Bill Text: CA SB1012 | 2023-2024 | Regular Session | Amended
Bill Title: The Regulated Psychedelic Facilitators Act and the Regulated Psychedelic-Assisted Therapy Act.
Spectrum: Strong Partisan Bill (Democrat 13-1)
Status: (Introduced) 2024-05-16 - May 16 hearing: Held in committee and under submission. [SB1012 Detail]
Download: California-2023-SB1012-Amended.html
Amended
IN
Senate
March 20, 2024 |
Introduced by Senator Wiener (Principal coauthors: Assembly Members Lowenthal and Waldron) (Coauthors: Senators Becker, Bradford, Dodd, and Skinner) (Coauthors: Assembly Members Bryan, Haney, Jackson, Kalra, Lee, Rendon, and Wilson) |
February 05, 2024 |
LEGISLATIVE COUNSEL'S DIGEST
(4)
(5)
(6)This
(7)This bill would state that its provisions are severable.
(8)
(9)Existing constitutional provisions require that a statute that limits the right of access to the meetings of public bodies or the writings of public officials and agencies be adopted with findings demonstrating the interest protected by the limitation and the need for protecting that interest.
This bill would make legislative findings to that effect.
Digest Key
Vote: MAJORITY Appropriation: NO Fiscal Committee: YES Local Program: YESBill Text
The people of the State of California do enact as follows:
SECTION 1.
(a) (1) California’s current approach to mental health has failed to fulfill its promise. Californians deserve more tools to address mental health issues, including approaches such as regulated psychedelic-assisted therapy, that are grounded in treatment, recovery, health, and wellness rather than criminalization, stigma, suffering, and punishment.(1)Establish a regulated program to allow safe access to regulated psychedelic-assisted therapy for adults 21 years of age and older under the supervision of a licensed psychedelic-assisted therapy facilitator.
(2)To house the regulatory program within the California Business, Consumer Services, and Housing Agency and to authorize that agency to oversee and regulate manufacture, testing, quality control, transport, and safety of regulated psychedelic substances.
(3)To create and establish a professional licensing board for psychedelic-assisted therapy facilitators to govern the qualifications for education, training, experience, licensure, professional practice, standards of care, appropriate locations for the provision of psychedelic-assisted therapy, ethics, and discipline for psychedelic-assisted therapy facilitators.
(4)To create an advisory committee housed within the California Business, Consumer Services, and Housing Agency to advise and make recommendations to the agency, the professional licensing board, and other involved agencies and departments on the adoption of rules and the implementation of this act.
(5)
(6)Respect
(7)To create a fund that may receive both public and private dollars to provide grants to public and private entities to develop and advance education and harm reduction curricula, public education campaigns, trainings, and information for the public related to the use of psychedelic substances, including an internet website, screening tool, and information about contraindications and adverse effects and education and training for first responders and multiresponders including law enforcement, emergency medical services, social services, and fire services.
(8)
SEC. 2.
Section 101 of the Business and Professions Code is amended to read:101.
The department is comprised of the following:SEC. 3.
Section 729 of the Business and Professions Code is amended to read:729.
(a) Any physician and surgeon, psychotherapist, alcohol and drug abuseSEC. 3.SEC. 4.
Chapter 7.1 (commencing with Section 3200) is added to Division 2 of the Business and Professions Code, to read:
CHAPTER
7.1. Regulated Psychedelic TherapyFacilitators
(a)This act shall be known as the Regulated Psychedelic-assisted Therapy Act.
(b)The intent of the Legislature in acting this act is as follows:
(1)Establish a regulated program to allow safe access to psychedelic-assisted therapy for adults 21 years of age and older under the supervision of a licensed facilitator.
(2)To create and establish a professional licensing board for psychedelic-assisted therapy facilitators to govern the qualifications for education, training, experience, licensure, professional practice, standards of care, ethics, and discipline for psychedelic-assisted therapy facilitators.
(3)Ensure that regulated psychedelic-assisted therapy is available, equitable, and affordable for all adults 21 years of age and older for whom regulated psychedelic-assisted therapy is appropriate and potentially beneficial.
(4)Respect indigenous cultures, traditions, and uses of psychedelic substances and not affect rights or undermine any protected status, or practice under other laws related to indigenous uses of psychedelic substances, or affect churches operating pursuant to the Religious Freedom Restoration Act of 1993.
(5)Provide education and harm reduction information for the public related to the use of regulated psychedelic substances, including information about contraindications and adverse effects and training for first responders and multiresponders, including law enforcement, emergency medical services, social services, and fire services.
(6)Not affect or limit any rights or activities protected under any other local, state, or federal law to expand upon any rights or activities protected by this act.
The Board of Regulated Psychedelic Facilitators is hereby created within the Department of Consumer Affairs to carry out the responsibilities and duties set forth in this chapter.
Unless otherwise specified, the following definitions apply for purposes of this chapter:
(a)“Administration session” means a session conducted at a regulated psychedelic-assisted therapy establishment or other approved location during which a participant consumes and experiences the effects of a regulated psychedelic substance under the supervision of a regulated psychedelic-assisted therapy facilitator.
(b)“Adverse event” or “adverse reaction” means any adverse reaction during or after the psychedelic experience requiring psychiatric, medical, or psychological care.
(c)“Approved location” means a location approved by the board for
the provision of regulated psychedelic-assisted therapy or a clinic, center, or other premises approved by the State Department of Public Health for the provision of regulated psychedelic-assisted therapy.
(d)“Approved school” means a school or educational program approved by the board that meets minimum standards for training and curriculum in regulated psychedelic-assisted therapy facilitation and related subjects established by the board and that has not been otherwise unapproved by the board.
(e)“Board” means the Board of Regulated Psychedelic Facilitators.
(f)“Compensation” means a payment, loan, advance, donation, contribution, deposit, gift of money, or anything of value.
(g)“Followup session” means a meeting between a participant and a
regulated psychedelic-assisted therapy facilitator that occurs within 12 to 36 hours after the completion of an administration session or sooner, if warranted, to assess well-being, screen for adverse reactions and, if needed, make referrals to needed care, additional psychosocial support, or other interventions.
