reglab/statecodes huggingface dataset:
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 333 - PSILOCYBIN › Section 333-333-4640 - Video Recordings of Administration Sessions

Current through Register Vol. 63, No. 7, July 1, 2024
(1) A service center licensee may not install
			 video recording equipment in client administration areas. Service centers may
			 make video and audio recordings of administration, preparation and integration
			 sessions using portable equipment with the prior written consent of every
			 client and facilitator who will be recorded. Clients are prohibited from
			 recording administration, preparation and integration sessions using their own
			 recording equipment. No person, including clients, facilitators, licensee
			 representatives or clients support persons, may record an administration,
			 preparation or integration session without obtaining prior written consent as
			 required by this rule.
(2) Service
			 centers must make recordings made under this rule available to the clients and
			 facilitators who were recorded to view upon request at the service center's
			 licensed premises. Service centers must create and maintain records that
			 documents when and to whom recordings are made available. Service centers are
			 prohibited from charging a fee to view recordings.
(3) Service centers must securely store
			 recordings made under this rule and may not publish, share or otherwise
			 distribute, to any person, including persons recorded, without the obtaining
			 the prior written consent of every person recorded using the form described in
			 OAR 333-333-4810(3)  or as otherwise allowed under ORS
			 475A.450.
(4) Licensee representatives of a service
			 center may only access recordings made under this rule under the following
			 circumstances:
(a) To provide access to
			 clients and facilitators who have been recorded.
(b) With prior written consent described in
			 section (3) of this rule.
(c) To
			 provide access to the Oregon Health Authority (Authority) or law enforcement
			 when required by ORS 475A.450 or these
			 rules.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 333 - PSILOCYBIN › Section 333-333-4650 - Video Recording Requirements for Licensed Facilities

Current through Register Vol. 63, No. 7, July 1, 2024
(1) A service center, manufacturer or
			 laboratory licensee must have cameras that continuously record, 24 hours a day:
(a) In all areas where psilocybin products
			 are produced or stored on the licensed premises.
(b) In all areas where psilocybin waste may
			 be present on the licensed premises.
(c) All points of ingress and egress to and
			 from:
(A) Indoor areas of the licensed
			 premises.
(B) Areas where
			 psilocybin products are produced or stored.
(C) Areas where psilocybin waste may be
			 present.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 333 - PSILOCYBIN › Section 333-333-4660 - Location and Maintenance of Video Equipment

Current through Register Vol. 63, No. 7, July 1, 2024
(1) Except as provided in OAR 333-333
			 4620(3), a service center, manufacturer or laboratory licensee must house the
			 recording equipment in a designated, locked, and secured room or other
			 enclosure within the licensed premises with access limited to:
(a) The licensee, licensee representatives,
			 and authorized personnel.
(b)
			 Employees of the Oregon Health Authority (Authority).
(c) Service personnel or
			 contractors.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 333 - PSILOCYBIN › Section 333-333-4810 - Client Confidentiality

Current through Register Vol. 63, No. 7, July 1, 2024
(1) A
			 service center or facilitator may not disclose any information that may be used
			 to identify a client, or disclose any communication made by a client related to
			 psilocybin services or selling psilocybin products to a client, except with a
			 client's consent or otherwise as allowed by ORS
			 475A.450. Service centers may
			 allow facilitators to access records related to services a facilitator provided
			 to clients at the service center without the client's consent. A licensed
			 facilitator may only access client records for clients to whom they have
			 provided preparation, administration, or integration sessions. A licensed
			 facilitator may not access the client records of any other client unless the
			 client has provided prior written consent and the facilitator accesses the
			 records for the purpose of providing services to the client.
(2) A service center or facilitator must have
			 a completed client consent form to disclose identifiable client information
			 that contains the following:
(a) A specific
			 description of the client's identifiable information to be used or
			 disclosed.
(b) The name or specific
			 identification of the person(s) or class of person(s) the client's information
			 will be disclosed to.
(c) The
			 specific purpose for which the information will be used or disclosed.
(d) The date and signature of the
			 client.
(e) An expiration date when
			 the consent to use or disclose is withdrawn.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 333 - PSILOCYBIN › Section 333-333-4820 - Record Retention

