Florida Senate - 2020 COMMITTEE AMENDMENT
Bill No. SB 512
Ì846704+Î846704
LEGISLATIVE ACTION
Senate . House
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The Committee on Health Policy (Hutson) recommended the
following:
1 Senate Amendment (with title amendment)
2
3 Delete everything after the enacting clause
4 and insert:
5 Section 1. Section 381.06017, Florida Statutes, is created
6 to read:
7 381.06017 Nonembryonic stem cell banks; collection,
8 manufacturing, storage, dispensing, and use of human
9 nonembryonic stem cells.—
10 (1) DEFINITIONS.—As used in this section, the term:
11 (a) “Compounding” means combining, mixing, or altering the
12 ingredients of one or more drugs or products to create another
13 drug or product.
14 (b) “Dispense” has the same meaning as in s. 465.003(6).
15 (c) “Establishment” means a place of business which is at
16 one general physical location and may extend to one or more
17 contiguous suites, units, floors, or buildings operated and
18 controlled exclusively by entities under common operation and
19 control. The term includes multiple buildings with an
20 intervening thoroughfare if the buildings are under common
21 exclusive ownership, operation, and control. For purposes of
22 permitting, each suite, unit, floor, or building must be
23 identified in the most recent permit application.
24 (d) “Federal act” means the Federal Food, Drug, and
25 Cosmetic Act, 21 U.S.C. ss. 301 et seq.; 52 Stat. 1040 et seq.
26 (e) “Minimally manipulated” means:
27 1. For structural tissue, processing that does not alter
28 the original characteristics of the tissue which relate to the
29 tissue’s utility for reconstruction, repair, or replacement; or
30 2. For cells or nonstructural tissue, processing that does
31 not alter the relevant biological characteristics of the cell or
32 tissue.
33 (f) “Nonembryonic stem cell,” also referred to as a
34 “somatic stem cell” or an “adult human stem cell,” means an
35 allogenic or autologous cell that is undifferentiated and
36 unspecialized and that has the ability to divide for indefinite
37 periods of time in a medium and to become a specialized cell.
38 The term includes a human nonembryonic cell that is altered or
39 processed to become undifferentiated, losing its original
40 structural function, so that it can be differentiated into a
41 specialized cell type. The term does not include cells that are
42 minimally manipulated or are only rinsed, cleaned, or sized and
43 remain differentiated.
44 (g) “Nonembryonic stem cell bank” means a publicly or
45 privately owned establishment that does any of the following:
46 1. Collects and stores human nonembryonic stem cells for
47 use in a product or patient-specific medical administration.
48 2. Provides patient-specific health care services using
49 human nonembryonic stem cells.
50 3. Advertises human nonembryonic stem cell services,
51 including, but not limited to, collection, manufacturing,
52 storage, dispensing, use, or purported use of human nonembryonic
53 stem cells or products containing human nonembryonic stem cells,
54 which have not been approved by the United States Food and Drug
55 Administration or are not the subject of clinical trials
56 approved by the United States Food and Drug Administration and
57 which are intended to diagnose, cure, mitigate, treat, provide
58 therapy for, or prevent an injury or a disease.
59 4. Performs any procedure that is intended to:
60 a. Collect or store human nonembryonic stem cells for any
61 purpose; or
62 b. Diagnose, cure, mitigate, treat, provide therapy for, or
63 prevent an injury or a disease with the use or purported use of
64 human nonembryonic stem cells or any product containing human
65 nonembryonic stem cells which has not been approved by the
66 United States Food and Drug Administration or is not the subject
67 of a clinical trial approved by the United States Food and Drug
68 Administration.
69 5. Compounds human nonembryonic stem cells from human
70 nonembryonic cells or tissue into products by combining, mixing,
71 or altering the ingredients of one or more drugs or products to
72 create another drug or product.
73 6. Manufactures, through recovery, processing,
74 manipulation, enzymatic digestion, mechanical disruption, or a
75 similar process, human nonembryonic stem cells from human
76 nonembryonic cells or tissue into undifferentiated human
77 nonembryonic stem cells, causing the cells to lose their
78 original structural function so that the nonembryonic stem cells
79 may be differentiated into specialized cell types.