(h)“Integration session” means counseling provided by the regulated psychedelic-assisted facilitator or other personnel trained in postpsychedelic support that is intended to help the participant ground themselves and feel oriented, better understand their psychedelic experience, and apply insights from their experience to healthy behavioral change in their daily life.
(i)“License” means a valid license issued by the board pursuant to this chapter.
(j)“Participant” means an individual who is 21 years of
age or older and who received regulated psychedelic-assisted therapy performed by and under the supervision of a regulated psychedelic-assisted therapy facilitator.
(k)“Preparation session” means a session conducted between the participant and the facilitator before the administration of the regulated psychedelic substance. More than one preparation session may be indicated to provide participants adequate education and instruction, to develop sufficient rapport between participant and facilitator before psychedelic substance administration, and to revisit informed consent and safety planning. The initial preparation session shall include review of the safety screen and considerations for exclusion; presentation and discussion of detailed information about the psychedelic substance, including its potential risks and benefits; presentation and discussion of the therapeutic process, including administration session parameters; obtaining informed
consent; safety planning; and other information as the board may determine. If three months or more have passed since the last psychedelic administration session conducted by a given participant with a given facilitator, this will be considered a new course of care, and another initial preparation session must be conducted.
(l)“Regulated psychedelic substances” has the same meaning as in subdivision (i) of Section 27002.
(m)“Regulated psychedelic-assisted therapy” means services provided pursuant to this chapter by a regulated psychedelic-assisted therapy facilitator or other authorized person to a participant before, during, and after the participant’s consumption of a regulated psychedelic substance, that includes all of the following:
(1)A safety screen.
(2)One or more preparation sessions.
(3)An administration session.
(4)One or more followup sessions.
(n)“Regulated psychedelic-assisted therapy establishment” or “establishment” means an approved location where regulated psychedelic-assisted therapy is performed for compensation.
(o)“Regulated psychedelic-assisted therapy facilitator” means a person licensed by the board who satisfies the requirements set forth in Section 3220.
(p)“Safety screen” means a screening for medical conditions, mental health conditions, family history, contraindications, and pharmacological interactions that must be provided to every participant
before an administration session.
(q)“Set” means the mindset of an individual, including the individual’s history, personality, and intentions going into psychedelic-assisted therapy.
(r)“Setting” means the physical and social environment in which the psychedelic-assisted therapy experience occurs.
(s)“Sole provider” means a regulated psychedelic-assisted therapy business where the owner owns 100 percent of the business and is the only person who provides regulated psychedelic-assisted therapy for compensation for that business pursuant to a valid and active license issued in accordance with this chapter.
Protection of the public shall be the highest priority for the board in exercising its licensing, regulatory, and disciplinary functions. Whenever the protection of the public is inconsistent with other interests sought to be promoted, the protection of the public shall be paramount.
(a)The board shall consist of nine members. Seven members shall be appointed by the Governor, one public member shall be appointed by the Senate Committee on Rules, and one public member shall be appointed by the Speaker of the Assembly. Members of the board shall include five members who have experience facilitating psychedelic-assisted therapy and four public members. At least one member shall have experience as a facilitator as part of a United States Food and Drug Administration-approved clinical trial; at least one member shall have experience in training and supervising facilitators; at least one member shall be a licensed physician or licensed nurse practitioner; at least one member shall have experience providing care health care to veterans; and at least one member shall be a licensed marriage and
family therapist or a licensed clinical social worker.
(b)A member of the board shall be appointed for a four-year term. A person shall not serve as a member of the board for more than two consecutive terms. A member shall hold office until the appointment and qualification of the member’s successor, or until one year from the expiration of the term for which the member was appointed, whichever first occurs. Any vacancy shall be filled by appointment by the appointing authority which originally appointed the member whose position has become vacant.
(c)A public member of the board shall be a resident of this state for at least one year preceding the public member’s appointment.
(d)A person shall not be appointed as a public member if the person or the person’s immediate family owns an economic interest in a
college, school, or institution engaged in regulated psychedelic-assisted therapy education. “Immediate family” means the public member’s spouse, domestic partner, parent, child, or child’s spouse or domestic partner.
(e)Each member of the board shall receive a per diem and expenses as provided in Section 103.
(f)The board may appoint a person exempt from civil service who shall be designated as an executive officer and who shall exercise the powers and perform the duties delegated by the board and vested in the executive officer by this chapter.
(g)Each appointing authority has power to remove from office at any time any member of the board appointed by that authority pursuant to Section 106.
(a)The board may take any reasonable actions necessary to carry out the responsibilities and duties set forth in this chapter, including, but not limited to, hiring staff, entering into contracts, and developing policies, procedures, rules, and bylaws to implement this chapter.
(b)The board may require background checks for employees, contractors, volunteers, and board members as a condition of their employment, formation of a contractual relationship, or participation in board activities.
(c)The board shall establish educational, training, examination, practicum, and supervision requirements, different tiers of licensing, scope of practice, and qualifications for regulated
psychedelic-assisted therapy facilitators that protect participant safety, eliminate abuse, and reduce harm, and establish procedures to collect and report data to better inform use and increase equitable access to services.
(d)The board shall issue requirements for psychedelic-assisted therapy for both individuals and groups, including those that include veterans.
(e)The board shall issue a license to an individual applicant who satisfies the requirements of this chapter for that license.
(f)The board shall determine whether the information provided to the board in relation to the licensure of an applicant is true and accurate and meets the requirements of this chapter. If the board has any reason to question whether the information provided is true or accurate, or meets the requirements of this chapter, the
board may make any investigation it deems necessary to establish that the information received is accurate and satisfies the criteria established by this chapter. The applicant has the burden to prove that they are entitled to licensure.
(g)The board shall establish fees for the reasonable regulatory costs to the board in administering this chapter. Initial license and renewal fees shall be in an amount sufficient, but shall not exceed the amount necessary, to support the functions of the board in the administration of this chapter. The renewal fee shall be reassessed biennially by the board.
(h)The meetings of the board shall be subject to the rules of the Bagley-Keene Open Meeting Act (Article 9 (commencing with Section 11120) of Chapter 1 of Part 1 of Division 3 of Title 2 of the Government Code). The board may adopt additional policies and procedures that provide greater
transparency to licenseholders and the public than required by the Bagley-Keene Open Meeting Act.