Current through Register Vol. 63, No. 7, July 1, 2024
(1)
			 Licensees shall store, maintain and destroy records, including client records,
			 in a manner that prevents unauthorized access, protects client confidentiality
			 and prevents alteration of client records.
(a)
			 All client records and copies of client records, including records created by
			 facilitators, must be stored at the service center where the client
			 participates or intends to participate in an administration session.
(b) Service centers may store electronic
			 records on cloud-based platforms that use security measures to effectively
			 prevent unauthorized access and protect client confidentiality. Electronic
			 records must be accessible at the licensed premises. Electronic records stored
			 pursuant to this subsection are considered to be stored at the service
			 center.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 333 - PSILOCYBIN › Section 333-333-4900 - Collection and Maintenance of 303 Client Data

Current through Register Vol. 63, No. 7, July 1, 2024
(1) On and after January 1, 2025, service
			 centers must collect 303 client data in a manner prescribed by the Oregon
			 Health Authority (Authority), consistent with OAR chapter 950, division 30, by
			 using the form published by the Authority on its website prior to beginning an
			 administration session for every client who will participate in an
			 administration session at the licensed premises.
(2) Service centers must store, maintain and
			 destroy 303 client data, in a manner that prevents unauthorized access and
			 protects client confidentiality.
(3) 303 client data may only be accessed by
			 licensee representatives of a service center and only for the purposes of
			 aggregating and reporting the data to the Authority as required by OAR
			 333-333-4910.
(4) Prior to beginning an administration
			 session, every client must provide written confirmation, in a form and manner
			 prescribed by the Authority, that the client has had an opportunity to request
			 that 303 client data related to their receipt of psilocybin services be
			 withheld from data submitted to the Authority.
(5) A service center must collect 303 client
			 data by using the form described in section (1) from every client, even if a
			 client requests their information be withheld from data submitted to the
			 Authority.
(6) Failure to comply
			 with this rule is a violation.
Statutory/Other Authority: OL 2023, ch. 150
Statutes/Other Implemented: OL 2023, ch.
				  150
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 333 - PSILOCYBIN › Section 333-333-4910 - Required Reporting of Data

Current through Register Vol. 63, No. 7, July 1, 2024
(1)
			 Beginning March 31, 2025, all data required to be submitted under this rule
			 must be submitted in a form and manner prescribed by the Oregon Health
			 Authority (Authority) on a quarterly basis no later than 15 days after the last
			 day of the quarter. The last days of each quarter are March 31, June 30,
			 September 30 and December 31 of every calendar year.
(2) A service center must aggregate and
			 submit the following aggregated 303 client data that pertains to the previous
			 quarter for clients who participated in an administration session at the
			 licensed premises, except for clients who have requested that their data be
			 withheld from being submitted to the Authority:
(a) The race, ethnicity, preferred spoken and
			 written languages, disability status, sexual orientation, gender identity,
			 income, age and if applicable the county of residence.
(b) The reasons, or reasons, for which
			 clients requested psilocybin services.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 333 - PSILOCYBIN › Section 333-333-4920 - Sale of Records

Current through Register Vol. 63, No. 7, July 1, 2024
Licensees may not sell, monetize, or otherwise profit from
				client records, 303 client data or 303 service center data.
Statutory/Other Authority: ORS
				  475A.235 & OL 2023, ch.
				  150
Statutes/Other Implemented: ORS
				  475A.235 & OL 2023, ch.
				  150
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 333 - PSILOCYBIN › Section 333-333-5050 - Client Information Form

Current through Register Vol. 63, No. 7, July 1, 2024
(1) A
			 client must review and complete a client information form in coordination with
			 a facilitator prior to participating in an administration session. This
			 requirement must be satisfied by using the designated form published by the
			 Oregon Health Authority (Authority) on its website.
(2) A facilitator must provide a client
			 information form in other languages or accessible formats upon a client's
			 request. If a facilitator is unable to provide a translated or accessible
			 client information form upon a client's request, they may not conduct an
			 administration session with the client.
(3) The client information form must include
			 the following questions, and a client must answer each question by indicating
			 "yes" or "no":
(a) Have you taken the
			 prescription drug Lithium in the last 30 days?
(b) Are you currently being treated by a
			 medical, clinical or other healthcare provider for a medical, mental health, or
			 behavioral health condition?
(c)
			 Have you ever had an allergic reaction to consuming mushrooms or other
			 fungi?
(d) Are you currently taking
			 any medications that might need to be consumed during an administration
			 session?
(e) Will you require
			 assistance from an interpreter during an administration session?
(f) Will you require assistance from a client
			 support person for catheter, ostomy, or toileting assistance, ambulation or
			 transfer mobility support, or medical device assistance during the
			 administration session?
(g) Will
			 you require assistance from a client support person for augmentative and
			 alternative communication (AAC) device support or assistive listening device
			 support during the administration session?
(h) Are you having thoughts of causing harm,
			 or wanting to cause harm, to self or others?
(i) Do you have a history of causing harm, or
			 wanting to cause harm, to self or others?
(j) Have you ever been diagnosed with active
			 psychosis or treated for active psychosis?
(k) Are you pregnant or feeding with breast
			 milk?
(l) Do you require any
			 assistive mobility devices?
(m)
			 Will you require assistance to consume psilocybin products?
(n) Would you like to share any other
			 conditions, sensitivities or health concerns with your
			 facilitator?
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 333 - PSILOCYBIN › Section 333-333-5070 - Interpreters and Client Support Persons

