Florida Senate - 2020 SENATOR AMENDMENT
Bill No. CS for CS for CS for SB 512
Ì492054"Î492054
LEGISLATIVE ACTION
Senate . House
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Floor: 1/AD/2R .
03/04/2020 02:40 PM .
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Senator Hutson moved the following:
1 Senate Amendment (with title amendment)
2
3 Delete lines 31 - 346
4 and insert:
5 manufacturing, storing, dispensing, concentrating, and using
6 adult human nonembryonic stem cells and HCT/Ps.—
7 (1) DEFINITIONS.—As used in this section, the term:
8 (a) “Adult human nonembryonic stem cells” means cells and
9 cellular material that are derived from autologous or allogeneic
10 human tissue intended for implantation, transplantation,
11 infusion, or transfer into a human recipient.
12 (b) “Agency” means the Agency for Health Care
13 Administration.
14 (c) “Allogenic use” means the collection of human cells or
15 tissue from one person and the implantation, transplantation,
16 infusion, or transfer of those human cells or tissue into
17 another person.
18 (d) “Autologous use” means the implantation,
19 transplantation, infusion, or transfer of human cells or tissue
20 back into the individual from which they were collected.
21 (e) “Dispense” has the same meaning as in s. 465.003(6).
22 (f) “Establishment” means a place of business that is at
23 one general physical location and may extend to one or more
24 contiguous suites, units, floors, or buildings operated and
25 controlled exclusively by entities under common operation and
26 control. The term includes multiple buildings with an
27 intervening thoroughfare if the buildings are under common
28 exclusive ownership, operation, and control. For purposes of
29 permitting, each suite, unit, floor, or building must be
30 identified in the most recent permit application.
31 (g) “FD&C Act” means the Federal Food, Drug, and Cosmetic
32 Act, 21 U.S.C. ss. 301 et seq.; 52 Stat. 1040 et seq.
33 (h) ”HCT/Ps“ means human cells, tissues, or cellular or
34 tissue-based products that are intended for implantation,
35 transplantation, infusion, or transfer into a human recipient.
36 This term includes adult human nonembryonic stem cells, but does
37 not include any of the following:
38 1. Vascularized human organs for transplantation.
39 2. Whole blood, blood components, blood derivative
40 products, or platelet-rich plasma that are exempt under 21 C.F.R
41 607.65.
42 3. Human secretions, including milk, collagen, and cell
43 factors, but not semen.
44 4. Minimally manipulated bone marrow that is for homologous
45 use only and that is not combined with any other article except
46 water, crystalloids, or sterilizing, preserving, or storage
47 agents.
48 5. Ancillary products used in the manufacture of
49 nonembryonic adult human allogenic or autologous HCT/Ps.
50 6. Cells, tissue, or organs derived from animals.
51 7. In vitro diagnostic products.
52 8. Blood vessels recovered with an organ for
53 transplantation.
54 (i) “Homologous use” means the repair, reconstruction, or
55 supplementation of a recipient’s cells or tissues with adult
56 human nonembryonic stem cells or adult human nonembryonic HCT/Ps
57 that perform the same basic function or functions in the
58 recipient as in the donor.
59 (j) “Manufacture” means the preparing, deriving,
60 compounding, propagating, processing, producing, or fabricating
61 of any drug, device, or cosmetic.
62 (k) “Minimally manipulated” means:
63 1. For structural tissues, processing that does not alter
64 the original relevant characteristics of the tissue which relate
65 to the tissue’s utility for reconstruction, repair, or
66 replacement.
67 2. For cells or nonstructural tissues, processing that does
68 not alter the relevant biological characteristics of the cells
69 or tissues.
70 3. The washing, rinsing, cleaning, sizing, shaping, or
71 concentrating of adult human nonembryonic HCT/Ps which does not
72 alter the relevant characteristics or basic functions of the
73 tissue or cell.
74 (l) “Nonembryonic stem cell bank” means a publicly or
75 privately owned establishment that operates its own
76 laboratories, retains control over all aspects of processing and
77 storage, is managed by a single entity, and performs any of the
78 following activities in the course of its business:
79 1. Engages in the manufacture, use, implantation,
80 transplantation, infusion, dispensing, transfer, or storage of
81 adult human allogenic and autologous nonembryonic stem cells.
82 2. Accepts, receives, carries, or delivers human allogenic
83 and autologous nonembryonic stem cells, drugs, or products that
84 are approved by United States Food and Drug Administration and
85 regulated as drugs, devices, or biological products by the FD&C
86 Act, s. 351 of the PHS Act, or part I of chapter 499.
87 3. Recovers, collects, screens, and tests, in the facility,
88 adult human autologous nonembryonic HCT/Ps from a specific
89 patient for implantation, transplantation, infusion, or transfer
90 back into the same patient during a single surgery within the
91 facility.
