S 1092

ENROLLED
2026 Legislature  CS for CS for SB 1092
                                                      20261092er
1
2An act relating to podiatric medicine; amending s.
3461.007, F.S.; requiring certain podiatric physicians,
4instead of all podiatric physicians, to complete
5specified continuing education; creating s. 461.011,
6F.S.; providing legislative findings and intent;
7defining terms; authorizing podiatric physicians to
8perform procedures using cellular or tissue-based
9products not approved by the United States Food and
10Drug Administration under certain circumstances;
11specifying requirements for the cellular or tissue
12based products that may be used by such podiatric
13physicians; requiring such podiatric physicians to
14include a specified notice in any form of
15advertisement; specifying requirements for such
16notice; requiring podiatric physicians to obtain a
17signed consent form from the patient or his or her
18representative before performing procedures using
19cellular or tissue-based products; specifying
20requirements for the consent form; providing
21applicability; providing for disciplinary action;
22providing criminal penalties; authorizing the Board of
23Podiatric Medicine to adopt rules; providing an
24effective date.
25
26Be It Enacted by the Legislature of the State of Florida:
27
28Section 1. Subsection (3) of section 461.007, Florida
29Statutes, is amended to read:
30461.007 Renewal of license.—
31(3) The board may by rule prescribe continuing education,
32not to exceed 40 hours biennially, as a condition for renewal of
33a license, with a minimum of 2 hours of continuing education
34related to the safe and effective prescribing of controlled
35substances for licensees who are registered with the United
36States Drug Enforcement Administration and authorized to
37prescribe controlled substance pursuant to 21 U.S.C. s. 822. The
38criteria for such programs or courses shall be approved by the
39board.
40Section 2. Section 461.011, Florida Statutes, is created to
41read:
42461.011 Cellular and tissue-based products.—
43(1) The Legislature recognizes the significant potential of
44cellular and tissue-based products in advancing medical
45treatments and improving patient outcomes and further recognizes
46the need to ensure that such treatments are provided using
47cellular or tissue-based products obtained in an ethical manner
48that does not involve cells derived from aborted fetuses. It is
49the intent of the Legislature to foster medical innovation while
50upholding ethical standards that respect the sanctity of life.
51By encouraging the use of cellular or tissue-based products, the
52state will advance regenerative medicine in a manner consistent
53with the values of the state.
54(2) As used in this section, the term:
55(a) “Cellular or tissue-based products” means products
56containing or consisting of human cells or tissues which are
57intended for implantation, transplantation, infusion, or
58transfer into a human recipient. The term does not include:
591. Vascularized human organs for transplantation;
602. Whole blood or blood components or blood derivative
61products;
623. Secreted or extracted human products, such as milk,
63collagen, and cell factors, other than semen;
644. Minimally manipulated bone marrow for homologous use and
65not combined with another article other than water,
66crystalloids, or a sterilizing, preserving, or storage agent, if
67the addition of the agent does not raise new clinical safety
68concerns with respect to the bone marrow;
695. Ancillary products used in the manufacture of human
70cells, tissues, or cellular or tissue-based products;
716. Cells, tissues, and organs derived from animals;
727. In vitro diagnostic products;
738. Blood vessels recovered with an organ which are intended
74for use in organ transplantation and labeled “For use in organ
75transplantation only”; or
769.Harvesting and reimplantation of autologous tissue.
77(b) “Minimally manipulated” means:
781. For structural tissue, processing that does not alter
79the original relevant characteristics of the tissue relating to
80the tissue’s utility for reconstruction, repair, or replacement.
812. For cells or nonstructural tissues, processing that does
82not alter the relevant biological characteristics of cells or
83tissues.
84(c)“Procedure using cellular or tissue-based products”
85means a treatment involving the use of human cells, tissues, or
86cellular or tissue-based products which complies with the
87regulatory requirements provided in this section. The term does
88not include treatment or research using human cells or tissues
89derived from a fetus or an embryo after an abortion.
