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.
Psilocybin Work Group, Task Force, and Therapy Services Pilot. In 2022, the Health Care Authority (HCA) formed an interagency Psilocybin Work Group based on Legislative direction in the supplemental budget to study issues related to the implementation of a regulated psilocybin system in Washington State. In 2023, the Legislature passed SSB 5263 which:
The bill as referred to committee not considered.
Overview. A Regulated Psilocybin Program is created at the Department of Health (DOH) and the Liquor and Cannabis Board (LCB), allowing adults 21 years of age and older to purchase psilocybin produced by a cultivator and tested by a laboratory licensed by LCB, and consume it during an administration session conducted under the supervision of a facilitator or clinical facilitator licensed by DOH, either at a service center licensed by DOH or at another authorized location, where the client must remain until the effects of the drug have left their system. Rulemaking must be completed by October 31, 2027, following a two-year development period ending September 1, 2027.
Licensed Facilitators and Clinical Facilitators. DOH must license facilitators and clinical facilitators. A facilitator must successfully complete an approved training program consisting of coursework, a 50-hour in-person practicum requirement, an approved exam, and 200 hours of supervised practice including 60 hours of direct supervision. Training must include information on cultural competency and may take place anywhere in the world. A clinical facilitator must meet all the above requirements, complete an approved course on psychedelic harm reduction integration, and hold a license or certification in good standing as a health professional in one of 20 enumerated health professions. DOH must offer a free course in psychedelic harm reduction integration on its website by September 1, 2027. An individual meeting all requirements for licensure except for the supervised experience requirement may be licensed as an associate facilitator or associate clinical facilitator if the individual certifies they are working towards full licensure. DOH may waive certain requirements in consideration of an applicant's previous experience and training.
DOH must develop facilitator guidelines by rules which promote skills which are affirming, nonjudgmental, culturally competent, and nondirective. The rules must provide considerations for the environment for the administration session, promote client safety, and include a facilitator code of ethics and professional conduct.
Administration Sessions. DOH must adopt rules that permit both group and individual psilocybin administration sessions, subject to health and safety considerations. Prior to an administration session, a client must receive educational information, which may be provided through a video presentation or through a remote or in-person preparation session with a clinical facilitator. The facilitator must make disclosures and warnings required by rule, make safety arrangements for transportation after the administrative session, and collect client information. If the client is identified as high risk for experiencing complications, the facilitator may problem solve with the client to mitigate risks, require the client to undergo an additional preparation session, refer the client to a clinical facilitator if applicable, or decline to hold the administrative session. All clients must be offered an integration session to be held within 72 hours after the administration session. A client bill of rights is created addressing dignity interests, autonomy, privacy, safety, support for informed decision-making, and reporting of violations to regulatory authorities.
Administration Session Locations. A administration session may be held at a service center licensed by DOH, a licensed health care facility, the regular place of business of a clinical facilitator, the residence of the client, or a temporary location permitted by DOH, subject to various rules and limitations; for example, an administration held in a clients home must be limited to no more than six occasions per 12-month period, and may include a pre-administration safety check by the facilitator, and recording of the administration session unless two or more licensed facilitators are present.
Cultivation. Psilocybin products produced by licensed cultivators must consist of naturally occurring psilocybin or psilocin, which may include whole mushrooms or products containing unadulterated psilocybin-producing fungi, such as dried mushrooms or ground mushroom powder. LCB may establish a maximum concentration of psilocybin, but may not establish a maximum dosage below 50 milligrams or the equivalent in grams of dried mushroom. The Department of Agriculture must assist LCB in regulation of licensed cultivators and is prohibited from regulating psilocybin as an agricultural activity, food additive, or adulterant.
Transportation, Storage, Tracking, Labeling, and Testing. Restrictions are provided on who may transport psilocybin products and how and where they may be stored. LCB must establish procedures for tracking psilocybin which prevent diversion and protect against tampering or substitution, from point of manufacture to point of sale to a service center, facilitator, or clinical facilitator. LCB must establish testing procedures for licensed laboratories, addressing topics such as batch sizes, sampling, and random testing. LCB's rules must require labelling of psilocybin products that communicates health and safety warnings, activation time, potency, and serving size. LCB may require preapproval of labels and packaging for psilocybin products.
