(1)Existing law provides for the regulation of various professions and vocations by boards established under the jurisdiction of the Department of Consumer Affairs. Affairs in the Business, Consumer Services, and Housing Agency. Existing law, the California Uniform Controlled Substances Act, classifies controlled substances into 5 schedules, and places the greatest restrictions and penalties on the use of those substances placed in Schedule I. Existing law classifies dimethyltryptamine, mescaline, 3,4-methylenedioxymethamphetamine (MDMA), ibogaine, psilocybin, and psilocyn as Schedule I substances, and prohibits various actions related to those substances, including their sale, possession, transportation, manufacture, or cultivation.

(2)This bill would enact the Regulated Psychedelic-assisted Therapy Psychedelic Facilitators Act, which would establish the Board of Regulated Psychedelic Facilitators in the Department of Consumer Affairs to license and regulate psychedelic-assisted therapy psychedelic facilitators, as defined. The bill would require the board to be appointed, as specified, by April 1, 2025. The bill would require the board to establish education, educational, training, and other qualifications and requirements for obtaining a license as a regulated psychedelic-assisted therapy psychedelic facilitator and would establish conditions of licensure. The bill would require the board to establish license fees for the reasonable regulatory costs to the board to administer the act. The bill would require the board to begin accepting license applications by April 1, 2026. The bill would make a license subject to renewal every 2 years. The bill would create the Regulated Psychedelic-assisted Therapy Psychedelic Facilitators Fund in the State Treasury, would require all funds received pursuant to the act to be credited to the fund, and would make moneys in the fund available to the board for the acts purposes upon appropriation by the Legislature. The bill would require the board, in consultation consistent with recommendations made by the Regulated Psychedelic Substances Advisory Committee, which would be created by the bill, to adopt regulations, on or before January 1, 2026, governing the safe provision of regulated psychedelic-assisted therapy, psychedelic facilitation, including regulations governing the scope of practice for regulated psychedelic-assisted therapy psychedelic facilitators and recordkeeping requirements, provided the recordkeeping does not result in the disclosure of personally identifiable information of participants. The bill would require the board to determine which schools and programs meet the requirements of the act and to adopt regulations governing the requirements and process for approving schools and programs related to the provision of regulated psychedelic-assisted therapy. psychedelic facilitation training. The bill would authorize the board to charge a reasonable fee for the inspection or approval of schools or programs. The bill would make a violation of the act a misdemeanor and subject a licenseholders license to suspension for 3 years and a $1,000 fine. suspension or revocation. The bill would make a violation of specified acts subject to discipline or denial of a license by the board in accordance with specified procedures. By creating a new crime, the bill would impose a state-mandated local program. The bill would make specified practices unfair business practices, including a person without a license holding themselves out as a licensed psychedelic-assisted therapy regulated psychedelic facilitator. The bill would prohibit a local government from enacting or enforcing an ordinance that conflicts with the act. authorize a local government to reasonably regulate the time, place, and manner of regulated psychedelic facilitation within its boundaries.

(3)This bill would enact the Regulated Psychedelic Substances Control Psychedelic-Assisted Therapy Act to establish a comprehensive system to control and regulate the cultivation, production, distribution, transportation, storage, processing, manufacturing, testing, quality control, and sale of regulated psychedelic substances for use in conjunction with regulated psychedelic-assisted therapy. psychedelic facilitation, as defined, the provision of psychedelic facilitation, the approval of locations where regulated psychedelic facilitation may take place, and the collection and publication of data on the implementation and outcomes of the act. The bill would define regulated psychedelic substances to include dimethyltryptamine; mescaline; 3,4-methylenedioxymethamphetamine (MDMA); psilocybin; psilocyn; and spores or mycelium capable of producing mushrooms that contain psilocybin or psilocyn. The bill would establish the Division of Regulated Psychedelic Substances Control Psychedelic-Assisted Therapy, to be under the supervision and control of a director appointed by the Governor, in the Business, Consumer Services, and Housing Agency to administer and enforce the act. The bill would require the division to adopt emergency regulations and to take other actions take specified actions to carry out its duties under the act, including conducting investigations and employing peace officers. The bill would grant to specified personnel the authority of peace officers while engaged in investigating the laws administered by the division or commencing criminal prosecution arising from investigations, as specified. The bill would require the division, no later than April 1, 2025, to convene a Regulated Psychedelic Substances Advisory Committee Expert Oversight Committee, to be appointed by the Governor, to advise the division and the Board of Regulated Psychedelic Facilitators on the development of standards and regulations that include best practices and guidelines that protect public health and safety. The bill would require the advisory oversight committee, commencing on January 1, 2026, to publish an annual public report that includes, among other things, the advisory oversight committees recommendations to the division and the board and whether those recommendations were implemented. The bill would require the division to adopt regulations regulations, consistent with the recommendations of the oversight committee, for the administration and enforcement of laws regulating regulated psychedelic substances and services, including regulations that, among other things, that establish categories of licensure and registration, establish requirements governing the safe provision of regulated psychedelic substances to participants, and that establish requirements governing the licensing and operation of psychedelic therapy centers and approved locations, as defined. registration. The bill would require the division, no later than April 1, 2026, to begin to accept and process applications for licensure. The bill would authorize the division to collect fees in connection with activities it regulates. The bill would create the Regulated Psychedelic Substances Control Psychedelic-Assisted Therapy Fund within the State Treasury, and would allocate the funds, upon appropriation by the Legislature, to the division for the purposes of implementing, administering, and enforcing the act. The bill would also create the Regulated Psychedelic Substances Public Education and Harm Reduction Fund, to be available to the Office of Community Partnerships and Strategic Communications, upon appropriation by the Legislature, to award grants for public education and harm reduction relating to psychedelic substances. The bill would authorize the division to accept moneys from private sources to supplement state funds, which may be appropriated by the Legislature to the fund. The bill would make a violation of the act a misdemeanor and subject to a fine of up to $1,000 and forfeiture of a license granted under the act for 3 years. misdemeanor. By creating a new crime, the bill would impose a state-mandated local program. The bill would require the division to work with state and local enforcement agencies to implement, administer, and enforce the divisions rules and regulations.

(5)This bill would declare that it is the public policy of the people of the State of California that contracts related to the operation of licenses under the Regulated Psychedelic Facilitators Act and the Regulated Psychedelic-assisted Psychedelic-Assisted Therapy Act and the Regulated Psychedelic Substances Control Act shall be enforceable.

(6)This bill would make conforming changes to the California Uniform Controlled Substances Act.

(8)This bill would include findings that changes proposed by this bill address a matter of statewide concern rather than a municipal affair and, therefore, apply to all cities, including charter cities.

(10)The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.

This bill would provide that no reimbursement is required by this act for a specified reason.

(1)Existing law provides for the regulation of various professions and vocations by boards established under the jurisdiction of the Department of Consumer Affairs. Existing law, the California Uniform Controlled Substances Act, classifies controlled substances into 5 schedules, and places the greatest restrictions and penalties on the use of those substances placed in Schedule I. Existing law classifies dimethyltryptamine, mescaline, 3,4-methylenedioxymethamphetamine (MDMA), ibogaine, psilocybin, and psilocyn as Schedule I substances, and prohibits various actions related to those substances, including their sale, possession, transportation, manufacture, or cultivation.

(2)This bill would enact the Regulated Psychedelic-assisted Therapy Act, which would establish the Board of Regulated Psychedelic Facilitators in the Department of Consumer Affairs to license and regulate psychedelic-assisted therapy facilitators, as defined. The bill would require the board to be appointed, as specified, by April 1, 2025. The bill would require the board to establish education, training, and other qualifications and requirements for obtaining a license as a regulated psychedelic-assisted therapy facilitator and would establish conditions of licensure. The bill would require the board to establish license fees for the reasonable regulatory costs to the board to administer the act. The bill would require the board to begin accepting license applications by April 1, 2026. The bill would make a license subject to renewal every 2 years. The bill would create the Regulated Psychedelic-assisted Therapy Fund in the State Treasury, would require all funds received pursuant to the act to be credited to the fund, and would make moneys in the fund available to the board for the acts purposes upon appropriation by the Legislature. The bill would require the board, in consultation with the Regulated Psychedelic Substances Advisory Committee, which would be created by the bill, to adopt regulations, on or before January 1, 2026, governing the safe provision of regulated psychedelic-assisted therapy, including regulations governing the scope of practice for regulated psychedelic-assisted therapy facilitators and recordkeeping requirements, provided the recordkeeping does not result in the disclosure of personally identifiable information of participants. The bill would require the board to determine which schools and programs meet the requirements of the act and to adopt regulations governing the requirements and process for approving schools and programs related to the provision of regulated psychedelic-assisted therapy. The bill would authorize the board to charge a reasonable fee for the inspection or approval of schools or programs. The bill would make a violation of the act a misdemeanor and subject a licenseholders license to suspension for 3 years and a $1,000 fine. The bill would make a violation of specified acts subject to discipline by the board in accordance with specified procedures. By creating a new crime, the bill would impose a state-mandated local program. The bill would make specified practices unfair business practices, including a person without a license holding themselves out as a licensed psychedelic-assisted therapy facilitator. The bill would prohibit a local government from enacting or enforcing an ordinance that conflicts with the act.

(3)This bill would enact the Regulated Psychedelic Substances Control Act to establish a comprehensive system to control and regulate the cultivation, distribution, transportation, storage, processing, manufacturing, testing, quality control, and sale of regulated psychedelic substances for use in conjunction with regulated psychedelic-assisted therapy. The bill would define regulated psychedelic substances to include dimethyltryptamine; mescaline; 3,4-methylenedioxymethamphetamine (MDMA); psilocybin; psilocyn; and spores or mycelium capable of producing mushrooms that contain psilocybin or psilocyn. The bill would establish the Division of Regulated Psychedelic Substances Control in the Business, Consumer Services, and Housing Agency to administer and enforce the act. The bill would require the division to adopt emergency regulations and to take other actions to carry out its duties under the act, including conducting investigations and employing peace officers. The bill would require the division, no later than April 1, 2025, to convene a Regulated Psychedelic Substances Advisory Committee to advise the division and the Board of Regulated Psychedelic Facilitators on the development of standards and regulations that include best practices and guidelines that protect public health and safety. The bill would require the advisory committee, commencing on January 1, 2026, to publish an annual public report that includes, among other things, the advisory committees recommendations to the division and whether those recommendations were implemented. The bill would require the division to adopt regulations for the administration and enforcement of laws regulating regulated psychedelic substances and services, including regulations that, among other things, establish categories of licensure and registration, establish requirements governing the safe provision of regulated psychedelic substances to participants, and that establish requirements governing the licensing and operation of psychedelic therapy centers and approved locations, as defined. The bill would require the division, no later than April 1, 2026, to begin to accept and process applications for licensure. The bill would create the Regulated Psychedelic Substances Control Fund within the State Treasury, and would allocate the funds, upon appropriation by the Legislature, to the division for the purposes of implementing, administering, and enforcing the act. The bill would also create the Regulated Psychedelic Substances Education and Harm Reduction Fund, to be available to the Office of Community Partnerships and Strategic Communications, upon appropriation by the Legislature, to award grants for public education and harm reduction relating to psychedelic substances. The bill would authorize the division to accept moneys from private sources to supplement state funds, which may be appropriated by the Legislature to the fund. The bill would make a violation of the act a misdemeanor and subject to a fine of up to $1,000 and forfeiture of a license granted under the act for 3 years. By creating a new crime, the bill would impose a state-mandated local program. The bill would require the division to work with state and local enforcement agencies to implement, administer, and enforce the divisions rules and regulations.

(4)This bill would declare that it is the public policy of the people of the State of California that contracts related to the operation of licenses under the Regulated Psychedelic-assisted Therapy Act and the Regulated Psychedelic Substances Control Act shall be enforceable.

(5)This bill would make conforming changes to the California Uniform Controlled Substances Act.

(6)This bill would include findings that changes proposed by this bill address a matter of statewide concern rather than a municipal affair and, therefore, apply to all cities, including charter cities.

(7)This bill would state that its provisions are severable.

(8)The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.

This bill would provide that no reimbursement is required by this act for a specified reason.

(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.

SENATE COMMITTEE ON

Senator Anna Caballero, Chair

2023 - 2024 Regular Session

SB 1012 (Wiener) - The Regulated Psychedelic Facilitators Act and the Regulated Psychedelic-Assisted Therapy Act

Bill Summary:

SB 1012 establishes the Regulated Psychedelic Facilitators Act and Regulated Psychedelic-Assisted Therapy Act, to be administered by three new state entities: a Division of Regulated Psychedelic-Assisted Therapy, a Board of Regulated Psychedelic Facilitators, and a Regulated Psychedelic Substances Oversight Committee. SB 1012 tasks each new entity with specified regulatory oversight responsibilities to determine, define, and establish standards for psychedelic facilitation in California.

Fiscal Impact:

• Unknown significant ongoing costs, likely ranging in the low millions of dollars to establish and maintain the Board (General Fund and Regulated Psychedelic Facilitators Fund). The Board would require General Fund or other special fund support until it establishes and collects license fee revenue sufficient to support its operations. It is unknown at what level fees would need to be set, and will depend on the number of applicants who would seek licensure as a facilitator when the Board is required to accept applications in April 2026 and the extent that licensing may grow or be maintained in later years.

Based on boards of similar size, the Department of Consumer Affairs (DCA) estimates total costs of approximately $1.96 million in Fiscal Year (FY) 2025-26, $1.87 million in FY 2026-27, and $1.98 in FY 2027-28 and annually ongoing to establish and maintain the Board. Costs would generally include at least 10.0 staff to support the Board’s executive, licensing, and enforcement activities. Other costs would include board member training, per diem, IT expenses, and Attorney General and Office of Administrative Hearings costs. While the estimated fee revenue required to recover the Board’s costs is unknown at this time, DCA estimates fees would need to be at least $4,960 biennially between initial applications, renewals, and other licensing categories.

DCA’s Office of Information Services (OIS) estimates an unabsorbable one-time cost of $557,000 and ongoing costs of $153,000 associated with setting up a new licensing and enforcement system and will likely require a delayed implementation date to complete necessary IT work.