92 4. Provides patient-specific health care services using
93 adult human autologous nonembryonic HCT/Ps in the facility
94 during a single procedure.
95 5. Advertises adult human nonembryonic stem cell services
96 or adult human autologous nonembryonic HCT/P services,
97 including, but not limited to, the collection, manufacture
98 implantation, transplantation, infusion, transfer, storage,
99 dispensing, use, or purported use of United States Food and Drug
100 Administration-approved adult human autologous nonembryonic stem
101 cells or adult human autologous nonembryonic HCT/Ps that are
102 intended to diagnose, cure, mitigate, treat, provide therapy
103 for, or prevent an injury or a disease.
104 6. Performs any procedure that is intended to:
105 a. Collect or store adult human autologous nonembryonic
106 HCT/Ps for autonomous homologous use; or
107 b. Diagnose, cure, mitigate, treat, provide therapy for, or
108 prevent an injury or a disease through the use or purported use
109 of adult human autologous nonembryonic HCT/Ps.
110 7. Compounds patient-specific adult human autologous
111 nonembryonic HCT/Ps into a drug product by combining or mixing
112 the patient-specific adult human nonembryonic HCT/Ps, at the
113 prescriptive direction of a licensed physician authorized within
114 the scope of his or her license to prescribe and administer
115 adult human autologous nonembryonic HCT/Ps with one or more
116 drugs or products to create a patient-specific drug or product.
117 8. Dispenses adult human autologous nonembryonic stem cells
118 or HCT/Ps to any of the following for a specific patient
119 pursuant to a valid order from a licensed physician authorized
120 within the scope of his or her license to prescribe and
121 administer adult human autologous nonembryonic HCT/Ps:
122 a. The specific patient’s physician with privileges to
123 practice at the nonembryonic stem cell bank.
124 b. For office use, the specific patient’s physician’s
125 office or a health care facility or treatment setting where the
126 physician has privileges to administer adult human autologous
127 nonembryonic HCT/Ps.
128 (m) “Office use” includes the provision and administration
129 of any United States Food and Drug Administration-approved adult
130 human nonembryonic stem cell drug, compounded drug, or
131 compounded product regulated as a drug, device, or any
132 biological product under the FD&C Act, s. 351 of the PHS Act, or
133 part I of chapter 499, to a patient’s physician in the
134 physician’s office or in a health care facility or treatment
135 setting, including a hospital, an ambulatory surgical center, or
136 a health care clinic licensed under chapter 395 or chapter 400.
137 The term also includes the patient-specific dispensing,
138 provision, or administration of the patient’s adult human
139 autologous nonembryonic HCT/Ps.
140 (n) “PHS Act” means the Public Health and Safety Act, 42
141 U.S.C. ss. 262 et seq., and applicable regulations, including 21
142 C.F.R. parts 1270 and 1271.
143 (o) “Physician” means a person who is licensed to practice
144 medicine under chapter 458 or osteopathic medicine under chapter
145 459.
146 (2) DUTIES AND REGISTRATION.—
147 (a) Establishments that manufacture adult human
148 nonembryonic HCT/Ps are regulated by either s. 351 or s. 361 of
149 the PHS Act and part I of chapter 499.
150 (b) Establishments that are regulated by s. 361 of the PHS
151 Act must register with and submit a list of all HCT/Ps
152 manufactured to the Food and Drug Administration and obtain a
153 permit from the Department of Business and Professional
154 Regulation if the HCT/P manufactured:
155 1. Is minimally manipulated;
156 2. Is intended only for homologous use;
157 3. Is manufactured through a process that does not involve
158 the combination of the cells or tissue with another article,
159 except water, crystalloids, or a sterilizing, preserving, or
160 storing agent; and
161 4. For an adult human nonembryonic HCT/P, either:
162 a. Does not have a systemic effect and is not dependent
163 upon the metabolic activity of living cells for their primary
164 function; or
165 b. Has a systemic effect or is dependent upon the metabolic
166 activity of living cells for its primary function and is for
167 autologous use or for allogenic use in a first-degree or second
168 degree blood relative.
169 (c) Establishments that are regulated by s. 351 of the PHS
170 Act must obtain approval from the United States Food and Drug
171 Administration in the form of an approved investigational new
172 drug application or a biological license application and must
173 obtain a prescription drug manufacturing permit pursuant to s.
174 499.01(2)(a).
