Florida Senate - 2020 COMMITTEE AMENDMENT
Bill No. CS for CS for SB 512
Ì611058)Î611058
LEGISLATIVE ACTION
Senate . House
Comm: RCS .
02/27/2020 .
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The Committee on Rules (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; collecting,
8 manufacturing, storing, dispensing, and using adult human
9 nonembryonic stem cells and HCT/Ps.—
10 (1) DEFINITIONS.—As used in this section, the term:
11 (a) “Adult human nonembryonic stem cells” means cells that
12 are derived from adult human nonembryonic HCT/Ps through
13 enzymatic digestion, mechanical disruption, or similar
14 processing. The term includes only drugs, devices, or biological
15 products that are approved by the United States Food and Drug
16 Administration and are regulated by the FD&C Act, s. 351 of the
17 PHS Act, or part I of chapter 499.
18 (b) “Agency” means the Agency for Health Care
19 Administration.
20 (c) “Allogenic use” means the collection of human cells or
21 tissue from one person and the implantation, transplantation,
22 infusion, or transfer of those human cells or tissue into
23 another person.
24 (d) “Autologous use” means the implantation,
25 transplantation, infusion, or transfer of human cells or tissue
26 back into the individual from which they were collected.
27 (e) “Dispense” has the same meaning as in s. 465.003(6).
28 (f) “Establishment” means a place of business which is at
29 one general physical location and may extend to one or more
30 contiguous suites, units, floors, or buildings operated and
31 controlled exclusively by entities under common operation and
32 control. The term includes multiple buildings with an
33 intervening thoroughfare if the buildings are under common
34 exclusive ownership, operation, and control. For purposes of
35 permitting, each suite, unit, floor, or building must be
36 identified in the most recent permit application.
37 (g) “FD&C Act” means the Federal Food, Drug, and Cosmetic
38 Act, 21 U.S.C. ss. 301 et seq.; 52 Stat. 1040 et seq.
39 (h) ”HCT/Ps“ means human cells, tissues, or cellular or
40 tissue-based products that are intended for implantation,
41 transplantation, infusion, or transfer into a human recipient.
42 The term does not include any of the following:
43 1. Vascularized human organs for transplantation.
44 2. Whole blood, blood components, blood derivative
45 products, or platelet-rich plasma that are exempt under 21 C.F.R
46 607.65.
47 3. Human secretions, including milk, collagen, and cell
48 factors, but not semen.
49 4. Minimally manipulated bone marrow that is for homologous
50 use only and that is not combined with any other article except
51 water, crystalloids, or sterilizing, preserving, or storage
52 agents.
53 5. Ancillary products used in the manufacture of
54 nonembryonic adult human allogenic or autologous HCT/Ps.
55 6. Cells, tissue, or organs derived from animals.
56 7. In vitro diagnostic products.
57 8. Blood vessels recovered with an organ for
58 transplantation.
59 (i) “Homologous use” means the repair, reconstruction, or
60 supplementation of a recipient’s cells or tissues with adult
61 human nonembryonic stem cells or adult human nonembryonic HCT/Ps
62 that perform the same basic function or functions in the
63 recipient as in the donor.
64 (j) “Manufacture” means the preparing, deriving,
65 compounding, propagation, processing, producing, or fabricating
66 of any drug, device, or cosmetic.
67 (k) “Minimally manipulated” means:
68 1.a. For structural tissues, processing that does not alter
69 the original characteristics of the tissue which relate to the
70 tissue’s utility for reconstruction, repair, or replacement; or
71 b. For cells or nonstructural tissues, processing that does
72 not alter the relevant biological characteristics of the cells
73 or tissues.
74 2. The washing, rinsing, cleaning, sizing, shaping, or
75 concentrating of adult human nonembryonic HCT/Ps which does not
76 alter the relevant characteristics or basic functions of the
77 tissue or cell.
78 (l) “Nonembryonic stem cell bank” means a publicly or
79 privately owned establishment that operates its own
80 laboratories, retains control over all aspects of processing and
81 storage, is managed by a single entity, and performs any of the
82 following activities in the course of its business:
83 1. Engages in the manufacture, use, implantation,
84 transplantation, infusion, dispensing, transfer, or storage of
85 adult human allogenic and autologous nonembryonic stem cells.