• Unknown significant ongoing costs, ranging in the millions of dollars to establish and maintain the Division and Committee (General Fund and Regulated Psychedelic-Assisted Therapy Fund). Like the Board, the Division and Committee will also likely require General Fund support until the Division can establish and collect fee revenue sufficient to support its operations. (See Staff Comments for additional detail.)
• The California Department of Public Health reports ongoing costs of approximately $200,000 annually to provide guidance and best practices related to data collection, processing, and reporting methods for the Division (General Fund).
• Unknown fiscal impact to the Department of Justice’s (DOJ) applicant services program to intake and process fingerprint and related background information from and transmit state- and federal-level criminal offender record information on applicants to the Board. The DOJ may recover its costs to intake and process requests through fees charged to the Board. Actual costs to DOJ will depend on, among other things, the volume of applicants the program will have to process. To the extent there are a significant number of applicants applying for licensure under the Acts, the DOJ may have significant workload impacts.
• Unknown, potentially significant cost pressure to the state funded trial court system (Trial Court Trust Fund, General Fund) to adjudicate the crime created by this bill. Certain rights to the defendants are attached to criminal proceedings, including the right to a jury trial and the right to counsel (at public expense if the defendants are unable to afford the costs of representation) and creating new crimes, with increased penalties, could lead to lengthier and more complex court proceedings with attendant workload and resource costs to the court. An eight hour court day costs approximately $8,000 in staff in workload. If the bill results in 12 or more days spent in court, trial court costs could be in the hundreds of thousands of dollars.

While the courts are not funded on a workload basis, an increase in workload could result in delayed court services and would put pressure on the General Fund to fund additional staff and resources. For example, the 2021-22 Budget included $90 million one time General Fund to address case backlogs—with $30 million specifically for certain criminal case backlogs and $60 million for backlogs across all case types. The Governor’s 2024-25 state budget proposes $83.1 million ongoing General Fund to continue to backfill the Trial Court Trust Fund for expected revenue declines.

• Unknown, potentially significant reimbursable annual costs (General Fund, local funds) to counties in the hundreds of thousands of dollars to low millions of dollars to counties for increased incarceration costs. The average annual cost to incarcerate a defendant in county jail is approximately $29,000. If 10 defendants statewide are sentenced annually to an average of six months in county jail for any specified violation of the Acts, the total cost to counties would be $145,000.

Background:

Hallucinogens are a diverse group of drugs that alter a person’s perception or awareness of their surroundings. Some hallucinogens are found in plants and fungi, and some are synthetically produced. According to the National Institute on Drug Abuse, hallucinogens are commonly split into two categories: classic hallucinogens and dissociative drugs. Both types can cause hallucinations, and dissociative drugs can cause the user to feel disconnected from their body or environment. Hallucinogens can be consumed in a variety of ways, including swallowed as tablets, pills, or liquid, consumed raw or dried, snorted, injected, inhaled, vaporized, smoked, or absorbed through the lining of the mouth using drug-soaked pieces of paper. Common hallucinogens include DMT, psilocybin, peyote, and mescaline.

Many hallucinogenic substances, including DMT, mescaline, psilocybin, and psilocin are classified as Schedule I substances under the state’s Uniform Controlled Substances Act. Schedule I substances are defined as those controlled substances having no medical utility and that have a high potential for abuse. There is research, however, that indicates that many of these substances have therapeutic benefits.

Oregon Measure 109, Psilocybin Mushroom Services Program Initiative. In 2020, Oregon voters approved Measure 109, the Psilocybin Services Act, which directed the Oregon Health Authority to create a state-licensed, psilocybin-assisted therapy program over a two-year period. In implementing Measure 109, Oregon had to determine how to license and regulate the manufacturing, transportation, delivery, sale and purchase of psilocybin products as well as the provision of psilocybin services. Following the two-year development period for psilocybin services, the state began taking license applications on January 2, 2023. Psilocybin services refers to preparation, administration, and integration sessions provided by a licensed facilitator. Psilocybin services are available to individuals aged 21 and older and do not require a prescription or medical referral. The psilocybin products consumed must be cultivated or produced by a licensed psilocybin manufacturer and can only be provided to a client at a licensed psilocybin service center during an administration session.

Proposed Law:

Provisions related to the Psychedelic Facilitators Act, the Board of Regulated Psychedelic Facilitators, and Licensed Facilitators

• Establishes the Board of Regulated Psychedelic Facilitators within the Department of Consumer Affairs. Requires the Board to be appointed by April 1, 2025, adopt regulations before January 1, 2026, and begin accepting license applications by April 1, 2026.
  • Requires the Board to carry out all necessary activities in the regulation of licensed psychedelic facilitators, as specified. This includes, among other things, adopting regulations consistent with recommendations made by the Regulations Psychedelic Substances Expert Oversight Committee; establishing educational, training, examination, practicum, and supervision requirements; establishing professional standards for facilitators; and establishing requirements and processes for approving schools and programs offering regulated psychedelic facilitation training.
  • Requires the Board to establish reasonable initial license and renewal fees to cover its operational costs. Requires the Board to assess renewal license fees biennially. Establishes the Regulated Psychedelic Facilitators Fund in the State Treasury.
• Establishes requirements for licensure as a regulated psychedelic facilitator, as specified. Provides that a license is valid for two years.

Provisions related to the Regulated Psychedelic-Assisted Therapy Act, Division of Regulated Psychedelic-Assisted Therapy, and Marketplace Regulation for Psychedelic Facilitation

• Establishes the Regulated Psychedelic-Assisted Therapy Act to regulate:
  • The provision of psychedelic facilitation.
  • The production, distribution, transportation, storage, processing, manufacturing, testing, quality control, and sale of regulated psychedelic substances for use only in conjunction with regulated psychedelic facilitation at approved locations.
  • The approval of locations where regulated psychedelic facilitation may take place.
  • The collection and publication of deidentified and aggregate data and information on the implementation and outcomes of the Act.
• Establishes the Division of Regulated Psychedelic-Assisted Therapy in the Business, Consumer Services, and Housing Agency. Provides that the Division has the power, duty, purpose, responsibility, and jurisdiction to regulate regulated psychedelic substances and the provision of psychedelic facilitation, and to approve locations where psychedelic facilitation may take place.
  • Requires the Division to convene the Regulated Psychedelic Substances Expert Oversight Committee by April 1, 2025. Tasks the Committee with advising the Division and the Board on the development of standards and regulations that protect public health and safety while ensuring a regulate environment to provide safe access to regulated psychedelic facilitation.
  • Requires the Division to establish categories of licensure and registration, as specified.
  • Tasks the Division with enforcing the laws and regulations relating to the cultivation, producing, manufacturing, processing, preparing, delivery, storage, sale, and testing of regulated psychedelic substances.
  • Requires the Division to begin to accept and process applications for licensure by April 1, 2026.
  • Authorizes the Division to establish license fees. Establishes the Regulated Psychedelic-Assisted Therapy Fund in the State Treasury to support the Division’s administrative and enforcement operations.

Other Provisions

• Establishes a Psychedelic Substances Public Education and Harm Reduction Fund. Provides that moneys in the Fund be available to the Office of Community Partnerships and Strategic Communications within the Governor’s Office of Planning and Research upon appropriation by the Legislature to award grants for public education relating to psychedelic substances, including their limitations and potential risks, and mitigation measures, in addition to potential benefits as well as harm reduction.
• Establishes specified prohibitions for licenseholders and subjects them to enforcement and discipline by the Board and Division.
  • Creates a new misdemeanor and establishes specified penalties.
  • Provides that any penalties collected by the Board and Division be deposited directly into the General Fund.
• Authorizes a city, county, or a city and county to reasonably regulate the time, place, and manner of regulated psychedelic facilitation within its boundaries but prohibits a city, county, or a city and county from banning or completely prohibiting facilitator operations and regulated psychedelic facilitation.
• Prohibits a city, county, or a city and county from enacting a greater fine or penalty for conduct related to regulated psychedelic facilitation or substances than is allowed under state law. Additionally prohibits these jurisdictions from requiring an additional license or the payment of a fee in addition to the state license and fee for conduct related to regulated psychedelic facilitation or regulated psychedelic substance licensees, other than generally applicable licenses and fees that apply to all businesses operating with the jurisdiction.
• Prohibits a city, county, or a city and county from prohibiting the transportation of regulated psychedelic substances through its jurisdiction on public roads by a licensee or as otherwise allowed by the Acts.
• Specifies that an individual shall not be arrested, prosecuted, penalized, sanctioned, or otherwise denied any benefit. Specifies an individual 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 the Acts at an approved location or for enrolling or employing a person who engages in regulated psychedelic substance-related activities lawfully.
• Specifies that the use of regulated psychedelic substances in connection with regulated psychedelic facilitation shall not disqualify a person from any needed medical procedure or medical treatment or any other lawful health-related service, shall not, by itself, be the basis for punishing a person currently under parole, probation, or other state-supervised release, including pretrial release.
• Specifies that the Acts shall not restrict the sale, possession, display, or cultivation of living fungi, plants, or seeds that were lawful before the enactment of the Acts and that engaging in regulated psychedelic substance-related activities shall not, by itself, be the basis to deny eligibility for any public assistance program, unless required by federal law.
• States legislative declarations and intent.
• Establishes definitions for purposes of the new Acts.

Related Legislation:

SB 58 (Weiner, 2023) would have decriminalized the use of certain psychedelics for personal use by individuals 21 years of age or older. SB 58 would have also created a workgroup to study and recommend a framework for governing the therapeutic use of psychedelics. SB 58 also would have defined “facilitated or supported use” as supervised or assisted personal use of a psychedelic by an individual or group of persons 21 years of age or older, or the assisting or supervising of such persons in such use, within the context of spiritual guidance, community-based healing, or related service. SB 58 was vetoed.

Staff Comments: While the total fiscal impact of this bill is unknown at this time, one-time and ongoing costs will likely range in the millions of dollars and will depend on the scope and size of the licensing programs and the ability for the Board, Division, and Committee to meet their responsibilities on the timeline required by the bill. The programs will likely need significant General Fund or other special fund support until fees established by the Acts can support their operations.

For comparison, the Oregon Psilocybin Services (OPS) section in the Oregon Health Authority is tasked with similar regulatory responsibilities as those required of the Board, Division, and Committee under this bill.

Oregon passed its Measure 109 and after a two-year development process from January 1, 2021 to December 31, 2022 to establish regulations for implementation of the measure, OPS adopted rules on December 21, 2022 and began accepting applications for licensure on January 2, 2023. OPS received $2.5 million General Fund and $760,000 other special fund for start-up costs and 22.0 staff positions for the 2021-23 biennium to begin implementation. OPS additionally received $3.1 million General Fund for the 2023-25 biennium, as OPS anticipated fees would take several months to a year following when it began accepting license applications before these fees could cover the cost of OPS’s work^[1]. OPS regulates four license types: Facilitator, Manufacturer, Service Center, and Laboratory.

This bill requires the Board to be appointed by April 1, 2025, adopt regulations by January 1, 2026, and begin accepting license applications by April 1, 2026. The bill requires the Division to convene the Committee by April 1, 2025, adopt regulations concerning psilocybin, psilocin, and MDMA by January 1, 2026, and begin accepting license applications by April 1, 2026. The bill also requires the Committee to publish its first annual report on its activities and recommendations by January 1, 2026. It is unknown if the Board, Division, and Committee may complete all necessary work—including hiring staff, developing and adopting regulations, conducting meetings and stakeholder outreach, approving programs, building an IT licensing system, and establishing professional qualifications for education, training, experience, professional practice, standards of care, and ethics—before the Board and Division would be required to start accepting license applications. To meet these timelines, these programs will likely have higher start-up costs that may necessitate greater General Fund or other special fund support until fee revenue is sufficient to cover their costs.

-- END --

1. 2023-25 Oregon Health Authority Legislatively Adopted Budget. Noted in the Center for Health Protection Program Unit Summary. ↑

SENATE COMMITTEE ON PUBLIC SAFETY

Senator Aisha Wahab, Chair

2023 - 2024 Regular

Bill No: SB 1012 Hearing Date: April 23, 2024

Subject: The Regulated Psychedelic Facilitators Act and the Regulated Psychedelic-Assisted Therapy Act

HISTORY

Source: Heroic Hearts

Law Enforcement Action Partnership

Veterans Exploring Treatment Options

Prior Legislation: SB 58 (Wiener), vetoed in 2023

SB 519 (Wiener), died on the Assembly Inactive File in 2022

Support: A New Path; Alameda County Democratic Central Committee; An Empathic Society; Board of Psychedelic Medicine and Therapies; California Association of Social Rehabilitation Agencies; California Coalition for Psychedelic Safety and Education; California Public Defenders Association; City of Berkeley Councilmember Ben Bartlett; City of West Hollywood; Dr. Bronner’s; End Well Foundation; Institute for Rural Psychedelic Care; NEST Harm Reduction & Consulting; New Approach Advocacy Fund; Sacramento Institute for Psychotherapy; Shamynds Healing Center; Smart Justice California; Smart Justice California; Sonoma County Democratic Party; Steinberg Institute; William G. Nash Foundation; 3 individuals

Opposition: Alliance for Better and Safer California; Americans Against the Legalization of Marijuana; Arcadia Police Officers’ Association; Burbank Police Officers’ Association; California Baptist for Biblical Values; California Coalition Against Drugs; California Coalition of School Safety Professionals; California Family Council; California Narcotic Officers’ Association; California Reserve Peace Officers Association; California State Sheriffs’ Association; Chinese American Institute for Empowerment; Citizens Commission on Human Rights; Claremont Police Officers Association; Corona Police Officers Association; Culver City Police Officers’ Association; Deputy Sheriffs’ Association of Monterey County; Fullerton Police Officers’ Association; Interfaithstatewide Coalition; Los Angeles School Police Management Association; Los Angeles School Police Officers Association; Murrieta Police Officers’ Association; Newport Beach Police Association; Novato Police Officers Association; Organization for Justice and Equality; Palos Verdes Police Officers Association; Placer County Deputy Sheriffs' Association; Pomona Police Officers’ Association; Riverside Police Officers Association; Riverside Sheriffs’ Association; SafeLaunch; Santa Ana Police Officers Association; Traditional Values for Next Generations; Upland Police Officers Association; 12 individuals

PURPOSE

The purpose of this bill is to establish the Regulated Psychedelic Facilitators Act (Facilitators Act) and Regulated Psychedelic-Assisted Therapy Act (Assisted Therapy Act) administered by new state entities, each of which is required to undertake regulatory efforts to determine, define, and establish standards for psychedelic facilitation in the state, and exempts from prosecution certain conduct related to controlled substances when the conduct occurs lawfully under the Facilitators Act or the Assisted Therapy Act.

