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FL S1508
Bill
AI Summary
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Creates registration requirements for clinics using or advertising stem cell treatments, unless operating as a licensed hospital, physician-owned practice, accredited medical school affiliate, or providing only umbilical cord blood banking, oocyte procedures, or platelet-rich plasma injections.
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Requires each clinic location to designate a licensed physician or osteopathic physician with an active, unencumbered license who must practice at that location; failure to maintain a designated physician may result in summary suspension of registration.
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Prohibits physicians and osteopathic physicians from practicing in unregistered stem cell clinics and mandates compliance with federal good manufacturing practices for stem cell collection, processing, and transfer under 21 U.S.C. § 301 et seq. and 21 C.F.R. 1271.
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Authorizes the Department of Health to impose administrative fines up to $5,000 per violation, with fines of $5,000 per day for operating unregistered clinics or failing to register after ownership changes; establishes factors for determining penalty amounts including violation gravity, corrective actions, prior violations, and financial benefits derived.
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Requires the Department of Health and medical boards to adopt rules for clinic registration, annual inspection, advertising standards, adverse incident reporting, and informed consent guidelines, with applicants bearing all registration and inspection costs.
Legislative Description
Use of Stem Cells in a Clinic Setting
Last Action
Died in Rules
3/10/2018