Current through Register Vol. 63, No. 7, July 1, 2024
(1) If an interpreter or client support
			 person will be present during receipt of psilocybin services, a client and
			 facilitator must meet with the interpreter or client support person prior to
			 beginning the administration session.
(2) During the meeting required by section
			 (1) of this rule a client and facilitator must work together with the
			 interpreter or client support person to complete a written support person plan
			 using the form published by the Oregon Health Authority (Authority) that
			 contains the following information:
(a) The
			 name of the interpreter or client support person who will attend the
			 session.
(b) The specific purpose
			 for which the interpreter or client support person will be present, including
			 but not limited to identifying any medications or medical devices that the
			 client will utilize during administration session.
(c) Whether the interpreter or client support
			 person will be present for the duration of an administration session or whether
			 they will be available as needed.
(d) A signed statement that the interpreter
			 or client support person agrees to the following conditions:
(A) Interpreters and client support persons
			 will be present for the specific purposes described in their support person
			 plan and shall not interfere or otherwise participate in the administration
			 session.
(B) Interpreters and
			 client support persons, facilitators and service centers shall not share or
			 disclose any information regarding clients' participation in psilocybin
			 services.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 333 - PSILOCYBIN › Section 333-333-5080 - Safety and Support Plans

Current through Register Vol. 63, No. 7, July 1, 2024
(1) A
			 facilitator must work with every client who will participate in an
			 administration session to draft a safety and support plan that identifies risks
			 and challenges specific to the client's circumstances and resources available
			 to mitigate those risks and challenges, including the client's existing support
			 network and appropriate external resources.
(2) Safety and support plans must include
			 contact information for a person to be contacted in the event the client
			 experiences a medical or other emergency.
(3) Safety and support plans may not be
			 changed during an administration session.
(4) Client records described by this rule
			 must be stored at the service center where the client participates or intends
			 to participate in an administration session or on cloud-based platforms as
			 required by OAR 333-333-4820.
Statutory/Other Authority: ORS
				  475A.235 & ORS
				  475A.340
Statutes/Other Implemented: ORS
				  475A.340
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 333 - PSILOCYBIN › Section 333-333-5100 - Facilitator and Service Center Record Keeping and Confidentiality

Current through Register Vol. 63, No. 7, July 1, 2024
(1) A facilitator
			 shall create the following records for every client to whom they provide
			 psilocybin services. These records must be shared with the service center and
			 stored at the service center where the client received services as required by
			 OAR 333-333-4820:
(a) Completed information
			 form described in OAR 333-333-5050.
(b) Completed informed consent document
			 described in OAR 333-333-5040.
(c)
			 Transportation plan described in OAR 333-333-5150.
(d) The date, start time and end time, for
			 every preparation, administration and integration session.
(e) The psilocybin products, including unique
			 identification number, consumed by each client, including the amount of product
			 consumed and whether it was consumed in a single dose or multiple
			 doses.
(f) Any deviation from the
			 client's transportation plan.
(g)
			 Any adverse behavioral reactions or adverse medical reactions, including a
			 record of severe adverse reactions.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 333 - PSILOCYBIN › Section 333-333-5120 - Facilitator Conduct

