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.
Psilocybin. Psilocybin is a naturally occurring, psychoactive chemical compound produced by over 200 species of mushrooms, many of which grow natively in the Pacific Northwest. Psilocybin is currently listed as a Schedule I controlled substance under the state and federal Uniform Controlled Substances Acts. Ingestion of psilocybin may produce changes in perception, mood, and cognitive processes common to other psychedelic drugs, a class of naturally-occurring and laboratory-produced substances, which includes mescaline, LSD, MDMA, ibogaine, and DMT. Psilocybin can be extracted or synthesized by chemical processes. A variety of studies have indicated that psilocybin may have applications relieving a range of behavioral health conditions ranging from substance use disorder, nicotine dependence, posttraumatic stress disorder, anxiety, and depression.
Recent State Legislative Action. In 2023, the Legislature directed the Health Care Authority (HCA) to establish a Psilocybin Task Force to study clinical information about the use of psilocybin and discuss regulatory structures for clinical use of psilocybin in Washington, and issue a final report on December 1, 2023.
In 2023, the Legislature also established a psilocybin therapy services pilot program at the University of Washington to offer facilitated psilocybin therapy services to first responders and veterans experiencing posttraumatic stress disorder, mood disorders, or substance use disorders, with services beginning January 1, 2025.
The legislation may be known and cited as the Psychedelic Substances Act (Act).
Definitions. "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.
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.
A service center is defined as a location licensed by 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.
Washington Psychedelic Substances Board. The Board is established within DOH to provide advice and assistance to DOH. The Board consists of six psychedelic substance facilitators and five public members. During a two-year program development period from September 1, 2025 to September 1, 2027, the Board must advise DOH on the formulation of rules as part of a regulatory framework for psychedelic substances.
Department of Health—Powers and Duties. A regulated psychedelic substances program is established within DOH and 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. DOH may approve training courses for facilitators and clinical facilitators. In making rules to implement its duties, 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.
Beginning November 1, 2027, 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, DOH must adopt rules and establish forms necessary for the implementation of its duties under the Act.
In adopting rules, DOH must consult with University of Washington, Department of Social and Health Services, Washington State Institute for Public Policy, and Liquor and Cannabis Board (LCB).
DOH serves as the disciplinary authority under the Uniform Disciplinary Act (UDA) for its licensees, and UDA is amended to allow for activities relating to psychedelic substances in accordance with the Act. DOH may make an examination of the books or premises of a licensee for the purpose of determining compliance. DOH may require a licensee to maintain general liability insurance. 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.
Facilitators, Clinical Facilitators, and Associates. Facilitator. 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.
Clinical Facilitator. 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 DOH may reduce or waive certain licensure requirements for applicants that meet specific criteria.
Associate Facilitator or Associate Clinical Facilitator. 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.
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.
Clients receiving psychedelic substance services have certain enumerated rights under the Act.
Health Professional Training. 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.
Authorized Locations for Psychedelic Substance Administration. A facilitator or clinical facilitator may hold a psychedelic substance administration session in one of the following locations:
Service Centers. 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.
Employees and Other Workers. An individual who performs work for or on behalf of a licensee must have a valid permit issued by DOH or LCB, if the individual participates in certain activities involving psychedelic substance services. DOH must conduct a criminal records check under UDA on an individual applying for a permit. DOH must adopt rules regarding worker permits and may require applicants to complete training.
Prerequisites for an Administration Session. Before holding an administration session, a facilitator must:
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.
All clients must be offered an integration session with a facilitator or clinical facilitator after participating in an administration session.
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.
Powers and Duties of the Liquor and Cannabis Board. A regulated psychedelic substances program is established within LCB. By October 31, 2027, 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, LCB must consult with DOH and Department of Agriculture.
Beginning November 1, 2027, LCB must begin accepting applications for the licensing of persons to manufacture psychedelic substances and test psychedelic substances. Upon certain findings, LCB may refuse to issue a license or may issue a restricted license.
