Read the full stored bill text
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
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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
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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
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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
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any biological product, except for blood and blood components
79
intended for transfusion or biological products that are also
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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
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suspected adverse reaction that results in death, a life
85
threatening adverse event, inpatient hospitalization or
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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
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medical or surgical intervention to prevent one of the outcomes
93
listed in this paragraph.
94
(h)
“Suspected adverse reaction” means any adverse event
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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
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prescription medication at its facility or in connection with
101
providing services must obtain and maintain a license from the
102
board.
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(b)
Failure to obtain a license or comply with any
104
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
111
person.
112
(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
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.
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(b)
A licensed medical spa may only acquire or receive
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prescription medication from a person who holds the license,
120
registration, permit, or other authorization required to
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distribute or otherwise transfer such prescription medication.
122
(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
127
requirements for controlled substances and medications,
128
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
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
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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
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patients directly affected by the serious adverse event.
164
(9)
DECEPTIVE AND UNFAIR TRADE PRACTICES.—A licensed
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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.