Licensure of Medical Spas

HB 1429 2026

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A bill to be entitled 1
An act relating to licensure of medical spas; creating 2
s. 381.9811, F.S.; providing a short title; providing 3
legislative findings and purpose; providing 4
definitions; requiring medical spas to be licensed 5
under certain circumstances; providing licensure 6
requirements; requiring the Board of Pharmacy to 7
maintain a public database of licensed medical spas; 8
providing database requirements; providing that a 9
medical spa is a dispenser; prohibiting a medical spa 10
from acquiring or receiving certain prescription 11
medications; providing storage requirements for 12
prescription medications and certain devices; 13
requiring medical spas to have certain security 14
controls; requiring medical spas to designate a 15
responsible person; providing requirements for a 16
responsible person; providing that submission of an 17
application for licensure by a medical spa constitutes 18
permission for inspections; providing requirements for 19
inspections; requiring medical spas to notify the 20
board of any adverse incidents within a specified 21
timeframe; providing notice requirements; providing 22
that a violation of specified provisions constitutes 23
an unfair and deceptive trade practice; authorizing 24
the board to investigate certain violations and 25

HB 1429 2026

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provide penalties; requiring the board to adopt rules; 26
providing an effective date. 27
28
Be It Enacted by the Legislature of the State of Florida: 29
30
Section 1. Section 381.9811, Florida Statutes, is created 31
to read: 32
381.9811 Licensure of medical spas.— 33
(1) SHORT TITLE.—This section may be cited as the "Medical 34
Spa Prescription Drug Oversight Act." 35
(2)(a) FINDINGS AND PURPOSE.—The Legislature finds that 36
patients are increasingly turning to medical spas for cosmetic 37
and medical procedures. Many of these medical spas prepare and 38
administer prescription medications intended to be sterile, 39
either compounded or commercially available formulations, with 40
no regulatory oversight by the Board of Pharmacy, which raises 41
significant patient safety concerns. 42
(b) The purpose of this section is to license a medical 43
spa that prepares, handles, stores, administers, dispenses, 44
distributes, or otherwise uses prescription medications at the 45
medical spa or in connection with providing services. 46
(3) DEFINITIONS.—As used in this section, the term: 47
(a) "Adverse event" means any untoward medical occurrence 48
associated with the use of a prescription medication, whether or 49
not the event itself is considered prescription medication-50

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related. 51
(b) "Board" means the Board of Pharmacy. 52
(c) "Medical spa" means any facility or practice that 53
offers medical or health care services and that holds itself out 54
as a facility or practice focused on cosmetic or lifestyle 55
treatments, such as weight loss, wellness, longevity, or 56
cosmetic or aesthetic health care services, including, but not 57
limited to, the preparation, administration, or dispensing of 58
prescription drugs for weight loss; botulinum toxin injections; 59
hormone therapies; or parenteral nutrient therapies. The term 60
does not include a facility or practice that otherwise holds a 61
health care facility license from the state. 62
(d) "Person" means an individual, a corporation, a 63
government, a governmental subdivision or agency, a statutory 64
trust, a business trust, an estate, a trust, a partnership, or 65
an unincorporated association, or one or more of the foregoing 66
having a joint or common interest, or any other legal or 67
commercial entity. 68
(e) "Prescription medication" means any drug, including, 69
but not limited to, finished dosage forms or active ingredients 70
that are subject to, defined in, or described in s. 503(b) of 71
the Federal Food, Drug, and Cosmetic Act or in s. 465.003, s. 72
499.003(17), s. 499.007(13), or s. 499.82(10). The term includes 73
any biological product, except for blood and blood components 74
intended for transfusion or biological products that are also 75

HB 1429 2026

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medical devices. 76
(f) "Responsible person" means a licensed healthcare 77
provider with supervising authority at a medical spa. 78
(g) "Serious adverse event" means an adverse event or 79
suspected adverse reaction that results in death, a life-80
threatening adverse event, inpatient hospitalization or 81
prolongation of existing hospitalization, a persistent or 82
significant incapacity or substantial disruption of the ability 83
to conduct normal life functions, or a congenital anomaly or 84
birth defect. The term includes events that may be considered 85
serious when, based upon appropriate medical judgment, such 86
events may jeopardize the patient's health and may require 87
medical or surgical intervention to prevent one of the outcomes 88
listed in this paragraph. 89
(h) "Suspected adverse reaction" means any adverse event 90
for which there is a reasonable possibility that a prescription 91
medication caused such event. 92
(4) LICENSURE.— 93
(a) Each medical spa location that prepares, handles, 94
stores, administers, dispenses, distributes, or otherwise uses 95
prescription medication at its facility or in connection with 96
providing services must obtain and maintain a license from the 97
board. 98
(b) Failure to obtain a license or comply with any 99
requirements in this section may result in disciplinary action, 100