80 7. Dispenses human nonembryonic stem cells and products
81 containing nonembryonic stem cells to any of the following for a
82 specific patient pursuant to a valid prescription from a
83 licensed health care practitioner authorized within the scope of
84 his or her license to prescribe and administer human
85 nonembryonic stem cells:
86 a. A pharmacy permitted under chapter 465.
87 b. A health care practitioner with privileges to practice
88 at nonembryonic stem cell banks.
89 c. A health care practitioner’s office, a health care
90 facility, or a treatment setting where the health care
91 practitioner has privileges to practice, for office use.
92 (h) “Office use” means the provision and administration of
93 a drug, compounded drug, or compounded product to a patient by a
94 health care practitioner in the practitioner’s office or in a
95 health care facility or treatment setting, including a hospital,
96 ambulatory surgery center, or health care clinic licensed under
97 chapter 395 or chapter 400. The term also includes the
98 dispensing by a pharmacist at a nonembryonic stem cell bank that
99 is also permitted as a pharmacy under chapter 465 to a
100 nonembryonic stem cell bank within this state of any of the
101 following:
102 1. Human nonembryonic stem cells.
103 2. A compounded drug containing human nonembryonic stem
104 cells.
105 3. A compounded product containing nonembryonic stem cells.
106 (2) DUTIES AND REGISTRATION.—A nonembryonic stem cell bank
107 that advertises, collects, stores, manufactures, dispenses,
108 compounds, uses, or purports to use nonembryonic stem cells or
109 products containing nonembryonic stem cells is deemed a clinic
110 as defined in s. 400.9905 and must comply with all of the
111 following requirements:
112 (a) Adhere to the applicable current good manufacturing
113 practices for the collection, removal, manufacturing,
114 processing, compounding, and implantation of nonembryonic stem
115 cells or products containing nonembryonic stem cells pursuant to
116 the federal act and 21 C.F.R., parts 1270-1271.
117 (b) Obtain a health care clinic license from the agency
118 pursuant to s. 400.991 and part II of chapter 408 and register
119 each establishment separately, unless:
120 1. The clinic is a facility licensed under chapter 395; or
121 2. The clinic is affiliated with an accredited medical
122 school that provides training to medical students, residents, or
123 fellows.
124 (c) Have a physician medical director who is responsible
125 for complying with all requirements related to licensure,
126 operation of a nonembryonic stem cell bank, and good
127 manufacturing practices under this section, part X of chapter
128 400, and the federal act and 21 C.F.R., parts 1270-1271.
129 (d) Notify the agency in writing on a form approved by the
130 agency within 10 days after termination of a physician medical
131 director and notify the agency within 10 days after such
132 termination of the identity of the physician medical director
133 who has assumed responsibility for that nonembryonic stem cell
134 bank. Failure to have a physician medical director practicing at
135 the location of the licensed nonembryonic stem cell bank shall
136 be the basis for a summary suspension of the nonembryonic stem
137 cell bank’s license pursuant to s. 400.607 or s. 120.60(6).
138 (e) Require a physician medical director to have a full,
139 active, and unencumbered license issued under chapter 458 or
140 chapter 459 and to actively practice at the nonembryonic stem
141 cell bank location for which he or she has assumed
142 responsibility.
143 (f) Maintain commercial and professional liability
144 insurance in an amount not less than $250,000 per claim.
145 (g) Operate each establishment using the same name as the
146 one used to obtain the health care clinic license from the
147 agency. All invoices, packing slips, and other business records
148 must list the same name.
149 (h) Obtain a pharmacy permit for each person and
150 establishment before dispensing, offering office use for the
151 compounding of human nonembryonic stem cells, or dispensing a
152 compounded product for office use.
153 (i) Pay all costs associated with licensure, registration,
154 and inspection.
155 (3) DISPENSING OF DRUGS OR COMPOUNDED DRUGS OR PRODUCTS.—
156 (a) A pharmacist at a nonembryonic stem cell bank that is
157 also permitted as a pharmacy under chapter 465 may dispense any
158 of the following to a stem cell bank within the state, for
159 office use:
160 1. Human nonembryonic stem cells;
161 2. A compounded drug containing human nonembryonic stem
162 cells; or
163 3. A compounded product containing human nonembryonic stem
164 cells.
