reglab/statecodes huggingface dataset:
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 333 - PSILOCYBIN › Section 333-333-2020 - General Manufacturer Requirements

Current through Register Vol. 63, No. 7, July 1, 2024
(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.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 333 - PSILOCYBIN › Section 333-333-2030 - Manufacturer Endorsements

Current through Register Vol. 63, No. 7, July 1, 2024
(1) A
			 manufacturer may only produce 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.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 333 - PSILOCYBIN › Section 333-333-2040 - Pesticides

Current through Register Vol. 63, No. 7, July 1, 2024
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
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 333 - PSILOCYBIN › Section 333-333-2050 - Adulterants

Current through Register Vol. 63, No. 7, July 1, 2024
(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.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 333 - PSILOCYBIN › Section 333-333-2060 - Psilocybin Extract Manufacturing Requirements

Current through Register Vol. 63, No. 7, July 1, 2024
(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
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 333 - PSILOCYBIN › Section 333-333-2070 - Psilocybin Extract Manufacturing Safety Procedures

Current through Register Vol. 63, No. 7, July 1, 2024
(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.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 333 - PSILOCYBIN › Section 333-333-2080 - Psilocybin Edible Manufacturing Requirements

Current through Register Vol. 63, No. 7, July 1, 2024
(1) A manufacturer with an edible psilocybin
			 production endorsement may only process in a food establishment licensed by the
			 Oregon Department of Agriculture (ODA) 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
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 333 - PSILOCYBIN › Section 333-333-2100 - Psilocybin Manufacturing Records

Current through Register Vol. 63, No. 7, July 1, 2024
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
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 333 - PSILOCYBIN › Section 333-333-2110 - Allowable Psilocybin Product Types

Current through Register Vol. 63, No. 7, July 1, 2024
(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
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 333 - PSILOCYBIN › Section 333-333-2120 - Psilocybin Product Delivery Methods

Current through Register Vol. 63, No. 7, July 1, 2024
(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
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 333 - PSILOCYBIN › Section 333-333-2200 - Psilocybin Product Quantity Limits

Current through Register Vol. 63, No. 7, July 1, 2024
(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
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 333 - PSILOCYBIN › Section 333-333-2300 - Packaging for Sale to Client

Current through Register Vol. 63, No. 7, July 1, 2024
(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 in sealed
			 client packaging for ultimate sale to a client.
(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.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 333 - PSILOCYBIN › Section 333-333-2400 - Labeling for Sale to Client

Current through Register Vol. 63, No. 7, July 1, 2024
(1) A
			 label required by these rules must:
(a) Be
			 printed or attached to client packaging containing psilocybin
			 products.
(b) Contain all required
			 information in a legible font at least eight points large.
(c) Be in English, though it may also be in
			 other languages.
(d) Be
			 unobstructed and clearly visible.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 333 - PSILOCYBIN › Section 333-333-2410 - Product Information Document

Current through Register Vol. 63, No. 7, July 1, 2024
(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.
(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.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 333 - PSILOCYBIN › Section 333-333-3010 - Psilocybin Training Program Curriculum Approval Process

Current through Register Vol. 63, No. 7, July 1, 2024
(1) A training program applicant must submit
			 the following to the Oregon Health Authority (Authority) to be considered for
			 curriculum approval to train psilocybin facilitators:
(a) A completed application package,
			 including a description of the proposed curriculum that shows the applicant
			 meets the requirements of OAR 333-333-3050, OAR 333-333-3060, OAR 333-333-3070  and OAR 333-333-3090; and
(b) A
			 US$500 non-refundable application evaluation fee paid in the form and manner
			 specified by the Authority.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 333 - PSILOCYBIN › Section 333-333-3020 - Psilocybin Training Program Application Requirements

