Florida Senate - 2026 SB 1092
By Senator Massullo
11-00695-26 20261092__
1 A bill to be entitled
2 An act relating to podiatric medicine; amending s.
3 461.007, F.S.; requiring certain podiatric physicians,
4 instead of all podiatric physicians, to complete
5 specified continuing education; creating s. 461.011,
6 F.S.; providing legislative findings and intent;
7 defining terms; authorizing podiatric physicians to
8 perform stem cell therapy not approved by the United
9 States Food and Drug Administration under certain
10 circumstances; specifying requirements for the stem
11 cells that may be used by such podiatric physicians;
12 requiring podiatric physicians who perform such
13 therapies to use stem cell therapy products obtained
14 from facilities that adhere to applicable current good
15 manufacturing practices; requiring podiatric
16 physicians to include a specified notice in any form
17 of advertisement; specifying requirements for such
18 notice; requiring podiatric physicians to obtain a
19 signed consent form from the patient or his or her
20 representative before performing such stem cell
21 therapy; specifying requirements for the consent form;
22 providing applicability; providing for disciplinary
23 action; providing criminal penalties; authorizing the
24 Board of Podiatric Medicine to adopt rules; providing
25 an effective date.
26
27 Be It Enacted by the Legislature of the State of Florida:
28
29 Section 1. Subsection (3) of section 461.007, Florida
30 Statutes, is amended to read:
31 461.007 Renewal of license.—
32 (3) The board may by rule prescribe continuing education,
33 not to exceed 40 hours biennially, as a condition for renewal of
34 a license, with a minimum of 2 hours of continuing education
35 related to the safe and effective prescribing of controlled
36 substances for licensees who are registered with the United
37 States Drug Enforcement Administration and authorized to
38 prescribe controlled substance pursuant to 21 U.S.C. s. 822. The
39 criteria for such programs or courses shall be approved by the
40 board.
41 Section 2. Section 461.011, Florida Statutes, is created to
42 read:
43 461.011 Stem cell therapy.—
44 (1) The Legislature recognizes the significant potential of
45 stem cell therapies in advancing medical treatments and
46 improving patient outcomes and further recognizes the need to
47 ensure that such therapies are provided using stem cells
48 obtained in an ethical manner that does not involve stem cells
49 derived from aborted fetuses. It is the intent of the
50 Legislature to foster medical innovation while upholding ethical
51 standards that respect the sanctity of life. By encouraging the
52 use of stem cell sources such as adult stem cells, umbilical
53 cord blood, and other ethically obtained human cells, tissues,
54 or cellular or tissue-based products, the state will advance
55 regenerative medicine in a manner consistent with the values of
56 this state.
57 (2) As used in this section, the term:
58 (a) “Human cells, tissues, or cellular or tissue-based
59 products” means articles containing or consisting of human cells
60 or tissues that are intended for implantation, transplantation,
61 infusion, or transfer into a human recipient. The term does not
62 include:
63 1. Vascularized human organs for transplantation;
64 2. Whole blood or blood components or blood derivative
65 products;
66 3. Secreted or extracted human products, such as milk,
67 collagen, and cell factors, other than semen;
68 4. Minimally manipulated bone marrow for homologous use and
69 not combined with another article other than water,
70 crystalloids, or a sterilizing, preserving, or storage agent, if
71 the addition of the agent does not raise new clinical safety
72 concerns with respect to the bone marrow;
73 5. Ancillary products used in the manufacture of human
74 cells, tissues, or cellular or tissue-based products;
75 6. Cells, tissues, and organs derived from animals;
76 7. In vitro diagnostic products; or
77 8. Blood vessels recovered with an organ which are intended
78 for use in organ transplantation and labeled “For use in organ
79 transplantation only.”
80 (b) “Minimally manipulated” means:
81 1. For structural tissue, processing that does not alter
82 the original relevant characteristics of the tissue relating to
83 the tissue’s utility for reconstruction, repair, or replacement.
84 2. For cells or nonstructural tissues, processing that does
85 not alter the relevant biological characteristics of cells or
86 tissues.
87 (c) “Physician” means a podiatric physician licensed under
88 this chapter acting in the course and scope of his or her
89 employment.
90 (d) “Stem cell therapy” means a treatment involving the use
91 of afterbirth placental perinatal stem cells, or human cells,
92 tissues, or cellular or tissue-based products, which complies
93 with the regulatory requirements provided in this section. The
94 term does not include treatment or research using human cells or
95 tissues that were derived from a fetus or an embryo after an
96 abortion.
97 (3)(a) A physician may perform stem cell therapy that is
98 not approved by the United States Food and Drug Administration
99 if such therapy is used for treatment or procedures that are
100 within the scope of practice for such physician and the
101 therapies are related to orthopedics, wound care, or pain
102 management.