(i)The board shall have the authority to, and shall collect available and relevant information and data necessary to, perform its functions and duties under this act, but must not disclose the identity of any participant or publicly disclose any information that could disclose the identity of a participant.
(a)The board shall be appointed by April 1, 2025. The board shall adopt the regulations set forth in subdivision (b) on or before January 1, 2026, and begin accepting license applications by April 1, 2026.
(b)The board, in consultation with the Regulated Psychedelic Substances Advisory Committee established pursuant to Section 27018 and in compliance with the Regulated Psychedelic Substances Control Act (Division 11 (commencing with Section 27000)) and any regulations adopted pursuant to that act, shall adopt regulations governing the safe provision of regulated psychedelic-assisted therapy by regulated psychedelic-assisted therapy facilitators that include, at a minimum, the following:
(1)Requirements for holding and verifying completion of medical and mental health screenings, including a safety screening, at least one preparation session, an administration session, and at least one followup session and one integration session.
(2)Health and safety warnings required to be provided to participants before regulated psychedelic-assisted therapy begins.
(3)Educational materials required to be provided to participants before regulated psychedelic-assisted therapy begins.
(4)A medical, mental health, and contraindications safety screen that a participant must complete prior to an administration session.
(5)The informed consent form that each regulated psychedelic-assisted therapy facilitator and participant must sign before providing or receiving regulated psychedelic-assisted therapy verifying that the participant was provided accurate and complete health information in accordance with board rules, was informed of identified risk factors and contraindications, and provided informed consent to receive regulated psychedelic-assisted therapy. The form shall also include agreements that the participant and facilitator make about how the session will be conducted and safety measures that will be followed to ensure the participant remains safe for the duration of the session.
(6)Proper supervision during the administration session and safe transportation for the participant when the session is complete.
(7)Rules to prevent exploitation or abuse during the administration session.
(8)Requirements for group administration sessions where one or more regulated psychedelic-assisted therapy facilitators provide regulated psychedelic-assisted therapy to more than one participant as part of the same administration session.
(9)Conditions under which the session must take place, including what should not be present, such as weapons of any sort, mirrors, intense physical stimuli, or triggering or polarizing objects, art, or signs.
(10)Requirements for postsession integration.
(11)The restrictions on advertising and marketing regulated psychedelic-assisted therapy and substances, including prohibition on any claims of beneficial health or medical use.
(12)Insurance requirements to the extent the policies are commercially available and not cost prohibitive.
(13)Age verification procedures to ensure that a participant is 21 years of age or older.
(14)The scope of practice for regulated psychedelic-assisted therapy facilitators.
(15)The qualifications, education, and training requirements that regulated psychedelic-assisted therapy facilitators must meet before providing regulated psychedelic-assisted therapy, that shall satisfy all of the following:
(A)Be tiered depending on the prior education, experience, or training of the facilitator or the complexity of the conditions or the background of the participant.
(B)Include education and training on participant safety, contraindications, mental health, mental state, physical health, physical state, social and cultural considerations, physical environment, screening, preparation, administration, integration, ethics, facilitation skills, and compliance with new regulations and laws.
(C)Allow for limited waivers of education and training requirements based on an applicant’s prior experience, training, or skill, including, but not limited to, with regulated psychedelic substances, including credit for prior training and experience when that training or experience otherwise meets the standards set by the board.
(D)Include practicum requirements with a practicum supervisor.
(E)Do not require a professional license or professional degree other than a regulated psychedelic-assisted therapy facilitator license granted pursuant to this chapter for the first tier of licensing established pursuant to paragraph (1).
(16)Procedures and policies that allow for compensation for regulated psychedelic-assisted therapy.
(17)Procedures and policies that allow for the provision of regulated psychedelic-assisted therapy to more than one participant at a time in group administration sessions.
(18)Oversight and supervision requirements for regulated psychedelic-assisted therapy facilitators, including professional responsibility standards and continuing education requirements, including limited hours within a regulated psychedelic-assisted therapy facilitator support network with peer support.
(19)A complaint, review, and disciplinary process for regulated psychedelic-assisted therapy facilitators who engage in misconduct.
(20)Recordkeeping, privacy, and confidentiality requirements for regulated psychedelic-assisted therapy facilitators, provided the recordkeeping does not result in the disclosure to the public or any governmental agency of personally identifiable information of participants.
(21)Deidentified data collection and reporting requirements for psychedelic-assisted therapy facilitators and participants pertaining to the implementation and outcomes of this act, to comprehensively measure its success, safety, quality, impact on individuals’ well-being and public health, including adverse events experienced during, immediately after, or after the passage of time with information about substance, dosage, and other contextual information.
(22)Requirements for the safe and secure handling and assurance of quality control of regulated psychedelic substances by regulated psychedelic-assisted therapy facilitators.
The Regulated Psychedelic-assisted Therapy Advisory Committee established pursuant to Section 27018 shall advise the board on the development of standards and regulations pursuant to this chapter, including best practices and guidelines that protect the public health and safety while ensuring a regulated environment to provide safe access to regulated psychedelic-assisted therapy.
(a)The board shall determine which schools and programs meet the requirements of this chapter.
(b)The board shall adopt regulations governing the requirements and process for approving schools and programs for the provision of regulated psychedelic-assisted therapy training. The regulations shall include, among other things, acceptable curriculums, facility requirements, student-teacher ratios, practicum requirements, substance-specific training, and provisions for the acceptance of accreditation from a recognized accreditation body or other form of acceptance.
(c)The board may consider expedited approval or partial approval for programs that are already in existence in the
state to train licensed mental health professionals in the provision of psychedelic-assisted therapy.
(d)The board shall exercise its authority to approve, deny approval of, and unapprove schools or programs and specify corrective action in keeping with the purposes set forth in subdivision (b) of Section 3200.
(e)The board may charge a reasonable fee for the inspection or approval of schools or programs, provided the fees do not exceed the reasonable cost of the inspection or approval process.
(f)The board shall post on its internet website the date that a letter proposing to deny a school or program’s application for approval or reapproval or requesting corrective action has been sent to the school and the final outcome and date of that proposed action.
The board may hold hearings, take testimony, administer oaths, subpoena witnesses, and issue subpoenas for the production of books, records, or documents of any kind.