86 2. Accepts, receives, carries, or delivers human allogenic
87 and autologous nonembryonic stem cells, drugs, or products that
88 are approved by United States Food and Drug Administration and
89 regulated as drugs, devices, or biological products by the FD&C
90 Act, s. 251 of the PHS Act, or part I of chapter 499.
91 3. Recovers, collects, screens, and tests, in the facility,
92 adult human autologous nonembryonic HCT/Ps from a specific
93 patient for implantation, transplantation, infusion, or transfer
94 back into the same patient during a single surgery within the
95 facility.
96 4. Provides patient-specific health care services using
97 adult human autologous nonembryonic HCT/Ps in the facility
98 during a single procedure.
99 5. Advertises adult human nonembryonic stem cell services
100 or adult human autologous nonembryonic HCT/P services,
101 including, but not limited to, the collection, manufacture
102 implantation, transplantation, infusion, transfer, storage,
103 dispensing, use, or purported use of United States Food and Drug
104 Administration-approved adult human autologous nonembryonic stem
105 cells or adult human autologous nonembryonic HCT/Ps that are
106 intended to diagnose, cure, mitigate, treat, provide therapy
107 for, or prevent an injury or a disease.
108 6. Performs any procedure that is intended to:
109 a. Collect or store adult human autologous nonembryonic
110 HCT/Ps for autonomous homologous use; or
111 b. Diagnose, cure, mitigate, treat, provide therapy for, or
112 prevent an injury or a disease through the use or purported use
113 of adult human autologous nonembryonic HCT/Ps.
114 7. Compounds patient-specific adult human autologous
115 nonembryonic HCT/Ps into a drug product by combining or mixing
116 the patient-specific adult human nonembryonic HCT/Ps, at the
117 prescriptive direction of a licensed physician authorized within
118 the scope of his or her license to prescribe and administer
119 adult human autologous nonembryonic HTC/Ps with one or more
120 drugs or products to create a patient-specific drug or product.
121 8. Dispenses adult human autologous nonembryonic stem cells
122 or HTC/Ps to any of the following for a specific patient
123 pursuant to a valid order from a licensed physician authorized
124 within the scope of his or her license to prescribe and
125 administer adult human autologous nonembryonic HTC/Ps:
126 a. The specific patient’s physician with privileges to
127 practice at the nonembryonic stem cell bank.
128 b. For office use, the specific patient’s physician’s
129 office or a health care facility or treatment setting where the
130 physician has privileges to administer adult human autologous
131 nonembryonic HTC/Ps.
132 (l) “Office use” includes the provision and administration
133 of any United States Food and Drug Administration-approved adult
134 human nonembryonic stem cell drug, compounded drug, or
135 compounded product regulated as a drug, device, or any
136 biological product under the FD&C Act, the PHS Act, 42 U.S.C.
137 262, s. 351, or part I of chapter 499, to a patient’s physician
138 in the physician’s office or in a health care facility or
139 treatment setting, including a hospital, an ambulatory surgical
140 center, or a health care clinic licensed under chapter 395 or
141 chapter 400. The term also includes the patient-specific
142 dispensing, provision, or administration of the patient’s adult
143 human autologous nonembryonic HTC/Ps.
144 (m) “PHS Act” means the Public Health and Safety Act, 42
145 U.S.C. ss. 262 et seq., and applicable regulations, including 21
146 C.F.R. part 1271.
147 (n) “Physician” means a person who is licensed to practice
148 medicine under chapter 458 or osteopathic medicine under chapter
149 459.
150 (2) DUTIES AND REGISTRATION.—
151 (a) Establishments that manufacture adult human
152 nonembryonic HTC/Ps are regulated by s. 361 of the PHS Act and
153 part I of chapter 499. Such establishments must register with
154 and submit a list of all HCT/Ps manufactured to the Food and
155 Drug Administration and obtain a permit from the Department of
156 Business and Professional Regulation if the HCT/P manufactured
157 is:
158 1. Minimally manipulated;
159 2. Intended only for homologous use;
160 3. Manufactured through a process that does not involve the
161 combination of the cells or tissue with another article, except
162 water, crystalloids, or a sterilizing, preserving, or storing
163 agent; and
164 4. For an adult human nonembryonic HCT/P, either:
165 a. Does not have a systemic effect and is not dependent
166 upon the metabolic activity of living cells for their primary
167 function; or
168 b. Has a systemic effect or is dependent upon the metabolic
169 activity of living cells for its primary function and is for
170 autologous use or for allogenic use in a first-degree or second
171 degree blood relative.