Current through Register Vol. 63, No. 7, July 1, 2024
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 all instructors, including at
			 least two lead educators and list the instructors' qualifications to teach
			 curriculum modules identified in these rules;
(5) Identify a program director who is
			 responsible for tracking student progress and has authority to confer student
			 enrollment and program completion; and
(6) 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
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 333 - PSILOCYBIN › Section 333-333-3030 - Psilocybin Training Instructor Qualifications and Program Performance

Current through Register Vol. 63, No. 7, July 1, 2024
(1) In order for
			 curriculum to be approved, a training program must demonstrate that each
			 instructor and person who trains instructors at a training program has
			 sufficient experience, knowledge, skills and ability to competently train
			 students in their assigned subject matter.
(2) Sufficient experience, knowledge, skills
			 and ability can be demonstrated via education, certifications, professional
			 experience, personal narratives and references.
(3) Training programs shall treat personal
			 narratives and references as confidential unless an instructor has consented to
			 their publication.
(4) Each
			 instructor at a training program must:
(a)
			 Understand the objectives of the training program and be able to communicate
			 effectively with students; and
(b)
			 Demonstrate skill in instruction and student supervision.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 333 - PSILOCYBIN › Section 333-333-3035 - Psilocybin Training Curriculum Reapproval

Current through Register Vol. 63, No. 7, July 1, 2024
(1) A training program that wishes for its
			 curriculum to be reapproved upon expiration of its initial approval term must
			 submit a completed reapproval application, including proof that the program has
			 received and continues to hold any approvals required from the Higher Education
			 Coordinating Commission in accordance with applicable law governing the type of
			 school or institution and a non-refundable US$500 reapproval fee.
(2) The Oregon Health Authority (Authority)
			 must receive the reapproval application and fee at least 30 days prior to the
			 date that the training program's approval is set to expire.
(3) If a training program files a reapproval
			 application and fee at least 30 days prior to the date that the training
			 program's approval is set to expire, the training program's curriculum approval
			 remains valid while the Authority considers their reapproval application. A
			 training program must use its previously approved curriculum until the
			 reapproval application is approved.
(4) If a training program does not file a
			 reapproval application and fee at least 30 days prior to the date that the
			 training program's approval is set to expire, the training program's curriculum
			 approval will expire, and the training program must submit a new
			 application.
(5) If the Authority
			 approves reapproval, the reapproval is valid for five years.
(6) The Authority may deny the application
			 for reapproval if:
(a) The training program
			 has not complied with these rules; or
(b) The training program instructors, staff
			 or representatives have made false or misleading statements to the Authority,
			 students or the public.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 333 - PSILOCYBIN › Section 333-333-3040 - Psilocybin Training Program Record Keeping

Current through Register Vol. 63, No. 7, July 1, 2024
(1) Training programs shall maintain records
			 for each class, including course syllabi, location, date and student attendance
			 for every online and in-person class. These records must be maintained for five
			 years. Training programs shall provide these records to current and former
			 students upon request. Training programs shall provide these records to the
			 Authority upon request.
(2)
			 Training programs shall maintain enrollment records, including the name of each
			 student enrolled, their date of completion and examination results. These
			 records must be maintained for five years.
(3) Training programs shall provide records
			 required to be maintained under this rule to the Authority upon request, and in
			 the manner requested.
(4) Except as
			 required by sections (1) and (3) of this rule, student records shall not be
			 released without the student's written consent.
Statutory/Other Authority: ORS 475A.235 & ORS
				  475A.380
Statutes/Other Implemented: ORS 475A.235 & ORS
				  475A.380
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 333 - PSILOCYBIN › Section 333-333-3050 - Psilocybin Training Program Core Requirements