175 (d) Establishments that manufacture adult human
176 nonembryonic HCT/Ps that do not meet the criteria described in
177 paragraph (a) are exempt from the registration and listing
178 requirements of s. 361 of the PHS Act, but must obtain a permit
179 from, and submit a list of all HCT/Ps manufactured to, the
180 Department of Business and Professional Regulation if the
181 establishment:
182 1. Uses the adult human nonembryonic HCT/Ps for
183 nonmedicinal scientific purposes; or
184 2. Removes human adult nonembryonic HCT/Ps from a patient,
185 through a surgical procedure performed by a physician on that
186 patient, and implants the same HCT/Ps into the same patient
187 during that same surgical procedure, with the HCT/Ps being only
188 minimal manipulated through washing, rinsing, cleaning, sizing,
189 shaping, or concentrating that does not alter the original
190 structural or relevant biological characteristics of the cells
191 or tissues.
192 (e) A nonembryonic stem cell bank that manufactures adult
193 human nonembryonic HCT/Ps may not perform enzymatic digestion on
194 or mechanical disruption of or similarly process any adult human
195 nonembryonic stem cell or HCT/P to alter the HCT/P’s original
196 structural characteristics or relevant biological
197 characteristics or to isolate differentiated cells from
198 undifferentiated cells that have lost their original structural
199 function, so that the undifferentiated cells can be
200 differentiated into a specialized cell type, unless the
201 nonembryonic stem cell bank has first registered the HCT/P with
202 the United States Food and Drug Administration and registered
203 with the Department of Business and Professional Regulation as a
204 drug, device, or biological product manufacturer and complies
205 with all applicable regulations under the FD&C Act, s. 351 of
206 the PHS Act, 21 C.F.R. parts 1-1299, and part I of chapter 499.
207 (d) A nonembryonic stem cell bank that advertises,
208 collects, stores, manufactures, dispenses, compounds, uses, or
209 purports to use adult human nonembryonic stem cells or adult
210 human autologous nonembryonic HCT/Ps is deemed a clinic as
211 defined in s. 400.9905 and must comply with all of the following
212 requirements:
213 1. Adhere to the applicable current good tissue practices
214 for the collecting, removing, manufacturing, processing, using,
215 concentrating, and implanting of adult human nonembryonic stem
216 cells or products containing adult human nonembryonic stem cells
217 pursuant to the FD&C Act, the PHS Act, 21 C.F.R. part 1271, and
218 part I of chapter 499.
219 2. Adhere to the applicable current good manufacturing
220 practices for the collecting, removing, manufacturing,
221 processing, using, concentrating, compounding, and implanting of
222 adult human autologous nonembryonic HCT/Ps so that it does not
223 alter the relevant tissue or cellular characteristics or basic
224 functions.
225 3. Obtain a health care clinic license from the agency
226 pursuant to s. 400.991 and part II of chapter 408 and register
227 each establishment separately, unless:
228 a. The clinic is a facility licensed under chapter 395; or
229 b. The clinic is affiliated with an accredited medical
230 school that provides training to medical students, residents, or
231 fellows.
232 4. Have a physician medical director who is responsible for
233 the establishment’s compliance with all requirements related to
234 licensure, operation of a nonembryonic stem cell bank, and
235 current good manufacturing practices under this section, part X
236 of chapter 400, and the FD&C Act, the PHS Act, 21 C.F.R. parts
237 1-1299, and part I of chapter 499.
238 5. Notify the agency, in writing, on a form approved by the
239 agency, within 10 days after termination of a physician medical
240 director and notify the agency within 10 days after such
241 termination of the identity of the physician medical director
242 who has assumed responsibility for that nonembryonic stem cell
243 bank. Failure to have a physician medical director practicing at
244 the location of the licensed nonembryonic stem cell bank is the
245 basis for a summary suspension of the nonembryonic stem cell
246 bank’s license pursuant to s. 120.60(6) or s. 400.607.
247 6. Require a physician medical director with a full,
248 active, and unencumbered license to actively practice at the
249 nonembryonic stem cell bank location for which he or she has
250 assumed responsibility.
251 7. Maintain commercial and professional liability insurance
252 in an amount not less than $250,000 per claim.
253 8. Operate each establishment using the same name as the
254 one used to obtain the health care clinic license from the
255 agency. All invoices, packing slips, and other business records
256 must list the same name.
257 9. Obtain a pharmacy permit for each person and
258 establishment before dispensing, offering office use of, or
259 compounding adult human nonembryonic stem cells with any other
260 drug, compound, or product.
261 (3) DISPENSING OF DRUGS OR COMPOUNDED DRUGS OR PRODUCTS.—
262 (a) A pharmacist at a nonembryonic stem cell bank that is
263 also permitted as a pharmacy under chapter 465 may dispense for
264 office use only any of the following to a stem cell bank within
265 this state:
266 1. Adult human nonembryonic stem cells.