90(3)(a)A podiatric physician may perform a procedure using
91cellular or tissue-based products that are not approved by the
92United States Food and Drug Administration if such products are
93used for treatment or procedures within the scope of practice
94for such podiatric physician and the treatment or procedures are
95related to connective tissue, ligament, and tendon repair; wound
96care; or pain management.
97(b)To ensure that the retrieval, manufacture, storage, and
98use of any cellular or tissue-based products pursuant to this
99section meet the highest standards, any cellular or tissue-based
100products used by a podiatric physician for a procedure provided
101under this section must meet all of the following conditions:
1021.Be retrieved, manufactured, and stored in a facility
103that is registered and regulated by the United States Food and
104Drug Administration.
1052.Be retrieved, manufactured, and stored in a facility
106that is certified or accredited by one of the following
107entities:
108a.The National Marrow Donor Program.
109b.The World Marrow Donor Association.
110c.The Association for the Advancement of Blood and
111Biotherapies.
112d.The American Association of Tissue Banks.
1133.Contain viable or live cells upon post-thaw analysis and
114be included in a post-thaw viability analysis report for the
115product lot, which must be sent to the podiatric physician
116before use with the podiatric physician’s patient.
117(4)(a)A podiatric physician who performs a procedure using
118cellular or tissue-based products pursuant to this section shall
119include the following in any form of advertisement:
120
121THIS NOTICE MUST BE PROVIDED TO YOU UNDER FLORIDA LAW.
122This podiatric physician performs procedures using
123cellular or tissue-based products that have not yet
124been approved by the United States Food and Drug
125Administration. You are encouraged to consult with
126your primary care provider before undergoing any
127procedure using these products.
128
129(b)The notice required under paragraph (a) must be clearly
130legible and in a type size no smaller than the largest type size
131used in the advertisement.
132(5)(a)A podiatric physician who performs a procedure using
133cellular or tissue-based products pursuant to this section shall
134obtain a signed consent form from the patient before performing
135the procedure.
136(b)The consent form must be signed by the patient or, if
137the patient is not legally competent, the patient’s
138representative, and must state all of the following in language
139the patient or his or her representative may reasonably be
140expected to understand:
1411.The nature and character of the proposed treatment.
1422.That the proposed procedure uses cellular or tissue
143based products that have not yet been approved by the United
144States Food and Drug Administration.
1453.The anticipated results of the proposed treatment.
1464.The recognized serious possible risks, complications,
147and anticipated benefits involved in the treatment and in the
148recognized possible alternative forms of treatment, including
149nontreatment.
1505.That the patient is encouraged to consult with his or
151her primary care provider before undergoing the procedure.
152(6)This section does not apply to the following:
153(a)A podiatric physician who has obtained approval for an
154investigational new drug or device from the United States Food
155and Drug Administration for the use of human cells, tissues, or
156cellular or tissue-based products; or
157(b)A podiatric physician who performs procedures using
158cellular or tissue-based productsunder an employment or other
159contract on behalf of an institution certified or accredited by
160any of the following:
1611.The Foundation for the Accreditation of Cellular
162Therapy.
1632.The Blood and Marrow Transplant Clinical Trials Network.
1643.The Association for the Advancement of Blood and
165Biotherapies.
166(7)A violation of this section may subject the podiatric
167physician to disciplinary action by the board.
168(8)A podiatric physician who willfully performs, or
169actively participates in, the following commits a felony of the
170third degree, punishable as provided in s. 775.082, s. 775.083,
171or s. 775.084, and is subject to disciplinary action under this
172chapter and s. 456.072:
173(a)Treatment or research using human cells or tissues
174derived from a fetus or an embryo after an abortion; or
175(b)The sale, manufacture, or distribution of computer
176products created using human cells, tissues, or cellular or
177tissue-based products.
178(9)The board may adopt rules necessary to implement this
179section.
180Section 3. This act shall take effect upon becoming a law.