Current through Register Vol. 63, No. 7, July 1, 2024
(1) Programs shall provide core training that
			 consists of at least 120 hours of instruction.
(2) For training that is not conducted in
			 person, at least 50 percent of the training shall be conveyed through online
			 synchronous learning.
(3)
			 Applicants for training programs must demonstrate that their curriculum
			 consists of the following minimum hours of instruction, in the following areas
			 consistent with the requirements of OAR 333-333-3060:
(a) Historical, Traditional, and Contemporary
			 Practices and Applications: 12 hours.
(b) Cultural Equity in relation to Psilocybin
			 Services: 12 hours.
(c) Safety,
			 Ethics and Responsibilities: 12 hours.
(d) Psilocybin Pharmacology, Neuroscience,
			 and Clinical Research: 4 hours.
(e)
			 Core Facilitation Skills: 16 hours.
(f) Preparation and Orientation: 16
			 hours.
(g) Administration: 20
			 hours.
(h) Integration; 12
			 hours.
(i) Group Facilitation: 16
			 hours.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 333 - PSILOCYBIN › Section 333-333-3060 - Psilocybin Training Curriculum Modules

Current through Register Vol. 63, No. 7, July 1, 2024
(1) "Historical, Traditional, and
			 Contemporary Practices and Applications" module shall include:
(a) Current and historical use of plant and
			 fungal medicines in indigenous and western cultures;
(b) The Controlled Substances Act and its
			 effect on psilocybin research and drug policy; and
(c) Overview of historical and recent
			 academic research.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 333 - PSILOCYBIN › Section 333-333-3070 - Psilocybin Facilitator Practicum Requirements

Current through Register Vol. 63, No. 7, July 1, 2024
(1) Programs shall require students to
			 complete practicum training that provides an opportunity to observe the
			 facilitation of non-ordinary states of consciousness.
(2) If a practicum site is available,
			 practicum training shall include placement at a practicum site where students
			 can observe psilocybin services under the supervision of a practicum site
			 supervisor.
(3) Any licensed
			 Service Center can function as practicum site. If a training program uses a
			 Service Center as a practicum site to satisfy the requirements of this rule,
			 the training program shall notify the Oregon Health Authority (Authority) in a
			 form and manner prescribed by the Authority.
(4) A practicum site must obtain written
			 client consent prior to allowing a client to be observed by practicum students
			 and prior to sharing any client information with practicum students or a
			 training program.
(5) The practicum
			 site supervisor is responsible for developing students' practicum skills and
			 evaluating students' practicum performance, related to psilocybin
			 services.
(6) If a practicum site
			 is not reasonably available or accessible to students, a training program may
			 identify alternative practicum in its application for approval that reasonably
			 approximates training at a practicum site. For alternative practicum, the lead
			 educator or program director is responsible for developing students'
			 alternative practicum skills and evaluating students' alternative practicum
			 performance, focusing on services with clients.
(7) Alternative practicum may include but is
			 not limited to observation of taped facilitation sessions that were recorded
			 with participants' consent, participating in psychedelic peer support
			 organization, role playing, and experience with altered states of consciousness
			 that are not drug-induced, for example breath work, meditation or spiritual
			 journeys.
(8) Students shall
			 complete a minimum of 40 hours of practicum training, including at least 30
			 hours of direct practice in which students directly observe clients receiving
			 psilocybin services or directly participate in alternative practicum activity
			 as described in section (7), and at least 10 hours of consultation relating to
			 the student's direct practice
(9)
			 All practicum training, including direct practice, consultation and alternative
			 practicum, must be conducted in person.
Statutory/Other Authority: ORS
				  475A.235 & ORS
				  475A.380
Statutes/Other Implemented: ORS
				  475A.235 & ORS
				  475A.380
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 333 - PSILOCYBIN › Section 333-333-3080 - Accelerated Training Hours

