Psychedelic Drugs.
Psychedelic drugs, a class of naturally occurring and laboratory-produced substances, are generally understood to include 5-HT2 agonists such as psilocybin and lysergic acid diethylamide (LSD), as well as entactogens and empathogens such as methylenedioxymethamphetamine (MDMA).? Psychedelic drugs can temporarily alter a person's mood, cognitive processes, and perceptions.
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Psilocybin is a naturally occurring psychedelic compound that is found in over 200 species of fungi, and it can be extracted or synthesized by chemical processes.? Psilocybin is currently listed as a Schedule 1 controlled substance under the state and federal Uniform Controlled Substances Act.? Medical professionals licensed in Washington may not be subject to adverse licensing action for recommending psilocybin therapy services.
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Psilocybin Task Force and Pilot Program.
In 2023 the Legislature passed legislation that directed the Health Care Authority to establish a Psilocybin Task Force (Task Force) and provide a report on psilocybin services by December 1, 2023. ?The Task Force was required to review clinical information around specific clinical indications for use of psilocybin and review regulatory structures for clinical use of psilocybin.
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In 2023 the Legislature also established a psilocybin therapy services pilot program at the University of Washington, to be implemented by January 1, 2025. ?The pilot program is required to offer facilitated psilocybin therapy services to certain populations.
Overview.
The legislation may be known and cited as the Psychedelic Substances Act (Act).
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"Psychedelic substance" is defined as psilocybin or psilocin and, after December 31, 2029, may include any of the following additional substances if recommended by the Washington Psychedelic Substances Board (Board) and subsequently adopted in rule by the Department of Health (DOH):? dimethyltryptamine, ibogaine, bufotenin, methylenedioxymethamphetamine, and mescaline (excluding peyote and any parts or extracts of the plant classified as the Lophophora williamsii plant).
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A "client" is an individual who is 21 years of age or older who consumes or intends to consume a psychedelic substance at an administration session.
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A "service center" is defined as a location licensed by the DOH where facilitators and clinical facilitators may hold administration sessions with clients, and which can acquire, possess, transfer, transport, deliver, supply, sell, or dispense psychedelic substances to authorized entities or individuals.
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Washington Psychedelic Substances Board.
The Board is established within the DOH to provide advice and assistance to the DOH.? The Board consists of six psychedelic substance facilitators and five public members.? During a two-year program development period, the Board must advise the DOH on the formulation of rules as part of a regulatory framework for psychedelic substances.
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Powers and Duties of the Department of Health.
A regulated psychedelic substances program is established within the DOH. ?The DOH may adopt rules necessary to implement the program, including establishing requirements for administration sessions, facilitator guidelines, issuance of temporary location permits, the operation of psychedelic substance service centers, and other requirements. ?The DOH may approve training courses for facilitators and clinical facilitators. ?In making rules to implement its duties, the DOH may not require a client to have any particular medical condition as a condition to being provided psychedelic substance services or require a professional license or degree to license an individual as a facilitator.
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Beginning November 1, 2027, the DOH must begin accepting applications for the licensing of persons to operate a service center or facilitate psychedelic substance services. ?After a two-year program development period, by December 31, 2027, the DOH must adopt rules and establish forms necessary for the implementation of its duties under the Act.
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In adopting rules, the DOH must consult with the University of Washington, the Department of Social and Health Services, the Washington State Institute for Public Policy, and the Liquor and Cannabis Board (LCB).
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The DOH serves as the disciplinary authority under the Uniform Disciplinary Act (UDA) for its licensees, and the UDA is amended to allow for activities relating to psychedelic substances in accordance with the Act. ?The DOH may make an examination of the books or premises of a licensee for the purpose of determining compliance. ?The DOH may require a licensee to maintain general liability insurance. ?The DOH may require a licensee or applicant to submit a sworn statement regarding financial interests in the business operating or to be operated under a license.
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Facilitators, Clinical Facilitators, and Associates.
Facilitator.? The DOH must license an applicant as a facilitator if the applicant demonstrates completion of an approved facilitator training program, including coursework and an in-person practicum requirement, completion of a minimum number of supervised practice hours, and completion of an approved examination.?
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Clinical Facilitator.? The DOH must license an applicant as a clinical facilitator if the applicant demonstrates that the applicant has completed all requirements to be licensed as a facilitator, including an enhanced examination, and completed an approved course on psychedelic harm reduction integration. ?At the time of licensure, the facilitator must also hold a license or certification in good standing as a health professional in Washington or a substantially equivalent credential issued by another jurisdiction. ?The Board or the DOH may reduce or waive certain licensure requirements for applicants that meet specific criteria.
