conditions which may result in contamination of psilocybin products and that is suitable for safe and sanitary operations. (d) Store all psilocybin products in a locked area when not in use, including psilocybin products that require refrigeration. (e) Associate every process lot and harvest lot with a unique identification number and enter this information into the product tracking system. (2) A manufacturer may not produce, transfer or sell a psilocybin product that appeals to minors, including but not limited to: (a) Products that are modeled after non-psilocybin products primarily consumed by and marketed to children; or (b) Products in the shape of an animal, vehicle, person or character. Statutory/Other Authority: ORS 475A.235 Statutes/Other Implemented: ORS 475A.235 & ORS 475A.290 History: PH 58-2023, amend filed 12/21/2023, effective 01/01/2024 PH 74-2022, adopt filed 05/19/2022, effective 05/20/2022
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; (b) Psilocybin extraction; and (c) Edible psilocybin production. (2) An applicant for a manufacturer license must request an endorsement upon submission of an initial application but may also request to add or remove an endorsement at any time following licensure. (3) To apply for an endorsement, an applicant or licensee must submit a form prescribed by the Authority that identifies the proposed endorsement. (4) Only one application and license fee are required regardless of how many endorsements an applicant or licensee requests or when the request is made. (5) An individual manufacturer may hold multiple endorsements. (6) The Authority may deny a manufacturer’s request for an endorsement or revoke an existing endorsement if the manufacturer cannot or does not meet the requirements of these rules. If the Authority denies or revokes approval, the manufacturer has a right to a hearing under ORS chapter 183. Statutory/Other Authority: ORS 475A.235 & ORS 475A.295 Statutes/Other Implemented: ORS 475A.235 & ORS 475A.295 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 74-2022, adopt filed 05/19/2022, effective 05/20/2022
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 use, including but not limited to monoamine oxidase inhibitors (MAOI’s), beverage alcohol or cannabis. (2) A licensee may not produce, store or transfer adulterated psilocybin products. (3) A psilocybin product that contains an adulterant is considered adulterated (4) In addition to section (3) of this rule, a psilocybin product may be considered adulterated if: (a) It bears or contains any poisonous or deleterious substance in a quantity rendering the psilocybin product a risk to human health; (b) It bears or contains any added poisonous or deleterious substance exceeding a safe tolerance if such tolerance has been established; (c) It consists in whole or in part of any unsanitary, putrid, or decomposed substance, or is otherwise unfit for human consumption; (d) It is processed, prepared, packaged or held under improper time-temperature conditions or under conditions increasing the probability of contamination with excessive microorganisms or physical contaminants; (e) It is processed, prepared, packaged, or held under unsanitary conditions increasing the probability of contamination or cross-contamination; (f) It is held or packaged in containers composed, in whole or in part of any poisonous or deleterious substance rendering the contents potentially injurious to health; (g) Any substance has been substituted wholly or in part; (h) Damage or inferiority has been concealed in any manner; or (i) Any substance has been added, mixed or packaged to make it appear better or of greater value than it is. (5) Except for extraction allowed under these rules, a licensee may not utilize any manufacturing process that alters potency, intoxicating effect, duration of effect, toxicity or potential for excessive use. (6) Psilocybin products that are intended for product development and will not be made available for consumption must be labeled in bold, capital letters, no smaller than 12-point font, "NOT FOR CONSUMPTION" and may be stored in states that are unfit for human consumption. 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 74-2022, adopt filed 05/19/2022, effective 05/20/2022
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 psilocybin extraction endorsement may not use extraction processes intended to manipulate the ratio of any analyte or to manipulate the ratio of compound relative to another analyte or compound present in the fungi used in extraction. (3) A manufacturer with a psilocybin extraction endorsement may not remove psilocybin analyte from psilocybin extracts. This section does not prevent diluting extracts with inactive ingredients. (4) A manufacturer with a psilocybin extraction endorsement may not use denatured alcohol. (5) A manufacturer with a psilocybin extraction endorsement may not apply pressure or heat over 140 degrees Fahrenheit when using the solvents ethanol or methanol to manufacture psilocybin extracts. (6) If using methanol or ethanol, a manufacturer must process psilocybin extracts in a room with equipment, including all electrical installations that meet the requirements of the Oregon Structural Specialty Code, related Oregon Specialty Codes and the Oregon Fire Code. (7) The manufacturer’s licensed premises must be licensed by the Oregon Department of Agriculture as a food establishment and must comply with applicable provisions of OAR chapter 603, division 21, division 24, division 25 and division 28. 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 74-2022, adopt filed 05/19/2022, effective 05/20/2022