Current through Register Vol. 63, No. 7, July 1, 2024
(1)
			 Programs may grant qualified students accelerated training hours not to exceed
			 40 percent of the total number of core training hours required by OAR
			 333-333-3050.
(2) Accelerated
			 training hours may be awarded based on students' professional credentialing,
			 prior training and education, or relevant experiences such as practicing in
			 established plant or fungi-based healing traditions.
(3) Training programs that offer accelerated
			 training hours must establish and document criteria for conferring accelerated
			 hours to qualifying students.
(4)
			 Student transcripts and other records shall document the number and type of
			 accelerated training hours conferred to each student.
(5) Training programs may not offer
			 accelerated training hours for the following modules:
(a) "Cultural Equity in relation to
			 Psilocybin Services;"
(b) "Safety,
			 Ethics and Responsibilities;"
(c)
			 "Preparation and Orientation;"
(d)
			 "Administration;" or
(e)
			 "Integration."
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 333 - PSILOCYBIN › Section 333-333-3090 - Training Program Completion and Exams

Current through Register Vol. 63, No. 7, July 1, 2024
(1) Training programs shall maintain a level
			 of training for students such that students who successfully complete the
			 program's training could reasonably expect to possess the knowledge and skills
			 required to practice as a facilitator.
(2) Training programs must administer a
			 comprehensive skills-based exam and each student must receive a passing score,
			 established by the training program, as a condition of completing the training
			 program.
(3) The exam required by
			 section (2) of this rule is in addition to the exam required by ORS
			 475A.330.
(4) A lead educator or program director must
			 ensure completion of core curriculum, practicum and comprehensive skills exam
			 and must endorse each student as qualified to provide psilocybin services as a
			 condition of completing the training program.
(5) Training programs shall provide every
			 student written confirmation of program completion, including the endorsement
			 described in section (4) of this rule, signed by a lead educator or program
			 director upon the student's successful completion of the program, that
			 includes:
(a) Student's full legal
			 name;
(b) Date of completion;
			 and
(c) Approved training program
			 name and training program number issued by the Oregon Health
			 Authority.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 333 - PSILOCYBIN › Section 333-333-4010 - Communication with the Oregon Health Authority

Current through Register Vol. 63, No. 7, July 1, 2024
(1) If an applicant or licensee is required
			 to or elects to submit anything in writing to the Oregon Health Authority
			 (Authority), unless otherwise prescribed by the Authority, the applicant or
			 licensee may submit the writing to the Authority via:
(a) Mail; or
(b) Electronic mail.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 333 - PSILOCYBIN › Section 333-333-4020 - Social Equity Plans

Current through Register Vol. 63, No. 7, July 1, 2024
(1) In
			 addition to the requirements of OAR 333-333-4000  applicants for a manufacturer,
			 service center, facilitator or laboratory license must submit a social equity
			 plan for their initial application to be considered complete.
(2) Social equity plans required by section
			 (1) of this rule must include a description of the following:
(a) Application of diversity, equity, justice
			 and inclusion principles to the licensee's internal practices and
			 policies.
(b) Objective performance
			 measures that the licensee will use to evaluate their social equity
			 plan.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 333 - PSILOCYBIN › Section 333-333-4060 - License Fees

Current through Register Vol. 63, No. 7, July 1, 2024
(1) At the time of
			 initial license application:
(a) An applicant
			 for a service center, manufacturer or laboratory license must pay a US$500
			 non-refundable application fee.
(b)
			 An applicant for a facilitator license must pay a US$150 non-refundable
			 application fee.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 333 - PSILOCYBIN › Section 333-333-4070 - Worker Permit Term and Fees

Current through Register Vol. 63, No. 7, July 1, 2024
(1)
			 An individual who is a licensee representative must have a valid worker permit
			 if the individual participates in:
(a) The
			 provision of psilocybin services at a licensed premises.
(b) The possession, manufacturing, securing
			 or selling of psilocybin products at a licensed premises.
(c) The recording of the possession,
			 manufacturing, securing or selling of psilocybin products at a licensed
			 premises.
(d) The verification of
			 any document described in ORS
			 475A.445.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 333 - PSILOCYBIN › Section 333-333-4120 - Approval and Issuance

Current through Register Vol. 63, No. 7, July 1, 2024
(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
			 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 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
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 333 - PSILOCYBIN › Section 333-333-4130 - Application Denial

