THE BILL ITSELF
HB 1429
Licensure of Medical Spas
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A bill to be entitled
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An act relating to licensure of medical spas; creating
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s. 381.9811, F.S.; providing a short title; providing
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legislative findings and purpose; providing
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definitions; requiring medical spas to be licensed
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under certain circumstances; providing licensure
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requirements; requiring the Board of Pharmacy to
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maintain a public database of licensed medical spas;
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providing database requirements; providing that a
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medical spa is a dispenser; prohibiting a medical spa
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from acquiring or receiving certain prescription
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medications; providing storage requirements for
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prescription medications and certain devices;
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requiring medical spas to have certain security
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controls; requiring medical spas to designate a
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responsible person; providing requirements for a
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responsible person; providing that submission of an
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application for licensure by a medical spa constitutes
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permission for inspections; providing requirements for
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inspections; requiring medical spas to notify the
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board of any adverse incidents within a specified
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timeframe; providing notice requirements; providing
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that a violation of specified provisions constitutes
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an unfair and deceptive trade practice; authorizing
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the board to investigate certain violations and
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provide penalties; requiring the board to adopt rules;
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providing an effective date.
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Be It Enacted by the Legislature of the State of Florida:
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Section 1. Section 381.9811, Florida Statutes, is created
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to read:
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381.9811 Licensure of medical spas.—
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(1) SHORT TITLE.—This section may be cited as the "Medical
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Spa Prescription Drug Oversight Act."
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(2)(a) FINDINGS AND PURPOSE.—The Legislature finds that
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patients are increasingly turning to medical spas for cosmetic
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and medical procedures. Many of these medical spas prepare and
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administer prescription medications intended to be sterile,
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either compounded or commercially available formulations, with
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no regulatory oversight by the Board of Pharmacy, which raises
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significant patient safety concerns.
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(b) The purpose of this section is to license a medical
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spa that prepares, handles, stores, administers, dispenses,
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distributes, or otherwise uses prescription medications at the
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medical spa or in connection with providing services.
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(3) DEFINITIONS.—As used in this section, the term:
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(a) "Adverse event" means any untoward medical occurrence
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associated with the use of a prescription medication, whether or
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not the event itself is considered prescription medication-
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related.
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(b) "Board" means the Board of Pharmacy.
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(c) "Medical spa" means any facility or practice that
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offers medical or health care services and that holds itself out
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as a facility or practice focused on cosmetic or lifestyle
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treatments, such as weight loss, wellness, longevity, or
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cosmetic or aesthetic health care services, including, but not
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limited to, the preparation, administration, or dispensing of
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prescription drugs for weight loss; botulinum toxin injections;
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hormone therapies; or parenteral nutrient therapies. The term
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does not include a facility or practice that otherwise holds a
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health care facility license from the state.
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(d) "Person" means an individual, a corporation, a
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government, a governmental subdivision or agency, a statutory
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trust, a business trust, an estate, a trust, a partnership, or
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an unincorporated association, or one or more of the foregoing
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having a joint or common interest, or any other legal or
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commercial entity.
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(e) "Prescription medication" means any drug, including,
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but not limited to, finished dosage forms or active ingredients
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that are subject to, defined in, or described in s. 503(b) of
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the Federal Food, Drug, and Cosmetic Act or in s. 465.003, s.
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499.003(17), s. 499.007(13), or s. 499.82(10). The term includes
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any biological product, except for blood and blood components
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intended for transfusion or biological products that are also
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medical devices.
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(f) "Responsible person" means a licensed healthcare
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provider with supervising authority at a medical spa.
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(g) "Serious adverse event" means an adverse event or
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suspected adverse reaction that results in death, a life-
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threatening adverse event, inpatient hospitalization or
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prolongation of existing hospitalization, a persistent or
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significant incapacity or substantial disruption of the ability
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to conduct normal life functions, or a congenital anomaly or
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birth defect. The term includes events that may be considered
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serious when, based upon appropriate medical judgment, such
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events may jeopardize the patient's health and may require
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medical or surgical intervention to prevent one of the outcomes
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listed in this paragraph.
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(h) "Suspected adverse reaction" means any adverse event
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for which there is a reasonable possibility that a prescription
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medication caused such event.
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(4) LICENSURE.—
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(a) Each medical spa location that prepares, handles,
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stores, administers, dispenses, distributes, or otherwise uses
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prescription medication at its facility or in connection with
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providing services must obtain and maintain a license from the
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board.