Current through Register Vol. 63, No. 7, July 1, 2024
(1) Facilitators
			 have a duty to put clients' interest above their own and to use a standard of
			 care that other reasonable facilitators would use under similar
			 circumstances.
(2) A facilitator
			 shall not make any misrepresentations to clients regarding psilocybin products
			 or services, the requirements of ORS
			 475A.210 to
			 475A.722 and these rules, or the
			 facilitator's qualifications and experience.
(3) A facilitator must use a nondirective
			 facilitation approach to providing psilocybin services to clients during
			 preparation, administration and integration sessions.
(4) A facilitator shall utilize their
			 training to distinguish between typical side effects of consuming psilocybin
			 and medical emergencies. In the event of a medical emergency, a facilitator
			 must contact emergency responders or other appropriate medical professionals
			 immediately.
(5) A facilitator
			 shall determine whether they are able to provide psilocybin services to a
			 client. If a facilitator determines that they are unable to provide services to
			 a client for any reason, the facilitator may refer the client to another
			 facilitator.
(6) If a facilitator
			 has supervisory, evaluative, or other authority over a client, the facilitator
			 shall provide the client an opportunity to receive psilocybin services from
			 another facilitator.
(7)
			 Facilitators may provide supportive touch during administration sessions when
			 requested by the client and with the client's prior written consent.
(a) Supportive touch is limited to hugs or
			 placing hands on a client's hands, feet or shoulders. A facilitator shall not
			 use any other forms of touch, nor permit another person to use any other form
			 of touch during an administration session.
(b) Clients participating in a group
			 administration session may provide prior written consent to authorize
			 supportive touch from other clients participating in the administration
			 session. Supportive touch is limited to hugs or placing hands on a client's
			 hands, feet or shoulders.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 333 - PSILOCYBIN › Section 333-333-5140 - Duty to Report Misconduct

Current through Register Vol. 63, No. 7, July 1, 2024
(1)
			 Any licensee, licensee representative or permittee who witnesses or becomes
			 aware of conduct involving a client that violates ORS chapter 475A or these
			 rules must report that conduct to the Oregon Health Authority (Authority)
			 within 24 hours.
(2) Any licensee,
			 licensee representative or permittee who witnesses or becomes aware of conduct
			 that harms or potentially endangers a client must report that conduct to the
			 Authority within 24 hours in a form and manner prescribed by the
			 Authority.
(3) Failure to report as
			 required by sections (1) and (2) of this rule is a violation, separate from any
			 violations that may have occurred as a result of the underlying
			 conduct.
Statutory/Other Authority: ORS
				  475A.235 & ORS
				  475A.340
Statutes/Other Implemented: ORS
				  475A.340
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 333 - PSILOCYBIN › Section 333-333-5150 - Transportation Plans

Current through Register Vol. 63, No. 7, July 1, 2024
(1) A facilitator
			 must create and record a transportation plan for every client that receives
			 psilocybin services.
(2)
			 Transportation plans must be signed by the client and describe how the client
			 will access safe transportation away from the service center at the conclusion
			 of an administration session.
(3)
			 Transportation plans shall advise a client not to operate a motor vehicle
			 directly following an administration session. Facilitators shall make
			 reasonable efforts to prevent clients from operating a motor vehicle at the
			 conclusion of an administration session. If a client's failure to follow their
			 transportation plan creates a danger to the client's safety or the safety of
			 others, a facilitator must make reasonable efforts to resolve the safety
			 issue.
(4) If facilitators are
			 unable to resolve safety issues caused by clients failure to follow their
			 transportation plan after making reasonable efforts required by section (3) of
			 this rule, facilitators must contact appropriate emergency services.
(5) If a client is unable to follow their
			 transportation plan, a facilitator must make reasonable efforts to arrange for
			 alternative transportation.
(6) A
			 facilitator must document in writing and retain documentation for all instances
			 in which a client does not follow their transportation plan.
(7) All client records, including any copies
			 of client records, described by this rule must be stored at the service center
			 where the client participates or intends to participate in an administration
			 session as required by OAR 333-333-4820.
Statutory/Other Authority: ORS
				  475A.235 & ORS
				  475A.340
Statutes/Other Implemented: ORS
				  475A.340
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 333 - PSILOCYBIN › Section 333-333-5240 - Consumption Limits