LCB serves as the disciplinary authority for licensees engaged in manufacturing and testing of psychedelic substances. LCB may make an examination of the books or premises of a licensee for the purpose of determining compliance. LCB may require a licensee to maintain general liability insurance. 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.
License to Manufacture Psychedelic Substances. The manufacture of psychedelic substances is subject to regulation by LCB. A manufacturer must have a manufacturer license issued by 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.
Testing of Psychedelic Substances. 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. LCB may require a manufacturer to test psychedelic substances before selling or transferring them, and may conduct random testing.
A laboratory that conducts testing of psychedelic substances must be licensed by LCB to operate at the premises at which the psychedelic substances are tested, and LCB must adopt rules establishing requirements for licensure. Licensure fees must be deposited in the Psychedelic Substance Manufacture and Testing Control and Regulation Account.
Packaging, Labeling, and Dosage of Psychedelic Substance Products. 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. LCB may require a licensee to submit a label or packaging intended for use on a psychedelic substance product for preapproval.
LCB must also adopt rules establishing the maximum concentration of a psychedelic substance permitted in a single serving of a psychedelic substance product and the number of servings permitted in a psychedelic substance package.
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:
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 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.
License Eligibility. All individuals licensed by DOH or 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. DOH or 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 DOH or LCB.
For the purpose of requesting a criminal records check, DOH may require the listed individual's fingerprints on a licensure application.
Department of Agriculture. The Department of Agriculture must assist and cooperate with DOH, and it may possess, test, and dispose of psychedelic substance products.
Civil and Criminal Enforcement. In addition to other liability or penalty provided by law, DOH or 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.
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.
Law enforcement officers may enforce the Act and assist DOH and 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 DOH.
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.
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.
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 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.
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.
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.
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.
Certain licensee information is exempt from public disclosure under the Public Records Act.
The committee recommended a different version of the bill than what was heard. PRO: This bill is a new and balanced approach—its clinical and supervised. It is not recreational. This bill is a new approach to mental health and wellness that is based on science and safety. It promotes lasting sense of wellbeing and this model makes it possible to do so above ground in a safe environment. There is no need for another work group or for another study. There are hundreds of clinical studies that have been completed on this topic. This bill offers an opportunity to really help people heal. This treatment should be available for people. It is safe and if it helps people with substance use disorder or a mental illness, then this bill should be passed.
CON: It takes more time to gain an understanding of a product's safety and effectiveness. Any framework must prioritize patient safety, scientific rigor, and professional oversight. The state is not there yet to set up a regulatory framework and this is premature and potentially dangerous for vulnerable patients.. This is a recreational bill masking as a medical bill. The University of Washington is two years into a three-year study looking into the utility of these substances. Legislation should not be advanced until the study has been completed. There are also public health concerns regarding the legal use of psilocybin. There is a request for the bill to include decriminalization for personal use as this bill creates more barriers and medical gatekeepers, not solutions.
OTHER: There should be more clarity on the authority between DOH and the new Board, the application of the Uniform Disciplinary Act, and the storage requirements. There are concerns about the short timelines and the broad range of locations for services including unlicensed areas to client residences. This bill would make personal use illegal and unjustly regulates usage of psilocybin. It would create a two-tier system of access. There is a request for the state to fully decriminalize the use of psilocybin as there is already some local and county-wide decriminalization efforts happening. There is a request for an accountability structure that can also be within a decriminalization model. Also, there is concern that the LCB may not be the appropriate regulatory body for this framework.
PRO: Senator Jesse Salomon, Prime Sponsor; Ralph Baard; Mark Johnson, Washington Retail Association; Matthew Thierfelder; Wendy Lynn; Claudia Cuentas, Cora Center; Tom Eckert, InnerTrek; Aaron Loehr, Coalition for Better Community Health.
PRO: Mark Gaskill, Adventure Psychotherapy / Mark Gaskill; Leonora Russell, ADAPT-WA; Darron Smith, NovelPath Behavioral Wellness; David Trieweiler, Washington Association of Criminal Defense Lawyers/Washington Defender Association; Bryan Hubbard.