(a)To obtain licensure as a regulated psychedelic-assisted therapy facilitator, an applicant shall submit a written application and provide the board with satisfactory evidence that the applicant meets all of the following requirements for the tier of facilitator license they are applying for:
(1)The applicant is 21 years of age or older.
(2)The applicant has successfully completed the curriculum in regulated psychedelic-assisted therapy facilitation and related subjects and the number of hours established by the board, that incorporates appropriate school assessment of student knowledge and skills, prior experience accepted by the board as an equivalent to, or equivalent to a portion of, the required curricula or practicum requirement, including existing licensure in a health or mental health profession, and any practicum experience that is required by the board. All of the hours shall be from schools or programs approved by the board. For purposes of this section, “unapproved” means that the board determined that it will not accept hours from a school toward licensure.
(3)The applicant has passed a regulated psychedelic-assisted therapy facilitator competency assessment examination that meets generally recognized principles and standards and that is created and administered by the board or an entity designated by the board.
(4)The applicant has successfully passed a background investigation pursuant to Section 3222, and has not violated any of the provisions of this chapter.
(5)All fees required by the board have been paid.
(b)The board may issue a license to an applicant who meets the qualifications of this chapter if the applicant holds a current and valid registration, licensure, or license from any other state whose licensure requirements meet or exceed those defined within this chapter. If an applicant has received education at a school or program that is not approved by the board, the board shall have the discretion to give credit for comparable academic or experiential work completed by an applicant in a program outside of California, or for work completed by an applicant in a program in California before the enactment of this act.
(c)If an applicant has received education at a school or program located outside of California or a school located in a country outside of the United States that does not meet the requirements of Section 3215 to be an
approved school or program, the board shall have the discretion to give credit for comparable academic or experiential work completed by an applicant toward licensure.
(d)A license issued pursuant to this chapter and any identification card issued by the board shall be surrendered to the board by any licenseholder whose license is suspended or revoked.
Except as otherwise provided, a license issued pursuant to this chapter shall be subject to renewal every two years in the manner prescribed by the board. A license issued by the board shall expire after two years unless renewed as prescribed.
(a)Before issuing a license to an applicant, the board shall require the applicant to submit fingerprint images as directed by the board in a form consistent with the requirements of this section.
(b)The board shall submit the fingerprint images and related information to the Department of Justice to obtaining information as to the existence and nature of a record of state and federal level convictions and of state and federal level arrests for which the Department of Justice establishes that the applicant or candidate was released on bail or on their own recognizance pending trial.
(c)Requests for federal-level criminal offender record information received by the Department
of Justice pursuant to this section shall be forwarded to the Federal Bureau of Investigation by the Department of Justice. The Department of Justice shall review the information returned from the Federal Bureau of Investigation, and shall compile and disseminate a fitness determination regarding the applicant or candidate to the board. The Department of Justice shall provide information to the board pursuant to subdivision (p) of Section 11105 of the Penal Code.
(d)The Department of Justice and the board shall charge a fee sufficient to cover the cost of processing the request for state and federal level criminal offender record information.
(e)The board shall request subsequent arrest notification service from the Department of Justice, as provided under Section 11105.2 of the Penal Code, for all applicants for licensure for whom fingerprint images and related information are
submitted to conduct a search for state and federal level criminal offender record information.
(f)The board may receive arrest notifications and other background materials about applicants and licenseholders from a city, county, or city and county.
In addition to the other requirements of this chapter, a licenseholder shall do all of the following:
(a)Make available for display the licenseholder’s original license at any location where the licenseholder provides regulated psychedelic-assisted therapy for compensation. A licenseholder shall have their identification card in their possession while providing regulated psychedelic-assisted therapy for compensation.
(b)Provide their full name and license number upon the request of a member of the public, the board, or a member of law enforcement, or a local governmental agency charged with regulating establishments, at the location where they are providing regulated psychedelic-assisted therapy for
compensation.
(c)Include the name under which the individual is licensed and their license number in any advertising of regulated psychedelic-assisted therapy for compensation.
(d)Notify the board within 30 days of any changes in the licenseholder’s home address or the address of any establishment or other location where the licenseholder provides regulated psychedelic-assisted therapy for compensation. A licenseholder also shall notify the board of the licenseholder’s primary email address, if any, and notify the board within 30 days of a change of the primary email address.
Unless otherwise specified, a violation of this chapter is a misdemeanor and shall result in suspension of the licenseholder’s license for three years and a fine not to exceed one thousand dollars ($1,000).
(a)It is a violation of this chapter for an applicant or a licenseholder to commit any of the following acts, the commission of which is grounds for the board to deny an application for a license or to impose discipline on a licenseholder:
(1)Unprofessional conduct, including, but not limited to, any of the following:
(A)Engaging in sexual relations with a client or a former client within two years following termination of therapy, soliciting sexual relations with a client, or committing an act of sexual abuse, or sexual misconduct with a client, or committing an act punishable as a sexually related crime, if that act or solicitation is substantially related to the qualifications, functions, or duties of a licensed psychedelic-assisted therapy facilitator or occurs before, during, or after a preparation, administration, or followup session.
(B)Practicing facilitation on a suspended license, practicing without a license, or practicing outside of the conditions of a license.
(C)Engaging in financial misconduct, manipulation, or a conflict of interest with a client.
(D)Engaging in fraud, coercion, or verbal abuse with a client.
(E)Violating the terms of consent or agreements entered into with the client during the preparation session.
(F)Discriminating against a client on the basis of race, color, ancestry, national origin, religion, creed, gender, sex, sexual orientation, age, disability, marital status, and any other basis enumerated under California law.
(2)Procuring or attempting to procure a license by fraud, misrepresentation, or mistake.
(3)Failing to fully disclose all information requested on the application.
(4)Impersonating an applicant or acting as a proxy for an applicant in any examination referred to in this chapter for the issuance of a license.
(5)Impersonating a licenseholder or permitting or allowing a nonlicensed person to use a license.
(6)Violating or attempting to violate, directly or indirectly, or assisting in or abetting the violation of, or conspiring to violate, any provision of this chapter or any rule or regulation adopted by the board.
(7)Committing any fraudulent, dishonest, or corrupt act that is substantially related to the qualifications, functions, or duties of a licenseholder.
(8)Offering or giving commissions, rebates, or other forms of remuneration for the referral of clients.