172 (b) Establishments that manufacture adult human
173 nonembryonic HCT/Ps that do not meet the criteria described in
174 paragraph (a) are exempt from the registration and listing
175 requirements of s. 361 of the PHS Act, but must obtain a permit
176 from and submit a list of all HTC/Ps manufactured to the
177 Department of Business and Professional Regulation if the
178 establishment:
179 1. Uses the adult human nonembryonic HTC/Ps for
180 nonmedicinal scientific purposes; or
181 2. Removes human adult nonembryonic HCT/Ps from a patient
182 and implants the same HCT/Ps into the same patient during the
183 same surgical procedure with only minimal manipulation of the
184 HCT/Ps which does not alter the original relevant biological
185 characteristics of the cells or tissues.
186 (c) A nonembryonic stem cell bank that manufactures adult
187 human nonembryonic HCT/Ps may not more than minimally
188 manipulate, through enzymatic digestion, mechanical disruption,
189 or similar processing, any adult human nonembryonic stem cell or
190 HCT/P to alter the HCT/P’s original structural characteristics
191 or relevant biological characteristics or to isolate
192 differentiated cells from undifferentiated cells that have lost
193 their original structural function, so that the undifferentiated
194 cells can be differentiated into a specialized cell type, unless
195 the nonembryonic stem cell bank has first registered the HCT/P
196 with the United States Food and Drug Administration and the
197 Department of Business and Professional Regulation as a drug,
198 device, or biological product manufacturer and complies with all
199 applicable regulations under the FD&C Act, s. 351 of the PHS
200 Act, 21 C.F.R. parts 1-1299, and part I of chapter 499.
201 (d) A nonembryonic stem cell bank that advertises,
202 collects, stores, manufactures, dispenses, compounds, uses, or
203 purports to use adult human nonembryonic stem cells or adult
204 human autologous nonembryonic HCT/Ps is deemed a clinic as
205 defined in s. 400.9905 and must comply with all of the following
206 requirements:
207 1. Adhere to the applicable current good manufacturing
208 practices for the collecting, removing, manufacturing,
209 processing, using, compounding, and implanting of adult human
210 nonembryonic stem cells or products containing adult human
211 nonembryonic stem cells pursuant to the FD&C Act, the PHS Act,
212 21 C.F.R., parts 1270-1271, and part I of chapter 499.
213 2. Adhere to the applicable current good manufacturing
214 practices for the collecting, removing, manufacturing,
215 processing, using, compounding, and implanting of adult human
216 autologous nonembryonic HCT/Ps so that it does not alter the
217 relevant tissue or cellular characteristics or basic functions.
218 3. Obtain a health care clinic license from the agency
219 pursuant to s. 400.991 and part II of chapter 408 and register
220 each establishment separately, unless:
221 a. The clinic is a facility licensed under chapter 395; or
222 b. The clinic is affiliated with an accredited medical
223 school that provides training to medical students, residents, or
224 fellows.
225 4. Have a physician medical director who is responsible for
226 the establishment’s compliance with all requirements related to
227 licensure, operation of a nonembryonic stem cell bank, and
228 current good manufacturing practices under this section, part X
229 of chapter 400, and the FD&C Act, the PHS Act, 21 C.F.R. parts
230 1-1299, and part I of chapter 499.
231 5. Notify the agency, in writing, on a form approved by the
232 agency, within 10 days after termination of a physician medical
233 director and notify the agency within 10 days after such
234 termination of the identity of the physician medical director
235 who has assumed responsibility for that nonembryonic stem cell
236 bank. Failure to have a physician medical director practicing at
237 the location of the licensed nonembryonic stem cell bank is the
238 basis for a summary suspension of the nonembryonic stem cell
239 bank’s license pursuant to s. 120.60(6) or s. 400.607.
240 6. Require a physician medical director with a full,
241 active, and unencumbered license to actively practice at the
242 nonembryonic stem cell bank location for which he or she has
243 assumed responsibility.
244 7. Maintain commercial and professional liability insurance
245 in an amount not less than $250,000 per claim.
246 8. Operate each establishment using the same name as the
247 one used to obtain the health care clinic license from the
248 agency. All invoices, packing slips, and other business records
249 must list the same name.
250 9. Obtain a pharmacy permit for each person and
251 establishment before dispensing, offering office use of, or
252 compounding adult human nonembryonic stem cells with any other
253 drug, compound, or product.
254 (3) DISPENSING OF DRUGS OR COMPOUNDED DRUGS OR PRODUCTS.—
255 (a) A pharmacist at a nonembryonic stem cell bank that is
256 also permitted as a pharmacy under chapter 465 may dispense for
257 office use only any of the following to a stem cell bank within
258 this state:
259 1. Adult human nonembryonic stem cells.