Current through Register Vol. 63, No. 7, July 1, 2024
(1) The Oregon
			 Health Authority (Authority) shall deny an application if:
(a) An applicant is under the age of
			 21.
(b) The applicant for a
			 facilitator license is not an individual person.
(c) The applicant's land use compatibility
			 statement shows that the proposed land use is prohibited if a land use
			 compatibility statement is required by these rules.
(d) The proposed licensed premises is located
			 on state or federal land.
(e) If
			 required, the applicant does not have an approved fitness determination in
			 accordance with OAR 333-333-4100.
(f) The application identifies more than one
			 licensed premises.
(g) The
			 application identifies a licensed premises that fails to comply with the
			 requirements of OAR 333-333-4300.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 333 - PSILOCYBIN › Section 333-333-4200 - Notification of Changes

Current through Register Vol. 63, No. 7, July 1, 2024
(1) An
			 applicant or licensee must notify the Oregon Health Authority (Authority) in
			 writing within 10 business days of any of the following:
(a) Adding or removing an individual or legal
			 entity who qualifies as an applicant under OAR 333-333-1010  or OAR
			 333-333-4030.
(b) A change in
			 contact information for any person listed as an applicant or
			 licensee.
(c) A change in
			 licensee's operational name.
(d)
			 Any closure of the licensed premises lasting more than 30 days.
(e) Any conviction for any misdemeanor or
			 felony committed by an individual listed as an applicant or licensee.
(f) Any arrest for conduct that occurred on
			 the licensed premises.
(g) Any
			 theft of psilocybin products or cash from the licensed
			 premises.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 333 - PSILOCYBIN › Section 333-333-4210 - Modifying Licensed Premises

Current through Register Vol. 63, No. 7, July 1, 2024
(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.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 333 - PSILOCYBIN › Section 333-333-4250 - License Renewal

Current through Register Vol. 63, No. 7, July 1, 2024
(1) Renewal
			 Applications:
(a) A renewal application must
			 include documents, and information required by the Oregon Health Authority
			 (Authority) to be complete.
(b) For
			 facilitator applicants, a renewal application must include documentation that
			 the applicant has completed training at a training program with curriculum that
			 has been approved by the Authority and that meets the requirements of OAR
			 333-333-3005  to OAR 333-333-3090.
(c) A renewal application will be considered
			 timely if a complete renewal application is received by the Authority at least
			 60 calendar days before the date the license expires. Applications received
			 less than 60 days before the date the license expires will be considered
			 untimely.
(d) A licensee who
			 submits a complete timely renewal application may continue to operate after the
			 stated license expiration date, pending a decision by the Authority on the
			 renewal application.
(e) A licensee
			 who submits an untimely or incomplete renewal application or who does not
			 submit a renewal application must cease engaging in the licensed activity when
			 the license expires.
(f) A person
			 who, while not actively licensed, engages in any activity that would require a
			 license may be subject to administrative and criminal sanctions regardless of
			 their prior licensure status.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 333 - PSILOCYBIN › Section 333-333-4300 - Licensed Premises Location Requirements

Current through Register Vol. 63, No. 7, July 1, 2024
(1) A licensed premises may not be located on
			 state or federally owned land.
(2)
			 The interior and exterior areas of a licensed premises may not overlap with:
(a) An area that is licensed with an
			 adult-use cannabis license issued under ORS
			 475C.065, ORS
			 475C.085, ORS
			 475C.093 or ORS
			 475C.097.
(b) A medical marijuana grow site registered
			 under ORS 475C.792.
(c) A medical marijuana processing site
			 registered under ORS 475C.815.
(d) A medical marijuana dispensary registered
			 under ORS 475C.833.
(e) An area that is licensed with a liquor
			 license issued under ORS chapter 471 or a retail liquor agent appointed by the
			 Oregon Liquor and Cannabis Commission.
(f) A health care facility licensed under ORS
			 chapter 441.
(g) An area that is
			 operating as a restaurant, seasonal temporary restaurant, intermittent
			 temporary restaurant, limited-service restaurant, single event temporary
			 restaurant, commissary, mobile unit, bed and breakfast, or warehouse licensed
			 under ORS chapter 624.
(h) A
			 residence.
(i) An area that has
			 been issued another license under ORS chapter 475A.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 333 - PSILOCYBIN › Section 333-333-4400 - Licensed Premises Operating Requirements