103 (b) To ensure that the retrieval, manufacture, storage, and
104 use of stem cells used for therapies conducted under this
105 section meet the highest standards, any stem cells used by a
106 physician for therapy provided under this section must meet all
107 of the following conditions:
108 1. Be retrieved, manufactured, and stored in a facility
109 that is registered and regulated by the United States Food and
110 Drug Administration.
111 2. Be retrieved, manufactured, and stored in a facility
112 that is certified or accredited by one of the following
113 entities:
114 a. The National Marrow Donor Program.
115 b. The World Marrow Donor Association.
116 c. The Association for the Advancement of Blood and
117 Biotherapies.
118 d. The American Association of Tissue Banks.
119 3. Contain viable or live cells upon post-thaw analysis and
120 be included in a post-thaw viability analysis report for the
121 product lot which will be sent to the physician before use with
122 the physician’s patient.
123 (c) A physician performing stem cell therapy may not obtain
124 stem cells for therapies from a facility engaging in the
125 retrieval, manufacture, or storage of stem cells intended for
126 human use under this section unless the facility maintains valid
127 certification or accreditation as required by this subsection.
128 Any contract or other agreement by which a physician obtains
129 stem cells for therapies from such a facility must include the
130 following:
131 1. A requirement that the facility provide all of the
132 following information to the physician:
133 a. The name and address of the facility.
134 b. The certifying or accrediting organization.
135 c. The type and scope of certification or accreditation.
136 d. The effective and expiration dates of the certification
137 or accreditation.
138 e. Any limitations or conditions imposed by the certifying
139 or accrediting organization.
140 2. A requirement that the facility notify the physician
141 within 30 days after any change in certification or
142 accreditation status, including renewal, suspension, revocation,
143 or expiration.
144 (4) In the performance of any procedure using or purporting
145 to use stem cells or products containing stem cells, the
146 physician shall use stem cell therapy products obtained from
147 facilities that adhere to the applicable current good
148 manufacturing practices for the collection, removal, processing,
149 implantation, and transfer of stem cells, or products containing
150 stem cells, pursuant to the Federal Food, Drug, and Cosmetic
151 Act, 21 U.S.C. ss. 301 et seq.; 52 Stat. 1040 et seq.; and 21
152 C.F.R. part 1271, Human Cells, Tissues, and Cellular and Tissue
153 Based Products.
154 (5)(a) A physician who conducts stem cell therapy pursuant
155 to this section shall include the following in any form of
156 advertisement:
157
158 THIS NOTICE MUST BE PROVIDED TO YOU UNDER FLORIDA LAW.
159 This physician performs one or more stem cell
160 therapies that have not yet been approved by the
161 United States Food and Drug Administration. You are
162 encouraged to consult with your primary care provider
163 before undergoing any stem cell therapy.
164
165 (b) The notice required under paragraph (a) must be clearly
166 legible and in a type size no smaller than the largest type size
167 used in the advertisement.
168 (6)(a) A physician who conducts stem cell therapy pursuant
169 to this section shall obtain a signed consent form from the
170 patient before performing the stem cell therapy.
171 (b) The consent form must be signed by the patient or, if
172 the patient is not legally competent, the patient’s
173 representative and must state all of the following in language
174 the patient or his or her representative may reasonably be
175 expected to understand:
176 1. The nature and character of the proposed treatment.
177 2. That the proposed stem cell therapy has not yet been
178 approved by the United States Food and Drug Administration.
179 3. The anticipated results of the proposed treatment.
180 4. The recognized serious possible risks, complications,
181 and anticipated benefits involved in the treatment and in the
182 recognized possible alternative forms of treatment, including
183 nontreatment.
184 5. That the patient is encouraged to consult with his or
185 her primary care provider before undergoing any stem cell
186 therapy.
187 (7) This section does not apply to the following:
188 (a) A physician who has obtained approval for an
189 investigational new drug or device from the United States Food
190 and Drug Administration for the use of human cells, tissues, or
191 cellular or tissue-based products; or
192 (b) A physician who performs stem cell therapy under an
193 employment or other contract on behalf of an institution
194 certified or accredited by any of the following:
195 1. The Foundation for the Accreditation of Cellular
196 Therapy.
197 2. The Blood and Marrow Transplant Clinical Trials Network.
198 3. The Association for the Advancement of Blood and
199 Biotherapies.
200 4. An entity with expertise in stem cell therapy as
201 determined by the department.
202 (8) A violation of this section may subject the physician
203 to disciplinary action by the board.
204 (9) A physician who willfully performs, or actively
205 participates in, the following commits a felony of the third
206 degree, punishable as provided in s. 775.082, s. 775.083, or s.
207 775.084, and is subject to disciplinary action under this
208 chapter and s. 456.072:
209 (a) Treatment or research using human cells or tissues
210 derived from a fetus or an embryo after an abortion; or
211 (b) The sale, manufacture, or distribution of computer
212 products created using human cells, tissues, or cellular or
213 tissue-based products.
214 (10) The board may adopt rules necessary to implement this
215 section.
216 Section 3. This act shall take effect July 1, 2026.