Existing law classifies controlled substances into five schedules according to their danger and potential for abuse. Schedule I controlled substances have the greatest restrictions and penalties, including prohibiting the prescribing of a Schedule I controlled substance. (Health & Saf. Code, §§ 11054-11058.)

Existing law classifies several hallucinogenic substances including DMT, mescaline, psilocybin, and psilocyn as Schedule I substances. (Health & Saf. Code, § 11054, subd. (d).)

Existing law prohibits the possession of several specified controlled substances. (Health & Saf. Code, § 11350, subd. (a).)

Existing law makes it unlawful for a person to possess for sale or purchase for purpose of sale specified controlled substances. (Health & Saf. Code, § 11351.)

Existing law makes it unlawful for a person to transport, import, sell, furnish, administer, or give away, or offer or attempt to transport, import, sell, furnish, administer, or give away specified controlled substances. (Health & Saf. Code, § 11352.)

Existing law make it unlawful for any person to deliver, furnish, or transfer, possess with intent to deliver, furnish, or transfer, or manufacture with the intent to deliver, furnish, or transfer, drug paraphernalia, knowing 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. (Health & Saf. § 11364.7.)

Existing law provides that the possession of methamphetamine and other specified controlled substances is unlawful. (Health & Saf. Code, § 11377, subd. (a).)

Existing law makes it unlawful for a person to possess for sale specified controlled substances. (Health & Saf. Code, § 11378.)

Existing law makes it unlawful for a person to transport, import into this state, sell, furnish, administer, or give away, or offer to transport, import into this state, sell, furnish, administer, or give away, or attempt to import into this state or transport specified controlled substances. (Health & Saf. Code, § 11379.)

Existing law makes it unlawful for a person who, with the intent to produce psilocybin or psilocyn, cultivates any spores or mycelium capable of producing mushrooms or other material which contains such a controlled substance. (Health & Saf. Code, § 11390.)

Existing law makes it unlawful to transport, import into this state, sell, furnish, gives away, or offer to transport, import into this state, sell, furnish, or give away any spores or mycelium capable of producing mushrooms or other material which contain psilocybin or psilocyn. (Health & Saf. Code, § 11391.)

Existing law provides that a controlled substance analog shall be treated the same as the controlled substance classified in Section 11054 or 11055. Defines “controlled substance analog” to mean either of the following: (1) a substance the chemical structure of which is substantially similar to the chemical structure of a controlled substance classified in Section 11054 or 11055; or (2) a substance that has, is represented as having, or is intended to have a stimulant, depressant, or hallucinogenic effect on the central nervous system that is substantially similar to, or greater than, the stimulant, depressant, or hallucinogenic effect on the central nervous system of a controlled substance classified in Section 11054 or 11055. (Health & Saf. Code, § 11401, subds. (a) & (b).)

Existing law establishes various practice acts in the Business and Professions Code (BPC) governed by various boards within the Department of Consumer Affairs (DCA) which provide for the licensing and regulation of health care professionals and include statutory requirements for education, training, clinical experience, competency assessments in order to become licensed, as well as specific statutory practice authority. (Bus. & Prof. Code, § 500 et seq.)

Existing law prohibits any person from writing or issuing a prescription for a controlled substance other than a physician, dentist, podiatrist, veterinarian, naturopathic doctor (according to certain supervision and protocol requirements), pharmacist (according to certain authorization and according to certain policies and procedures), certified nurse-midwife (if furnished or ordered incidentally to the provision of family planning services, routine health care or perinatal care, or care rendered consistent with their practice; occurs under physician and surgeon supervision; and is in accordance with standardized procedures or protocols as specified), nurse practitioner (if it is consistent with their educational preparation or for which clinical competency has been established and maintained; occurs under physician and surgeon supervision; and is in accordance with standardized procedures or protocols as specified); a pharmacist or registered nurse or physician assistant acting within the scope of an experimental health workforce project; an optometrist licensed under the Optometry Practice Act, or an out-of-state prescriber acting in an emergency situation. (Health & Saf. Code, § 11150.)

Existing law provides that a prescription for a controlled substance shall only be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of their professional practice, and that the responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing practitioner, but a corresponding responsibility rests with the pharmacist who fills the prescription. (Health & Saf. Code, § 11153.)

Existing law, the state Confidentiality of Medical Information Act, prohibits a provider of health care and others from intentionally sharing, selling, using for marketing, or otherwise using any medical information, as defined, for any purpose not necessary to provide health care services to a patient, except as expressly authorized by the patient, enrollee, or subscriber, as specified, or as otherwise required or authorized by law. (Civ. Code, § 56 et seq.)

Existing federal law, the federal Health Insurance Portability and Accountability Act of 1996 (HIPAA), establishes certain requirements relating to the provision of health insurance, including provisions relating to the confidentiality of health records. (Public Law 104–191, 104th Congress)

Existing federal law makes it unlawful for any person to knowingly or intentionally possess a controlled substance unless such substance was obtained directly, or pursuant to a valid prescription or order, from a practitioner, while acting in the course of their professional practice, or as otherwise specified. (21 U.S.C. § 844.)

Existing federal law makes it unlawful to knowingly open, lease, rent, use, or maintain any place, whether permanently or temporarily, for the purpose of manufacturing, distributing, or using any controlled substance. (21 U.S.C. § 856 (a).)

Existing federal law makes it unlawful to manage or control any place, whether permanently or temporarily, either as an owner, lessee, agent, employee, occupant, or mortgagee, and knowingly and intentionally renting, leasing, profiting from, or making available for use, with or without compensation, the place for the purpose of unlawfully manufacturing, storing, distributing, or using a controlled substance. (21 U.S.C. § 856, (b).)

This bill defines various terms for purposes of regulation by the Board of Regulated Psychedelic Facilitators (Board) and the Division of Regulated Psychedelic-Assisted Therapy (Division), including, among others:

• “Administration session” means a session conducted at an approved location during which a participant consumes and experiences the effects of a regulated psychedelic substance under the supervision of a facilitator.
• “Approved location” means a location approved by the Division or a clinic, center, or other facility licensed by the State Department of Public Health (DPH).
• “Approved school” means a school or educational program approved by the Board that meets minimum standards for training and curriculum in regulated psychedelic facilitation and related subjects.
• “Integration session” means counseling provided by a facilitator or other personnel trained in postpsychedelic support that is intended to help the participant better understand their psychedelic experience and apply insights from their experience to their daily life.
• “Regulated psychedelic substances” means the following substances as defined in Section 11054 of the Health and Safety Code: DMT, mescaline, MDMA, psilocybin, psilocyn and spores or mycelium capable of producing mushrooms that contain psilocybin or psilocyn. Specifies that regulated psychedelic substances does not include peyote.
• “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.

This bill specifies various aspects of the Board, including:

• Requires membership of nine be appointed by the Governor, one public member appointed by the Senate Committee on Rules, and one public member appointed by the Speaker of the Assembly. Requires the board to include five members who have expertise in psychedelic facilitation and four public members. Requires at least one member to have experience as a facilitator as part of a U.S. Food and Drug Administration-approved clinical trial; at least one member to have experience in training and supervising facilitators; at least one member to be a licensed physician or licensed advanced practice clinician; at least one member to have experience providing mental health care to veterans; and at least one member to be a licensed marriage and family therapist, a licensed clinical social worker or board-certified chaplain.
• Prohibitions on family members of individuals with economic interests in psychedelic facilitation education programs and institutions from being Board members.
• Administrative operations such as the authority to hire staff, being subject to open meetings laws, authority to require licensees to collect and report relevant information and data, and the requirement that the Board establish, through regulations, a complaint, review, and disciplinary process for facilitators who engage in misconduct.
• Requirements for the Board to establish all of the professional standards for facilitators and for the Board to develop a system to allow for the purchase and administration of regulated psychedelic substances in the presence of a facilitator but without the facilitator directly handling the regulated psychedelic substances so that the facilitator may avoid trafficking in Schedule I or Schedule II substances.
• Authority for the Board to establish all fees related to the regulation of facilitators.

This bill requires the Board to adopt regulations by January 1, 2026 and begin accepting applications for licensure as a facilitator by April 1, 2026 that outline how regulated facilitation happens, including but not limited to regulations establishing:

• The scope of practice for facilitators and the qualifications, education, and training requirements that facilitators must meet.
• Requirements for holding and verifying completion of medical and mental health screenings, including a safety screen, at least one preparation session, an administration session, at least one follow-up evaluation, and at least one integration session.
• A medical, mental health, family history and contraindications safety screen that a participant must complete prior to an administration session.
• The informed consent form that each regulated psychedelic facilitator and participant must sign before providing or receiving regulated psychedelic facilitation verifying the participant was provided accurate and complete health information, the participant was informed the regulated psychedelic substances have not received FDA approval, and the participant was informed of potential and identified risks, benefits, contraindications, and negative outcomes of the psychedelic substance, and the method of administration and facilitation process.
• Conditions of the set and setting in which the administration session must take place and proper locations for where regulated psychedelic facilitation may take place.
• Age verification procedures to ensure that a participant is 21 years of age or older.

This bill specifies that education standards the Board adopts through regulation 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 California regulations and laws. Allows for limited waivers of education and training requirements based on an applicant’s prior experience, training, or skill with regulated psychedelic substances. Requires education and training standards adopted by the Board to include practicum requirements with a practicum supervisor but specifies that a facilitator is not required to have a professional license or professional degree other than a facilitator license. Authorizes the Board to consider expedited approval or partial approval for education programs that are already in existence in the state to train licensed mental health professionals in the provision of psychedelic facilitation.

This bill requires Board regulations to also include de-identified data collection and reporting requirements for facilitators in order to comprehensively measure the Facilitators Act’s 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.

This bill authorizes the Board to license facilitators 21 years of age or older who: complete the education and curriculum requirements the Board will establish by regulation at a Board approved school; who passes a facilitator competency assessment the Board creates and administers or that is offered by an entity designated by the Board; who successfully passes a background investigation; who pays all fees the Board will establish through regulation or; who holds a current and valid registration, licensure, or license from any other state whose licensure requirements meet or exceed these.

This bill establishes various prohibited activities for applicants and licensees.

This bill provides title protection for facilitators.

This bill specifies various aspects of the Division, including:

• The purpose and intent of the Division is to establish a comprehensive system to control and regulate the provision of psychedelic facilitation; the production, distribution, transportation, storage, processing, manufacturing, testing, quality control, and sale of regulated psychedelic substances for use only in conjunction with regulated psychedelic facilitation at approved locations; the approval of locations where regulated psychedelic facilitation may take place and; the collection and publication of deidentified and aggregate data and information on the implementation and outcomes of the Act.
• The Director is appointed by the Governor and subject to confirmation by the Senate Committee on Rules.
• The Division has as the power, duty, purpose, responsibility, and jurisdiction to regulate regulated psychedelic substances and the provision of psychedelic facilitation, and to approve locations where psychedelic facilitation may take place.
• The Division must adopt regulations by January 1, 2026 concerning psilocybin, psilocyn, the spores or mycelium capable of producing mushrooms that contain psilocybin and psilocyn, and MDMA and must, at least every two years thereafter, adopt regulations concerning additional substances identified as regulated psychedelic substances, if recommended by the Oversight Committee.
• Authority to employ individuals who are not peace officers to provide investigative services.

This bill requires the Division to convene the Oversight Committee to advise the Division and the Board, composed of 14 individuals who reside in California appointed by the Governor with at least one person in expertise in the following areas: mental or behavioral health; psychedelic facilitation; issues confronting veterans; developing and implementing evaluation methodologies to assess the outcomes of a program, including its achievements, safety, quality, and impact on individuals; health care insurance or barriers in access to health care; emergency medical services or first responders; mycology and regulated psychedelic substance cultivation; training psychedelic facilitators; the provision of harm reduction; harm reduction systems; regulated psychedelic substance research; indigenous uses of psychedelic substances; public health data collection and; expertise in naturopathic medicine.

This bill requires the Division to adopt regulations to establish categories of licensure and registration including, but not limited to:

• A cultivation, processing, or manufacture license that would allow solely for the provision and sale of regulated psychedelic substances at the premises of an approved location for use during the administration session of a regulated psychedelic facilitation at that approved location.
• A testing license for the testing of regulated psychedelic substances for quality, concentration, and contaminants.

This bill requires the Division to adopt regulations for:

• Limitations on the number of licenses for cultivation, processing, or manufacture of regulated psychedelic substances and the volume of regulated psychedelic substances produced by licensees to ensure the amount of regulated psychedelic substances does not exceed the amount necessary to meet the demand for regulated psychedelic facilitation.
• Requirements and standards for testing regulated psychedelic substances for quality, concentration, and contaminants.
• Requirements for labeling regulated psychedelic substances.
• Prohibitions on advertising, branding, and marketing regulated psychedelic substances, including prohibitions on claiming the regulated psychedelic substance is safe and effective or making health or medical claims about regulated psychedelic substances unless in compliance with federal law.
• Requirements governing the licensing and operation of licensees, including psychedelic facilitation centers and approved locations
• Procedures, policies, and programs to ensure that the licensing of regulated psychedelic substances and the provision of regulated psychedelic facilitation is equitable and inclusive and to promote the licensing of and the provision of regulated psychedelic facilitation to persons from low-income communities; to persons who face barriers to access to health care; to persons who have a history of traditional or indigenous use of regulated psychedelic substances; to persons who are or were first responders; and to persons who are veterans.

This bill requires the Division to enforce laws related to the cultivation, producing, manufacturing, processing, preparing, delivery, storage, sale, and testing of regulated psychedelic substances.

This bill requires the Division to collect and annually publish information on the its website pertaining to the implementation and outcomes of the Assisted Therapy Act to comprehensively measure its success, safety, quality, and impact on individuals’ well-being and public health. Requires the Division to consult with DPH on the best data collection, processing, and reporting methodologies and authorizes it to contract or collaborate with one or more California public universities to research and evaluate the Assisted Therapy Act. Specifies that information is deidentified or aggregated so no individual participant is identified and that information and data shall not be sold.

This bill establishes a Psychedelic Substances Public Education and Harm Reduction Fund available to the Office of Community Partnerships and Strategic Communications within the Governor’s Office of Planning and Research upon appropriation by the Legislature to award grants for public education relating to psychedelic substances, including their limitations and potential risks, and mitigation measures, in addition to potential benefits as well as harm reduction.

