27030.
(a) Except as specified in Section 27014, the division shall, 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, 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.
(C) Establishing license application, issuance, denial, renewal, suspension, and revocation procedures.
(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 facilitator is properly licensed pursuant to 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.
(F) Safe transportation for the participant when the session is complete.
(G) Provisions to allow a psychedelic facilitation center or psychedelic facilitator to refuse to provide regulated psychedelic substances or facilitation to a participant.
(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.
(J) The requirements and standards for testing regulated psychedelic substances for quality, concentration, and contaminants.
(K) The requirements for labeling regulated psychedelic substances.
(L) 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 the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Sec. 301 et seq.).
(M) Insurance requirements to the extent that the policies are commercially available and not cost prohibitive.
(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 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 facilitation center location.
(E) Procedures and policies that allow for regulated psychedelic licensees to receive compensation for regulated psychedelic substances provided in conjunction with facilitation services at approved locations.
(F) Procedures and policies to ensure statewide access to regulated psychedelic facilitation.
(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.
(H) Rules that allow a regulated psychedelic facilitator to provide regulated psychedelic facilitation to a participant at an approved location.
(I) Rules that allow for approval of locations where regulated psychedelic facilitation may be provided by licensed 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 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. 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 facilitation at a reduced cost to low-income individuals.
(C) Incentivizing geographic and cultural diversity in licensing and the provision and availability of psychedelic facilitation.
(D) A process for annually reviewing the effectiveness of the policies and programs promulgated under this paragraph.
(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-Assisted Therapy Fund established in Section 27080.
(h) In carrying out its duties under this division, the division shall be guided by the Regulated Psychedelic Substances Expert Oversight Committee and may also consult with other state agencies or any other individual or entity the division finds necessary.