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 processing; (c) Have an emergency eye-wash station, rinse kit and emergency shower in any room in which solvents other than water are used; and (d) Make appropriate personal protective equipment available to employees. (2) A manufacturer with a psilocybin extraction endorsement must create and maintain a comprehensive training program that includes the hazards presented by all solvents used at the licensed premises as described in the material safety data sheet for each solvent. Statutory/Other Authority: ORS 475A.235 Statutes/Other Implemented: ORS 475A.235 History: PH 74-2022, adopt filed 05/19/2022, effective 05/20/2022
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, division 24, division 25 and division 28. (2) A manufacturer with an edible psilocybin production endorsement may not use a psilocybin product to produce edible psilocybin products unless that psilocybin product was processed or cultivated in a food establishment licensed by the ODA in compliance with the applicable provisions of OAR chapter 603, division 21, division 24, division 25 and division 28. 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 74-2022, adopt filed 05/19/2022, effective 05/20/2022
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 psilocybin product; (2) The procedure for making each process lot homogenous; (3) If applicable, the procedure for purging and disposing of any solvent or other unwanted product from a psilocybin extract; (4) Procedures for conducting necessary safety checks prior to commencing production of psilocybin products; (5) Procedures for cleaning all equipment, counters and surfaces; (6) Procedures for preventing growth of pathogenic organisms and toxin formations; (7) Proper handling and storage of any solvent or other chemical used in processing in accordance with material safety data sheets and other applicable laws; (8) Proper disposal of any waste produced during processing in accordance with applicable laws, rules and regulations; (9) Appropriate use of any necessary safety or sanitary equipment; and (10) Emergency procedures to be followed in case of fire, chemical spill or other emergencies. Statutory/Other Authority: ORS 475A.235 Statutes/Other Implemented: ORS 475A.235 History: PH 74-2022, adopt filed 05/19/2022, effective 05/20/2022
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 any substrates and growing mediums allowed by these rules. A manufacturer with a fungi cultivation endorsement must completely dry all fungi before transferring to another licensee. (2) A manufacturer with a psilocybin extraction endorsement may produce psylocibin extract. (3) A manufacturer with an edible psilocybin production endorsement product may produce edible psilocybin products. (4) A manufacturer may only produce those psilocybin products for which they hold an endorsement. (5) Psilocybin products not included in this rule are prohibited and may not be manufactured, nor possessed by any licensee. Statutory/Other Authority: ORS 475A.235 Statutes/Other Implemented: ORS 475A.235 History: PH 74-2022, adopt filed 05/19/2022, effective 05/20/2022
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 that can be delivered to clients through any method other than orally or another enteral method. A manufacturer is prohibited from designing or manufacturing psilocybin products that include but not limited to, transdermal patches, inhalers, nasal sprays, suppositories and injections. Statutory/Other Authority: ORS 475A.235 Statutes/Other Implemented: ORS 475A.235 History: PH 74-2022, adopt filed 05/19/2022, effective 05/20/2022
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 required by OAR 333-333-7040 are completed within 180 days of recording a harvest lot or process lot in the product tracking system. (3) A manufacturer may possess a total of no more than 200 grams of psilocybin analyte, as described in section (1) of this rule, at any given time. (4) A service center may possess a total of no more than 100 grams of psilocybin analyte, as described in section (1) of this rule, at any given time. (5) A manufacturer or service center may request authorization in writing to exceed the limits described in sections (3) and (4) of this rule in a form and manner prescribed by the Oregon Health Authority. (6) Psilocybin products that have been designated as psilocybin waste will not be considered when calculating the limits described in sections (3) and (4) of this rule. Statutory/Other Authority: ORS 475A.235 & ORS 475A.300 Statutes/Other Implemented: ORS 475A.300 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