This bill authorizes a city, county, or a city and county to reasonably regulate the time, place, and manner of regulated psychedelic facilitation within its boundaries but prohibits a city, county, or a city and county from banning or completely prohibiting facilitator operations and regulated psychedelic facilitation. Prohibits a city, county, or a city and county from enacting a greater fine or penalty for conduct related to regulated psychedelic facilitation or substances than is allowed under state law and from requiring an additional license or the payment of a fee in addition to the state license and fee for conduct related to regulated psychedelic facilitation or regulated psychedelic substance licensees, other than generally applicable licenses and fees that apply to all businesses operating with the jurisdiction. Prohibits a city, county, or a city and county from prohibiting the transportation of regulated psychedelic substances through its jurisdiction on public roads by a licensee or as otherwise allowed by the Acts.

This bill prohibits an individual form being arrested, prosecuted, penalized, sanctioned, or otherwise denied any benefit and prohibits a person from being 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 the Acts at an approved location or for enrolling or employing a person who engages in regulated psychedelic substance-related activities lawfully. Specifies that the use of regulated psychedelic substances in connection with regulated psychedelic facilitation shall not disqualify a person from any needed medical procedure or medical treatment or any other lawful health-related service, shall not, by itself, be the basis for punishing a person currently under parole, probation, or other state-supervised release, including pretrial release. Specifies that the Acts shall not restrict the sale, possession, display, or cultivation of living fungi, plants, or seeds that were lawful before the enactment of the Acts and that engaging in regulated psychedelic substance-related activities shall not, by itself, be the basis to deny eligibility for any public assistance program, unless required by federal law.

This bill makes it a misdemeanor for any person who violates any of the provisions of the Facilitator’s Act punishable by imprisonment in county jail not exceeding six months, by a fine not to exceed $2500, or by both, and which may result in the suspension or revocation of the licenseholder’s license.

This bill includes uncodified findings and declarations.

This bill contains a severability provision.

This bill contains technical and conforming changes.

COMMENTS

1. Need For This Bill

According to the author:

Senate Bill 1012 authorizes the use of certain psychedelic substances in a regulated, therapeutic context under the supervision of a licensed and trained facilitator for adults 21 and older. SB 1012 establishes the Regulated Psychedelic Substances Advisory Committee to oversee and make recommendations to the Board of Regulated Psychedelic Facilitators to license and train facilitators in providing psychedelic assisted therapy, including preliminary safety screenings and follow-up integration sessions. This bill does not allow the sale, personal possession, or use of psychedelics outside of a regulated context.

When administered with proper screening and support, psychedelics have been shown to offer powerful relief to people struggling with mental health and addiction disorders. SB 1012 takes an evidence-based approach to providing access to these promising treatments.

Last fall, the Legislature passed SB 58, my legislation that would have decriminalized the personal use and possession of certain psychedelic substances. In a message explaining his decision to veto the bill, Governor Newsom urged the Legislature to send him a bill establishing therapeutic guidelines for the use of psychedelics in California. As the Governor stated in his veto message:

“Both peer-reviewed science and powerful personal anecdotes lead me to support new opportunities to address mental health through psychedelic medicines like those addressed in this bill. Psychedelics have proven to relieve people suffering from certain conditions such as depression, PTSD, traumatic brain injury, and other addictive personality traits. This is an exciting frontier and California will be on the front-end of leading it. . . . I urge the legislature to send me legislation next year that includes therapeutic guidelines.”

Senate Bill 1012 is a direct response to the Governor’s well-articulated request.

1. Hallucinogens

Hallucinogens^[1] are a diverse group of drugs that alter a person’s perception or awareness of their surroundings. Some hallucinogens are found in plants and fungi, and some are synthetically produced. According to the National Institute on Drug Abuse, hallucinogens are commonly split into two categories: classic hallucinogens and dissociative drugs. Both types can cause hallucinations, and dissociative drugs can cause the user to feel disconnected from their body or environment. Hallucinogens can be consumed in a variety of ways, including swallowed as tablets, pills, or liquid, consumed raw or dried, snorted, injected, inhaled, vaporized, smoked, or absorbed through the lining of the mouth using drug-soaked pieces of paper. Common hallucinogens include DMT, psilocybin, peyote, and mescaline.

Many hallucinogenic substances, including DMT, mescaline, psilocybin, and psilocyn are classified as Schedule I substances under the state’s Uniform Controlled Substances Act. Schedule I substances are defined as those controlled substances having no medical utility and that have a high potential for abuse. There is research, however, that indicates that many of these substances have therapeutic benefits. (See Davis et. al, Effects of Psilocybin-Assisted Therapy on Major Depressive Disorder, JAMA Psychiatry (2020) available at <https://jamanetwork.com/journals/jamapsychiatry/fullarticle/2772630>; D’Souza et al., Exploratory Study of the Dose-Related Safety, Tolerability, and Efficacy of Dimethyltryptamine (DMT) in Healthy Volunteers and Major Depressive Disorder, Neuropsychopharmacol (2022) available at <https://www.nature.com/articles/s41386-022-01344-y>.)

In recent years, the U.S. Federal Drug Administration (FDA) has designated psilocybin as a “breakthrough therapy” to treat severe depression. (<https://www.livescience.com/psilocybin-depression-breakthrough-therapy.html> [as of Mar. 15, 2023].) The “breakthrough therapy” designation is “a process designed to expedite the development and review of drugs that are intended to treat a serious condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint.” (<https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/breakthrough-therapy> [as of Mar. 15, 2023].)

1. Reform Efforts Related to Hallucinogens

Local Efforts

Efforts to deprioritize the policing or prosecution of conduct related to certain hallucinogens and to acknowledge the therapeutic value of hallucinogens have gained support in recent years. In 2019, voters in Denver approved a measure to make the personal use and possession of psilocybin by adults 21 years of age and older the lowest law enforcement priority and to prohibit the city from spending resources to impose criminal penalties related to such conduct. (Tom Angell, Denver Voters Approve Measure to Decriminalize Psychedelic Mushrooms (May 8, 2019) available at <https://www.forbes.com/sites/tomangell/2019/05/08/denver-voters-approve-measure-to-decriminalize-psychedelic-mushrooms/?sh=7c3f101b3ddc>.) The same year, the Oakland City Council passed a resolution prohibiting the use of city funding “to assist in the enforcement of laws imposing criminal penalties for the use and possession of entheogenic plants by adults” and specifies that investigating people for growing, buying, distributing or possessing those substances “shall be amongst the lowest law enforcement priority for the City of Oakland.” (Merritt Kennedy, Oakland City Council Effectively Decriminalizes Psychedelic Mushrooms (Jun. 5, 2019) available at <https://www.npr.org/2019/06/05/730061916/oakland-city-council-effectively-decriminalizes-psychedelic-mushrooms>.) A resolution passed by the Santa Cruz City Council in 2020 made the personal possession and use of entheogenic plants and fungi a low priority for law enforcement. (David E. Carpenter, Santa Cruz is Third U.S. City to Decriminalize Psilocybin, Plant Medicine, as Advocacy Expands (Feb. 1 2020) available at <https://www.forbes.com/sites/davidcarpenter/2020/02/01/santa-cruz-is-third-us-city-to-decriminalize-psilocybin-plant-medicine-as-advocacy-expands/?sh=16cd782c5d0d>.) A similar measure was passed by the Ann Arbor City Council the same year. (Associated Press, Ann Arbor Decriminalizes Magic Mushrooms, Psychedelic Plants (Sept. 26, 2020) available at <https://apnews.com/article/plants-archive-fungi-ann-arbor-b0ce69ca0961c150e0f900e8ea4cf432>.) Initiative 81, the Entheogenic Plant and Fungus Policy Act of 2020, makes “the investigation and arrest of persons 18 years of age or older, for non-commercial planting, cultivating, purchasing, transporting, distributing, engaging in practices with, and/or possessing entheogenic plants and fungi” among the lowest enforcement priorities for Washington D.C.’s local police department. (https://decrimnaturedc.org/wp-content/uploads/2020/02/Entheogenic_Plant_and_Fungus_Policy_Act_of_2020_published_2_18_2020.pdf) Additional jurisdictions have passed similar measures since 2020.

Statewide Efforts

In 2020, Oregon voters approved Measure 109, the Psilocybin Services Act, which directed the Oregon Health Authority to create a state-licensed, psilocybin-assisted therapy program over a two-year period. (Kristian Foden-Vencil, Oregon Voters Legalize Therapeutic Psilocybin (Nov. 4, 2020) available at <https://www.opb.org/article/2020/11/04/oregon-measure-109-psilocybin/>.) In implementing Measure 109, Oregon had to determine how to license and regulate the manufacturing, transportation, delivery, sale and purchase of psilocybin products as well as the provision of psilocybin services. (https://www.oregon.gov/oha/ph/preventionwellness/pages/oregon-psilocybin-services.aspx) Following the two-year development period for psilocybin services, the state began taking license applications on January 2, 2023. (https://sharedsystems.dhsoha.state.or.us/DHSForms/Served/le4226.pdf.) Psilocybin services refers to preparation, administration, and integration sessions provided by a licensed facilitator. (Id.) Psilocybin services are available to individuals aged 21 and older and do not require a prescription or medical referral. (Id.) The psilocybin products consumed must be cultivated or produced by a licensed psilocybin manufacturer and can only be provided to a client at a licensed psilocybin service center during an administration session. (Id.) Psilocybin services are expected to be available to the public later this year. (Andrew Selsky and Mike Corder, Oregon Closer to Magic Mushroom Therapy, But Has Setback (Mar. 10, 2023) available at <https://apnews.com/article/magic-mushroom-therapy-psilocybin-legalization-oregon-bd1b3c43cab74437e8868751c9c9591d>.)

During the same election, Oregon voters approved Measure 110 which reduced the personal noncommercial possession of small amounts of a Schedule I-IV controlled substance, including several hallucinogens, from a criminal offense to a civil violation resulting in a maximum fine of $100. (Legislative Policy and Research Office, Measure 110 (2020): Background Brief (December 2020) available at <https://www.oregonlegislature.gov/lpro/Publications/Background-Brief-Measure-110-(2020).pdf>.)

More recently, Colorado voters approved Proposition 122 which, among things, decriminalized the personal possession and use of psilocybin, psilocyn, DMT, ibogaine and mescaline for adults aged 21 and older. (Andrew Kenney, Coloradans Voted to Legalize Psilocybin. What’s Next? (Nov. 25, 2022) available at <https://www.cpr.org/2022/11/25/colorado-psilocybin-legalization-whats-next/>.) The measure additionally establishes a program for licensed “healing centers” to administer psilocybin and psilocyn to adults by licensed professionals, and creates a regulatory framework for the manufacture, cultivation, testing, storage, transport, transfer, delivery, sale, and purchase of the covered substances between healing centers and other permitted entities. (Id.; https://www.sos.state.co.us/pubs/elections/Initiatives/titleBoard/filings/2021-2022/58Final.pdf)

1. SB 58

SB 58 (Wiener) was vetoed last year. SB 58 would have made it lawful to possess, prepare, obtain, or transport specified quantities of psilocybin, psilocyn, dimethyltryptamine (DMT), and mescaline, for personal use, as defined, by persons 21 years of age or older. In his veto message, Governor Newsom wrote:

This bill would, beginning on January 1, 2025, decriminalize the possession, preparation, obtaining, or transportation of specified quantities of mescaline, dimethyltryptamine (DMT), psilocybin, and psilocyn, for personal use by persons 21 years of age or older. This bill would also decriminalize the therapeutic use of the substances following the Legislature’s adoption of a framework governing therapeutic use.

Both peer-reviewed science and powerful personal anecdotes lead me to support new opportunities to address mental health through psychedelic medicines like those addressed in this bill. Psychedelics have proven to relieve people suffering from certain conditions such as depression, PTSD, traumatic brain injury, and other addictive personality traits. This is an exciting frontier and California will be on the front-end of leading it.

California should immediately begin work to set up regulated treatment guidelines - replete with dosing information, therapeutic guidelines, rules to prevent against exploitation during guided treatments, and medical clearance of no underlying psychoses. Unfortunately, this bill would decriminalize possession prior to these guidelines going into place, and I cannot sign it.

I urge the legislature to send me legislation next year that includes therapeutic guidelines. I am, additionally, committed to working with the legislature and sponsors of this bill to craft legislation that would authorize permissible uses and consider a framework for potential broader decriminalization in the future, once the impacts, dosing, best practice, and safety guardrails are thoroughly contemplated and put in place.

1. Effect of This Bill

This bill establishes the Regulated Psychedelic Facilitators Act and Regulated Psychedelic-Assisted Therapy Act administered by new state entities, each of which is required to undertake regulatory efforts to determine, define, and establish standards for psychedelic facilitation in the state. For a detailed analysis of the provisions of the bill related to the creation of that regulatory framework, please see the Senate Committee on Business and Professions analysis.

This bill makes it a misdemeanor for any person to violate the provisions of the Facilitators Act punishable by imprisonment in county jail not exceeding six months, by a fine not to exceed $2,500, or by both, and provides that a violation may result in the suspension or revocation of the licenseholder’s license.

This bill makes a violation of the Assisted Therapy Act a misdemeanor punishable by imprisonment in county jail for six months, a fine of not less than one thousand dollars $1,000, or both, and forfeiture of any license granted under its provisions.

Finally, this bill exempts from prosecution certain conduct related to controlled substances when the substance involved is a “regulated psychedelic substance” and the conduct occurs lawfully within the context of the Facilitators Act or the Assisted Therapy Act. For example, possession of one of the “regulated psychedelic substances” when possessed lawfully under the Facilitators Act or the Assisted Therapy Act would not be subject to prosecution under Health and Safety Code section 11350. The bill includes exemptions for the following drug offenses when the conduct lawfully occurs under the Facilitators Act or the Therapy Act: possession for sale; transporting, importing, selling, furnishing, administering or giving away, or offering or attempting to do any of those things; delivering, furnishing, or transferring, possessing with intent to deliver, furnish, or transfer, or manufacturing with the intent to deliver, furnish, or transfer, drug paraphernalia, knowing 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; cultivating any spores or mycelium capable of producing mushrooms or other material which contains such a controlled substance with the intent to produce psilocybin or psilocyn; and transporting, importing, selling, furnishing, giving away, or offering to transport, import, sell, furnish, or give away any spores or mycelium capable of producing mushrooms or other material which contain psilocybin or psilocyn.