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Associate Facilitator or Associate Clinical Facilitator.? The DOH must issue an associate facilitator license or associate clinical facilitator license to an applicant who demonstrates that the applicant has met all requirements toward licensure as a facilitator or clinical facilitator except for the supervised experience requirement, and who submits a declaration that the applicant is working toward full licensure.?
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Client Disclosures. ?Associate facilitators or associate clinical facilitators must provide certain disclosures to clients while working under the supervision of an approved supervisor. ?A facilitator or associate facilitator who is not a clinical facilitator or associate clinical facilitator must make certain disclosures to clients regarding their role and the limitations of their scope of practice, among other information. ?A clinical facilitator must disclose information regarding health profession licensure and scope of practice, as well as insurance billing information. ?A clinical facilitator may not seek insurance reimbursement for services provided under the clinical facilitator's license as a health professional while simultaneously facilitating an administration session in which a client ingests a psychedelic substance.
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Clients receiving psychedelic substance services have certain enumerated rights under the Act.
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Health Professional Training.? The DOH must develop, or contract for the development of, a course for health professionals to learn how to apply their clinical skills to provide informed counseling to clients who are either contemplating engaging in therapeutic use of psychedelic substances or integrating the lessons from an experience in taking psychedelic substances for therapeutic purposes.
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Authorized Locations for Psychedelic Substance Administration.
A facilitator or clinical facilitator may hold a psychedelic substance administration session in one of the following locations:
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Service Centers.?
The DOH must establish procedures for licensure and rules for operation of psychedelic substance service centers. ?Such procedures and rules must include requiring applicants for a service center operator license to be 21 years of age or older, requiring the service center to have a secure limited access area for storage of psychedelic substances, and allowing group administration sessions, among other requirements. ?License and registration fees must be deposited in the Psychedelic Substance Facilitation Control and Regulation Account.
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Employees and Other Workers.
An individual who performs work for or on behalf of a licensee must have a valid permit issued by the DOH or the LCB if the individual participates in certain activities involving psychedelic substance services. ?The DOH must conduct a criminal records check under the UDA on an individual applying for a permit. ?The DOH must adopt rules regarding worker permits and may require applicants to complete training.
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Prerequisites for an Administration Session.
Before holding an administration session, a facilitator must collect client information, make required disclosures, verify that the client has reviewed education information and had the opportunity to have a preparation session, and confirm arrangements for safety contingencies and client transportation at the end of the session. ?If the client information reveals that the client is a high-risk for complications during the administration session, the facilitator may decline to hold the administration session or take other specified steps. ?
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All clients must be offered an integration session with a facilitator or clinical facilitator after participating in an administration session.
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Protection of Client Information.
Service center operators, facilitators, clinical facilitators, or their employees may not disclose information that may be used to identify a client, or any communication made by a client during the course of providing psychedelic substance services or selling psychedelic substance products to the client, or any time thereafter, to any third party, unless an exception applies.
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Powers and Duties of the Liquor and Cannabis Board.
A regulated psychedelic substances program is established within the LCB. ?By October 31, 2027, the LCB must adopt rules necessary to implement its duties under the Act. ?The rules must include establishing procedures for tracking, labeling, and testing psychedelic substances. ?In adopting rules, the LCB must consult with the DOH and the Department of Agriculture.
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Beginning November 1, 2027, the LCB must begin accepting applications for the licensing of persons to manufacture psychedelic substances and test psychedelic substances. ?Upon certain findings, the LCB may refuse to issue a license or may issue a restricted license.
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The LCB serves as the disciplinary authority for licensees engaged in manufacturing and testing of psychedelic substances. ?The LCB may make an examination of the books or premises of a licensee for the purpose of determining compliance. ?The LCB may require a licensee to maintain general liability insurance. ?The LCB may also require a licensee or applicant to submit a sworn statement regarding financial interests in the business operating or to be operated under a license.
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License to Manufacture Psychedelic Substances.
The manufacture of psychedelic substances is subject to regulation by the LCB.? A manufacturer must have a manufacturer license issued by the LCB for the premises at which the psychedelic substances are manufactured.? Licensure fees must be deposited in the Psychedelic Substance Manufacture and Testing Control and Regulation Account.?
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Testing of Psychedelic Substances.