Current through Register Vol. 63, No. 7, July 1, 2024
(1) A licensee or permittee may not permit:
(a) A person under 21 years of age to work or
			 be on a licensed premises except for persons temporarily at the premises to
			 make a service, maintenance, or repair call or for other purposes independent
			 of the premises operations.
(b)
			 On-site sale or transfer of a psilocybin product except for sales and transfers
			 to other licensed premises and retail sales by a service center in connection
			 with an administration session.
(c)
			 On-site consumption of a psilocybin product except for clients consuming
			 psilocybin products at a service center in connection with an administration
			 session.
(d) On-site consumption of
			 any intoxicants by any individual, except for clients consuming psilocybin
			 products during an administration session.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 333 - PSILOCYBIN › Section 333-333-4480 - Service Center Privileges and Prohibitions

Current through Register Vol. 63, No. 7, July 1, 2024
(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 products from a manufacturer or service
			 center.
(c) Transfer psilocybin
			 products to a manufacturer or service center, subject to product quantity
			 limits in OAR 333-333-2200.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 333 - PSILOCYBIN › Section 333-333-4510 - Storage

Current through Register Vol. 63, No. 7, July 1, 2024
(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.
(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).
(c) For products that require refrigeration,
			 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).
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 333 - PSILOCYBIN › Section 333-333-4550 - Security Requirements

Current through Register Vol. 63, No. 7, July 1, 2024
(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
			 diversion of psilocybin products.
(2) A service center, manufacturer or
			 laboratory licensee is responsible for taking adequate measures to prevent
			 unauthorized access to the licensed premises. Adequate measures include but are
			 not limited to locking or monitoring exterior doors to the licensed premises
			 during business hours. The exterior walls, doors and roof of the licensed
			 premises must be constructed of materials that effectively prevent unauthorized
			 entry. Any measures taken by a service center to prevent unauthorized access
			 must be consistent with the requirements for client administration areas in OAR
			 333-333-4450.
(3) A service center,
			 manufacturer or laboratory licensee is responsible for taking adequate measures
			 to prevent unauthorized access to records and maintain client
			 confidentiality.
(4) During hours
			 when the licensee is not operating, the licensee must ensure that all points of
			 ingress and egress to and from indoor areas of the licensed premises are
			 securely locked
(5) Licensees must
			 ensure that all limited access areas of a licensed premises are accessible only
			 to licensee representatives and other personnel authorized to be present under
			 these rules.
(6) The requirements
			 of these rules apply to all licensed premises regardless of whether the
			 licensed premises is located within a building that contains separate
			 unlicensed areas or located at an address that contains separate unlicensed
			 structures.
Statutory/Other Authority: ORS
				  475A.235
Statutes/Other Implemented: ORS
				  475A.235
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 333 - PSILOCYBIN › Section 333-333-4620 - Video Recording Equipment

Current through Register Vol. 63, No. 7, July 1, 2024
(1) A
			 licensed premises must have a fully operational video recording
			 system.
(2) Video recording
			 equipment must, at a minimum:
(a) Consist of:
(A) Digital or network video
			 recorders.
(B) Cameras capable of
			 meeting the requirements of OAR 333-333-4630 and this rule.
(C) Video monitors.
(D) Digital archiving devices.
(E) A minimum of one monitor on premises
			 capable of viewing video.
(F)
			 Interface devices, if required to adequately operate system or machinery such
			 as a mouse and keyboard.