1. CSAP Concerns

The California State Association of Psychiatrists submitted a letter to the Committee raising concerns with the bill but did not take a position. CSAP writes:

CSAP’s concerns with SB 1012 are related to the care of a vulnerable patient population with behavioral health illnesses and who best is able to provide the specialized care to help these patients. While new and innovative treatments to depression, anxiety, and other psychiatric disorders are needed, the evidence to support the therapeutic use of psychedelics is not yet robust enough to justify widespread access, especially for unsupervised use or use in the presence of non-medical individuals.

CSAP believes the Legislature should exercise extreme caution in this area until there is more specifically validated information on psychedelics with respect to the risks, benefits, and alternatives, not just at the individual level, but also at the level of public health and behavioral health.

…

CSAP also has concerns about the claim that psychedelics are rarely addictive when administered by a doctor to a patient with a mental illness. As with any mind-altering drug, psychedelics have the potential to be addictive. … [T]here is no system requirement in place for these substances to be required to be reported on the CURES database so other health care providers are aware that patients are on these substances that can affect their health and have medication interactions.

CSAP’s bottom line on SB 1012 or any other psychedelics-related legislation is patient safety and that no harm occurs to individuals who may seek them out. …

…

Ideally, controlled substances administered in California would only be those approved by the FDA and only prescribed by those who have a license to practice medicine and a DEA specific license for controlled substances.

1. Argument in Support

Heroic Hearts Project, one of the bill’s co-sponsors writes:

Senate Bill 1012 establishes a professional licensing board under the California Business, Consumer Services, and Housing Agency for regulated psychedelic facilitators to develop safety screening protocols, training programs, ethical standards, scope of practice guidelines, and regulatory oversight. This legislation will provide therapeutic access for persons 21 and older to certain psychedelic substances under the supervision of a licensed and trained facilitators at approved locations. The proposed legislation regulates the production and testing of certain psychedelic substances and establishes an expert oversight committee to direct all aspects of the program. The bill would create a public-private fund to support public health education related to psychedelics. This bill does not remove criminal penalties for activates involving psychedelic substances outside of the regulated program nor allow for retail sales for use outside the regulated, therapeutic context.

…

There is a growing body of credible evidence to show that psychedelics can help reduce symptoms of depression, anxiety, and PTSD when used in proper settings with safeguards like those proposed in this bill, which includes screening, preparation, integration and therapeutic support. …

Safety is paramount when it comes to psychedelics. Right now, many Californians are seeking psychedelics abroad or from underground sources. By establishing a regulated program for the therapeutic use of psychedelics, SB 1012 aims to enable more equitable and safer access to therapeutic psychedelic services within the state. …

SB 1012 takes an evidence-based approach to providing access and mitigates risks by requiring that patients and practitioners collaborate to help ensure a safe experience. …

…

Last fall, the Legislature passed SB 58, legislation that would have decriminalized the personal use and possession of certain psychedelic substances. In a message explaining his decision to veto the bill, Governor Newsom urged the Legislature to send him a bill establishing therapeutic guidelines for the use of psychedelics in California.

…

Senate Bill 1012 is a direct response to the Governor’s well-articulated request.

1. Argument in Opposition

According to the California Narcotics Officers’ Association:

SB 1012 omits any requirement that a licensed therapist, psychologist or psychiatrist to oversee the legalized psychedelic therapeutic treatment. The bill doesn’t limit the use of psychedelic substances for therapeutic treatment purposes – despite the proponents’ semantic gymnastics. Therapists were replaced [following amendments to the bill] with undefined, ambiguous “facilitators.”

… The purpose of SB 1012 is to make psychedelic facilitation available to the public with no requirement that medically-overseen “psychedelic-assisted therapy” take place.

SB 1012 remains inconsistent with Governor Newsom’s directive when he vetoed SB 58 (Wiener) that would have decriminalized various hallucinogens, but not ecstacy/MDMA. …

SB 1012 seeks to replicate and expand upon the Oregon psychedelic law which is limited to only mushrooms. …

SB 1012 permits non-doctors and others with no mental health training (facilitators) to dispense the most restricted of all drugs- Schedule I (including ecstasy) without a prescription, or a psychiatric referral or even a showing of a medical/therapeutic need. …

…

The psychological consequences of psilocybin use include hallucinogens and an inability to discern fantasy from reality. …

…

Under SB 1012, psychedelic “facilitators” will oversee the health and safety of persons using hallucinogenic drugs, despite no mandated education, licensing or training standards in the bill. …

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Our dedicated law enforcement professionals know all too well the detrimental and deadly effects caused by the decriminalization of intoxicating controlled substances – and we are not alone. Recently, the state of Oregon repealed their drug decriminalization laws after years of increasing addiction, homelessness, crime, overdoses and death.

SB 1012 is not a real medical, psychedelic-assisted psychotherapy bill. Regrettably, the public safety risks, local management issues and detrimental impact to our communities significantly outweigh the harm that decriminalizing these drugs under the guise of facilitated use will cause.

-- END --

1. Some advocates and researchers use the term psychedelic rather than hallucinogen while others use the terms interchangeably. Notably, some sources define psychedelics as a subset of hallucinogens. The term entheogenic has come into use more recently to describe this class of substances. This analysis uses the term hallucinogen due to its use in the controlled substance schedules in the state’s Uniform Controlled Substances Act. ↑

SENATE COMMITTEE ON

BUSINESS, PROFESSIONS AND ECONOMIC DEVELOPMENT

Senator Angelique Ashby, Chair

2023 - 2024 Regular

Bill No: SB 1012 Hearing Date: April 15, 2024

Subject: The Regulated Psychedelic Facilitators Act and the Regulated Psychedelic-Assisted Therapy Act

SUMMARY:

Establishes the Regulated Psychedelic Facilitators Act (Facilitators Act) and Regulated Psychedelic-Assisted Therapy Act (Assisted Therapy Act) administered by three new state entities: a Division of Regulated Psychedelic-Assisted Therapy (Division); a Board of Regulated Psychedelic Facilitators (Board) and; a Regulated Psychedelic Substances Oversight Committee (Oversight Committee), each of which is required to undertake significant regulatory efforts to determine, define, and establish standards for psychedelic facilitation in California.

NOTE:

This measure is double-referred to the Senate Committee on Public Safety, second.

Existing law:

1. Establishes various practice acts in the Business and Professions Code (BPC) governed by various boards within the Department of Consumer Affairs (DCA) which provide for the licensing and regulation of health care professionals and include statutory requirements for education, training, clinical experience, competency assessments in order to become licensed, as well as specific statutory practice authority.
2. Establishes the Uniform Controlled Substances Act which regulates controlled substances and defines an opiate as any substance having an addiction-forming or addiction-sustaining liability similar to morphine or being capable of conversion into a drug having addiction-forming or addiction-sustaining liability. (Health and Safety Code (HSC) § 11020)
3. Classifies controlled substances into five schedules according to their danger and potential for abuse. Classifies several hallucinogenic substances as Schedule I substances including Dimethyltryptamine (DMT), mescaline, psilocybin, and psilocyn. (HSC §§ 11054-11058)
4. Prohibits any person other than a physician, dentist, podiatrist, veterinarian, naturopathic doctor (according to certain supervision and protocol requirements), pharmacist (according to certain authorization and according to certain policies and procedures), certified nurse-midwife (if furnished or ordered incidentally to the provision of family planning services, routine health care or perinatal care, or care rendered consistent with their practice; occurs under physician and surgeon supervision; and is in accordance with standardized procedures or protocols as specified), nurse practitioner (if it is consistent with their educational preparation or for which clinical competency has been established and maintained; occurs under physician and surgeon supervision; and is in accordance with standardized procedures or protocols as specified); a pharmacist or registered nurse or physician assistant acting within the scope of an experimental health workforce project (HSC §§ 128125 et seq.); an optometrist licensed under the Optometry Practice Act, or an out-of-state prescriber acting in an emergency situation from writing or issuing a prescription for a controlled substance. (HSC § 11150)
5. States that a prescription for a controlled substance shall only be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of their professional practice, and that the responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing practitioner, but a corresponding responsibility rests with the pharmacist who fills the prescription. (HSC § 11153)
6. Establishes, pursuant to the federal Health Insurance Portability and Accountability Act of 1996 (HIPAA), certain requirements relating to the provision of health insurance, including provisions relating to the confidentiality of health records. (Public Law 104–191, 104th Congress) Prohibits, pursuant to the state Confidentiality of Medical Information Act (CMIA), a provider of health care and others from intentionally sharing, selling, using for marketing, or otherwise using any medical information, as defined, for any purpose not necessary to provide health care services to a patient, except as expressly authorized by the patient, enrollee, or subscriber, as specified, or as otherwise required or authorized by law. (Civil Code §§ 56, et seq.)
7. Makes it unlawful for any person to knowingly or intentionally possess a controlled substance unless such substance was obtained directly, or pursuant to a valid prescription or order, from a practitioner, while acting in the course of their professional practice, or as otherwise specified. (21 United States Code (U.S.C.) § 844)
8. Makes it unlawful to knowingly open, lease, rent, use, or maintain any place, whether permanently or temporarily, for the purpose of manufacturing, distributing, or using any controlled substance. (21 U.S.C. § 856 (a))
9. Makes it unlawful to manage or control any place, whether permanently or temporarily, either as an owner, lessee, agent, employee, occupant, or mortgagee, and knowingly and intentionally renting, leasing, profiting from, or making available for use, with or without compensation, the place for the purpose of unlawfully manufacturing, storing, distributing, or using a controlled substance. (21 U.S.C. § 856, (b))
10. Provides that, upon change in federal law permitting the prescription, furnishing, or dispensing of a cannabidiol product, a physician, pharmacist, or other authorized healing arts licensee acting within their scope of practice who prescribes, furnishes, or dispenses a cannabidiol product in accordance with federal law, is deemed to be in compliance with state law. (HSC §11150.2(a))
11. Prohibits the possession of several specified controlled substances. (HSC §11350(a))
12. Makes it unlawful for any person to deliver, furnish, or transfer, possess with intent to deliver, furnish, or transfer, or manufacture with the intent to deliver, furnish, or transfer, drug paraphernalia, knowing 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. (HSC §11364.7)
13. Makes it unlawful to visit or to be in any room or place where specified controlled substances are being unlawfully smoked or used with knowledge that such activity is occurring. (HSC §11365(a))
14. Makes it unlawful for a person to transport, import into this state, sell, furnish, administer, or give away, or offer to transport, import into this state, sell, furnish, administer, or give away, or attempt to import into this state or transport specified controlled substances. (HSC § 11379)
15. Provides that it is unlawful to be under the influence of specified controlled substances. (HSC §11550(a))
16. Makes it unlawful for a person who, with the intent to produce psilocybin or psilocyn, cultivates any spores or mycelium capable of producing mushrooms or other material which contains such a controlled substance. (HSC §11390)
17. Makes it unlawful to transport, import into this state, sell, furnish, give away, or offer to transport, import into this state, sell, furnish, or give away any spores or mycelium capable of producing mushrooms or other material which contain psilocybin or psilocyn. (HSC §11391)
18. Enacts the Medicinal and Adult-Use Cannabis Regulation and Safety Act (MAUCRSA) to provide for a comprehensive regulatory framework for the cultivation, distribution, transport, storage, manufacturing, processing, and sale of medicinal and adult-use cannabis. (Business and Professions Code (BPC) §§ 26000 et seq.)
19. Establishes the Department of Cannabis Control (DCC) to regulate cannabis with the sole authority to create, issue, deny, renew, discipline, suspend, or revoke licenses for microbusinesses, transportation, storage unrelated to manufacturing activities, distribution, testing, and sale of cannabis and cannabis products within the state. Requires the DCC to administer the portions of MAUCRSA related to and associated with the cultivation of cannabis and with the manufacturing of cannabis products. Delegates to the DCC authority to create, issue, deny, and suspend or revoke cultivation or manufacturing licenses for violations of MAUCRSA. (BPC §§ 26010, 26012)
20. Provides for twenty total types of cannabis licenses including subtypes for cultivation, manufacturing, testing, retail, distribution, and microbusiness; requires each licensee except for testing laboratories to clearly designate whether their license is for adult-use or medicinal cannabis. (BPC § 26050)
21. Establishes grounds for disciplinary action against cannabis licensees, including failures to comply with state licensing requirements as well as local laws and ordinances. (BPC § 26030)

This bill:

1. Makes various statements about the state’s current approach to mental health; that 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; that an extensive and growing body of research is advancing to support the efficacy of regulated psychedelic substances combined with therapy as treatment for depression, anxiety, substance use disorders, end-of-life distress, other conditions, and overall human wellness; the need for a pubic education campaign about the use of psychedelic substances; and the passage of Measure 109 by Oregon voters in 20201 and Proposition 122 by Colorado voters in 2022 to establish regulated systems of delivering one or more regulated psychedelic substances in conjunction with therapeutic services.
2. Establishes legislative intent to do many of the actions the bill undertakes in terms of establishing new government entities; to ensure that the psychedelic facilitation available under the new regulated program established by the bill be accessible, equitable, affordable, and safe for adults 21 years of age and older for whom psychedelic facilitation is potentially beneficial; and to respect and support 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.
3. Establishes various definitions for purposes of regulation by the Board and the Division, including but not limited to:
4. “Administration session” means a session conducted at an approved location during which a participant consumes and experiences the effects of a regulated psychedelic substance under the supervision of a facilitator.
5. “Approved location” means a location approved by the Division or a clinic, center, or other facility licensed by the State Department of Public Health (DPH).
6. “Approved school” means a school or educational program approved by the Board that meets minimum standards for training and curriculum in regulated psychedelic facilitation and related subjects.
7. “Integration session” means counseling provided by a facilitator or other personnel trained in postpsychedelic support that is intended to help the participant better understand their psychedelic experience and apply insights from their experience to their daily life.
8. “Regulated psychedelic substances” means the following substances as defined in Section 11054 of the HSC: DMT, mescaline, MDMA, psilocybin, psilocyn and spores or mycelium capable of producing mushrooms that contain psilocybin or psilocyn. Specifies that substances does not include peyote.
9. “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.