Current through Register Vol. 63, No. 7, July 1, 2024
(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 during an administration
			 session. Both initial doses and secondary doses described in this rule may be
			 transferred and consumed in multiple packages. For example, a dose consisting
			 of 20 mg of psilocybin analyte could be transferred to a client in the form of
			 two packages containing 10 mg of psilocybin of analyte.
(2) A service center licensee or licensee
			 representative may permit a client to consume secondary doses of psilocybin
			 product during an administration session as long as the total amount of
			 psilocybin analyte contained in the products is 50 mg or less.
(3) If a client wants the option to consume
			 secondary doses during their administration session, up to a total of 50 mg of
			 psilocybin analyte, a service center must:
(a) Receive written consent from the client
			 prior to the beginning of their administration session.
(b) Require the client to purchase and take
			 possession of secondary doses prior to beginning their administration
			 session.
(c) Require the client to
			 store secondary doses at a designated secured location outside of a limited
			 access area and within the service center's licensed premises.
(d) Require the client, or a client support
			 person, to retrieve secondary doses from the designated location and consume
			 without assistance from a licensee representative or facilitator if the client
			 chooses to consume the secondary dose.
(e) Ensure that secondary doses remain in
			 sealed client packaging until consumed.
(f) Require the client to return the
			 secondary dose to the service center at the conclusion of their administration
			 if they do not consume it during their administration
			 session.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 333 - PSILOCYBIN › Section 333-333-5250 - Duration of Administration Session

Current through Register Vol. 63, No. 7, July 1, 2024
(1) The minimum duration of an administration
			 session shall be dependent on the total amount of psilocybin a client consumes
			 during that session, including any secondary dose consumed.
(a) For clients consuming less than 2.5 mg of
			 psilocybin analyte, the minimum duration of the administration session shall be
			 one hour for the client's initial administration session at a service center.
			 Except as described in section (2) of this rule, after completing an initial
			 administration session at the service center, the minimum duration shall be 30
			 minutes when the client participates in any subsequent administration session
			 at the same service center within a period of 12 months following the initial
			 administration session.
(b) For
			 clients consuming equal or greater than 2.5 mg and less than 5 mg of psilocybin
			 analyte, the minimum duration of the administration session shall be one
			 hour.
(c) For clients consuming
			 equal or greater than 5 mg and less than 10 mg of psilocybin analyte, the
			 minimum duration of the administration session shall be two hours.
(d) For clients consuming equal or greater
			 than 10 mg and less than 25 mg of psilocybin analyte, the minimum duration of
			 the administration session shall be four hours.
(e) For clients consuming equal or greater
			 than 25 mg and up to 35 mg of psilocybin analyte, the minimum duration of the
			 administration session shall be five hours.
(f) For clients consuming equal or greater
			 than 35 mg and up to 50 mg of psilocybin analyte, the minimum duration of the
			 administration session shall be six hours.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 333 - PSILOCYBIN › Section 333-333-5260 - Integration Session

Current through Register Vol. 63, No. 7, July 1, 2024
(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 session and comply with
			 OAR 333-333-5130 during an integration session.
(3) Except practicum site supervisors, lead
			 educators and students participating in a practicum with the client's prior
			 written consent, only clients, facilitators and client support persons may be
			 present during an integration session.
(4) A facilitator may provide a client
			 information regarding other services, including but not limited to peer support
			 groups and community resources, in support of a client's ongoing integration
			 needs.
(5) Integration sessions may
			 be offered in person or virtually using video conferencing
			 technology.
Statutory/Other Authority: ORS
				  475A.235
Statutes/Other Implemented: ORS
				  475A.235 & ORS
				  475A.340
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 333 - PSILOCYBIN › Section 333-333-6000 - Prohibited Conduct

Current through Register Vol. 63, No. 7, July 1, 2024
(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 provide psilocybin services to a person
			 under 21 years of age.
(3)
			 Identification for Products. A licensee or licensee representative must require
			 a person to produce identification as required by ORS
			 475A.445 before selling or
			 providing a psilocybin product to that person.
(4) Identification for Services. A
			 facilitator must require a person to produce identification before providing
			 psilocybin services to that person.
(5) Access to Licensed Premises.
(a) A licensee, licensee representative or
			 permittee may not:
(A) During regular
			 business hours for the licensed premises, refuse to admit or fail to promptly
			 admit an authorized Oregon Health Authority (Authority) representative who
			 identifies themselves and who enters or wants to enter a licensed premises to
			 conduct an inspection to ensure compliance with ORS
			 475A.210 to
			 475A.722 or these
			 rules;
(B) Outside of regular
			 business hours or when the licensed premises appear closed, refuse to admit or
			 fail to promptly admit an authorized Authority representative who identifies
			 themselves and requests entry on the basis that there is a reason to believe a
			 violation of ORS 475A.210 to
			 475A.722 or these rules is
			 occurring; or
(C) Ask the
			 authorized Authority representative to leave until the authorized Authority
			 representative has had an opportunity to conduct an inspection to ensure
			 compliance with ORS chapter 475A or these rules.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 333 - PSILOCYBIN › Section 333-333-6030 - Laboratory Licensee Prohibited Conduct