(9)Denial of licensure, revocation, suspension, restriction, citation, or any other disciplinary action against an applicant or licenseholder by another state or territory of the United States, by any other governmental agency, or by another California healing arts professional licensing board. A certified copy of the decision, order, judgment, or citation shall be conclusive evidence of these actions.
(10)Being convicted of any felony or misdemeanor, or being held liable in an administrative or civil action for an act, that is substantially related to the qualifications, functions, or duties of a licenseholder. A record of the conviction or other judgment or liability shall be conclusive evidence of the crime or liability.
(11)Failing to act within the limitations created by a physical illness, physical condition, or behavioral, mental health, or substance use disorder that renders the licensee unable to perform psychedelic-assisted therapy services with reasonable skill and safety to the participant.
(b)The board may deny an application for a license for the commission of any of the acts described in subdivision (a). The board may also discipline a licenseholder, in any manner permitted by this chapter, for the commission of any of those acts by a licenseholder.
(c)The board shall deny an application for a license, or revoke the license of a licenseholder, if the applicant or licenseholder is required to register pursuant to the Sex Offender Registration Act (Chapter 5.5 (commencing with Section 290) of Title 9 of Part 1 of the Penal Code), or is required to register as a sex offender in another state.
(a)An applicant for a license shall not be denied a license and a licenseholder shall not be disciplined pursuant to this chapter except according to procedures that satisfy the requirements of this section.
(b)The board may discipline a licenseholder by any of the following methods:
(1)Placing the licenseholder on probation, which may include limitations or conditions on practice.
(2)Suspending the license and the rights conferred by this chapter on a licenseholder for a period not to exceed one year.
(3)Suspending or staying the disciplinary order, or portions of it, with or without conditions.
(4)Revoking the license.
(5)Taking other action the board deems proper, as authorized by this chapter.
(c)The board may issue an initial license on probation, with specific terms and conditions, to any applicant.
(d)Any denial or discipline shall be decided upon and imposed in good faith and in a fair and reasonable manner.
(e)Any notice required under this section may be given by any method reasonably calculated to provide actual notice. Notice given by mail shall be given by first-class or certified mail sent to the last address of the applicant or licensee shown on the board’s records.
(f)An applicant or licenseholder may challenge a denial or discipline decision issued pursuant to this section in a court of competent jurisdiction. Any action challenging a denial or discipline, including any claim alleging defective notice, shall be commenced within 90 days after the effective date of the denial or discipline. A license issued pursuant to this chapter is not a fundamental vested right and judicial review of denial and disciplinary decisions made by the board shall be conducted using the substantial evidence standard of review. If the action is successful, the court may order any relief, including reinstatement, that it finds equitable under the circumstances.
(g)This section governs only the procedures for denial or discipline decision and not the substantive grounds for the denial or discipline. Denial or discipline based upon substantive grounds that violates
contractual or other rights of the applicant or licensee, or is otherwise unlawful, is not made valid by compliance with this section.
(a)It is an unfair business practice for a person to do any of the following:
(1)To hold themselves out or to use the title of “licensed psychedelic-assisted therapy facilitator,” “regulated psychedelic-assisted therapy facilitator,” or any other term, such as “licensed,” or “certified,” in any manner that implies that the person is licensed as a psychedelic-assisted therapy facilitator, unless that person currently holds an active and valid license issued by the board pursuant to this chapter.
(2)To falsely state or advertise or put out any sign or card or other device, or to falsely represent to the public through any print or electronic media, that they or any other individual are licensed, certified, or registered by a governmental agency as a regulated psychedelic-assisted therapy facilitator.
(b)In addition to any other available remedies, engaging in any of the prohibited behaviors described in subdivision (a) constitutes unfair competition under Section 17200.
(c)Nothing in this chapter shall be construed to limit the provisions of the Medical Practice Act (Chapter 5 (commencing with Section 2000)), the Clinical Social Worker Practice Act (Chapter 14 (commencing with Section 4991)), the Nursing Practice Act (Chapter 6 (commencing with Section 2700)), the Psychology Licensing Law (Chapter 6.6 (commencing with Section 2901)), the Licensed Marriage and Family Therapist Act (Chapter 13 (commencing with Section 4980.04)), the Naturopathic Doctors Act (Chapter 8.2 (commencing with Section 3610)), or any other licensed
profession.
(a)Notwithstanding any other law, a city, county, or city and county shall not enact or enforce an ordinance that conflicts with this chapter.
(b)A local government shall impose and enforce only reasonable and necessary fees and regulations on establishments, in keeping with the requirements of existing law and being mindful of the need to protect legitimate business owners and regulated psychedelic-assisted therapy facilitators.
The superior court of a county of competent jurisdiction may, upon a petition by any person, issue an injunction or any other relief the court deems appropriate for a violation of this chapter by any person or establishment operating in that county subject to the provisions of this chapter. An injunction proceeding under this section shall be governed by Chapter 3 (commencing with Section 525) of Title 7 of Part 2 of the Code of Civil Procedure.
(a)This chapter shall be liberally construed to effectuate its purposes.
(b)The provisions of this chapter are severable. If any provision of this chapter or its application is held invalid, that invalidity shall not affect other provisions or applications that can be given effect without the invalid provision or application.
(c)If any provision of this chapter or the application of these provisions to any person or circumstance is held to be invalid, the invalidity shall not affect other provisions or applications of the chapter that can be given effect without the invalid provision or application, and to this end the provisions of this chapter are
severable.
The board may discipline an owner of an establishment for the conduct of any individual providing regulated psychedelic-assisted therapy on the establishment’s premises or under the supervision of the establishment.
A person engaged in a profession or occupation subject to licensure pursuant to this division shall not be subject to discipline by another professional licensing board solely for providing professional services related to activity permitted under this chapter or for engaging in any activity that is lawful under this chapter that is not subject to criminal penalty under state law. This act does not authorize a person to engage in malpractice or to violate the standards of professional practice for which a person is licensed.
It is the public policy of the people of the State of California that contracts related to the operation of licenses under this chapter should be enforceable and no contract entered into by a licensee, its employees, or its agents, as permitted pursuant to a valid license issued by the board, or by those who allow property to be used by a licensee, its employees, or its agents, as permitted pursuant to a valid license issued by the board, shall be deemed unenforceable on the basis that the actions or conduct permitted pursuant to the license are prohibited by federal law.