Provisions Related to the Board and Licensed Facilitators

1. Specifies various aspects of the Board, including:
2. Membership of nine 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.
3. Prohibitions on family members of individuals with economic interests in psychedelic facilitation education programs and institutions from being Board members.
4. Administrative operations such as the authority to hire staff, being subject to open meetings laws, authority to require licensees to collect and report relevant information and data, and the requirement that the Board establish, through regulations, a complaint, review, and disciplinary process for facilitators who engage in misconduct.
5. Requirements for the Board to establish all of the professional standards for facilitators and for the Board to develop a system to allow for the purchase and administration of regulated psychedelic substances in the presence of a facilitator but without the facilitator directly handling the regulated psychedelic substances so that the facilitator may avoid trafficking in Schedule I or Schedule II substances.
6. Authority for the Board to establish all fees related to the regulation of facilitators.
7. Requires the Board to adopt regulations by January 1, 2026 and begin accepting applications for licensure as a facilitator by April 1, 2026 that outline how regulated facilitation happens, including but not limited to regulations establishing:
8. The scope of practice for facilitators and the qualifications, education, and training requirements that facilitators must meet.
9. Requirements for holding and verifying completion of medical and mental health screenings, including a safety screen, at least one preparation session, an administration session, at least one followup evaluation, and at least one integration session.
10. A medical, mental health, family history and contraindications safety screen that a participant must complete prior to an administration session.
11. The informed consent form that each regulated psychedelic facilitator and participant must sign before providing or receiving regulated psychedelic facilitation verifying the participant was provided accurate and complete health information, the participant was informed the regulated psychedelic substances have not received FDA approval, and the participant was informed of potential and identified risks, benefits, contraindications, and negative outcomes of the psychedelic substance, and the method of administration and facilitation process.
12. Conditions of the set and setting in which the administration session must take place and proper locations for where regulated psychedelic facilitation may take place.
13. Age verification procedures to ensure that a participant is 21 years of age or older.
14. Specifies that education standards the Board adopts through regulation 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 California regulations and laws. Allows for limited waivers of education and training requirements based on an applicant’s prior experience, training, or skill with regulated psychedelic substances. Requires education and training standards adopted by the Board to include practicum requirements with a practicum supervisor but specifies that a facilitator is not required to have a professional license or professional degree other than a facilitator license. Authorizes the Board to consider expedited approval or partial approval for education programs that are already in existence in the state to train licensed mental health professionals in the provision of psychedelic facilitation.
15. Requires Board regulations to also include deidentified data collection and reporting requirements for facilitators in order to comprehensively measure the Facilitators’ Acts’ 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.
16. Authorizes the Board to license facilitators 21 years of age or older who: complete the education and curriculum requirements the Board will establish by regulation at a Board approved school; who passes a facilitator competency assessment the Board creates and administers or that is offered by an entity designated by the Board; who successfully passes a background investigation; who pays all fees the Board will establish through regulation or; who holds a current and valid registration, licensure, or license from any other state whose licensure requirements meet or exceed these.
17. Establishes various prohibited activities for applicants and licensees.
18. Provides title protection for facilitators.

Provisions Related to the Division And Marketplace Regulation

For Psychedelic Facilitation

1. Specifies various aspects of the Division, including:
2. The purpose and intent of the Division is to establish a comprehensive system to control and regulate the provision of psychedelic facilitation; the production, distribution, transportation, storage, processing, manufacturing, testing, quality control, and sale of regulated psychedelic substances for use only in conjunction with regulated psychedelic facilitation at approved locations; the approval of locations where regulated psychedelic facilitation may take place and; the collection and publication of deidentified and aggregate data and information on the implementation and outcomes of the Act.
3. The Director is appointed by the Governor and subject to confirmation by the Senate Committee on Rules.
4. The Division has as the power, duty, purpose, responsibility, and jurisdiction to regulate regulated psychedelic substances and the provision of psychedelic facilitation, and to approve locations where psychedelic facilitation may take place.
5. The Division must adopt regulations by January 1, 2026 concerning psilocybin, psilocyn, the spores or mycelium capable of producing mushrooms that contain psilocybin and psilocyn, and MDMA and must, at least every two years thereafter, adopt regulations concerning additional substances identified as regulated psychedelic substances, if recommended by the Oversight Committee.
6. Authority to employ individuals who are not peace officers to provide investigative services.
7. Requires the Division to convene the Oversight Committee to advise the Division and the Board, composed of 14 individuals who reside in California appointed by the Governor with at least one person in expertise in the following areas: mental or behavioral health; psychedelic facilitation; issues confronting veterans; developing and implementing evaluation methodologies to assess the outcomes of a program, including its achievements, safety, quality, and impact on individuals; health care insurance or barriers in access to health care; emergency medical services or first responders; mycology and regulated psychedelic substance cultivation; training psychedelic facilitators; the provision of harm reduction; harm reduction systems; regulated psychedelic substance research; indigenous uses of psychedelic substances; public health data collection and; expertise in naturopathic medicine.
8. Requires the Division to adopt regulations to establish categories of licensure and registration including, but not limited to:
9. A cultivation, processing, or manufacture license that would allow solely for the provision and sale of regulated psychedelic substances at the premises of an approved location for use during the administration session of a regulated psychedelic facilitation at that approved location.
10. A testing license for the testing of regulated psychedelic substances for quality, concentration, and contaminants.
11. Among other regulations the Division is required establish that mirror Board regulations, requires the Division to adopt regulations for:
12. Limitations on the number of licenses for cultivation, processing, or manufacture of regulated psychedelic substances and the volume of regulated psychedelic substances produced by licensees to ensure the amount of regulated psychedelic substances does not exceed the amount necessary to meet the demand for regulated psychedelic facilitation.
13. Requirements and standards for testing regulated psychedelic substances for quality, concentration, and contaminants.
14. Requirements for labeling regulated psychedelic substances.
15. Prohibitions on advertising, branding, and marketing regulated psychedelic substances, including prohibitions on claiming the regulated psychedelic substance is safe and effective or making health or medical claims about regulated psychedelic substances unless in compliance with federal law.
16. Requirements governing the licensing and operation of licensees, including psychedelic facilitation centers and approved locations
17. Procedures, policies, and programs to ensure that the licensing of regulated psychedelic substances and the provision of regulated psychedelic facilitation is equitable and inclusive and to promote the licensing of and the provision of regulated psychedelic facilitation to persons from low-income communities; to persons who face barriers to access to health care; to persons who have a history of traditional or indigenous use of regulated psychedelic substances; to persons who are or were first responders; and to persons who are veterans.
18. Requires the Division to enforce laws related to the cultivation, producing, manufacturing, processing, preparing, delivery, storage, sale, and testing of regulated psychedelic substances.
19. Requires the Division to collect and annually publish information on the its website pertaining to the implementation and outcomes of the Assisted Therapy Act to comprehensively measure its success, safety, quality, and impact on individuals’ well-being and public health. Requires the Division to consult with DPH on the best data collection, processing, and reporting methodologies and authorizes it to contract or collaborate with one or more California public universities to research and evaluate the Assisted Therapy Act. Specifies that information is deidentified or aggregated so no individual participant is identified and that information and data shall not be sold.

Other Provisions

1. Establishes a Psychedelic Substances Public Education and Harm Reduction Fund available to the Office of Community Partnerships and Strategic Communications within the Governor’s Office of Planning and Research upon appropriation by the Legislature to award grants for public education relating to psychedelic substances, including their limitations and potential risks, and mitigation measures, in addition to potential benefits as well as harm reduction.
2. Authorizes a city, county, or a city and county to reasonably regulate the time, place, and manner of regulated psychedelic facilitation within its boundaries but prohibits a city, county, or a city and county from banning or completely prohibiting facilitator operations and regulated psychedelic facilitation. Prohibits a city, county, or a city and county from enacting a greater fine or penalty for conduct related to regulated psychedelic facilitation or substances than is allowed under state law and from requiring an additional license or the payment of a fee in addition to the state license and fee for conduct related to regulated psychedelic facilitation or regulated psychedelic substance licensees, other than generally applicable licenses and fees that apply to all businesses operating with the jurisdiction. Prohibits a city, county, or a city and county from prohibiting the transportation of regulated psychedelic substances through its jurisdiction on public roads by a licensee or as otherwise allowed by the Acts.
3. Specifies that an individual 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 the Acts at an approved location or for enrolling or employing a person who engages in regulated psychedelic substance-related activities lawfully. Specifies that the use of regulated psychedelic substances in connection with regulated psychedelic facilitation shall not disqualify a person from any needed medical procedure or medical treatment or any other lawful health-related service, shall not, by itself, be the basis for punishing a person currently under parole, probation, or other state-supervised release, including pretrial release. Specifies that the Acts shall not restrict the sale, possession, display, or cultivation of living fungi, plants, or seeds that were lawful before the enactment of the Acts and that engaging in regulated psychedelic substance-related activities shall not, by itself, be the basis to deny eligibility for any public assistance program, unless required by federal law.

FISCAL EFFECT:

Unknown. This bill is keyed fiscal by Legislative Counsel.

COMMENTS:

1. Purpose. This bill is sponsored by Heroic Hearts Project. According to the Author:

“California is failing to provide residents with a safe, regulated program to access groundbreaking psychedelic-assisted therapy. As a result, many Californians are going abroad to access psychedelics or seeking out underground psychedelic facilitators and using unregulated substances. To ensure that Californians can access these substances as safely as possible, we must ensure Californians have the proper public education about the potential risks and harms around these substances and access to a safe, supervised, and regulated setting to use these substances for healing. Additionally, when Californians use substances in conjunction with psychedelic facilitation, those substances should be produced and tested by a licensed, regulated provider in accordance with proper safety standards. In addition, there is no state-supported effort to promote the development of professional standards of care for psychedelic-assisted therapy or educate the public about safe practices and the potential risks and benefits. This bill will fill this gap in California.

Current law lists psilocyn, psilocybin, mescaline, MDMA, and DMT as Schedule I Drugs. According to the Drug Enforcement Agency (DEA), Schedule I Drugs have “no accepted medical use and high potential for abuse.” However, within the medical research community, these psychedelic substances are well-documented as having therapeutic and medical benefits.

A promising 2020 study showed MDMA could be used in combination with psychotherapy to reduce anxiety in patients facing life-threatening illnesses. Recent clinical trials studying MDMA as a treatment for depression, anxiety, and Post-Traumatic Stress (PTSD) led the FDA to distinguish MDMA-assisted psychotherapy treatment as a “Breakthrough Therapy.” In 2018 and 2019, the FDA also issued the same distinction to psilocybin. Two different clinical trials showed psilocybin can reduce symptoms in patients with treatment-resistant depression. A Johns Hopkins study showed a significant decrease in depression and anxiety in cancer patients using psilocybin. These recent studies support decades of psychedelic research conducted in the medical field that demonstrates the potential of psychedelics to treat PTSD, anxiety, and depression. Observational studies have also documented the use of Ayahuasca (which contains DMT) to treat substance use disorder. When used in a safe and supervised setting, these substances have all been demonstrated to provide healing to their users and have documented medicinal use.

For California’s veterans and first responders, psychedelics have especially promising healing potential. Studies indicate that for veterans, many of whom live with PTSD, access to psychedelics can be effective in treating the acute trauma they face, and may even save their lives. Veterans die by suicide at a rate of one and a half times the general public. Many veterans who have used psychedelic medicines to treat their PTSD report that without this treatment, they would have taken their life. In January 2024, the Department of Veterans Affairs announced it would fund studies on the benefits of psychedelic substances, such as MDMA and psilocybin, when used with psychotherapy for treating PTSD and depression in veterans.

In recent years, a few states have acknowledged the healing potential of psychedelics and taken action to put a therapeutic framework in place for people to access these substances in a safe and controlled setting. In 2020, Oregon voters approved two ballot measures that decriminalized the personal use of all scheduled substances and authorized the creation of a state-licensed, psilocybin-assisted therapy program over the next two years. In 2022, Colorado voters approved a two-prong ballot measure that allowed access to psilocybin and ibogaine, and later to DMT and mescaline in a regulated therapeutic context, and decriminalized the noncommercial, personal possession of those same substances. The state is developing rules and regulations and will begin licensing facilitators in late 2024.

Last fall, the Legislature passed SB 58, my legislation that would have decriminalized the personal use and possession of certain psychedelic substances. In a message explaining his decision to veto the bill, Governor Newsom urged the Legislature to send him a bill establishing therapeutic guidelines for the use of psychedelics in California. As the Governor stated in his veto message:

‘Both peer-reviewed science and powerful personal anecdotes lead me to support new opportunities to address mental health through psychedelic medicines like those addressed in this bill. Psychedelics have proven to relieve people suffering from certain conditions such as depression, PTSD, traumatic brain injury, and other addictive personality traits. This is an exciting frontier and California will be on the front-end of leading it. . . . I urge the legislature to send me legislation next year that includes therapeutic guidelines.’

Senate Bill 1012 is a direct response to the Governor’s well-articulated request.”

1. Licensed Health Care Professionals. Numerous categories of licensed health professionals in California, including those who diagnose and treat various mental and behavioral health conditions, are subject to specific statutory requirements for the necessary education, training, clinical experience, and competency assessments in order to become licensed, as well as statutory frameworks for the practice authority that a license confers and requirements for continuing education.

Board of Behavioral Sciences. The BBS is responsible for the licensing and regulation of LMFTs, LCSWs, LPCCs, and LEPs. Each profession has its own scope of practice, entry-level requirements, and professional settings with some overlap in areas. All four of the BBS’s licensee and registrant categories provide some form of mental health services to a variety of clients in different settings. Licensed Marriage Family Therapists (LMFTs) are employed in mental health agencies, counseling centers, and private practice. LMFT’s utilize counseling or therapeutic techniques to assist individuals, couples, families, and groups with a focus on marriage, family, and relationship issues. Licensed Clinical Social Workers (LCSWs) are employed in health facilities, private practice, and state and county mental health agencies. LCSWs utilize counseling and psychotherapeutic techniques to assist individuals, couples, families, and groups. Licensed Professional Clinical Counselors (LPCCs) apply counseling interventions and psychotherapeutic techniques to identify and remediate cognitive, mental, and emotional issues, including personal growth, adjustment to disability, crisis intervention, and psychosocial and environmental problems. LPCCs work in a variety of settings including hospitals, private practice, and community-based mental health organizations. These license types also have assistant categories that allows individuals who have completed the required educational program and are in the process of obtaining the hours of supervisory experience required for licensure to have certain privileges.

Board of Psychology. BOP licenses psychologists and registers psychologists and psychological assistants. Applicants for a psychologist license must have a qualifying doctorate degree, complete a minimum of 3,000 hours of supervised professional experience, and pass a national examination and a California law and ethics examination. Psychological assistants must earn a qualifying master’s degree, must be registered to a licensed psychologist or a Board-certified psychiatrist as employees, and may provide limited psychological services under the direct supervision of the psychologist or psychiatrist with whom they are registered. Registered psychologists must earn a qualifying doctoral degree, must complete a specified number of hours of professional experience under supervision, and can only engage in psychological activities at qualifying nonprofit community agencies.