333-333-2300 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 service center for ultimate sale to a client in sealed client packaging using tamper tape, wrapping or a similar method that indicates the product has not been opened prior to purchase. Psilocybin products that have been transferred to a service center in client packaging may not be repackaged by the service center or any other licensee. (3) Psilocybin products for ultimate sale to a client must: (a) Not be packaged or labeled in a manner that is attractive to minors. (b) Comply with serving size requirements identified in OAR 333-333-2310. (c) Be labeled in accordance with OAR 333-333-2400. (4) Client packaging may not display any untruthful or misleading content. (5) Client packaging may be reused as long as it is effectively sanitized and complies with the requirements of these rules. Statutory/Other Authority: ORS 475A.235 & ORS 475A.634 Statutes/Other Implemented: ORS 475A.634 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
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/Other Implemented: ORS 475A.642 History: PH 206-2022, adopt filed 12/27/2022, effective 12/27/2022
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 manufacturer’s business or trade name and license number. (b) The business or trade name of the manufacturer that packaged the product, if different from the original manufacturer. (c) One of the following product type names: whole fungi, homogenized fungi, psilocybin extract, or edible psilocybin product. (d) Net quantity of contents using the metric system of measurement and expressed in terms of fluid measure if the item is liquid, or in terms of weight if the item is solid, semi-solid, or viscous. (e) Results of all laboratory tests required by OAR 333-333-7040, including information required by OAR 333-333-2400(5). (f) Species of fungi. (g) Harvest date for whole fungi. (h) Date of manufacture for all products other than whole fungi. (i) Unique identification number as defined in OAR 333-333-1010. (j) List of all active and inactive ingredients in descending order of predominance by weight or volume. (k) List of potential major food allergens by: (A) Listing the name of the food source of any major food allergen at the end of or immediately adjacent to the ingredient list; or (B) Placing the term for the appropriate major food allergen in parenthesis within the ingredient list after the common or usual name of the ingredient derived from that major food allergen. (l) “Best by” date indicating the time that the manufacturer has determined that their product will retain its original quality. (m) If the psilocybin product is perishable, a statement that the product must be refrigerated or kept frozen. (2) Any information contained in a product information document must be compliant with these rules, including but not limited to OAR 333-333-6040(2). (3) A facilitator must make reasonable efforts to provide a product information document for psilocybin products that may be consumed during an administration session during a client’s preparation session and provide the client an opportunity to discuss the document. If a client does not receive a product information document during their preparation session, a facilitator must provide the client a product information document for psilocybin products that may be consumed during an administration session and provide the client an opportunity to discuss the document at another time prior to beginning their administration session. (4) A service center must make reasonable efforts to translate the product information document to languages other than English and otherwise provide the product information document in an accessible format upon the client’s request. 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
333-333-3020 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 instruction meet the requirements of OAR 333-333-3050; (3) Demonstrate that its proposed practicum meets the requirements of OAR 333-333-3070; (4) Identify a training program director as defined in OAR 333-333-1010; (5) Identify at least two lead educators, as defined in OAR 333-333-1010, and list lead educator qualifications to meet the lead educator requirements; (6) Identify all instructors as defined in OAR 333-333-1010 and list the instructors’ qualifications to teach curriculum modules identified in these rules; and (7) Provide an address to receive mail from the Oregon Health Authority at an established physical location within the United States of America or U.S Territories or the freely associated states Republic of Marshall Islands, Palau, and the Federated States of Micronesia Statutory/Other Authority: ORS 475A.235 & ORS 475A.380 Statutes/Other Implemented: ORS 475A.235 & ORS 475A.380 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 74-2022, adopt filed 05/19/2022, effective 05/20/2022