Article 1. General Provisions
3200.
This act shall be known as the Regulated Psychedelic Facilitators Act.3201.
The Board of Regulated Psychedelic Facilitators is hereby created within the Department of Consumer Affairs to carry out the responsibilities and duties set forth in this chapter.3202.
For purposes of this chapter, the following definitions apply:Article 2. Administration
3210.
The protection of the public shall be the highest priority for the board in exercising its licensing, regulatory, and disciplinary functions under this chapter. Whenever the protection of the public is inconsistent with other interests sought to be promoted, the protection of the public shall be paramount.3211.
(a) The board shall consist of nine members. Seven members shall be appointed by the Governor, one public member shall be appointed by the Senate Committee on Rules, and one public member shall be appointed by the Speaker of the Assembly. Members of the board shall include five members who have expertise in psychedelic facilitation and four public members. At least one member shall have experience as a facilitator as part of a United States Food and Drug Administration-approved clinical trial; at least one member shall have experience in training and supervising facilitators; at least one member shall be a licensed physician or licensed advanced practice clinician; at least one member shall have experience providing mental health care to veterans; and at least one member shall be a licensed marriage and family therapist, a licensed clinical social worker or board-certified chaplain.3212.
(a) The board may take any reasonable actions necessary to carry out the responsibilities and duties set forth in this chapter, including, but not limited to, hiring staff, employing consultants, entering into contracts, and developing policies, procedures, rules, and bylaws to implement this chapter.3213.
(a) The board shall be appointed by April 1, 2025. The board shall adopt the regulations set forth in subdivision (b) on or before January 1, 2026, and begin accepting license applications by April 1, 2026.3214.
(a) The board shall determine which schools and programs meet the requirements of this chapter.3215.
The board may hold hearings, take testimony, administer oaths, subpoena witnesses, and issue subpoenas for the production of books, records, or documents of any kind.Article 3. Licensure
3220.
(a) To obtain licensure as a regulated psychedelic facilitator, an applicant shall submit a written application and provide the board with satisfactory evidence that the applicant meets all of the following requirements for the tier of facilitator license they are applying for:3221.
Except as otherwise provided, a license issued pursuant to this chapter shall be subject to renewal every two years in the manner prescribed by the board. A license issued by the board shall expire after two years unless renewed as prescribed.3222.
(a) Before issuing a license to an applicant, the board shall require the applicant to submit fingerprint images as directed by the board in a form consistent with the requirements of this section.3223.
In addition to the other requirements of this chapter, a licenseholder shall do all of the following:Article 4. Enforcement
3230.
Unless otherwise specified, any person who violates any of the provisions of this chapter is guilty of a misdemeanor punishable by imprisonment in county jail not exceeding six months, by a fine not to exceed two thousand five hundred dollars ($2500), or by both, and which may result in the suspension or revocation of the licenseholder’s license.3231.
(a) It is a violation of this chapter for an applicant or a licenseholder to commit any of the following acts, the commission of which is grounds for the board to deny an application for a license or to impose discipline on a licenseholder:3232.
(a) An applicant for a license shall not be denied a license and a licenseholder shall not be disciplined pursuant to this chapter except according to procedures that satisfy the requirements of this section.3233.
(a) It is an unfair business practice for a person to do any of the following:3234.
(a) The board shall establish a procedure for those persons and parties affected by decisions of the board to protest and appeal those decisions.3235.
This chapter shall not be construed to permit the sale of psychedelic substances to an individual for personal use or to permit the sale of psychedelic substances for any purpose outside of use for psychedelic facilitation with a licensed psychedelic facilitator at an approved location.3236.
This chapter shall not be construed to permit the knowing transfer of any psychedelic substances, with or without remuneration, to a person under 21 years of age or to allow a person under 21 years of age to possess, use, purchase, obtain, cultivate, process, prepare, deliver, or sell or otherwise transfer any psychedelic substance.3237.
(a) A city, county, or a city and county may reasonably regulate the time, place, and manner of regulated psychedelic facilitation within its boundaries.3238.
(a) Notwithstanding any other law, except as otherwise provided in this chapter, a person shall not be arrested, prosecuted, penalized, sanctioned, or otherwise denied any benefit and shall not be subject to seizure or forfeiture of assets for allowing property the person owns, occupies, or manages to be used for any of the activities conducted lawfully under this chapter at an approved location or for enrolling or employing a person who engages in regulated psychedelic substance-related activities lawfully under this act.3239.
Nothing in this chapter shall be construed to affect any of the following:3240.
A person engaged in a profession or occupation subject to licensure shall not be subject to disciplinary action by a professional licensing board solely for providing professional services related to activity permitted under this chapter or for engaging in any activity that is lawful under this chapter that is not subject to criminal penalty under state law. This chapter does not permit a person to engage in malpractice or to violate the standards of professional practice for which a person is licensed.Article 5. Revenue
3250.
(a) The RegulatedSEC. 4.SEC. 5.
Division 11 (commencing with Section 27000) is added to the Business and Professions Code, to read:DIVISION 11. Regulated Psychedelic Substances Control Psychedelic-Assisted Therapy Act
CHAPTER 1. General
27000.
(a) This division shall be known and may be cited as the Regulated27001.
The Division of Regulated27002.
As used in this division, the following definitions apply:(a)“Advisory committee” means the Regulated Psychedelic Substances Advisory Committee.
(b)“Board” means the Board of Regulated Psychedelic Facilitators established pursuant to Chapter 7.1 (commencing with Section 3200) of Division 2.
(c)“Clinic” shall have the same meaning as set forth in Section 1200 of the Health and Safety Code.
(d)“Cultivate” means the growing and cultivating of regulated psychedelic substances.
(e)“Division” means the
Division of Regulated Psychedelic Substances Control.
(f)“Participant” means a person 21 years of age or older who purchases or receives a regulated psychedelic substance from a regulated psychedelic licensee for use in conjunction with regulated psychedelic-assisted therapy at a licensed location and under the supervision of a licensed psychedelic-assisted therapy facilitator.