260 2. A compounded drug containing adult human nonembryonic
261 stem cells.
262 3. A compounded product containing adult human nonembryonic
263 stem cells.
264 (b) Adult human nonembryonic stem cells, compounded drugs
265 containing adult human nonembryonic stem cells, or products
266 containing adult human nonembryonic stem cells may not be sold
267 or dispensed by any person or establishment other than the adult
268 human nonembryonic stem cell bank or a pharmacist at the
269 nonembryonic stem cell bank that dispenses or receives the adult
270 human nonembryonic stem cells or the compounded drug or product
271 containing adult human nonembryonic stem cells, except that:
272 1. A physician who requests the dispensing of adult human
273 nonembryonic stem cells, a compounded drug, or a compounded
274 product from the manufacturing nonembryonic stem cell bank may
275 administer such items to his or her patient if the physician is
276 authorized within the scope of his or her license to prescribe
277 and administer adult human nonembryonic stem cells; or
278 2. A pharmacist, a pharmacy, or an establishment that
279 receives or carries adult human nonembryonic stem cells, a
280 compounded drug, or a compounded product that was manufactured
281 by a nonembryonic stem cell bank may sell or dispense such items
282 to a physician who is authorized within the scope of his or her
283 license to prescribe and administer adult human nonembryonic
284 stem cells to patients.
285 (4) HEALTH CARE PRACTITIONER RESPONSIBILITIES.—
286 (a) A physician, an advanced practice registered nurse
287 licensed under chapter 464, or a physician assistant licensed
288 under chapter 458 or chapter 459 may not practice in a
289 nonembryonic stem cell bank that is not licensed with the agency
290 as required by the rules adopted pursuant to s. 400.9925. The
291 license of a health care practitioner who violates this
292 paragraph is subject to disciplinary action by the appropriate
293 regulatory board.
294 (b) In the performance of any procedure collecting,
295 storing, using, or purporting to use adult human nonembryonic
296 stem cells or products containing adult human nonembryonic stem
297 cells, a health care practitioner must adhere to the applicable
298 current good manufacturing practices for the collecting,
299 removing, manufacturing, processing, using, compounding, and
300 implanting of stem cells or products containing stem cells
301 pursuant to the FD&C Act, 21 C.F.R., parts 1270-1271, the PHS
302 Act, and part I of chapter 499.
303 (5) RULEMAKING.—The agency, in consultation with the
304 Department of Health and the Department of Business and
305 Professional Regulation, shall adopt rules necessary to
306 administer the licensure, inspection, and regulation of
307 nonembryonic stem cell banks, including, but not limited to,
308 rules regarding all of the following which must be consistent
309 with the best practices specified in the FD&C Act, 21 C.F.R.
310 parts 1270-1271, the PHS Act, and part I of chapter 499:
311 (a) Advertising.
312 (b) Nonembryonic stem cell bank procedures and protocols
313 for the collecting, removing, manufacturing, storing,
314 dispensing, and using of adult human nonembryonic stem cells,
315 other drugs containing adult human nonembryonic stem cells, and
316 products containing adult human nonembryonic stem cells, in
317 accordance with applicable current best practices.
318 (c) Adverse incident reporting.
319 (d) Informed consent.
320 (e) Recordkeeping, record retention, and availability of
321 records for inspection.
322 Section 2. This act shall take effect July 1, 2020.
323
324 ================= T I T L E A M E N D M E N T ================
325 And the title is amended as follows:
326 Delete everything before the enacting clause
327 and insert:
328 A bill to be entitled
329 An act relating to nonembryonic stem cell banks;
330 creating s. 381.06017, F.S.; defining terms; providing
331 registration requirements for certain establishments;
332 prohibiting a nonembryonic stem cell bank from more
333 than minimally manipulating adult human nonembryonic
334 stem cells or HCT/Ps under certain circumstances;
335 providing that a nonembryonic stem cell bank that
336 performs certain functions is deemed a clinic;
337 requiring such nonembryonic stem cell banks to comply
338 with specified requirements; prohibiting an entity
339 other than certain nonembryonic stem cell banks and
340 pharmacists from dispensing certain compounded drugs
341 or products, with exceptions; prohibiting certain
342 health care practitioners from practicing in a
343 nonembryonic stem cell bank that is not licensed with
344 the agency; providing for disciplinary action;
345 requiring health care practitioners to adhere to
346 specified regulations in the performance of certain
347 procedures; requiring the Agency, in consultation with
348 the Department of Health and the Department of
349 Business and Professional Regulation, to adopt
350 specified rules; providing an effective date.