Current through Register Vol. 63, No. 7, July 1, 2024
(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 laboratory's accreditation through the Oregon Environmental
			 Laboratory Accreditation Program.
(b) Perform any required psilocybin sampling
			 or testing for any licensed psilocybin manufacturer in which the laboratory
			 licensee has a financial interest.
(c) Receive, possess or perform sampling and
			 testing of psilocybin products from any source other than a licensed premises
			 as allowed by these rules.
(d)
			 Engage in any activity that violates any provision of ORS chapter 475A, OAR
			 chapter 333, division 64 as applicable, or these rules.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 333 - PSILOCYBIN › Section 333-333-6040 - Dishonest Conduct

Current through Register Vol. 63, No. 7, July 1, 2024
(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 Misrepresentations. A
			 licensee or permittee may not misrepresent any psilocybin item or services to a
			 consumer, licensee, or the public, including:
(a) Misrepresenting the contents of a
			 psilocybin product.
(b)
			 Misrepresenting the testing results of a psilocybin product.
(c) Making representations or claims that the
			 psilocybin product or services have curative or therapeutic effects unless the
			 representation or claim is supported by the totality of publicly available
			 scientific evidence (including evidence from well-designed studies conducted in
			 a manner that is consistent with generally recognized scientific procedures and
			 principles), and for which there is significant scientific agreement, among
			 experts qualified by scientific training and experience to evaluate such
			 claims.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 333 - PSILOCYBIN › Section 333-333-7010 - Psilocybin Testing: Purpose

Current through Register Vol. 63, No. 7, July 1, 2024
(1) The
			 purpose of these rules is to establish minimum compliance testing standards for
			 psilocybin products.
(2) A person
			 licensed under ORS 475A.290, 475A.305, or 475A.325 may not transfer, accept or
			 provide a psilocybin product unless it has been sampled and tested in
			 accordance with these rules.
Statutory/Other Authority: ORS 475A.235 & ORS
				  475A.590
Statutes/Other Implemented: ORS 475A.235 & ORS
				  475A.590
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 333 - PSILOCYBIN › Section 333-333-7020 - Ordering Tests

Current through Register Vol. 63, No. 7, July 1, 2024
(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
			 psilocybin product;
(d) Unique
			 identification numbers assigned to products that will be sampled;
(e) Total mass or volume of each batch to be
			 sampled; and
(f) Identification of
			 tests requested.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 333 - PSILOCYBIN › Section 333-333-7030 - Speciation Testing

Current through Register Vol. 63, No. 7, July 1, 2024
(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 or converting the harvest lot to a psilocybin
			 extract or edible psilocybin product.
(2) Following the test described in section
			 (1) of this rule, a manufacturer must order tests for the first batch harvested
			 in each calendar month that a harvest lot is recorded to ensure that the lot
			 contains
Psilocybe cubensis.
(3) A batch fails speciation testing if the
			 test demonstrates that the batch does not contain
Psilocybe
			 cubensis.
(4) If a batch
			 fails speciation testing, a manufacturer must order tests for every harvest lot
			 for a period of 12 months following the failed test to ensure that batches
			 contain
Psilocybe cubensis.
This test must be performed prior
			 to transferring the harvest lot to another licensee or converting the harvest
			 lot to a psilocybin extract or edible psilocybin product.
(5) In addition to the requirements of
			 section (1) of this rule, a manufacturer must submit one or more batches from a
			 harvest lot or process lot for speciation testing upon written request by the
			 Oregon Health Authority.
Statutory/Other Authority: ORS
				  475A.235 & ORS
				  475A.590
Statutes/Other Implemented: ORS
				  475A.235 & ORS
				  475A.590
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 333 - PSILOCYBIN › Section 333-333-7040 - Potency Testing

Current through Register Vol. 63, No. 7, July 1, 2024
(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 extract or edible psilocybin product fails potency testing if the
			 amount of psilocybin or psilocin between primary and duplicate samples taken
			 from the batch exceeds 20 percent relative percent difference between
			 samples.
(3) In addition to the
			 requirements of section (1) of this rule, a manufacturer must submit one or
			 more batches from a harvest lot or process lot for potency testing upon written
			 request by the Oregon Health Authority.
Statutory/Other Authority: ORS
				  475A.235 & ORS
				  475A.590
Statutes/Other Implemented: ORS
				  475A.235 & ORS
				  475A.590
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 333 - PSILOCYBIN › Section 333-333-7050 - Solvent Testing

