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ENROLLED
2026
Legislature
CS for CS for SB 1092
20261092er
1
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 procedures using cellular or tissue-based
9 products not approved by the United States Food and
10 Drug Administration under certain circumstances;
11 specifying requirements for the cellular or tissue
12 based products that may be used by such podiatric
13 physicians; requiring such podiatric physicians to
14 include a specified notice in any form of
15 advertisement; specifying requirements for such
16 notice; requiring podiatric physicians to obtain a
17 signed consent form from the patient or his or her
18 representative before performing procedures using
19 cellular or tissue-based products; specifying
20 requirements for the consent form; providing
21 applicability; providing for disciplinary action;
22 providing criminal penalties; authorizing the Board of
23 Podiatric Medicine to adopt rules; providing an
24 effective date.
25
26 Be It Enacted by the Legislature of the State of Florida:
27
28 Section 1. Subsection (3) of section 461.007, Florida
29 Statutes, is amended to read:
30 461.007 Renewal of license.—
31 (3) The board may by rule prescribe continuing education,
32 not to exceed 40 hours biennially, as a condition for renewal of
33 a license, with a minimum of 2 hours of continuing education
34 related to the safe and effective prescribing of controlled
35 substances
for licensees who are registered with the United
36
States Drug Enforcement Administration and authorized to
37
prescribe controlled substance pursuant to 21 U.S.C. s. 822
. The
38 criteria for such programs or courses shall be approved by the
39 board.
40 Section 2. Section 461.011, Florida Statutes, is created to
41 read:
42
461.011
Cellular and tissue-based products
.—
43
(1) The Legislature recognizes the significant potential of
44
c
ellular and tissue-based products
in advancing medical
45
treatments and improving patient outcomes and further recognizes
46
the need to ensure that such t
reatments
are provided using
47
cellular
or
tissue-based products
obtained in an ethical manner
48
that does not involve cells derived from aborted fetuses. It is
49
the intent of the Legislature to foster medical innovation while
50
upholding ethical standards that respect the sanctity of life.
51
By encouraging the use of cellular or tissue-based products, the
52
state will advance regenerative medicine in a manner consistent
53
with the values of th
e
state.
54
(2) As used in this section, the term:
55
(a) “
C
ellular or tissue-based products” means
products
56
containing or consisting of human cells or tissues
which
are
57
intended for implantation, transplantation, infusion, or
58
transfer into a human recipient. The term does not include:
59
1. Vascularized human organs for transplantation;
60
2. Whole blood or blood components or blood derivative
61
products;
62
3. Secreted or extracted human products, such as milk,
63
collagen, and cell factors, other than semen;
64
4. Minimally manipulated bone marrow for homologous use and
65
not combined with another article other than water,
66
crystalloids, or a sterilizing, preserving, or storage agent, if
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the addition of the agent does not raise new clinical safety
68
concerns with respect to the bone marrow;
69
5. Ancillary products used in the manufacture of human
70
cells, tissues, or cellular or tissue-based products;
71
6. Cells, tissues, and organs derived from animals;
72
7. In vitro diagnostic products;
73
8. Blood vessels recovered with an organ which are intended
74
for use in organ transplantation and labeled “For use in organ
75
transplantation only”
; or
76
9.
Harvesting and reimplantation of autologous tissue
.
77
(b) “Minimally manipulated” means:
78
1. For structural tissue, processing that does not alter
79
the original relevant characteristics of the tissue relating to
80
the tissue’s utility for reconstruction, repair, or replacement.
81
2. For cells or nonstructural tissues, processing that does
82
not alter the relevant biological characteristics of cells or
83
tissues.
84
(c)
“
Procedure using cellular or tissue-based products
”
85
means a treatment involving the use of human cells, tissues, or
86
cellular or tissue-based products which complies with the
87
regulatory requirements provided in this section. The term does
88
not include treatment or research using human cells or tissues
89
derived from a fetus or an embryo after an abortion.
