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ARIZONA STATE SENATE
Fifty-Seventh Legislature, First Regular Session
AMENDED
psilocybin services; regulation; licensure
Purpose
Establishes the Arizona Psilocybin Advisory Board (Board) and prescribes Board membership and duties.
Background
The Legislature appropriated $5 million in FY 2024 to DHS to provide competitive research grants for whole mushroom psilocybin phase one, phase two and phase three clinical trials that are capable of being approved by the U.S. Food and Drug Administration (U.S. FDA), to evaluate the effects of whole mushroom psilocybin on treating outlined conditions, including but not limited to: 1) post-traumatic stress disorder; 2) autoimmune disorders; 3) depression; 4) anxiety disorders; 5) substance abuse and addiction disorders; 6) chronic pain; and 7) seizure disorders. This grant program is overseen by the Psilocybin Research Advisory Council, who is charged with establishing criteria for clinical trials and grant eligibility, overseeing the application process to select credible clinical trials and make recommendations to the Governor and Legislature each year on psychedelic-assisted therapy, based on federal and state research policy. Grants must be awarded by February 1 of each year. The Psilocybin Research Grant Program is repealed on July 1, 2026 (Laws 2023, Ch. 139).
On June 23, 2023, the U.S. FDA published a new draft guidance to highlight fundamental considerations to researchers investigating the use of psychedelic drugs for potential treatment of medical conditions, including psychiatric or substance use disorders. The purpose of the draft guidance is to advise researchers on study design and other considerations as they develop medications that contain psychedelics. This effectively creates a path for psychedelic drug trials to occur. The draft guidance includes guidance for the use of psilocybin as a method of treatment, as it acts on the brain’s serotonin system (FDA).
If there is a cost associated with DHS licensing and oversight of psychedelic-assisted therapy centers, there may be a fiscal impact to the state General Fund.
Provisions
1. Establishes the Board within DHS, consisting of no more than 12 members, who are appointed as follows:
a) four members appointed by the Governor, including a:
i. representative of DHS;
ii. representative of the Arizona Health Care Cost Containment System;
iii. representative of the Office of the Attorney General;
iv. representative of DHS who is familiar with health care institution licensing; or
v. professor or researcher at a university under the Arizona Board of Regents;
b) four members appointed by the President of the Senate, including:
i. an active member or a veteran of the U.S. Armed Forces;
ii. a law enforcement officer in Arizona;
iii. a representative of Arizona firefighters; and
iv. a legal representative of and advocate for persons with mental illness or severe mental illness; or
c) four members appointed by the Speaker of the House of Representatives, including a licensed:
i. psychologist with professional experience in diagnosing or treating mental, emotional or behavioral conditions;
ii. medical or osteopathic physician, preferably a psychiatrist, experienced in psychedelic-assisted therapy;
iii. naturopathic physician;
iv. nurse practitioner;
v. medical or osteopathic physician with expertise in addiction treatment; or
vi. medical or osteopathic physician with experience conducting clinical research trials involving the use of schedule I controlled substances.
2. Requires the Governor, President of the Senate and Speaker of the House of Representatives to make appointments to the Board by December 31, 2025.
3. Requires the Board to hold its first meeting, at a time and place specified by DHS, by March 1, 2026.
4. Limits Board members to two four-year terms, in addition to any time served on the Board to fill a vacancy.
5. Allows a person to be reappointed to the Board after the person has been off the Board for at least two full terms.
6. Requires the Board to annually elect a chairperson among members of the Board.
7. Requires the Board to meet at least once every two calendar months at a time and place determined by the chairperson or a majority of the voting Board members.
8. States that Board members are ineligible to receive compensation but are eligible for reimbursement of expenses.
9. Requires, by July 31, 2026, and each subsequent July 31, the Board, in consultation with DHS, to publish and distribute a public report that includes a summary of:
a) available medical, psychological and scientific studies, research and other information relating to the safety and efficacy of psilocybin in treating mental health conditions, including addiction, depression, anxiety disorders and end-of-life psychological distress; and
b) proposed and enacted laws, regulations and policies regarding psilocybin by other stats or the federal government.
10. Becomes effective on the general effective date.
Amendments Adopted by Committee
· Removes the establishment of a regulatory system for psychedelic-assisted therapy centers and related requirements.
Senate Action
HHS 2/20/25 DPA 5-0-2
Prepared by Senate Research
February 20, 2025
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