Medical Board of California. Physician and surgeon applicants for licensure must complete medical education at a medical school accredited by a national accrediting agency approved by MBC and recognized by the United States Department of Education or a foreign medical school listed on the World Directory of Medical Schools. They must pass nationally recognized examinations, the steps of the United States Medical Licensing Examination, and must complete postgraduate training.

Osteopathic Medical Board of California. In order to become licensed as a D.O., the law requires individuals to graduate from an accredited college of osteopathic medicine, complete postgraduate training, which includes a minimum of four months of medicine, and successfully complete all levels of the National Board of Osteopathic Medical Examiners Comprehensive Osteopathic Medical Licensing Examination which consists of three levels.

Naturopathic Medicine Committee. A licensed ND attends a four-year, graduate-level naturopathic medical school and is educated in all of the same basic sciences as an MD/DO, but also studies holistic and nontoxic approaches to therapy with a strong emphasis on disease prevention and optimizing wellness. In addition to a standard medical curriculum, the naturopathic doctor also studies clinical nutrition, homeopathic medicine, botanical medicine, psychology, and counseling. All applicants for ND licensure must pass the Naturopathic Physician Licensing Examination (NPLEX), a two-part examination that ensures a candidate is competent in their medical knowledge to safely practice naturopathic medicine. NDs are authorized to order physical and laboratory examinations, as well as diagnostic imaging studies under certain conditions. An ND may dispense, administer, order, prescribe, and furnish various foods, medicines, vitamins, therapies, and devices. An ND can engage in health education and counseling, and may treat superficial lacerations and abrasions, remove foreign bodies in superficial tissue. An ND is also authorized to furnish or order drugs in accordance with standardized procedures or protocols developed with a supervising physician and surgeon.

1. Controlled Substances. Through the Controlled Substances Act of 1970, the federal government regulates the manufacture, distribution, and dispensing of controlled substances. The Act ranks into five schedules those drugs known to have potential for physical or psychological harm, based on three considerations: (a) their potential for abuse; (b) their accepted medical use; and, (c) their accepted safety under medical supervision. California’s drug schedule is largely similar to the federal schedule. Schedule I includes the most serious and heavily controlled substances, while Schedule V includes the least serious and most lightly controlled substances.

Schedule I controlled substances have a high potential for abuse and no generally accepted medical use and include psychedelics.

Schedule II controlled substances have a currently accepted medical use in treatment, or a currently accepted medical use with severe restrictions, and have a high potential for abuse and psychological or physical dependence. Schedule II drugs can be narcotics or non-narcotic.

Schedule III and IV controlled substances have a currently accepted medical use in treatment, less potential for abuse but are known to be mixed in specific ways to achieve a narcotic-like end product.

Schedule V drugs have a low potential for abuse relative to substances listed in Schedule IV and consist primarily of preparations containing limited quantities of certain narcotics.

1. Psychedelics. According to National Institute on Drug Abuse (NIDA) hallucinogens are a class of drugs that cause hallucinations, profound distortions in a person’s perceptions of reality. Hallucinogens can be found in some plants and mushrooms (or their extracts) or can be man-made, and they are commonly divided into two broad categories: classic hallucinogens (such as LSD) and dissociative drugs (such as PCP).

While researchers debate how to describe and classify psychedelic and dissociative drugs and other drugs with similar properties, they generally group these drugs according to how they work in the brain. Some people use the term “hallucinogens” to refer to all or some psychedelic and dissociative drugs. When under the influence of either type of drug, people often report experiencing rapid, intense emotional swings and seeing images, hearing sounds, and feeling sensations that seem real but are not. While the exact mechanisms by which hallucinogens and dissociative drugs cause their effects are not yet clearly understood, research suggests that they work at least partially by temporarily disrupting communication between neurotransmitter systems throughout the brain and spinal cord that regulate mood, sensory perception, sleep, hunger, body temperature, sexual behavior, and muscle control.

Hallucinogenic and dissociative drugs have been used for a variety of reasons.

Historically, hallucinogenic plants have been used for religious rituals to induce

states of detachment from reality and precipitate “visions” thought to provide

mystical insight or enable contact with a spirit world or “higher power.” More

recently, people report using hallucinogenic drugs for more social or recreational

purposes, including to have fun, help them deal with stress, or enable them

to enter into what they perceive as a more enlightened sense of thinking or

being. Hallucinogens have also been investigated as therapeutic agents to treat

diseases associated with perceptual distortions, such as schizophrenia, obsessivecompulsive disorder, bipolar disorder, and dementia.

The U.S. Food and Drug Administration (FDA) has approved the ketamine derivative esketamine (under the brand name Spravato®) as a treatment for severe depression in patients who do not respond to other treatments. The FDA has also granted “Breakthrough Therapy” designation, a process designed to expedite the development and review of drugs that are intended to treat a serious condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint, for two formulations of psilocybin being studied as potential medical treatments for depression.

According to a 2022 JAMA Psychiatry article, Psychedelic Drug Legislative Reform and Legalization in the US, the legal status of psychedelic drugs is evolving. Though most of these substances remain federally controlled, some states and the District of Columbia have decriminalized possession of psilocybin and some similar drugs, or deprioritized enforcement of laws against the substances. Twenty-five states have considered 74 bills (69 legislative initiatives, 5 ballot measures). Nearly all bills specified psilocybin (67, or 90 percent), and many also included MDMA (27, or 36 percent). While bills varied in their framework, most (43, or 58 percent) proposed decriminalization, of which few delineated medical oversight (10 of 43) or training and/or licensure requirements (15 of 43).

In 2019, voters in Denver approved a measure to make the personal use and possession of psilocybin by adults 21 years of age and older the lowest law enforcement priority and to prohibit the city from spending resources to impose criminal penalties related to such conduct. That same year, the Oakland, California, City Council passed a resolution prohibiting the use of city funding “to assist in the enforcement of laws imposing criminal penalties for the use and possession of entheogenic plants by adults” and specifies that investigating people for growing, buying, distributing or possessing those substances “shall be amongst the lowest law enforcement priority for the City of Oakland.” Similarly, a resolution passed by the Santa Cruz, California, City Council in 2020 made the personal possession and use of entheogenic plants and fungi a low priority for law enforcement. The Ann Arbor, Michigan, City Council passed a similar measure that same year. Initiative 81, the Entheogenic Plant and Fungus Policy Act of 2020, makes “the investigation and arrest of persons 18 years of age or older, for non-commercial planting, cultivating, purchasing, transporting, distributing, engaging in practices with, and/or possessing entheogenic plants and fungi” among the lowest enforcement priorities for Washington D.C.’s local police department. Additional jurisdictions have passed similar measures since 2020.

In 2020, Oregon voters approved Measure 109, the Psilocybin Services Act, which directed the Oregon Health Authority to create a state-licensed, psilocybin-assisted therapy program over a two-year period. In implementing Measure 109, Oregon had to determine how to license and regulate the manufacturing, transportation, delivery, sale and purchase of psilocybin products as well as the provision of psilocybin services. Following the two-year development period for psilocybin services, the state began taking license applications on January 2, 2023. Psilocybin services refers to preparation, administration, and integration sessions provided by a licensed facilitator. Psilocybin services are available to individuals aged 21 and older and do not require a prescription or medical referral. The psilocybin products consumed must be cultivated or produced by a licensed psilocybin manufacturer and can only be provided to a client at a licensed psilocybin service center during an administration session.

Colorado voters approved Proposition 122 in November 2022 which, among other provisions, decriminalized the personal possession and use of psilocybin, psilocyn, DMT, Ibogaine and mescaline for adults aged 21 and older. The measure additionally established a program for licensed “healing centers” to administer psilocybin and psilocyn to adults by licensed professionals, and created a regulatory framework for the manufacture, cultivation, testing, storage, transport, transfer, delivery, sale, and purchase of the covered substances between healing centers and other permitted entities.

In 2021, Texas adopted House Bill 1802, which directed their Department of State Health Services to, in collaboration with the Texas Medical Board, conduct a study to evaluate the therapeutic efficacy of alternative therapies, including the use of MDMA, psilocybin, and ketamine in the treatment of mental health and other medical conditions including, depression, anxiety, PTSD, bipolar disorder, chronic pain, and migraines. The evaluation should include a determination of whether alternative therapies are effective in treating the mental health and other medical conditions described in the bill and to compare the efficacy of the alternative therapies with the efficacy of treatments currently used for those conditions.

1. Sunrise Questionnaire Response. Rules of the Senate Committee on Business, Professions, and Economic Development (Rule No. 6, Setting and Hearing of Bills) specify that “Prior to hearing any bill or other measure that proposes to create a new state licensing agency or a new category of licensed or regulated professional, the Author or sponsor of the legislation shall develop a plan for the establishment and operation of the agency or creation of the new licensed category in accordance with the requirements of Government Code Section 9148 et seq. The plan shall include the completion of an occupational regulation proposal review worksheet titled the ‘Sunrise Questionnaire’ by the Author or sponsor of the legislation.”

The Author and “Alliance for Safer Use of Psychedelics”, which states that it is an unincorporated association seeking regulation on behalf of the occupation of psychedelic facilitators, provided this information to the Committee (Psychedelic Acts Sunrise Response) on March 13, 2024.

In response to the questions related to public demand for a regulatory standard and the nature and severity of the harm a lack of licensure may result in, the responses in the Psychedelic Acts Sunrise Response state that “…in a recent poll conducted by the UC Berkeley Center for the Science of Psychedelics, 61% of American voters supported legalizing regulated therapeutic access to psychedelics, including 35% who reported “strong” support. In addition, 75% of people support making it easier for researchers to study psychedelic substances. According to a pilot study that examined the attitudes and knowledge of National Health Services psychiatrists of all levels towards psychedelic-assisted psychotherapy and explored potential barriers and facilitators to its implementation, 77% of psychiatrists felt there should be a role for the controlled or therapeutic use of psychedelics…Despite the renewed interest in psychedelic therapy and the findings of these studies, the general understanding of psychiatrists' perspectives on medicinal psychedelics remains limited due to the current lack of a regulated framework.

To address this gap, an anonymous survey was conducted among 106 psychiatrists attending psychedelic educational sessions at two national conferences, using a 26-item questionnaire. Overall, respondents expressed confidence in the therapeutic potential of psychedelics. Key concerns among psychiatrists included the scarcity of trained providers, logistical hurdles in therapy administration, safety considerations for clients with contraindications, and risks of diversion.”

The Psychedelic Acts Sunrise Response states the following as examples of consumer harm necessitating licensure:

• Requiring a psychedelic practitioner to practice in an unregulated environment, without mandated training or ethical duties imposed by similar professions, may bring about the following harms: lack of adequate screening for contraindications and pharmacological interactions, facilitator misconduct, increased risk of adverse psychological reactions, potential physical health complications, fear of seeking professional medical care, and the absence of proper guidance and therapeutic support, which could exacerbate mental health issues and lead to unsafe or traumatic experiences.
• A recent Stanford study found that California hospitalizations and emergency department visits related to the unregulated use of hallucinogens increased by more than 50% between 2016 and 2022. A regulated environment will reduce the risk of harm and allow practitioners to better understand the complexities of potential risks and adopt practices to mitigate them. Without a regulated alternative, many people interested in psychedelics who do not know how to find a facilitator or would like to avoid using an underground facilitator, may be more likely to use psychedelics alone or in a more dangerous context.
• While psychedelics generally have positive safety profiles, as with the use of any psychoactive substance, a participant or patient should go through a careful assessment of potential physiological and psychological risks before use. For many clients with complex conditions that can benefit from regulated psychedelics, their medications and underlying conditions may increase the risk for severe psychiatric, neurologic, or cardiovascular injury.
• In addition to physical harm, there have been several high-profile cases of sexual abuse during psychedelic sessions. As in any therapeutic relationship that involves therapist/patient power dynamics, there is a clear need for licensure and regulation to limit potential therapist abuse or exploitation.
• There is potential harm associated with improper facilitation and integration. A study that collected data from 608 participants identified anxiety, existential struggle, and social disconnection as potential long-term adverse effects of post-psychedelic use. Some of these difficulties persisted in some surveyed participants for weeks or longer. Some factors predicted a shorter duration or extent of difficulties, including knowledge of dosage and drug type, and having experiences in guided settings. This study suggests these risks can be addressed through proper facilitator training and oversight.
• While psychedelics have shown promise in treating various mental health conditions and facilitating profound personal insights, there are concerns about their potential to induce cognitive distortions or exacerbate pre-existing mental health issues when a participant is not screened properly. Prolonged or frequent use of psychedelics, especially in uncontrolled settings, may lead to disturbances in thought processes, memory impairment, or even acute psychosis in vulnerable individuals. The subjective nature of psychedelic experiences makes it difficult to predict their effects accurately, and without regulation, this lack of consistency could heighten the risk of unexpected intellectual and psychological consequences.
• As with many regulated professions, there is a risk of financial harm that can be largely mitigated by regulation and duties of care. There are several cases of unscrupulous people seeking money from people while they are on or in the days after taking psychedelics. There are also allegations of people using psychedelics to control vulnerable people and take control of their finances. Whether or not these allegations are true, a regulated profession will mandate facilitators to follow a code of ethics and regulatory oversight that will likely prohibit facilitators from engaging in financial transactions with their clients other than charging a reasonable fee for their services.

1. Licensure, Recognition and Regulation. According to a 2002 article featured in the Yale Journal of Regulation, to protect the public from potentially harmful health services rendered by unqualified people, each state has enacted licensing laws, or practice acts. The article noted that typically, these laws do three things: (1) They define the practice of the profession in question; (2) they limit that practice to people who satisfactorily complete a specified training regime and pass an examination; and (3) they restrict to license holders both the use of the professional title or credentials and the performance of the defined practice functions.

