Florida Senate - 2026 SB 1728
By Senator Gruters
22-01039A-26 20261728__
1 A bill to be entitled
2 An act relating to licensure of medical spas; creating
3 s. 381.9811, F.S.; providing a short title; providing
4 legislative findings and purpose; defining terms;
5 requiring medical spas to be licensed under certain
6 circumstances; providing for disciplinary action;
7 requiring the Board of Pharmacy to maintain a public
8 database of licensed medical spas; providing database
9 requirements; providing that a medical spa is a
10 dispenser for certain purposes; authorizing a medical
11 spa to acquire or receive prescription medication only
12 from certain parties; providing storage requirements
13 for prescription medications and certain devices;
14 requiring medical spas to have certain security
15 controls; requiring medical spas to designate a
16 responsible person; providing requirements for a
17 responsible person; providing that submission of an
18 application for licensure by a medical spa constitutes
19 permission for inspections; providing requirements for
20 inspections; requiring medical spas to notify the
21 board of any adverse incidents within a specified
22 timeframe; providing notice requirements; providing
23 that a violation of specified provisions constitutes
24 an unfair and deceptive trade practice; providing for
25 enforcement; authorizing the board to investigate
26 certain violations and impose penalties; requiring the
27 board to maintain a public record of disciplinary
28 actions against medical spas; requiring the board to
29 adopt rules within a specified timeframe; providing an
30 effective date.
31
32 Be It Enacted by the Legislature of the State of Florida:
33
34 Section 1. Section 381.9811, Florida Statutes, is created
35 to read:
36 381.9811 Licensure of medical spas.—
37 (1) SHORT TITLE.—This section may be cited as the “Medical
38 Spa Prescription Drug Oversight Act.”
39 (2) FINDINGS AND PURPOSE.—
40 (a) The Legislature finds that patients are increasingly
41 turning to medical spas for cosmetic and medical procedures.
42 Many of these medical spas prepare and administer prescription
43 medications intended to be sterile, either compounded or
44 commercially available formulations, with no regulatory
45 oversight by the Board of Pharmacy, which raises significant
46 patient safety concerns.
47 (b) The purpose of this section is to license a medical spa
48 that prepares, handles, stores, administers, dispenses,
49 distributes, or otherwise uses prescription medications at the
50 medical spa or in connection with providing services.
51 (3) DEFINITIONS.—As used in this section, the term:
52 (a) “Adverse event” means any untoward medical occurrence
53 associated with the use of a prescription medication, whether or
54 not the event itself is considered prescription medication
55 related.
56 (b) “Board” means the Board of Pharmacy.
57 (c) “Medical spa” means any facility or practice that
58 offers medical or health care services and that holds itself out
59 as a facility or practice focused on cosmetic or lifestyle
60 treatments, such as weight loss, wellness, longevity, or
61 cosmetic or aesthetic health care services, including, but not
62 limited to, the preparation, administration, or dispensing of
63 prescription drugs for weight loss; botulinum toxin injections;
64 hormone therapies; or parenteral nutrient therapies. The term
65 does not include a facility or practice that otherwise holds a
66 health care facility license from the state.
67 (d) “Person” means an individual, a corporation, a
68 government, a governmental subdivision or agency, a statutory
69 trust, a business trust, an estate, a trust, a partnership, or
70 an unincorporated association, or one or more of the foregoing
71 having a joint or common interest, or any other legal or
72 commercial entity.
73 (e) “Prescription medication” means any drug, including,
74 but not limited to, finished dosage forms or active ingredients
75 that are subject to, defined in, or described in s. 503(b) of
76 the Federal Food, Drug, and Cosmetic Act or in s. 465.003, s.
77 499.003(17), s. 499.007(13), or s. 499.82(10). The term includes
78 any biological product, except for blood and blood components
79 intended for transfusion or biological products that are also
80 medical devices.
81 (f) “Responsible person” means a licensed health care
82 provider with supervising authority at a medical spa.
83 (g) “Serious adverse event” means an adverse event or
84 suspected adverse reaction that results in death, a life
85 threatening adverse event, inpatient hospitalization or
86 prolongation of existing hospitalization, a persistent or
87 significant incapacity or substantial disruption of the ability
88 to conduct normal life functions, or a congenital anomaly or
89 birth defect. The term includes events that may be considered
90 serious when, based upon appropriate medical judgment, such
91 events may jeopardize the patient’s health and may require
92 medical or surgical intervention to prevent one of the outcomes
93 listed in this paragraph.
94 (h) “Suspected adverse reaction” means any adverse event
95 for which there is a reasonable possibility that a prescription
96 medication caused such event.
97 (4) LICENSURE.—
98 (a) Each medical spa location that prepares, handles,
99 stores, administers, dispenses, distributes, or otherwise uses
100 prescription medication at its facility or in connection with
101 providing services must obtain and maintain a license from the
102 board.