(g)“Regulated psychedelic substance licensee” means an entity that holds a license in any of the categories for licensure or registration established by the division pursuant to paragraph (1) of subdivision (a) of Section 27030. A regulated psychedelic substance licensee may receive compensation for regulated psychedelic substances in connection with use in regulated psychedelic-assisted therapy provided at a licensed establishment.
(h)
(i)“Regulated psychedelic-assisted therapy” means services provided by a regulated psychedelic-assisted therapy facilitator in accordance with the Regulated Psychedelic-assisted Therapy Act (Chapter 7.1 (commencing with Section 3200) of Division 2).
(j)“Regulated psychedelic-assisted therapy facilitator” means a person licensed by the Board of Regulated Psychedelic Facilitators pursuant to Chapter 7.1 (commencing with Section 3200) of Division 2.
CHAPTER 2. Administration
27010.
(a) The Governor shall appoint the director of the division, subject to confirmation by the Senate. The director shall serve under the direction and supervision of the Secretary of Business, Consumer Services, and Housing and at the pleasure of the Governor.27011.
The protection of the public shall be the highest priority for the division in exercising its licensing, regulatory, and disciplinary functions under this division. Whenever the protection of the public is inconsistent with other interests sought to be promoted, the protection of the public shall be paramount.27012.
(a) It being a matter of statewide concern, except as otherwise authorized in this division, the division shall have the sole authority to create, issue, deny, renew, discipline, condition, suspend, or revoke27013.
(a) The division shall provide on its internet website information regarding the status of every license issued by the division in accordance with the California Public Records Act (Division 10 (commencing with Section 7920.000) of Title 1 of the Government Code) and the Information Practices Act of 1977 (Chapter 1 (commencing with Section 1798) of Title 1.8 of Part 4 of Division 3 of the Civil Code).27014.
(a) The division shall adopt regulations as recommended by the expert oversight committee and as may be necessary to implement, administer, and enforce its duties under this division in accordance with Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code.27015.
(a) Notice of any action of the division required by this division to be given may be signed and given by the director or an authorized employee of the division and may be made personally or in the manner prescribed by Section 1013 of the Code of Civil Procedure, or in the manner prescribed by Section 124 of this code.27016.
(a) The division may make or cause to be made any investigation it deems necessary to carry out its duties under this division.27017.
For any hearing held pursuant to this division, the division may delegate the power to hear and decide to an administrative law judge. Any hearing before an administrative law judge shall be pursuant to the procedures, rules, and limitations prescribed in Chapter 5 (commencing with Section 11500) of Part 1 of Division 3 of Title 2 of the Government Code.27018.
(a) No later than April 1, 2025, the division shall convene an(b)
(9)Harm reduction.
(10)Municipal psychedelic policy.
(c)
(2)
(E)
(F)
(G)Whether other substances should be added pursuant to subdivision (d) of Section 27014.
(d)
(e)
CHAPTER 3. General Licensing
27030.
(a) Except as specified in Section 27014, the division shall,(B)
(C)
(E)
(F)
(G)
(H)
(I)
(J)
(K)
(G)Rules that prohibit an individual from having a financial interest in more than five psychedelic-assisted therapy locations.
(H)
(I)
(J)
(5)Gather and publish, on an annual basis, adequate information to evaluate the implementation, safety, equity, quality, and outcomes of this division and Chapter 7.1 (commencing with Section 3200) of Division 2, following sound data and privacy protocols, without revealing any identifiable details pertaining to individual participants.
(6)
27031.
(a)27032.
(a) Not later than April 1, 2026, the division shall begin to accept and process applications for licensure.CHAPTER 4. Enforcement
27040.
A violation of this division is a misdemeanor and shall27041.
(a) The division shall work with state and local law enforcement agencies for the purposes of implementing, administering, and enforcing the division’s rules and regulations and taking appropriate action against licensees and others who fail to comply with these rules and regulations or with state law.27042.
(a) The division shall establish a procedure for those persons and parties affected by decisions of the division to protest and appeal those decisions.27043.
This division shall not be construed to permit the sale of psychedelic substances to an individual for personal27044.
This division shall not be construed to permit the knowing transfer of any psychedelic substances, with or without remuneration, to a person under 21 years of age or to allow a person under 21 years of age to possess, use, purchase, obtain, cultivate, process, prepare, deliver or sell or otherwise transfer any psychedelic substance.27046.
(a) A city, county, or a city and county may reasonably regulate the time, place, and manner of the operation of regulated psychedelic substance licensees pursuant to this division within its boundaries.27047.
(a) Notwithstanding any other law, except as otherwise provided in this division, a person shall not be arrested, prosecuted, penalized, sanctioned, or otherwise denied any benefit and shall not be subject to seizure or forfeiture of assets for allowing property the person owns, occupies, or manages to be used for any of the activities conducted lawfully under this division at an approved location or for enrolling or employing a person who engages in regulated psychedelic substance-related activities lawfully under this act.27048.
Nothing in this division shall be construed to affect any of the following:27049.
A person engaged in a profession or occupation subject to licensure shall not be subject to disciplinary action by a professional licensing board solely for providing professional services related to activity permitted under this division or for engaging in any activity that is lawful under this division that is not subject to criminal penalty under state law. This division does not permit a person to engage in malpractice or to violate the standards of professional practice for which a person is licensed.27050.
Notwithstanding any other law, unless required by federal law, mental health, substance use disorder, or behavioral health services otherwise covered under the California Medical Assistance Program set forth in Chapter 7 (commencing with Section 14000) of Part 3 of Division 9 of the Welfare and Institutions Code shall not be denied on the basis that they are covered in conjunction with regulated27051.
It is the public policy of the people of the State of California that contracts related to the operation of licenses under this chapter and the Regulated Psychedelic Facilitators Act (Chapter 7.1 (commencing with Section 3200) of Division 2) should be enforceable and no contract entered into by a licensee, its employees, or its agents, as permitted pursuant to a valid license issued by the board or division, or by those who allow property to be used by a licensee, its employees, or its agents, as permitted pursuant to a valid license issued by the board or division, shall be deemed unenforceable on the basis that the actions or conduct permitted pursuant to the license are prohibited by federal law.27051.27052.
The provisions of this division are severable. If any provision of this division or its application is held invalid, that invalidity shall not affect other provisions or applications that can be given effect without the invalid provision or application.CHAPTER 5. Collection and Review of Information
27060.