Current through Register Vol. 63, No. 7, July 1, 2024
(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 another product type.
(2) A
			 batch fails solvent testing if a laboratory detects the presence of methanol
			 above 3000 µg/g or acetic acid above 5000 µg/g in any
			 sample.
(3) If a sample from a
			 batch fails solvent testing, the batch may be remediated using procedures that
			 would reduce the concentration of solvents to less than the action level.
(4) A batch that is remediated in
			 accordance with section (3) of this rule, must be re-sampled and re-tested for
			 solvents in accordance with these rules.
(5) In addition to the requirements of
			 section (1) of this rule, a manufacturer must submit one or more batches from a
			 process lot for solvent testing upon written request by the
			 Authority.
Statutory/Other Authority: ORS 475A.235 & ORS
				  475A.590
Statutes/Other Implemented: ORS 475A.235 & ORS
				  475A.590
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 333 - PSILOCYBIN › Section 333-333-7060 - Pesticide Testing

Current through Register Vol. 63, No. 7, July 1, 2024
(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 action levels in any sample,
			 including a field duplicate:
(a) During an
			 initial test where no reanalysis is requested; or
(b) Upon reanalysis as described in OAR
			 333-333-7120.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 333 - PSILOCYBIN › Section 333-333-7070 - Contaminant Testing

Current through Register Vol. 63, No. 7, July 1, 2024
(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 sampled using
			 appropriate aseptic technique and tested for total coliform count.
(3) If the presence of any fecal coliforms is
			 detected the sample must be assessed for Escherichia coli (E. Coli)
(4) A batch fails microbial contaminant
			 testing if the presence of E. Coli at more than 100 colony forming units per
			 gram is detected in a sample.
(5) A
			 psilocybin product required to be tested for contaminants may also be tested
			 for aflatoxins and other harmful mycotoxins.
(6) A psilocybin product fails testing for
			 aflatoxins and other harmful mycotoxins if the tests detect mycotoxins at
			 levels that are unsafe for human consumption.
(7) If a sample from a batch of psilocybin
			 product fails contaminant testing, the batch may not be remediated and must be
			 destroyed.
Statutory/Other Authority: ORS
				  475A.235 & ORS
				  475A.590
Statutes/Other Implemented: ORS
				  475A.235 & ORS
				  475A.590
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 333 - PSILOCYBIN › Section 333-333-7080 - Heavy Metals Testing

Current through Register Vol. 63, No. 7, July 1, 2024
(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 for lead, cadmium, mercury and
			 arsenic.
(3) A batch fails heavy
			 metal testing if the presence of metals above the limits in section (4) of this
			 rule are detected in any sample, including a field duplicate:
(a) During an initial test where no
			 reanalysis is requested; or
(b)
			 Upon reanalysis as described in OAR 333-333-7120.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 333 - PSILOCYBIN › Section 333-333-7090 - Psilocybin Batch Requirements

Current through Register Vol. 63, No. 7, July 1, 2024
(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 manufacturer must associate each batch with a unique identification number
			 and that unique identification number must be:
(a) Provided to the individual responsible
			 for taking samples; and
(b)
			 Included in the batch labels required by OAR 333-333-7110.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 333 - PSILOCYBIN › Section 333-333-7100 - Psilocybin Product Sampling Requirements

Current through Register Vol. 63, No. 7, July 1, 2024
(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 tests and samples must be taken in
			 a manner consistent with the laboratory's sampling policies and
			 procedures.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 333 - PSILOCYBIN › Section 333-333-7110 - Requirements for Pre-Tested Psilocybin Products

Current through Register Vol. 63, No. 7, July 1, 2024
(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 laboratory that took samples and the name of the laboratory
			 responsible for testing, if different;
(C) The test batch or sample unique
			 identification numbers supplied by the laboratory;
(D) The date the samples were taken:
			 and
(E) In bold, capital letters,
			 no smaller than 12-point font, "PRODUCT NOT TESTED."
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 333 - PSILOCYBIN › Section 333-333-7120 - Failed Test Samples

