27030.
(a) Except as specified in Section 27014, the division shall, in consultation with the advisory consistent with the recommendations of the expert oversight committee and in accordance with the Administrative Procedure Act (Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code), adopt regulations consistent with this division for the administration and enforcement of laws regulating regulated psychedelic substances and services. The regulations shall do all of the following:(1) License qualified persons or entities for activities related to regulated psychedelic substances that include:
(A) Establishing categories of licensure and registration including, but not limited to, the following:
(i) A cultivation, processing, manufacture, delivery, or sales-only license that would allow for the provision and sale of regulated psychedelic substances at the premises of a separately licensed psychedelic-assisted therapy center or approved location for use during an administration session at that psychedelic-assisted therapy center or
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.
(ii) A testing license for the testing of regulated psychedelic substances for quality, concentration, and contaminants.
(B) Approving locations where psychedelic substances may be provided to participants in conjunction with psychedelic facilitation by a regulated psychedelic facilitator.
(B)
(C) Establishing license application, issuance, denial, renewal, suspension, and revocation procedures.
(C)
(D) Establishing application, licensing, and renewal fees that shall be sufficient, but not exceed the amount necessary, to cover the cost of administering this division, and, for licensing and renewal fees, scaled based on either the volume of business of the licensee or the gross annual revenue of the licensee.
(2) In collaboration with the Board of Regulated Psychedelic Facilitators, establish requirements governing the safe provision of regulated psychedelic substances to participants at approved locations that include:
(A) Contraindications due to medical condition, mental health history, family history, and pharmacological interactions and contraindications for the particular substances being used.
(B) Health and safety warnings to be provided to participants before regulated psychedelic substances are provided.
(C) Recommended dosages of regulated psychedelic substances.
(D) Documentation that the regulated psychedelic-assisted therapy
psychedelic facilitator is properly licensed pursuant to Chapter 7.1 (commencing with Section 3200) of Division 2. this division.
(E) Documentation that the location of the regulated psychedelic facilitation is properly licensed or approved pursuant to regulations promulgated pursuant to this division.
(E)
(F) Safe transportation for the participant when the session is complete.
(F)
(G) Provisions to allow a psychedelic-assisted therapy center or facilitator to refuse to provide regulated psychedelic substances or therapy
psychedelic facilitation center or psychedelic facilitator to refuse to provide regulated psychedelic substances or facilitation to a participant.
(G)
(H) Procedures for handling and reporting adverse reactions and serious adverse reactions.
(I) 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.
(H)
(J) The requirements and standards for testing of regulated psychedelic substances for quality, concentration, and contaminants.
(K) The requirements for labeling
regulated psychedelic substances.
(I)
(L) Prohibitions on advertising, branding, and marketing regulated psychedelic substances or making substances, including prohibitions on claiming the regulated psychedelic substance is safe and effective or making health or medical claims about regulated psychedelic substances.
substances unless in compliance with the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Sec. 301 et seq.).
(J)
(M) Insurance requirements to the extent that the policies are commercially available and not cost prohibitive.
(K)
(N) Age verification
procedures to ensure that a participant is 21 years of age or older.
(3) Establish the requirements governing the licensing and operation of psychedelic-assisted therapy
licensees, including psychedelic facilitation centers and approved locations that include:
(A) Oversight requirements for regulated psychedelic licensees.
(B) Recordkeeping, privacy, and confidentiality requirements for regulated psychedelic licensees, provided the recordkeeping does not result in the disclosure to the public or any unauthorized governmental agency of personally identifiable information of participants.
(C) Deidentified data collection and reporting requirements for pertaining to the implementation and outcomes of this act.
(D) Security requirements for regulated psychedelic licensees, including requirements for protection of each licensed psychedelic-assisted therapy
psychedelic facilitation center location.
(E) Procedures and policies that allow for regulated psychedelic licensees to receive compensation for services and regulated psychedelic substances provided in conjunction with therapeutic services. facilitation services at approved locations.
(F) Procedures and policies to ensure statewide access to regulated psychedelic-assisted therapy.
psychedelic facilitation.
(G)Rules that prohibit an individual from having a financial interest in more than five psychedelic-assisted therapy locations.
(H)
(G) Rules that allow for regulated psychedelic licensees to share the same premises with other regulated psychedelic licensees or to share the same premises with health care facilities so that a participant may receive regulated psychedelic substances from one regulated psychedelic licensee and complete the administration session at a separately owned and approved location.
facilities.
