Florida Senate - 2020 CS for CS for SB 512
By the Committees on Appropriations; and Health Policy; and
Senator Hutson
576-03986-20 2020512c2
1 A bill to be entitled
2 An act relating to nonembryonic stem cell banks;
3 creating s. 381.06017, F.S.; defining terms; providing
4 that a nonembryonic stem cell bank that performs
5 certain functions is deemed a clinic; requiring such
6 nonembryonic stem cell banks to comply with specified
7 requirements; prohibiting an entity other than certain
8 nonembryonic stem cell banks and pharmacists from
9 dispensing certain compounded drugs or products, with
10 exceptions; prohibiting certain health care
11 practitioners from practicing in a nonembryonic stem
12 cell bank that is not licensed with the agency;
13 providing for disciplinary action; requiring health
14 care practitioners to adhere to specified regulations
15 in the performance of certain procedures; requiring
16 the agency to adopt specified rules; providing a
17 contingent effective date.
18
19 Be It Enacted by the Legislature of the State of Florida:
20
21 Section 1. Section 381.06017, Florida Statutes, is created
22 to read:
23 381.06017 Nonembryonic stem cell banks; collection,
24 manufacturing, storage, dispensing, and use of human
25 nonembryonic stem cells.—
26 (1) DEFINITIONS.—As used in this section, the term:
27 (a) “Compounding” means combining, mixing, or altering the
28 ingredients of one or more drugs or products to create another
29 drug or product.
30 (b) “Dispense” has the same meaning as in s. 465.003(6).
31 (c) “Establishment” means a place of business which is at
32 one general physical location and may extend to one or more
33 contiguous suites, units, floors, or buildings operated and
34 controlled exclusively by entities under common operation and
35 control. The term includes multiple buildings with an
36 intervening thoroughfare if the buildings are under common
37 exclusive ownership, operation, and control. For purposes of
38 permitting, each suite, unit, floor, or building must be
39 identified in the most recent permit application.
40 (d) “Federal act” means the Federal Food, Drug, and
41 Cosmetic Act, 21 U.S.C. ss. 301 et seq.; 52 Stat. 1040 et seq.
42 (e) “Minimally manipulated” means:
43 1. For structural tissue, processing that does not alter
44 the original characteristics of the tissue which relate to the
45 tissue’s utility for reconstruction, repair, or replacement; or
46 2. For cells or nonstructural tissue, processing that does
47 not alter the relevant biological characteristics of the cell or
48 tissue.
49 (f) “Nonembryonic stem cell,” also referred to as a
50 “somatic stem cell” or an “adult human stem cell,” means an
51 allogenic or autologous cell that is undifferentiated and
52 unspecialized and that has the ability to divide for indefinite
53 periods of time in a medium and to become a specialized cell.
54 The term includes a human nonembryonic cell that is altered or
55 processed to become undifferentiated, losing its original
56 structural function, so that it can be differentiated into a
57 specialized cell type. The term does not include cells that are
58 minimally manipulated or are only rinsed, cleaned, or sized and
59 remain differentiated.
60 (g) “Nonembryonic stem cell bank” means a publicly or
61 privately owned establishment that does any of the following:
62 1. Collects and stores human nonembryonic stem cells for
63 use in a product or patient-specific medical administration.
64 2. Provides patient-specific health care services using
65 human nonembryonic stem cells.
66 3. Advertises human nonembryonic stem cell services,
67 including, but not limited to, collection, manufacturing,
68 storage, dispensing, use, or purported use of human nonembryonic
69 stem cells or products containing human nonembryonic stem cells,
70 which have not been approved by the United States Food and Drug
71 Administration or are not the subject of clinical trials
72 approved by the United States Food and Drug Administration and
73 which are intended to diagnose, cure, mitigate, treat, provide
74 therapy for, or prevent an injury or a disease.
