Assigned to HHS                                                                                                                                                                                                                                         FOR COMMITTEE
ARIZONA STATE SENATE
Fifty-Sixth Legislature, First Regular Session
public safety; technical correction
(NOW: prescriptions; approval; controlled substance)
Effective on federal approval of a 3, 4-methylenedioxymethamphetamine (MDMA) product, declares that any U.S. Food and Drug and Administration (FDA) approved compound, mixture or preparation containing MDMA that is rescheduled by the U.S. Drug Enforcement Administration (U.S. DEA), to a schedule other than schedule I is a controlled substance and may be prescribed in Arizona.
MDMA is a synthetic drug that alters mood and perception and is chemically similar to both stimulants and hallucinogens. MDMA increases the activity of dopamine, norepinephrine and serotonin in the brain and its effects last about three to six hours. MDMA is currently in clinical trials as a possible treatment aid for post-traumatic stress disorder (PTSD), anxiety in terminally ill patients and for social anxiety in autistic adults (National Institute on Drug Abuse). Recently, the FDA designated MDMA-assisted psychotherapy for PTSD as a breakthrough therapy drug, which are intended to treat a serious or life-threatening disease or condition. A breakthrough therapy designation also means that preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints (FDA).
The federal Controlled Substances Act (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).
PTSD is a mental health condition that is triggered by either experiencing or witnessing a terrifying event. Symptoms may start within one month of a traumatic event but may not appear until years later and can cause significant problems in social and work situations as well as in relationships. Symptoms may include flashbacks, nightmares, severe anxiety and uncontrollable thoughts about the event (Mayo Clinic).
There is no anticipated fiscal impact to the state General Fund associated with this legislation.
1.   Declares that any FDA-approved compound, mixture or preparation that contains MDMA and is rescheduled by the U.S. DEA, to a schedule other than schedule I, is a controlled substance and may be prescribed in Arizona.
2.   Declares that it is the Legislatures intent that patients have rapid access to this treatment option if MDMA medication is approved by the FDA and rescheduled by the U.S. DEA.
3.   Conditions the enactment of this legislation on the approval of an MDMA investigational product, by January 1, 2026, that is:
a)   a newly approved prescription medication;
b)   controlled under an issued federal interim final rule; and
c)   published in the Federal Register.
4.   Requires the Director of the Arizona State Board of Pharmacy to notify the Director of Legislative Council by February 1, 2026, in writing, of either:
a)   the date on which the condition was met; or
b)   that the condition was not met.
5.   Cites this legislation as the PTSD Treatment Act of 2023.
6.   Makes conforming changes.
7.   Contains a legislative findings clause.
8.   Becomes effective by January 1, 2026, subject to the provisions of the conditional enactment.
APPROP                 2/20/23           DPA/SE       15-0-0-0
3rd Read                   2/28/23                                               31-28-1
Prepared by Senate Research
March 10, 2023