267 2. A compounded drug containing adult human nonembryonic
268 stem cells.
269 3. A compounded product containing adult human nonembryonic
270 stem cells.
271 (b) Adult human nonembryonic stem cells, compounded drugs
272 containing adult human nonembryonic stem cells, or products
273 containing adult human nonembryonic stem cells may not be sold
274 or dispensed by any person or establishment other than the adult
275 human nonembryonic stem cell bank or a pharmacist at the
276 nonembryonic stem cell bank that dispenses or receives the adult
277 human nonembryonic stem cells or the compounded drug or product
278 containing adult human nonembryonic stem cells, except that:
279 1. A physician who requests the dispensing of adult human
280 nonembryonic stem cells, a compounded drug, or a compounded
281 product from the manufacturing nonembryonic stem cell bank may
282 administer such items to his or her patient if the physician is
283 authorized within the scope of his or her license to prescribe
284 and administer adult human nonembryonic stem cells; or
285 2. A pharmacist, a pharmacy, or an establishment that
286 receives or carries adult human nonembryonic stem cells, a
287 compounded drug, or a compounded product that was manufactured
288 by a nonembryonic stem cell bank may sell or dispense such items
289 to a physician who is authorized within the scope of his or her
290 license to prescribe and administer adult human nonembryonic
291 stem cells to patients.
292 (4) HEALTH CARE PRACTITIONER RESPONSIBILITIES.—
293 (a) A physician, an advanced practice registered nurse
294 licensed under chapter 464, or a physician assistant licensed
295 under chapter 458 or chapter 459 may not practice in a
296 nonembryonic stem cell bank that is not licensed by the agency
297 as required by the rules adopted pursuant to s. 400.9925. The
298 license of a health care practitioner who violates this
299 paragraph is subject to disciplinary action by the appropriate
300 regulatory board.
301 (b) In the performance of any procedure collecting,
302 storing, using, or purporting to use adult human nonembryonic
303 stem cells or products containing adult human nonembryonic stem
304 cells, a health care practitioner must adhere to the applicable
305 current good tissue practices for the collecting, removing,
306 manufacturing, processing, using, concentrating, compounding,
307 and implanting of stem cells or products containing stem cells
308 pursuant to the FD&C Act, the PHS Act, 21 C.F.R. part 1271, and
309 part I of chapter 499.
310 (5) RULEMAKING.—The agency, in consultation with the
311 Department of Health and the Department of Business and
312 Professional Regulation, shall adopt rules to administer the
313 licensure, inspection, and regulation of nonembryonic stem cell
314 banks, including, but not limited to, rules regarding all of the
315 following which must be consistent with the best practices
316 specified in the FD&C Act, the PHS Act, 21 C.F.R. parts 1270
317 1271, and part I of chapter 499:
318 (a) Advertising.
319 (b) Nonembryonic stem cell bank procedures and protocols
320 for the collecting, removing, manufacturing, storing,
321 dispensing, concentrating, and using of adult human nonembryonic
322 stem cells, other drugs containing adult human nonembryonic stem
323 cells, and products containing adult human nonembryonic stem
324 cells, in accordance with applicable current best practices.
325 (c) Adverse incident reporting.
326 (d) Informed consent.
327 (e) Recordkeeping, record retention, and availability of
328 records for inspection.
329 Section 2. This act shall take effect July 1, 2020,
330 contingent on SB 7066 or similar legislation taking effect on
331 that same date, if such legislation is adopted in the same
332 legislative session or an extension thereof and becomes a law.
333
334 ================= T I T L E A M E N D M E N T ================
335 And the title is amended as follows:
336 Delete lines 4 - 24
337 and insert:
338 registration and permitting requirements for certain
339 establishments; prohibiting a nonembryonic stem cell
340 bank from performing certain processes on adult human
341 nonembryonic stem cells or HCT/Ps under certain
342 circumstances; providing that a nonembryonic stem cell
343 bank that performs certain functions is deemed a
344 clinic; requiring such nonembryonic stem cell banks to
345 comply with specified requirements; prohibiting an
346 entity other than certain nonembryonic stem cell banks
347 and pharmacists from dispensing certain compounded
348 drugs or products, with exceptions; prohibiting
349 certain health care practitioners from practicing in a
350 nonembryonic stem cell bank that is not licensed by
351 the agency; providing for disciplinary action;
352 requiring health care practitioners to adhere to
353 specified regulations in the performance of certain
354 procedures; requiring the Agency for Health Care
355 Administration, in consultation with the Department of
356 Health and the Department of Business and Professional
357 Regulation, to adopt specified rules; providing a
358 contingent effective date.