Legal Protections for Licensees, Agencies, Health Workers, and Clients. Psilocybin-related activities authorized by this act are exempt from criminal liability under Washington's Controlled Substance Act. Psilocybin licensees may rely on information provided to them by clients without criminal or civil liability unless a reasonable person would not have relied on the information. State agencies are immune for engaging in or omitting to perform activities authorized by this act. Licensed health workers are immune from civil penalties or disciplinary action under the Uniform Disciplinary Act for advising or counseling a person related to psilocybin. Health workers, clients, and their caregivers must not be subject to arrest or other sanctions for engaging in activities permitted by this act. Employers may not discriminate against an employee for receiving psilocybin services or test employees for the presence of psilocybin absent the employee's visible impairment at work.
Agency Enforcement and Infractions. DOH and LCB may conduct unannounced inspections of licensed premises, have subpoena power, and may inspect a licensee's books on 72 hours notice. The agencies may impose civil penalties up to $5,000 for rule violations, or up to $500 per day for licensed laboratories. Law enforcement may enforce agency psilocybin rules and may impose class II civil infractions for rule violations. It is a class I civil infraction for a person to produce false identification in connection with psilocybin activities.
Interaction With Local Laws. State psilocybin laws preempt any inconsistent local ordinances, but do not preclude or supersede ordinances related to decriminalization of psilocybin or deprioritization of criminal law enforcement. Authority to impose local taxes on psilocybin activities or require additional licenses is preempted. City or county governing bodies may impose reasonable time, place, and manner restrictions on the operation of licensed psilocybin businesses, but may not prohibit the establishment of those entities except in areas zoned primarily for residential use, and may not restrict the proximity of a licensed business to a school or other specific location. No locality may prohibit transportation of psilocybin under this act through its jurisdiction on public roads.
Washington Psilocybin Board. The Washington Psilocybin Board (Board) is established within DOH, consisting of 11 members, to provide advice and assistance to DOH, which must appoint members by September 1, 2025. Six Board members must be psilocybin facilitators and five must be public members. Three of the facilitator members must also be licensed or certified health professionals, and after July 1, 2028, the facilitator positions must be split between three licensed facilitators and three licensed clinical facilitators. The 11 members must include at least four persons with knowledge of business, at least one BIPOC member, at least one person with knowledge of academic health research processes, and at least one person with knowledge of indigenous practices and experiences. Members are appointed to staggered three-year terms, and after January 1, 2030, the number of public members must be reduced by attrition from five to three.
Beginning January 1, 2028, the Board must receive periodic reports from the University of Washington Center for Novel Therapeutics in Addiction Psychiatry concerning new research studies related to use of psilocybin and analysis of data collection concerning psilocybin use in Washington State.
Protection of Information. Psilocybin licensees may not disclose information which could identify a client to third parties without client consent, subject to certain exceptions. DOH must establish in rule what client information must be collected and reported to DOH, in consultation with the University of Washington Center for Novel Therapeutics, Washington State Institute for Public Policy, and Research and Data Administration of the Department of Social and Health Services to maximize research opportunities and advance knowledge about benefits, risks, and outcomes of psilocybin administration. The addresses of licensed premises and their security and operational plans are exempt from public disclosure, expect to law enforcement agencies.
Licensure and Rulemaking. Licensure processes at DOH and LCB must not cause undue delay or charge more than necessary to cover the costs of the Regulated Psilocybin Program. Proceeds must be deposited in state Treasury accounts designated for this purpose. Licensees regulated by DOH are under the Uniform Disciplinary Act with DOH acting as disciplinary authority. All licensees must undergo background checks, but may not be disqualified from holding a license for offenses related to possession or manufacture of psilocybin or cannabis. All employees of a licensee must be at least 21 years of age. Licensees may be required to maintain general liability insurance in an amount reasonably available and affordable. LCB may limit the availability of cultivation and testing licenses to control costs, as long as the opportunity for licensure remains available in diverse regions of the state and the number of licenses available of each type does not fall below 20. DOH and LCB are directed to consider the cost and complexity of regulatory compliance when enacting rules, and to exercise its discretion to maximize flexibility and lower costs for licensees and streamline the experience for clients, while maintaining due regard for safety.
Public Awareness. By December 31, 2025, and from time to time thereafter, DOH must publish and distribute available medical, psychological, and scientific research and information about the safety and efficacy of psilocybin in relieving behavioral health conditions.
This act may be known and cited as the Clinical and Supervised Access to Psilocybin Act.
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.