165 (b) Human nonembryonic stem cells, compounded drugs
166 containing human nonembryonic stem cells, or products containing
167 human nonembryonic stem cells may not be sold or dispensed by
168 any person or establishment other than the nonembryonic stem
169 cell bank or pharmacist at the nonembryonic stem cell bank that
170 manufactured the human nonembryonic stem cells or the compounded
171 drug or product containing human nonembryonic stem cells, except
172 that:
173 1. A health care practitioner who requests the dispensing
174 of the human nonembryonic stem cells, compounded drug, or
175 compounded product from the manufacturing nonembryonic stem cell
176 bank may sell or dispense such items to his or her patient if
177 the health care practitioner is authorized within the scope of
178 his or her license to prescribe and administer human
179 nonembryonic stem cells; or
180 2. A pharmacist, pharmacy, or establishment that requests
181 the dispensing of the human nonembryonic stem cells, compounded
182 drug, or compounded product from the manufacturing nonembryonic
183 stem cell bank may sell or dispense such items to a health care
184 practitioner who is authorized within the scope of his or her
185 license to prescribe and administer human nonembryonic stem
186 cells to patients.
187 (4) HEALTH CARE PRACTITIONER RESPONSIBILITIES.—
188 (a) A physician licensed under chapter 458 or chapter 459,
189 an advanced practice registered nurse licensed under chapter
190 464, or a physician assistant licensed under chapter 458 or
191 chapter 459 may not practice in a nonembryonic stem cell bank
192 that is not licensed with the agency as required by the rules
193 adopted pursuant to s. 400.9925. The license of a health care
194 practitioner who violates this paragraph is subject to
195 disciplinary action by the appropriate regulatory board.
196 (b) In the performance of any procedure collecting,
197 storing, using, or purporting to use nonembryonic stem cells or
198 products containing nonembryonic stem cells, a health care
199 practitioner must adhere to the applicable current good
200 manufacturing practices for the collection, removal,
201 manufacturing, processing, compounding, and implantation of stem
202 cells or products containing stem cells pursuant to the federal
203 act and 21 C.F.R., parts 1270-1271.
204 (5) RULEMAKING.—The agency shall adopt rules necessary to
205 administer the licensure and regulation of nonembryonic stem
206 cell banks, including, but not limited to, rules regarding all
207 of the following, which must be consistent with the best
208 practices specified in the federal act and 21 C.F.R., parts
209 1270-1271:
210 (a) Advertising.
211 (b) Nonembryonic stem cell bank procedures and protocols
212 for the collection, manufacturing, storing, dispensing, and use
213 of nonembryonic stem cells, drugs containing nonembryonic stem
214 cells, and products containing nonembryonic stem cells in
215 accordance with the applicable current best practices.
216 (c) Adverse incident reporting.
217 (d) Informed consent.
218 (e) Recordkeeping, record retention, and availability of
219 records for inspection.
220 Section 2. The act shall take effect July 1, 2020.
221
222 ================= T I T L E A M E N D M E N T ================
223 And the title is amended as follows:
224 Delete everything before the enacting clause
225 and insert:
226 A bill to be entitled
227 An act relating to nonembryonic stem cell banks;
228 creating s. 381.06017, F.S.; defining terms; providing
229 that a nonembryonic stem cell bank that performs
230 certain functions is deemed a clinic; requiring such
231 nonembryonic stem cell banks to comply with specified
232 requirements; prohibiting an entity other than certain
233 nonembryonic stem cell banks and pharmacists from
234 dispensing certain compounded drugs or products, with
235 exceptions; prohibiting certain health care
236 practitioners from practicing in a nonembryonic stem
237 cell bank that is not licensed with the agency;
238 providing for disciplinary action; requiring health
239 care practitioners to adhere to specified regulations
240 in the performance of certain procedures; requiring
241 the agency to adopt specified rules; providing an
242 effective date.