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ARIZONA STATE SENATE
Fifty-Seventh Legislature, First Regular Session
AMENDED
psilocybin services; regulation; licensure
(NOW: approved medication; rescheduling; controlled substance)
As passed by the Senate, S.B. 1555 established the Arizona Psilocybin Advisory Board and prescribes membership and duties.
The House of Representatives adopted a strike-everything amendment that does the following:
Purpose
Declares any pharmaceutical composition of crystalline polymorph psilocybin approved by the U.S. Food and Drug Administration (U.S. FDA) and rescheduled by the U.S. Drug Enforcement Administration (U.S. DEA) to a schedule other than Schedule I of the federal Controlled Substances Act (CSA) as a controlled substance that may be prescribed in Arizona.
Background
The federal CSA places all substances that are in some manner regulated under existing federal law into one of five schedules. The placements of the substances are based upon the substance's medical use, potential for abuse, and safety or dependence liability. The CSA states that if the U.S. Secretary of the Department of Health and Human Services (Secretary) recommends that the U.S. Attorney General (U.S. AG) control the drug in schedule II, III, IV or V, the U.S. AG must issue an interim final rule controlling the drug no later than 90 days after the date the U.S. AG receives the: 1) scientific and medical evaluation and the scheduling recommendation from the Secretary; or 2) notification of the approval of the application from the Secretary. Federal law requires any person to apply, and gain approval, through the Secretary prior to introducing or delivering any new drug for introduction into interstate commerce (U.S. DEA; 21 U.S.C. §§ 355 and 811).
On June 23, 2023, the U.S. FDA published a new draft guidance to highlight fundamental considerations to researchers investigating the use of psychedelic drugs, including natural and synthetic psilocybin, for potential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 The purpose of the draft guidance is to advise researchers on study design and other considerations as they develop medications that contain psychedelics.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 The draft guidance includes guidance for the use of psilocybin as a method of treatment, as it acts on the brain’s serotonin system (U.S. FDA).
There is no anticipated fiscal impact to the state General Fund associated with this legislation.
Provisions
1. Declares any pharmaceutical composition of crystalline polymorph psilocybin approved by the U.S. FDA and rescheduled by the U.S. DEA to a schedule other than Schedule I of the CSA as a controlled substance that may be prescribed in Arizona.
2. Declares it is the Legislature's intent that patients have rapid access to crystalline polymorph psilocybin treatment if approved by the U.S. FDA and rescheduled by the U.S. DEA.
3. Conditions the enactment of this legislation on, by January 1, 2031, federal approval of crystalline polymorph psilocybin as a newly approved prescription medication that is controlled under an issued federal interim final rule and published in the Federal Register.
4. Requires, by February 1, 2031, the Executive Director of the State Board of Pharmacy to notify the Director of the Arizona Legislative Council of either the date that the condition was met or that the condition was not met.
5. Makes conforming changes.
6. Becomes effective on the general effective date.
Amendments Adopted by the House of Representatives
· Adopted the strike-everything amendment relating to crystalline polymorph psilocybin.
House Action
HHS 3/24/25 DPA/SE 9-2-0-1
3rd Read 6/18/25 40-19-1
Prepared by Senate Research
June 18, 2025
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