75 4. Performs any procedure that is intended to:
76 a. Collect or store human nonembryonic stem cells for any
77 purpose; or
78 b. Diagnose, cure, mitigate, treat, provide therapy for, or
79 prevent an injury or a disease with the use or purported use of
80 human nonembryonic stem cells or any product containing human
81 nonembryonic stem cells which has not been approved by the
82 United States Food and Drug Administration or is not the subject
83 of a clinical trial approved by the United States Food and Drug
84 Administration.
85 5. Compounds human nonembryonic stem cells from human
86 nonembryonic cells or tissue into products by combining, mixing,
87 or altering the ingredients of one or more drugs or products to
88 create another drug or product.
89 6. Manufactures, through recovery, processing,
90 manipulation, enzymatic digestion, mechanical disruption, or a
91 similar process, human nonembryonic stem cells from human
92 nonembryonic cells or tissue into undifferentiated human
93 nonembryonic stem cells, causing the cells to lose their
94 original structural function so that the nonembryonic stem cells
95 may be differentiated into specialized cell types.
96 7. Dispenses human nonembryonic stem cells and products
97 containing nonembryonic stem cells to any of the following for a
98 specific patient pursuant to a valid prescription from a
99 licensed health care practitioner authorized within the scope of
100 his or her license to prescribe and administer human
101 nonembryonic stem cells:
102 a. A pharmacy permitted under chapter 465.
103 b. A health care practitioner with privileges to practice
104 at nonembryonic stem cell banks.
105 c. A health care practitioner’s office, a health care
106 facility, or a treatment setting where the health care
107 practitioner has privileges to practice, for office use.
108 (h) “Office use” means the provision and administration of
109 a drug, compounded drug, or compounded product to a patient by a
110 health care practitioner in the practitioner’s office or in a
111 health care facility or treatment setting, including a hospital,
112 ambulatory surgery center, or health care clinic licensed under
113 chapter 395 or chapter 400. The term also includes the
114 dispensing by a pharmacist at a nonembryonic stem cell bank that
115 is also permitted as a pharmacy under chapter 465 to a
116 nonembryonic stem cell bank within this state of any of the
117 following:
118 1. Human nonembryonic stem cells.
119 2. A compounded drug containing human nonembryonic stem
120 cells.
121 3. A compounded product containing nonembryonic stem cells.
122 (2) DUTIES AND REGISTRATION.—A nonembryonic stem cell bank
123 that advertises, collects, stores, manufactures, dispenses,
124 compounds, uses, or purports to use nonembryonic stem cells or
125 products containing nonembryonic stem cells is deemed a clinic
126 as defined in s. 400.9905 and must comply with all of the
127 following requirements:
128 (a) Adhere to the applicable current good manufacturing
129 practices for the collection, removal, manufacturing,
130 processing, compounding, and implantation of nonembryonic stem
131 cells or products containing nonembryonic stem cells pursuant to
132 the federal act and 21 C.F.R., parts 1270-1271.
133 (b) Obtain a health care clinic license from the agency
134 pursuant to s. 400.991 and part II of chapter 408 and register
135 each establishment separately, unless:
136 1. The clinic is a facility licensed under chapter 395; or
137 2. The clinic is affiliated with an accredited medical
138 school that provides training to medical students, residents, or
139 fellows.
140 (c) Have a physician medical director who is responsible
141 for complying with all requirements related to licensure,
142 operation of a nonembryonic stem cell bank, and good
143 manufacturing practices under this section, part X of chapter
144 400, and the federal act and 21 C.F.R., parts 1270-1271.
145 (d) Notify the agency in writing on a form approved by the
146 agency within 10 days after termination of a physician medical
147 director and notify the agency within 10 days after such
148 termination of the identity of the physician medical director
149 who has assumed responsibility for that nonembryonic stem cell
150 bank. Failure to have a physician medical director practicing at
151 the location of the licensed nonembryonic stem cell bank shall
152 be the basis for a summary suspension of the nonembryonic stem
153 cell bank’s license pursuant to s. 400.607 or s. 120.60(6).
154 (e) Require a physician medical director to have a full,
155 active, and unencumbered license issued under chapter 458 or
156 chapter 459 and to actively practice at the nonembryonic stem
157 cell bank location for which he or she has assumed
158 responsibility.