103 (b) Failure to obtain a license or comply with any
104 requirements in this section may result in disciplinary action,
105 including, but not limited to, fines, suspension, or revocation
106 of the license.
107 (c) The board shall maintain a public database of each
108 medical spa licensed by this state. The database shall include,
109 at a minimum, the name, address, and license number of each
110 medical spa and the name and license number of the responsible
111 person.
112 (5) PRESCRIPTION MEDICATIONS.—
113 (a) A licensed medical spa is a dispenser under s.
114 581(3)(A) of the Federal Food, Drug, and Cosmetic Act, 21
115 U.S.C., and shall comply with the requirements provided in s.
116 582 of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. s.
117 360eee-1.
118 (b) A licensed medical spa may only acquire or receive
119 prescription medication from a person who holds the license,
120 registration, permit, or other authorization required to
121 distribute or otherwise transfer such prescription medication.
122 (c)1. Prescription medications, and active pharmaceutical
123 ingredients for use in such medications, and devices shall be
124 stored in areas that are dry, well-lit, well-ventilated, and
125 maintained in a clean and orderly condition. Prescription
126 medications shall be stored in accordance with specific storage
127 requirements for controlled substances and medications,
128 consistent with the label and instructions for use of the
129 prescription medication.
130 2. Noncontrolled prescription medications and hypodermic
131 syringes, needles, and other objects used, intended for use, or
132 designed for use in parenterally injecting controlled substances
133 into the human body shall be maintained under appropriate
134 supervision and control at all times.
135 (d) A licensed medical spa shall have security controls and
136 procedures to deter and detect the theft and diversion of
137 prescription drugs. The security and control of prescription
138 drugs is the responsibility of both the responsible person and
139 the medical spa.
140 (6) RESPONSIBLE PERSON.—
141 (a) Each licensed medical spa shall have a designated
142 responsible person. The board may approve a responsible person
143 to be the responsible person at more than one location.
144 (b) The responsible person shall be physically present at
145 the medical spa location for a sufficient amount of time to
146 perform his or her responsibilities.
147 (c) The responsible person must ensure the medical spa is
148 in compliance with this section.
149 (7) INSPECTIONS.—Submission of an application for a license
150 by a medical spa constitutes permission for entry and onsite
151 inspection by the board or a third party approved by the board.
152 Such inspection must occur in connection with initial licensure
153 and as determined by the board. Refusal to allow the board or
154 third party access to conduct an inspection is a violation of
155 this section.
156 (8) ADVERSE INCIDENTS.—
157 (a) A licensed medical spa shall notify the board within 5
158 business days after the occurrence of a serious adverse event.
159 (b) The notice shall include, to the extent such
160 information is obtained by or reasonably available to the
161 medical spa from any source, the date, the nature, and the
162 location of the adverse event and medical spa records of
163 patients directly affected by the serious adverse event.
164 (9) DECEPTIVE AND UNFAIR TRADE PRACTICES.—A licensed
165 medical spa engages in deceptive and unfair trade practices, in
166 violation of the Florida Deceptive and Unfair Trade Practices
167 Act, when, in the course of business, the medical spa
168 misrepresents a prescription medication as having:
169 (a) A particular standard, quality, or grade;
170 (b) Sponsorship, approval, characteristics, ingredients,
171 uses, or benefits;
172 (c) A function similar to a drug approved by the federal
173 Food and Drug Administration; or
174 (d) Approval from the federal Food and Drug Administration.
175 (10) INVESTIGATIONS AND PENALTIES.—
176 (a) The board shall enforce this section, including actions
177 for which a license is required under this section when a
178 medical spa has failed to obtain a license. If the board has or
179 receives information that any provision of this section has been
180 violated, the board shall investigate and take appropriate
181 action.
182 (b) Violations include, but are not limited to, all of the
183 following:
184 1. Violations of the practice of pharmacy as provided under
185 chapter 465;
186 2. Violations of any rule or regulation of the board;
187 3. Violations that pose a threat to the public health, as
188 determined by the board;
189 4. Engaging or attempting to engage in the possession,
190 sale, or distribution of controlled substances as set forth in
191 chapter 893, for any other than legitimate purposes authorized
192 by this section; or
193 5. Violations of any provision of the Federal Food, Drug,
194 and Cosmetic Act, 52 Stat. 1040 (1938), 21 U.S.C. ss. 301 et
195 seq. or 21 U.S.C. ss. 801-971.
196 (c) The board shall maintain a public record of
197 disciplinary actions involving medical spas, subject to
198 transparency and confidentiality laws.
199 (11) RULES.—The board shall adopt rules to implement this
200 section within 6 months after this section takes effect.
201 Section 2. This act shall take effect July 1, 2026.