The division shall collect and annually publish information on the division’s website pertaining to the implementation and outcomes of this act to comprehensively measure its success, safety, quality, and impact on individuals’ well-being and public health.27061.
The division shall consult with the State Department of Public Health on the best data collection, processing, and reporting methodologies.27062.
The division may contract or collaborate with one or more California public universities to research and evaluate the implementation and outcomes of this act pertaining to its success, safety, quality, and impact on individuals’ well-being and public health, and the potential benefits and risks of regulated psychedelic substances and psychedelic facilitation.27063.
The division shall ensure that any information shared publicly is deidentified or aggregated such that no individual participant is identified.27064.
Information and data collected pursuant to the requirements of this division shall not be sold.CHAPTER 6. Revenue
27060.27070.
(a) The Regulated27061.27071.
TheSEC. 5.SEC. 6.
Section 1550.6 is added to the Civil Code, to read:1550.6.
Notwithstanding any law, it is the public policy of the people of the State of California that contracts related to the operation of licenses under the RegulatedSEC. 6.SEC. 7.
Section 11350 of the Health and Safety Code is amended to read:11350.
(a) Except as otherwise provided in thisSEC. 7.SEC. 8.
Section 11351 of the Health and Safety Code is amended to read:11351.
Except as otherwise provided in thisSEC. 8.SEC. 9.
Section 11352 of the Health and Safety Code is amended to read:11352.
(a) Except as otherwise provided in this(a)Except as provided in Division 11 (commencing with Section 27000) of the Business and Professions Code, it is unlawful to possess an opium pipe or any device, contrivance, instrument, or paraphernalia used for unlawfully injecting or smoking (1) a controlled substance specified in subdivision (b), (c), or (e) or paragraph (1) of subdivision (f) of Section 11054, specified in paragraph (14), (15), or (20) of subdivision (d) of Section 11054, specified in subdivision (b) or (c) of Section 11055, or specified in paragraph (2) of subdivision (d) of Section 11055, or (2) a controlled substance that is a narcotic drug classified in Schedule III, IV, or V.
(b)This section shall
not apply to hypodermic needles or syringes that have been containerized for safe disposal in a container that meets state and federal standards for disposal of sharps waste.
(c)Until January 1, 2026, as a public health measure intended to prevent the transmission of HIV, viral hepatitis, and other bloodborne diseases among persons who use syringes and hypodermic needles, and to prevent subsequent infection of sexual partners, newborn children, or other persons, this section shall not apply to the possession solely for personal use of hypodermic needles or syringes.
SEC. 10.
Section 11364.7 of the Health and Safety Code is amended to read:11364.7.
(a) (1) Except as provided in Chapter 7.1 (commencing with Section 3200) of Division 2 of the Business and Professions Code or Division 11 (commencing with Section 27000) of the Business and Professions Code and as otherwise authorized by law, any person who delivers, furnishes, or transfers, possesses with intent to deliver, furnish, or transfer, or manufactures with the intent to deliver, furnish, or transfer, drug paraphernalia, knowing, or under circumstances where one reasonably should know, that it will be used to plant, propagate, cultivate, grow, harvest, compound, convert, produce, process, prepare, test, analyze, pack, repack, store, contain, conceal, inject, ingest, inhale, or otherwise introduce into the human body a controlled substance, except as provided in subdivision (b), in violation of this division, is guilty of a misdemeanor.SEC. 11.
Section 11377 of the Health and Safety Code is amended to read:11377.
(a) Except as authorized by law and as otherwise provided in subdivision (b) or Section 11375, or in Article 7 (commencing with Section 4211) of Chapter 9 of DivisionSEC. 12.
Section 11378 of the Health and Safety Code is amended to read:11378.
Except as otherwise provided in Article 7 (commencing with Section 4110) of Chapter 9 of DivisionSEC. 13.
Section 11379 of the Health and Safety Code is amended to read:11379.
(a) Except as otherwise provided in subdivision (b) and in Article 7 (commencing with Section 4211) of Chapter 9 of DivisionSEC. 14.
Section 11390 of the Health and Safety Code is amended to read:11390.
Except as provided in Chapter 7.1 (commencing with Section 3200) of Division 2 of the Business and Professions Code or Division 11 (commencing with Section 27000) of the Business and Professions Code and as otherwise authorized by law, every person who, with intent to produce a controlled substance specified in paragraph (18) or (19) of subdivision (d) of Section 11054, cultivates any spores or mycelium capable of producing mushrooms or other material that contains such a controlled substance shall be punished by imprisonment in the county jail for a period of not more than one year or in the state prison.SEC. 15.
Section 11391 of the Health and Safety Code is amended to read:11391.
(a) Except as provided in Chapter 7.1 (commencing with Section 3200) of Division 2 of the Business and Professions Code or Division 11 (commencing with Section 27000) of the Business and Professions Code and as otherwise authorized by law, every person who transports, imports into this state, sells, furnishes, gives away, or offers to transport, import into this state, sell, furnish, or give away any spores or mycelium capable of producing mushrooms or other material that contain a controlled substance specified in paragraph (18) or (19) of subdivision (d) of Section 11054 for the purpose of facilitating a violation of Section 11390 shall be punished by imprisonment in the county jail for a period of not more than one year or in the state prison.SEC. 16.
This act shall not be construed to require a person to violate a federal law, exempt a person from a federal law, or obstruct the enforcement of a federal law.SEC. 17.
The provisions of this act are severable. If any provision of this act or its application is held invalid, that invalidity shall not affect other provisions or applications that can be given effect without the invalid provision or application.SEC. 17.SEC. 18.
The Legislature finds and declares that, in order to protect the health, safety, and welfare of persons in the entire state, establishing a uniform standard of licensure for regulatedThe provisions of this act are severable. If any provision of this act or its application is held invalid, that invalidity shall not affect other provisions or applications that can be given effect without the invalid provision or application.
No reimbursement is required by this act pursuant to Section 6 of Article XIII B of the California Constitution because the only costs that may be incurred by a local agency or school district will be incurred because this act creates a new crime or infraction, eliminates a crime or infraction, or changes the penalty for a crime or infraction, within the meaning of Section 17556 of the Government Code, or changes the definition of a crime within the meaning of Section 6 of Article XIII B of the California Constitution.