Florida Senate - 2026 CS for SB 1092
By the Committee on Health Policy; and Senator Massullo
588-02785-26 20261092c1
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) “Stem cell therapy” means a treatment involving the use
88 of human cells, tissues, or cellular or tissue-based products
89 which complies with the regulatory requirements provided in this
90 section. The term does not include treatment or research using
91 human cells or tissues that were derived from a fetus or an
92 embryo after an abortion.
93 (3)(a) A podiatric physician may perform stem cell therapy
94 that is not approved by the United States Food and Drug
95 Administration if such therapy is used for treatment or
96 procedures that are within the scope of practice for such
97 podiatric physician and the therapies are related to
98 orthopedics, wound care, or pain management.
99 (b) To ensure that the retrieval, manufacture, storage, and
100 use of stem cells used for therapies conducted under this
101 section meet the highest standards, any stem cells used by a
102 podiatric physician for therapy provided under this section must
103 meet all of the following conditions:
104 1. Be retrieved, manufactured, and stored in a facility
105 that is registered and regulated by the United States Food and
106 Drug Administration.
107 2. Be retrieved, manufactured, and stored in a facility
108 that is certified or accredited by one of the following
109 entities:
110 a. The National Marrow Donor Program.
111 b. The World Marrow Donor Association.
112 c. The Association for the Advancement of Blood and
113 Biotherapies.
114 d. The American Association of Tissue Banks.
115 3. Contain viable or live cells upon post-thaw analysis and
116 be included in a post-thaw viability analysis report for the
117 product lot which will be sent to the podiatric physician before
118 use with the podiatric physician’s patient.
119 (c) A podiatric physician performing stem cell therapy may
120 obtain stem cells for therapies from a facility engaging in the
121 retrieval, manufacture, or storage of stem cells intended for
122 human use under this section only if the facility maintains
123 valid certification or accreditation as required by this
124 subsection. Any contract or other agreement by which a podiatric
125 physician obtains stem cells for therapies from such a facility
126 must include the following:
127 1. A requirement that the facility provide all of the
128 following information to the podiatric physician:
129 a. The name and address of the facility.
130 b. The certifying or accrediting organization.
131 c. The type and scope of certification or accreditation.
132 d. The effective and expiration dates of the certification
133 or accreditation.
134 e. Any limitations or conditions imposed by the certifying
135 or accrediting organization.
136 2. A requirement that the facility notify the podiatric
137 physician within 30 days after any change in certification or
138 accreditation status, including renewal, suspension, revocation,
139 or expiration.
140 (4) In the performance of any procedure using or purporting
141 to use stem cells or products containing stem cells, the
142 podiatric physician shall use stem cell therapy products
143 obtained from facilities that adhere to the applicable current
144 good manufacturing practices for the collection, removal,
145 processing, implantation, and transfer of stem cells, or
146 products containing stem cells, pursuant to the Federal Food,
147 Drug, and Cosmetic Act, 21 U.S.C. ss. 301 et seq.; 52 Stat. 1040
148 et seq.; and 21 C.F.R. part 1271, Human Cells, Tissues, and
149 Cellular and Tissue-Based Products.
150 (5)(a) A podiatric physician who conducts stem cell therapy
151 pursuant to this section shall include the following in any form
152 of advertisement:
153
154 THIS NOTICE MUST BE PROVIDED TO YOU UNDER FLORIDA LAW.
155 This podiatric physician performs one or more stem
156 cell therapies that have not yet been approved by the
157 United States Food and Drug Administration. You are
158 encouraged to consult with your primary care provider
159 before undergoing any stem cell therapy.
160
161 (b) The notice required under paragraph (a) must be clearly
162 legible and in a type size no smaller than the largest type size
163 used in the advertisement.
164 (6)(a) A podiatric physician who conducts stem cell therapy
165 pursuant to this section shall obtain a signed consent form from
166 the patient before performing the stem cell therapy.
167 (b) The consent form must be signed by the patient or, if
168 the patient is not legally competent, the patient’s
169 representative and must state all of the following in language
170 the patient or his or her representative may reasonably be
171 expected to understand:
172 1. The nature and character of the proposed treatment.
173 2. That the proposed stem cell therapy has not yet been
174 approved by the United States Food and Drug Administration.
175 3. The anticipated results of the proposed treatment.
176 4. The recognized serious possible risks, complications,
177 and anticipated benefits involved in the treatment and in the
178 recognized possible alternative forms of treatment, including
179 nontreatment.
180 5. That the patient is encouraged to consult with his or
181 her primary care provider before undergoing any stem cell
182 therapy.
183 (7) This section does not apply to the following:
184 (a) A podiatric physician who has obtained approval for an
185 investigational new drug or device from the United States Food
186 and Drug Administration for the use of human cells, tissues, or
187 cellular or tissue-based products; or
188 (b) A podiatric physician who performs stem cell therapy
189 under an employment or other contract on behalf of an
190 institution certified or accredited by any of the following:
191 1. The Foundation for the Accreditation of Cellular
192 Therapy.
193 2. The Blood and Marrow Transplant Clinical Trials Network.
194 3. The Association for the Advancement of Blood and
195 Biotherapies.
196 (8) A violation of this section may subject the podiatric
197 physician to disciplinary action by the board.
198 (9) A podiatric physician who willfully performs, or
199 actively participates in, the following commits a felony of the
200 third degree, punishable as provided in s. 775.082, s. 775.083,
201 or s. 775.084, and is subject to disciplinary action under this
202 chapter and s. 456.072:
203 (a) Treatment or research using human cells or tissues
204 derived from a fetus or an embryo after an abortion; or
205 (b) The sale, manufacture, or distribution of computer
206 products created using human cells, tissues, or cellular or
207 tissue-based products.
208 (10) The board may adopt rules necessary to implement this
209 section.
210 Section 3. This act shall take effect upon becoming a law.