Current through Register Vol. 63, No. 7, July 1, 2024
(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
			 subcontract the reanalysis. If a primary sample or a field duplicate sample
			 fails, both must be reanalyzed. If the sample passes, another laboratory must
			 resample the batch and confirm that result for the batch to pass testing.
(a) If a manufacturer wishes to have a sample
			 reanalyzed, the manufacturer must request a reanalysis within seven calendar
			 days from the date the laboratory sent notice of the failed test to the
			 manufacturer. The reanalysis must be completed by the laboratory within 30 days
			 from the date the reanalysis was requested.
(b) If a manufacturer has requested a
			 reanalysis in accordance with subsection (1)(a) of this rule and the sample
			 passes, the manufacturer has seven calendar days from the date the laboratory
			 sent notice of the passed test to request that another laboratory resample the
			 batch and confirm the passed test result. The retesting must be completed by
			 the second laboratory within 30 days from the date the retesting was
			 requested.
(c) A manufacturer must
			 inform the Oregon Health Authority (Authority) immediately, of the following,
			 in a manner prescribed by the Authority:
(A) A
			 request for reanalysis of a sample;
(B) The testing results of the
			 reanalysis;
(C) A request for
			 retesting; and
(D) The results of
			 retesting.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 333 - PSILOCYBIN › Section 333-333-7150 - Quality Control and Product Development Testing

Current through Register Vol. 63, No. 7, July 1, 2024
(1) A manufacturer may request that a
			 laboratory conduct testing for the purpose of assuring quality control or
			 product development, except as provided in section (2) of this rule.
(2) A manufacturer may not request that a
			 laboratory conduct pesticide testing on psilocybin products for the purpose of
			 quality control or product development. A pesticide test is always a compliance
			 test.
(3) A manufacturer that
			 submits a psilocybin product for quality control or product development testing
			 is not subject to OAR 333-333-7010  to OAR 333-333-7120.
(4) A laboratory result from a quality
			 control or product development test cannot be used as a compliance test result
			 and may not be displayed on client packaging or labels. A psilocybin product
			 that has undergone a quality control or product development test may not be
			 transferred or sold without undergoing required compliance tests.
(5) Manufacturers must retain all quality
			 control and product development test results for at least two years and provide
			 copies of such results upon request to the Oregon Health Authority.
Statutory/Other Authority: ORS
				  475A.235 & ORS
				  475A.590
Statutes/Other Implemented: ORS
				  475A.235 & ORS
				  475A.590
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 333 - PSILOCYBIN › Section 333-333-8000 - Waste Management

Current through Register Vol. 63, No. 7, July 1, 2024
(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 which may include but are not limited to:
(a) Solid waste requirements in ORS chapter
			 459 and OAR chapter 340, divisions 93 to 96.
(b) Hazardous waste requirements in ORS
			 chapter 466 and OAR chapter 340, divisions 100 to 106.
(c) Wastewater requirements in ORS chapter
			 468B and OAR chapter 340, divisions 41 to 42, 44 to 45, 53, 55 and
			 73.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 333 - PSILOCYBIN › Section 333-333-8100 - Product Transportation

Current through Register Vol. 63, No. 7, July 1, 2024
(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 products obtained
			 by a laboratory licensee pursuant to OAR 333-333-7100  may only be transported
			 by the laboratory licensee or a laboratory licensee representative of the
			 receiving laboratory.
(c) Every
			 manufacturer, service center and laboratory licensee must maintain a list of
			 licensee representatives authorized to transport product or travel in vehicles
			 transporting product.
(d)
			 Psilocybin products transferred between licensed premises must not exceed
			 possession quantities described in OAR 333-333-2200.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 333 - PSILOCYBIN › Section 333-333-8200 - Product Tracking - General Requirements

Current through Register Vol. 63, No. 7, July 1, 2024
(1) A service center, manufacturer or
			 laboratory licensee must use the product tracking system as an inventory and
			 recordkeeping system.
(2) Each
			 individual service center, manufacturer and laboratory licensee will have
			 access to the product tracking system. A licensee may authorize additional
			 licensee representatives to use the product tracking system for their licensed
			 premises.
(3) Each service center,
			 manufacturer and laboratory licensee must:
(a) Maintain an accurate and complete list of
			 all product tracking system users for each licensed premises and must update
			 the list when a new product tracking system user is added.
(b) Train and authorize any new product
			 tracking system users before those users are permitted to access the product
			 tracking system or input, modify, or delete any information in the product
			 tracking system.
(c) Remove access
			 for any product tracking system user from an associated product tracking system
			 account if that individual is no longer a licensee representative.
(d) Correct any data that is entered into the
			 product tracking system in error.