(I)
(H) Rules that allow a regulated psychedelic-assisted therapy psychedelic facilitator to provide regulated psychedelic-assisted therapy psychedelic facilitation to a participant at an approved
location.
(J)
(I) Rules that allow for approval of locations where regulated psychedelic-assisted therapy
psychedelic facilitation may be provided by licensed psychedelic-assisted therapy psychedelic facilitators, including, but not limited to, health care facilities, clinics, and private residences.
(4) Establish procedures, policies, and programs to ensure that the licensing of regulated psychedelic substances and the provision of regulated psychedelic-assisted therapy psychedelic facilitation is equitable and inclusive and to promote the licensing of and the provision
of regulated psychedelic-assisted therapy
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. The procedures, policies, and programs shall include, but are not limited to:
(A) Reduced fees for licensure and other support services for applicants, which may include loans and grants.
(B) Incentivizing the provision of regulated psychedelic-assisted therapy psychedelic facilitation
at a reduced cost to low-income individuals.
(C) Incentivizing geographic and cultural diversity in licensing and the provision and availability of regulated psychedelic-assisted therapy. psychedelic facilitation.
(D) A process for annually reviewing the effectiveness of the policies and programs promulgated under this paragraph.
(5)Gather and publish, on an annual basis, adequate information to evaluate the implementation, safety, equity, quality, and outcomes of this division and Chapter 7.1 (commencing with Section 3200) of Division 2, following sound data and privacy protocols, without revealing any identifiable details pertaining to individual participants.
(6)
(5) Adopt, amend, and repeal rules as necessary to implement this division and to protect the public health and safety.
(b) Upon receiving a complete application for a license under this division, the division shall have 120 days to issue its decision on the application.
(c) The division may suspend or revoke a regulated psychedelic substances license under regulations made pursuant to this division upon written notice of a violation and, if applicable, an opportunity to cure any violation within 30 days of the notice.
(d) The division shall enforce the laws and regulations
relating to the cultivation, producing, manufacturing, processing, preparing, delivery, storage, sale, and testing of regulated psychedelic substances. The division shall conduct investigations of compliance with this division and shall perform regular inspections of licensees and the books and records of licensees as necessary to enforce this division. The division shall cooperate with appropriate state and local organizations to provide training to law enforcement officers of the state and its political subdivisions.
(e) The division shall annually publish a report of its actions during each year containing a comprehensive description of its activities and a statement of revenue and expenses of the division.
(f) The division shall have the authority to collect available and relevant information and data necessary to performs its functions and duties under this act, but must not disclose the identity of any participant or publicly disclose any information that could disclose the identity of a participant.
(g) The division shall deposit all license fees, registration fees, and monetary penalties collected pursuant to this division in the Regulated Psychedelic Substances Control Psychedelic-Assisted Therapy Fund established in Section 27060.
27080.
(h) In carrying out its duties under this division, the division shall consult with
be guided by the Regulated Psychedelic Substances Advisory Expert Oversight Committee and may also consult with other state agencies or any other individual or entity the division finds necessary.
27031.
(a) Actions Notwithstanding any other law, actions and conduct by a licensee that are authorized pursuant to a valid license issued by the division, and by those who allow property to be used by a licensee, as permitted pursuant to a valid license issued by the division, are lawful under state and local law, and shall not be a violation of state or local law.(b) No state or local governmental agency shall impose any criminal, civil, or administrative penalty on any licensee or on those who allow
property to be used by a licensee solely for actions or conduct permitted pursuant to a valid license issued by the division.
(c) Actions and conduct by a licensee that are permitted pursuant to a valid license issued by the division, and by those who allow property to be used by a licensee, as permitted pursuant to a valid license issued by the division, shall not be a basis for seizure or forfeiture of any products, materials, equipment, property, or assets under state or local law.
(d) Nothing in this section shall be construed or interpreted to:
(1) Prevent the division from enforcing its rules and regulations against a licensee.
(2) Prevent a state or
local governmental agency from enforcing a law, rule, or regulation that is not in conflict with the provisions of this division or the rules and regulations of the division, and is consistent with the intents and purposes of the
Regulated Psychedelic-assisted Therapy Act (Chapter 7.1 (commencing with Section 3200) of Division 2), as specified in Section 3200. division.
(3) Prevent a city, county, or a city and county from enforcing a local zoning ordinance, local ordinance of general application, or local ordinance enacted pursuant to Section 27046. 27055.