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including, but not limited to, fines, suspension, or revocation 101
of the license. 102
(c) The board shall maintain a public database of each 103
medical spa licensed by this state. The database shall include, 104
at a minimum, the name, address, and license number of each 105
medical spa and the name and license number of the responsible 106
person. 107
(5) PRESCRIPTION MEDICATIONS.— 108
(a) A licensed medical spa is a dispenser under s. 109
581(3)(A) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C., 110
and shall comply with the requirements provided in s. 582 of the 111
Federal Food, Drug, and Cosmetic Act, 21 U.S.C. s. 360eee-1. 112
(b) A licensed medical spa may only acquire or receive 113
prescription medication from any person who holds the license, 114
registration, permit, or other authorization required to 115
distribute or otherwise transfer such prescription medication. 116
(c)1. Prescription medications, and active pharmaceutical 117
ingredients for use in such medications, and devices shall be 118
stored in areas that are dry, well-lit, well-ventilated, and 119
maintained in a clean and orderly condition. Prescription 120
medications shall be stored in accordance with specific storage 121
requirements for controlled substances and medications, 122
consistent with the label and instructions for use of the 123
prescription medication. 124
2. Noncontrolled prescription medications and hypodermic 125

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syringes, needles, and other objects used, intended for use, or 126
designed for use in parenterally injecting controlled substances 127
into the human body shall be maintained under appropriate 128
supervision and control at all times. 129
(d) A licensed medical spa shall have security controls 130
and procedures to deter and detect the theft and diversion of 131
prescription drugs. The security and control of prescription 132
drugs is the responsibility of both the responsible person and 133
the medical spa. 134
(6) RESPONSIBLE PERSON.— 135
(a) Each licensed medical spa shall have a designated 136
responsible person. The board may approve a responsible person 137
to be the responsible person at more than one location. 138
(b) The responsible person shall be physically present at 139
the medical spa location for a sufficient amount of time to 140
perform his or her responsibilities. 141
(c) The responsible person must ensure the medical spa is 142
in compliance with this section. 143
(7) INSPECTIONS.—Submission of an application for a 144
license by a medical spa constitutes permission for entry and 145
onsite inspection by the board or a third party approved by the 146
board. Such inspection will occur in connection with initial 147
licensure and as determined by the board. Refusal to allow the 148
board or third-party access to conduct an inspection is a 149
violation of this section. 150

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(8) ADVERSE INCIDENTS.— 151
(a) A licensed medical spa shall notify the board within 5 152
business days after the occurrence of a serious adverse event. 153
(b) The notice shall include, to the extent such 154
information is obtained by or reasonably available to the 155
medical spa from any source, the date, the nature, and the 156
location of the adverse event and medical spa records of 157
patients directly affected by the serious adverse event. 158
(9) DECEPTIVE AND UNFAIR TRADE PRACTICES.—A licensed 159
medical spa engages in deceptive and unfair trade practices, in 160
violation of the Florida Deceptive and Unfair Trade Practices 161
Act, when, in the course of business, the medical spa 162
misrepresents a prescription medication as having: 163
(a) A particular standard, quality, or grade; 164
(b) Sponsorship, approval, characteristics, ingredients, 165
uses, or benefits; 166
(c) A function similar to a drug approved by the federal 167
Food and Drug Administration; or 168
(d) Approval from the federal Food and Drug 169
Administration. 170
(10) INVESTIGATIONS AND PENALTIES.— 171
(a) The board shall enforce this section, including 172
actions for which a license is required under this section when 173
a medical spa has failed to obtain a license. If the board has 174
or receives information that any provision of this section has 175

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been violated, the board shall investigate and take appropriate 176
action. 177
(b) Violations include, but are not limited to, all of the 178
following: 179
1. Violations of the practice of pharmacy as provided 180
under chapter 465; 181
2. Violations of any rule or regulation of the board; 182
3. Violations that pose a threat to the public health, as 183
determined by the board; 184
4. Engaging or attempting to engage in the possession, 185
sale, or distribution of controlled substances as set forth in 186
chapter 893, for any other than legitimate purposes authorized 187
by this section; or 188
5. Violations of any provision of the Federal Food, Drug, 189
and Cosmetic Act, 52 Stat. 1040 (1938), 21 U.S.C. ss. 301 et 190
seq. or 21 U.S.C. ss. 801-971. 191
(c) The board shall maintain a public record of 192
disciplinary actions involving medical spas, subject to 193
transparency and confidentiality laws. 194
(11) RULES.—The board shall adopt rules to implement this 195
section within 6 months after this section takes effect. 196
Section 2. This act shall take effect upon becoming a law. 197