159 (f) Maintain commercial and professional liability
160 insurance in an amount not less than $250,000 per claim.
161 (g) Operate each establishment using the same name as the
162 one used to obtain the health care clinic license from the
163 agency. All invoices, packing slips, and other business records
164 must list the same name.
165 (h) Obtain a pharmacy permit for each person and
166 establishment before dispensing, offering office use for the
167 compounding of human nonembryonic stem cells, or dispensing a
168 compounded product for office use.
169 (3) DISPENSING OF DRUGS OR COMPOUNDED DRUGS OR PRODUCTS.—
170 (a) A pharmacist at a nonembryonic stem cell bank that is
171 also permitted as a pharmacy under chapter 465 may dispense any
172 of the following to a stem cell bank within the state, for
173 office use:
174 1. Human nonembryonic stem cells;
175 2. A compounded drug containing human nonembryonic stem
176 cells; or
177 3. A compounded product containing human nonembryonic stem
178 cells.
179 (b) Human nonembryonic stem cells, compounded drugs
180 containing human nonembryonic stem cells, or products containing
181 human nonembryonic stem cells may not be sold or dispensed by
182 any person or establishment other than the nonembryonic stem
183 cell bank or pharmacist at the nonembryonic stem cell bank that
184 manufactured the human nonembryonic stem cells or the compounded
185 drug or product containing human nonembryonic stem cells, except
186 that:
187 1. A health care practitioner who requests the dispensing
188 of the human nonembryonic stem cells, compounded drug, or
189 compounded product from the manufacturing nonembryonic stem cell
190 bank may sell or dispense such items to his or her patient if
191 the health care practitioner is authorized within the scope of
192 his or her license to prescribe and administer human
193 nonembryonic stem cells; or
194 2. A pharmacist, pharmacy, or establishment that requests
195 the dispensing of the human nonembryonic stem cells, compounded
196 drug, or compounded product from the manufacturing nonembryonic
197 stem cell bank may sell or dispense such items to a health care
198 practitioner who is authorized within the scope of his or her
199 license to prescribe and administer human nonembryonic stem
200 cells to patients.
201 (4) HEALTH CARE PRACTITIONER RESPONSIBILITIES.—
202 (a) A physician licensed under chapter 458 or chapter 459,
203 an advanced practice registered nurse licensed under chapter
204 464, or a physician assistant licensed under chapter 458 or
205 chapter 459 may not practice in a nonembryonic stem cell bank
206 that is not licensed with the agency as required by the rules
207 adopted pursuant to s. 400.9925. The license of a health care
208 practitioner who violates this paragraph is subject to
209 disciplinary action by the appropriate regulatory board.
210 (b) In the performance of any procedure collecting,
211 storing, using, or purporting to use nonembryonic stem cells or
212 products containing nonembryonic stem cells, a health care
213 practitioner must adhere to the applicable current good
214 manufacturing practices for the collection, removal,
215 manufacturing, processing, compounding, and implantation of stem
216 cells or products containing stem cells pursuant to the federal
217 act and 21 C.F.R., parts 1270-1271.
218 (5) RULEMAKING.—The agency shall adopt rules necessary to
219 administer the licensure and regulation of nonembryonic stem
220 cell banks, including, but not limited to, rules regarding all
221 of the following, which must be consistent with the best
222 practices specified in the federal act and 21 C.F.R., parts
223 1270-1271:
224 (a) Advertising.
225 (b) Nonembryonic stem cell bank procedures and protocols
226 for the collection, manufacturing, storing, dispensing, and use
227 of nonembryonic stem cells, drugs containing nonembryonic stem
228 cells, and products containing nonembryonic stem cells in
229 accordance with the applicable current best practices.
230 (c) Adverse incident reporting.
231 (d) Informed consent.
232 (e) Recordkeeping, record retention, and availability of
233 records for inspection.
234 Section 2. This act shall take effect July 1, 2020,
235 contingent on SB 7066 or similar legislation taking effect on
236 that same date, if such legislation is adopted in the same
237 legislative session or an extension thereof and becomes a law.