The LCB must adopt rules regarding the testing of psychedelic substances, establishing procedures for determining batch sizes and for sampling psychedelic substances, and establishing minimum standards for different varieties of psychedelic substances. ?The LCB may require a manufacturer to test psychedelic substances before selling or transferring them, and may conduct random testing.
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A laboratory that conducts testing of psychedelic substances must be licensed by the LCB to operate at the premises at which the psychedelic substances are tested, and the LCB must adopt rules establishing requirements for licensure. ?Licensure fees must be deposited in the Psychedelic Substance Manufacture and Testing Control and Regulation Account.
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Packaging, Labeling, and Dosage of Psychedelic Substance Products.
The LCB must adopt rules establishing standards for the labeling and packaging of psychedelic substances. ?All psychedelic substances provided for sale or transferred to or by a service center must be appropriately packaged and labeled, including labeling that communicates health and safety warnings, activation time, potency, content, and applicable serving size. ?The LCB may require a licensee to submit a label or packaging intended for use on a psychedelic substance product for preapproval.
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The LCB must also adopt rules establishing the maximum concentration of a psychedelic substance that is permitted in a single serving of a psychedelic substance product and the number of servings that are permitted in a psychedelic substance package.?
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Transportation of Psychedelic Substances.
An employee of a service center, or an employee of a manufacturer or laboratory, may transport and deliver a psychedelic substance only to:
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Storage of Psychedelic Substances.
Psychedelic substances may be stored at a service center, a licensed manufacturer or laboratory, or in a limited access location at a licensed health care facility registered with the DOH as a location where an administration session may be held. ?Subject to certain requirements, a facilitator or clinical facilitator may temporarily store a psychedelic substance in certain other secure locations. ?
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License Eligibility.?
All individuals licensed by the DOH or the LCB under the Act must be at least 21 years of age, and licensees may not employ a person under 21 years of age at a premises for which a license has been issued. ?The DOH or the LCB may refuse to issue a license, or may issue a restricted license upon certain findings, including if the applicant has been convicted of violating certain federal or state laws or has made false statements to the DOH or the LCB.?
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For the purpose of requesting a criminal records check, the DOH may require the fingerprints of an individual listed on a licensure application.
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Department of Agriculture.
The Department of Agriculture must assist and cooperate with the DOH, and it may possess, test, and dispose of psychedelic substance products.
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Civil and Criminal Enforcement.
In addition to other liability or penalty provided by law, the DOH or the LCB may impose a civil penalty for each violation of the Act or a rule adopted under the Act. ?A violation of a rule adopted under the Act is a class 2 civil infraction.
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A person may not produce a piece of identification in connection with psychedelic substance-related activities that falsely indicates the person's age. ?A violation of this requirement is a class 1 civil infraction.
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Law enforcement officers may enforce the Act and assist the DOH and the LCB in detecting violations. ? The county courts, prosecuting attorneys, and municipal authorities, immediately upon conviction of a licensee of a violation relating to psychedelic substances must notify the DOH.
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A licensee who relies on information provided by a client before sale or service of a psychedelic substance to a client may not be found guilty or civilly liable for any offense relating to the sale or service of the psychedelic substance, unless it is demonstrated that a reasonable person would have determined that the responses provided by the client were incorrect or altered.
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Regulation by Cities and Counties.?
The regulatory framework established by DOH is designed to operate uniformly throughout the state and supersedes any municipal charter or local ordinance that is inconsistent. ?The authority to require a license for, or impose a tax or fee on, the manufacturing or sale of a psychedelic substance, or for the provision of psychedelic substance services, is vested solely in the Legislature.
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Cities and counties may adopt ordinances placing reasonable restrictions on the operation of businesses located at premises for which a license has been issued under the Act. ?Cities and counties may not prohibit the establishment of entities licensed by the DOH except in areas zoned primarily for residential use, and may not restrict the proximity of a licensee under the Act to a school or other specific entity or location. ?
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Other.?
Certain health professionals may not be subject to any penalty or disciplinary action solely for advising a person relating to use of a psychedelic substance, or for stating that, in the health professional's professional opinion, a patient is likely to receive therapeutic or palliative benefit from the use of a psychedelic substance.
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It is an unfair practice for any employer to discharge or bar a person from employment because of the use of psychedelic substances, in accordance with the Act, in the absence of visible impairment at work.
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The term "controlled substance" in the Uniform Controlled Substances Act does not include a psychedelic substance, but only if, and to the extent that, a person manufactures, delivers, or possesses the psychedelic substance in accordance with the Act and rules adopted under the Act.
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Certain licensee information is exempt from public disclosure under the Public Records Act.