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(b) Failure to obtain a license or comply with any
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requirements in this section may result in disciplinary action,
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including, but not limited to, fines, suspension, or revocation
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of the license.
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(c) The board shall maintain a public database of each
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medical spa licensed by this state. The database shall include,
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at a minimum, the name, address, and license number of each
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medical spa and the name and license number of the responsible
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person.
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(5) PRESCRIPTION MEDICATIONS.—
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(a) A licensed medical spa is a dispenser under s.
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581(3)(A) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C.,
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and shall comply with the requirements provided in s. 582 of the
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Federal Food, Drug, and Cosmetic Act, 21 U.S.C. s. 360eee-1.
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(b) A licensed medical spa may only acquire or receive
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prescription medication from any person who holds the license,
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registration, permit, or other authorization required to
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distribute or otherwise transfer such prescription medication.
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(c)1. Prescription medications, and active pharmaceutical
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ingredients for use in such medications, and devices shall be
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stored in areas that are dry, well-lit, well-ventilated, and
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maintained in a clean and orderly condition. Prescription
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medications shall be stored in accordance with specific storage
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requirements for controlled substances and medications,
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consistent with the label and instructions for use of the
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prescription medication.
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2. Noncontrolled prescription medications and hypodermic
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syringes, needles, and other objects used, intended for use, or
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designed for use in parenterally injecting controlled substances
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into the human body shall be maintained under appropriate
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supervision and control at all times.
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(d) A licensed medical spa shall have security controls
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and procedures to deter and detect the theft and diversion of
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prescription drugs. The security and control of prescription
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drugs is the responsibility of both the responsible person and
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the medical spa.
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(6) RESPONSIBLE PERSON.—
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(a) Each licensed medical spa shall have a designated
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responsible person. The board may approve a responsible person
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to be the responsible person at more than one location.
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(b) The responsible person shall be physically present at
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the medical spa location for a sufficient amount of time to
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perform his or her responsibilities.
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(c) The responsible person must ensure the medical spa is
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in compliance with this section.
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(7) INSPECTIONS.—Submission of an application for a
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license by a medical spa constitutes permission for entry and
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onsite inspection by the board or a third party approved by the
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board. Such inspection will occur in connection with initial
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licensure and as determined by the board. Refusal to allow the
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board or third-party access to conduct an inspection is a
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violation of this section.
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(8) ADVERSE INCIDENTS.—
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(a) A licensed medical spa shall notify the board within 5
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business days after the occurrence of a serious adverse event.
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(b) The notice shall include, to the extent such
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information is obtained by or reasonably available to the
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medical spa from any source, the date, the nature, and the
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location of the adverse event and medical spa records of
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patients directly affected by the serious adverse event.
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(9) DECEPTIVE AND UNFAIR TRADE PRACTICES.—A licensed
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medical spa engages in deceptive and unfair trade practices, in
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violation of the Florida Deceptive and Unfair Trade Practices
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Act, when, in the course of business, the medical spa
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misrepresents a prescription medication as having:
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(a) A particular standard, quality, or grade;
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(b) Sponsorship, approval, characteristics, ingredients,
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uses, or benefits;
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(c) A function similar to a drug approved by the federal
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Food and Drug Administration; or
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(d) Approval from the federal Food and Drug
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Administration.
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(10) INVESTIGATIONS AND PENALTIES.—
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(a) The board shall enforce this section, including
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actions for which a license is required under this section when
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a medical spa has failed to obtain a license. If the board has
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or receives information that any provision of this section has
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been violated, the board shall investigate and take appropriate
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action.
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(b) Violations include, but are not limited to, all of the
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following:
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1. Violations of the practice of pharmacy as provided
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under chapter 465;
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2. Violations of any rule or regulation of the board;
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3. Violations that pose a threat to the public health, as
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determined by the board;
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4. Engaging or attempting to engage in the possession,
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sale, or distribution of controlled substances as set forth in
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chapter 893, for any other than legitimate purposes authorized
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by this section; or
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5. Violations of any provision of the Federal Food, Drug,
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and Cosmetic Act, 52 Stat. 1040 (1938), 21 U.S.C. ss. 301 et
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seq. or 21 U.S.C. ss. 801-971.
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(c) The board shall maintain a public record of
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disciplinary actions involving medical spas, subject to
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transparency and confidentiality laws.
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(11) RULES.—The board shall adopt rules to implement this
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section within 6 months after this section takes effect.
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Section 2. This act shall take effect upon becoming a law.