Bill > H0549

Introduced Session

An act relating to the use of psilocybin for mental health treatment; providing a short title; creating s. 381.99, F.S.; providing definitions; providing purposes for the act; providing authority and duties of the Department of Health relating to the use of psilocybin for mental health treatment; prohibiting the department from issuing licenses relating to psilocybin products during a specified period; requiring the department to publish certain information on its Internet website by a specified date and periodically thereafter; requiring the department to prescribe forms and adopt rules by a specified date; establishing the Psilocybin Advisory Board within the department; providing a purpose for the board; providing for membership, meetings, and duties of the board; requiring the Governor to appoint certain persons to the board by a specified date; requiring that the board hold its first meeting by a specified date; requiring that the board submit its findings and recommendations to certain persons by a specified date; requiring the department to determine whether to develop a certain tracking system for psilocybin products or enter into an agreement with the Office of Medical Marijuana Use; providing hb0549-00 HB 549 requirements for such tracking system; requiring the department to preapprove labels and packaging of psilocybin products; providing requirements and prohibitions relating to the sale of psilocybin products; providing penalties; prohibiting the imposition of an additional tax on the sale of psilocybin products; requiring the department to regularly review the tax rate for psilocybin products and make recommendations to the Legislature regarding adjustments to such rate; authorizing a psilocybin product manufacturing facility to deliver psilocybin products under certain circumstances; prohibiting persons younger than 21 years of age from entering or attempting to enter any portion of a psilocybin product manufacturing facility or psilocybin service center; providing penalties and exceptions; requiring that the Department of Law Enforcement make the investigation and arrest of certain persons for specified offenses relating to psilocybin products a low priority; requiring a law enforcement officer to immediately notify the department of violations relating to psilocybin products; requiring certain governmental entities and authorities to immediately notify the department of a conviction of a licensee or licensee representative; providing sovereign immunity hb0549-00 HB 549 for officers and employees of the department in the performance of their duties relating to psilocybin products; preempting the regulation of psilocybin products and services to the state; creating s. 381.991, F.S.; providing duties of the department relating to the licensing of psilocybin product manufacturing facilities, service centers, facilitators, and testing laboratories and the permitting of licensee representatives; requiring that the department receive applications for such licensure or permitting by a specified date; providing requirements for the application process for such licensure or permitting; authorizing the department to revoke, suspend, or refuse to issue or renew a license or permit; authorizing an applicant to appeal department determinations relating to such licensure or permitting; providing certain requirements for an application for licensure or permitting; providing fingerprinting and background screening requirements; providing requirements and prohibitions relating to the licensure and operation of psilocybin product manufacturing facilities, service centers, facilitators, and testing laboratories and the permitting of licensee representatives; providing grounds for the revocation, suspension, or restriction hb0549-00 HB 549 of a license or permit and refusal to issue a license or permit; requiring the department to adopt rules establishing standards relating to the operation of psilocybin product manufacturing facilities, service centers, facilitators, and testing laboratories and the permitting of licensee representatives; authorizing the department to inspect the records and premises of licensees; providing certain prohibitions; authorizing the department to require licensees to maintain general liability insurance coverage; authorizing the department to investigate and take disciplinary action against licensees and licensee representatives for certain violations; providing for the enforceability of contracts; providing certain protections for licensee representatives; providing for the rights of deceased, insolvent, or bankrupt persons or licensees and their property interests; providing construction and severability; providing an effective date. WHEREAS, the state has one of the highest prevalence rates of mental illness among adults in the nation, and WHEREAS, an estimated one in every five adults in the state is coping with a mental health condition, and WHEREAS, in 2020, the Governor announced a plan to use $5 hb0549-00 HB 549 million from a grant provided through the United States Department of Labor for the Support to Communities: Fostering Opioid Recovery Through Workforce Development pilot program to combat addiction in the state, and WHEREAS, the Governor's budget for the 2020-2021 fiscal year proposes spending more than $770 million on mental and behavioral health programs, and WHEREAS, studies conducted by nationally and internationally recognized medical institutions indicate that psilocybin has shown efficacy, tolerability, and safety in the treatment of a variety of mental health conditions, including, but not limited to, addiction, depression, anxiety disorders, and end-of-life psychological distress, and WHEREAS, the United States Food and Drug Administration has determined that preliminary clinical evidence indicates that psilocybin may demonstrate substantial improvement over available therapies for treatment-resistant depression, has granted a Breakthrough Therapy designation for a treatment that uses psilocybin as a therapy for such depression, and has determined that microdose amounts of psilocybin products may improve mental health, reduce neuroticism, and alter attentional capacities by reducing mind wandering and increasing absorption, NOW, THEREFORE,

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Michael Grieco (D)*,  Nicholas Duran (D), 

Died in Professions & Public Health Subcommittee (on 04/30/2021)

Official Document