90
(3)(a)
A podiatric physician may perform
a procedure using
91
cellular or tissue-based products
that
are
not approved by the
92
United States Food and Drug Administration if such
products are
93
used for treatment or procedures within the scope of practice
94
for such podiatric physician and the
treatment or procedures
are
95
related to
connective tissue, ligament, and tendon repair;
wound
96
care
;
or pain management.
97
(b)
To ensure that the retrieval, manufacture, storage, and
98
use of
any cellular or tissue-based products pursuant to
this
99
section meet the highest standards, any
cellular or tissue-based
100
products
used by a podiatric physician for
a procedure
provided
101
under this section must meet all of the following conditions:
102
1.
Be retrieved, manufactured, and stored in a facility
103
that is registered and regulated by the United States Food and
104
Drug Administration.
105
2.
Be retrieved, manufactured, and stored in a facility
106
that is certified or accredited by one of the following
107
entities:
108
a.
The National Marrow Donor Program.
109
b.
The World Marrow Donor Association.
110
c.
The Association for the Advancement of Blood and
111
Biotherapies.
112
d.
The American Association of Tissue Banks.
113
3.
Contain viable or live cells upon post-thaw analysis and
114
be included in a post-thaw viability analysis report for the
115
product lot
,
which
must
be sent to the podiatric physician
116
before use with the podiatric physician’s patient.
117
(
4
)(a)
A podiatric physician who
performs a procedure using
118
cellular or tissue-based products
pursuant to this section shall
119
include the following in any form of advertisement:
120
121
THIS NOTICE MUST BE PROVIDED TO YOU UNDER FLORIDA LAW.
122
This podiatric physician performs
procedures using
123
cellular or tissue-based products
that have not yet
124
been approved by the United States Food and Drug
125
Administration. You are encouraged to consult with
126
your primary care provider before undergoing any
127
procedure using these products
.
128
129
(b)
The notice required under paragraph (a) must be clearly
130
legible and in a type size no smaller than the largest type size
131
used in the advertisement.
132
(
5
)(a)
A podiatric physician who
performs
a procedure
using
133
cellular or tissue-based products
pursuant to this section shall
134
obtain a signed consent form from the patient before performing
135
the
procedure
.
136
(b)
The consent form must be signed by the patient or, if
137
the patient is not legally competent, the patient’s
138
representative
,
and must state all of the following in language
139
the patient or his or her representative may reasonably be
140
expected to understand:
141
1.
The nature and character of the proposed treatment.
142
2.
That the proposed
procedure uses cellular or tissue
143
based products that have
not yet been approved by the United
144
States Food and Drug Administration.
145
3.
The anticipated results of the proposed treatment.
146
4.
The recognized serious possible risks, complications,
147
and anticipated benefits involved in the treatment and in the
148
recognized possible alternative forms of treatment, including
149
nontreatment.
150
5.
That the patient is encouraged to consult with his or
151
her 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
154
investigational new drug or device from the United States Food
155
and Drug Administration for the use of human cells, tissues, or
156
cellular or tissue-based products; or
157
(b)
A podiatric physician who performs procedure
s
us
ing
158
cellular or tissue-based products
under an employment or other
159
contract on behalf of an institution certified or accredited by
160
any of the following:
161
1.
The Foundation for the Accreditation of Cellular
162
Therapy.
163
2.
The Blood and Marrow Transplant Clinical Trials Network.
164
3.
The Association for the Advancement of Blood and
165
Biotherapies.
166
(7)
A violation of this section may subject the podiatric
167
physician to disciplinary action by the board.
168
(8)
A podiatric physician who willfully performs, or
169
actively participates in, the following commits a felony of the
170
third degree, punishable as provided in s. 775.082, s. 775.083,
171
or s. 775.084, and is subject to disciplinary action under this
172
chapter and s. 456.072:
173
(a)
Treatment or research using human cells or tissues
174
derived from a fetus or an embryo after an abortion; or
175
(b)
The sale, manufacture, or distribution of computer
176
products created using human cells, tissues, or cellular or
177
tissue-based products.
178
(9)
The board may adopt rules necessary to implement this
179
section.
180 Section 3. This act shall take effect upon becoming a law.