According to “A Theory of Regulation: A Platform for State Regulatory Reform”, 5:2 CAL. REG. L. REP. 3 (Spring 1985), “Government should regulate a particular trade or profession only after an honest assessment of the marketplace and any flaws which present a threat of irreparable harm, or prevent normal marketplace functioning from driving out incompetent, dishonest, or impaired practitioners. The article outlines that “licensing is one form of regulation but should be reserved for trades and professions in which incompetence is likely to cause irreparable harm — that is, harm for which money cannot compensate. If there is likely irreparable harm, then a prior restraint- type barrier to entry (licensing) which addresses and prevents that precise harm should be imposed; additionally, the licensing agency should set industrywide standards of conduct and ethics, and police violations of those standards through a vigorous enforcement program”. According to the article, in the absence of probable irreparable harm, numerous regulatory alternatives to licensing exist, including the posting of a bond to ensure a fund to compensate injured consumers, a certification program which has the effect of disclosing information to consumers about the qualifications of a practitioner and protects the use of a title or a permit program, as some examples.

A practice act along with licensure typically confers the exclusive right to practice a given profession on practitioners who meet specified criteria related to education, experience, and examination, and often is embodied in a statutory licensing act (i.e., those who are not licensed cannot lawfully practice the profession). A practice act is the highest and most restrictive form of professional regulation, and is intended to avert severe harm to the public health, safety or welfare that could be caused by unlicensed practitioners.

A title act and a certification or registration program, on the other hand, often reserves the use of a particular professional (named) designation to practitioners who have demonstrated specified education, experience or other criteria such as certification by another organization. A title act typically does not restrict the practice of a profession or occupation and allows others to practice within that profession; it merely differentiates between practitioners who meet the specified criteria, and are authorized by law to represent themselves accordingly, (usually by a specified title) and those who do not. Some title acts also include a state certification or registration program, or reliance on a national certification or registration program, so that those who use the specified title, and hold themselves out to the public, have been certified or registered by a state created or national entity as having met the specified requirements. This entity may also regulate to some extent the activities of the particular profession by setting standards for the profession to follow, and to also provide oversight of the practice of the profession by reporting unfair business practices or violations of the law and either denying or revoking a certification or registration if necessary.

This bill proposes licensure for facilitators and title protection for facilitators but does not delineate the specific standards for licensure and instead authorizes an entirely new regulatory program that the measure also creates to determine necessary education, training, experience, and knowledge to engage in the practice. The bill also proposes licensure for cultivation, processing, manufacture, and transportation of psychedelic substances and requires state approval of psychedelic facilitation locations.

1. Related Legislation. AB 941 (Waldron, 2024) requires the California Health and Human Services Agency to convene a workgroup to study and make recommendations on the establishment of a framework governing psychedelic-assisted therapy. Requires the workgroup to send a report to the Legislature containing those recommendations on or before January 1, 2026. Makes, contingent upon the Legislature enacting a framework governing psychedelic-assisted therapy, the use of hallucinogenic/psychedelic substances for psychedelic-assisted therapy lawful. (Status: The bill is pending in the Senate Committee on Rules.)

SB 58 (Weiner, 2023) would have decriminalized the use of certain psychedelics for personal use by individuals 21 years of age or older, would have also created a workgroup to study and recommend a framework for governing the therapeutic use of psychedlics, and would have defined “facilitated or supported use” as supervised or assisted personal use of a psychedelic by an individual or group of persons 21 years of age or older, or the assisting or supervising of such persons in such use, within the context of spiritual guidance, community-based healing, or related service. (Status: The bill was vetoed by the Governor who indicated in a veto message “California should immediately begin work to set up regulated treatment guidelines - replete with dosing information, therapeutic guidelines, rules to prevent against exploitation during guided treatments, and medical clearance of no underlying psychoses…I urge the legislature to send me legislation next year that includes therapeutic guidelines. I am, additionally, committed to working with the legislature and sponsors of this bill to craft legislation that would authorize permissible uses and consider a framework for potential broader decriminalization in the future, once the impacts, dosing, best practice, and safety guardrails are thoroughly contemplated and put in place.”)

SB 519 (Wiener, 2022) was substantially similar to SB 58 and was eventually amended to just establish a workgroup similar to AB 941. (Status: The bill failed passage in the Assembly.)

1. Arguments in Support. Supporters echo the Author’s statement in 1. above and note that “There is a growing body of credible evidence to show that psychedelics can help reduce symptoms of depression, anxiety, and PTSD when used in proper settings with safeguards like those proposed in this bill, which includes screening, preparation, integration and therapeutic support. Supporters also write that this bill “takes an evidence-based approach to providing access and mitigates risks by requiring that patients and practitioners collaborate to help ensure a safe experience…The bill also creates a first-in-the-nation public-private fund to support a public education program to promote safer use and increase understanding of psychedelic substances.” According to supporters, “This legislation provides Californians in need of alternative treatments the opportunity for psychedelic therapy and personal healing, with no threat to public safety.”
2. Stakeholder Comments. The California State Association of Psychiatrists is concerned about “the care of a vulnerable patient population with behavioral health illnesses and who best is able to provide the specialized care to help these patients. While new and innovative treatments to treat depression, anxiety, and other psychiatric disorders are needed, the evidence to support the therapeutic use of psychedelics is not yet robust enough to justify widespread access, especially for unsupervised use or use in the presence of non-medical individuals. CSAP believes the Legislature should exercise extreme caution in this area until there is more scientifically validated information on psychedelics with respect to the risks, benefits, and alternatives, not just at the individual level, but also at the level of public health and behavioral health.
3. Arguments in Opposition. Opponents write that “There is no conclusive evidence from scientific medical research substantiating the efficacy and innocuousness of the psychedelics. All drugs should go through proper FDA approval process for the protection of citizens.” Opponents write that “According to Dr. Roneet Lev, former Chief Medical Officer of the White House Office of National Drug Control Policy, psychedelics can cause serious negative consequences such as cardiac issues, seizures, depression, amnesia, acute anxiety, and hallucination, and are dangerous to users and bystanders alike. People can react to the drugs differently regardless. Recently, an off-duty pilot almost killed 83 passengers due to his using magic mushrooms. Even though he was handcuffed, the drug still empowered him to try turn off the engine. There are many medications for pain and depression without the serious negative consequences. Our veterans deserve better than being guinea pigs.”

The California State Sherriffs’ Association writes “…we are concerned about government condoning and facilitating the use of mind-altering drugs, especially those included as Schedule I controlled substances. We believe SB 1012 sends the wrong message about using drugs especially since the bill requires government licensure and a regulatory scheme to facilitate such use. Additionally, there are provisions of the bill’s regulatory plan to which we object. Specifically, the bill provides that a local government shall not ban or completely prohibit regulated psychedelic facilitators operating in accordance with the bill and rules created pursuant to the bill within its boundaries. At the very least, local governments should have some say as to whether they will be complicit in this risky venture.”

1. Policy Comments and Concerns.

Sunrise Review. The creation of a comprehensive new regulatory system, including multiple new state agencies and entities, requires significant input from stakeholders, existing licensees, experts in the particular field, advocates, industry, existing state agencies and state government players, and more. The effort contained in this bill would benefit from public meetings like informational hearings and other opportunities to fully evaluate the need for the state to regulate new categories of individuals, businesses, and industry players in the area of psychedelics through multiple new regulatory frameworks. Among other aspects, the bill contains significant duplication by establishing multiple programs that, with broad engagement and collective efforts, may be better structured and consolidated in an appropriate state entity.

Effective implementation of MAUCRSA has been ongoing since Prop 64 was passed by voters in 2016 and the Legislature is still asked annually to consider dozens of bills aimed at ensuring that the law works. This bill leaves the administration of the Acts entirely to the rulemaking process by requiring the Board and Division to promulgate myriad regulations. This process can take years, given requirements for notification, public comment and additional delays that arise whenever amendments to proposed regulations are made. It is unlikely that the Board and Division would be able to meet the deadlines for regulations set forth in this bill, and the regulatory process in general has been criticized for lacking transparency and robust stakeholder input that the Legislative process allows for.

SB 1012 was introduced on February 5, 2024, in the second year of the current two-year legislative session. Rushing the establishment of a massive new framework to allow Californians to access psychedelics, funded by a fee structure that does not exist, will lead to confusion and implementation challenges.

Is there a simpler approach? California has a history of providing access to

Schedule I controlled substances to certain patients under specified conditions. In 1996, California first legalized medicinal cannabis via Proposition 215, also known as the Compassionate Use Act. Proposition 215 protected qualified patients and their primary caregivers, who obtained and used marijuana for medical purposes upon the recommendation of a physician, from prosecution related to the possession and cultivation of cannabis. If the goal is to ensure that individuals, particularly those with certain conditions and under the care of existing providers (like veterans with PTSD who are oft cited as a patient population who may benefit from additional access to psychedelics) are able to safely access these substances as part of treatment and therapy, it is unclear why the bill does not start simply with a framework that empowers patients and their providers together to make this determination.

Absence of clinical judgment. In order for a licensed facilitator to facilitate an individual’s psychedelics session, the bill requires the individual to undergo a “Safety screen”, defined as a “screening for medical conditions, mental health conditions, family history, contraindications, and pharmacological interactions.” The screening would be conducted by the new category of facilitator established by the bill, rather than by any of the many existing, well-trained licensed healthcare providers with significant education, clinical experience, and statutory authority to determine these various necessary pieces of information.

Removing the judgment of clinicians to evaluate whether existing medical conditions and mental health conditions are present, and whether psychedelic facilitation will result in contraindications and pharmacological interactions with an individual’s existing medication therapies, is premature. Every study the Author and Sponsors cite highlighting the effectiveness of psychedelics to treat specified conditions includes information from controlled clinical experiences. For example, the Author notes “A promising 2020 study showed MDMA could be used in combination with psychotherapy to reduce anxiety in patients facing life-threatening illnesses.” This bill does not include the clinician providing psychotherapy or the licensed professional who diagnosed anxiety and other illnesses in making the determination that their patient would benefit from psychedelics. The Author also notes that “Recent clinical trials studying MDMA as a treatment for depression, anxiety, and [PTSD] led the FDA to distinguish MDMA-assisted psychotherapy treatment as a ‘Breakthrough Therapy.’” However, this bill does not require facilitators to have a professional degree, which is a requirement to engage in psychotherapy, and instead does not delineate any specific education, clinical training, or other experience that facilitators must meet in order to be licensed, unlike licensed healthcare professionals who provide psychotherapy according to statutory requirements.

According to the Author, “When used in a safe and supervised setting, these substances have all been demonstrated to provide healing to their users and have documented medicinal use.” Yet this bill does not specify any role for the California licensees with expertise in medical and behavioral health conditions, and significant knowledge of treatment and therapies for those conditions, including medicinal therapies. The only individuals authorized to facilitate psychedelics through this bill are facilitators. Notably, while the bill authorizes facilitators licensed in another state to become licensed in California, its structure requires a California licensee (like a LCSW or MFT or psychologist or ND or physician and surgeon) to become a licensed facilitator in order to facilitate psychedelic sessions with and for their patients. The bill specifies that “regulated psychedelic facilitation means services provided…by a regulated psychedelic facilitator…” and “regulated psychedelic facilitator means a person licensed by the Board…” Board of Behavioral Sciences licensees and Board of Psychology licensees do not currently have prescribing authority for legal drugs but facilitators who provide a screening could facilitate specified psychedelics for their patients. While it is possible that Board regulations outlining every aspect of what it takes to become a facilitator could allow for equivalency, based on possession of an existing California healthcare professional license, the existing licensee would still have to obtain a separate license in order to, for example, engage in the practice of psychology or psychotherapy and offer psychedelic facilitation to their patients whose medical history and conditions they acutely know.

Barriers to access and employment. A regulated marketplace at the state level for Schedule I controlled substances, including cannabis and, as other states’ experiences demonstrate, psychedelics, imposes a number of barriers. Media reports from Oregon highlight the high cost of regulated psychedelic facilitation, with sessions starting at $3,000 and up. While this bill mandates the Oversight Committee to advise the Board and Division on “Affordable, equitable, ethical, inclusive, and culturally responsible access to regulated psychedelic-assisted therapy and requirements to ensure access to regulated psychedelic facilitation is affordable, equitable, ethical, inclusive, and culturally responsible” and on “Identifying existing state funds and programs for improving public health outcomes and advising as to how these funds and programs may include psychedelic facilitation and services as options and be used to make access to psychedelic facilitation and services more affordable to low-income individuals”, the creation of any new regulatory structure comes with significant costs to participants, the public, and the state.

As the experience of DCC has proven, the costs of every aspect of regulation of a product can be extremely high, often prohibitive. California’s illicit cannabis marketplace is still thriving and remains rampant. The potential costs for individuals in California to participate in any aspect of a regulated psychedelic facilitation system will likely be significant. Californians will have to pay for education and training to be eligible for licensure as a facilitator; will have to pay to obtain approval for locations eligible for facilitation; will have to pay for a license to cultivate or manufacture psychedelics; will have to pay for a license to transport psychedelics; will have to pay to test psychedelics; will have to pay to become facilitators and; notably will have to pay for regulated psychedelic facilitation sessions.

The payment required for sessions will no doubt take into account all of the various aspects of regulation. Patients and consumers in every community, who face rising prices for services when the basic costs of doing business are high, may be limited in their ability to access regulated psychedelic facilitation.

Impact of local control prohibitions. This bill explicitly prohibits local governments from banning psychedelic facilitation in their jurisdiction. As the DCC notes, “Cannabis use is legal in California. But cities and counties can prohibit cannabis businesses, like retail. As a result, the state is a patchwork of areas where it is and is not legal to establish a cannabis business.” The practical impact of the language in this bill is that in the 324 of 539 cities and counties in California that do not authorize retail cannabis activity (60 percent of cities and counties), an individual would remain prohibited from accessing a substance that is legal in this state but could undergo regulated psychedelic facilitation and access illegal controlled substances in that same jurisdiction.

SUPPORT AND OPPOSITION:

Support:

A New Path
An Empathic Society
Board of Psychedelic Medicine and Therapies
California Association of Social Rehabilitation Agencies
California Coalition for Psychedelic Safety and Education
City of West Hollywood

Dr. Bronner's
End Well Foundation
Heroic Hearts Project, INC.
Law Enforcement Action Partnership
Nest Harm Reduction & Consulting
New Approach Advocacy Fund
Sacramento Institute for Psychotherapy
Shamynds Healing Center
Sonoma County Democratic Party
Steinberg Institute
The Institute for Rural Psychedelic Care
Veterans Exploring Treatment Solutions

Opposition:

California Baptist for Biblical Values
California Coalition Against Drugs
California Family Council

California State Sherriffs’ Association
Chinese American Institute for Empowerment
Citizens Commission on Human Rights
Interfaithstatewide Coalition
Traditional Values for Next Generations

A number of individuals

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