CS for CS for CS for SB 512 First Engrossed
2020512e1
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 registration and permitting requirements for certain
5 establishments; prohibiting a nonembryonic stem cell
6 bank from performing certain processes on adult human
7 nonembryonic stem cells or HCT/Ps under certain
8 circumstances; providing that a nonembryonic stem cell
9 bank that performs certain functions is deemed a
10 clinic; requiring such nonembryonic stem cell banks to
11 comply with specified requirements; prohibiting an
12 entity other than certain nonembryonic stem cell banks
13 and pharmacists from dispensing certain compounded
14 drugs or products, with exceptions; prohibiting
15 certain health care practitioners from practicing in a
16 nonembryonic stem cell bank that is not licensed by
17 the agency; providing for disciplinary action;
18 requiring health care practitioners to adhere to
19 specified regulations in the performance of certain
20 procedures; requiring the Agency for Health Care
21 Administration, in consultation with the Department of
22 Health and the Department of Business and Professional
23 Regulation, to adopt specified rules; providing an
24 effective date.
25
26 Be It Enacted by the Legislature of the State of Florida:
27
28 Section 1. Section 381.06017, Florida Statutes, is created
29 to read:
30 381.06017 Nonembryonic stem cell banks; collecting,
31 manufacturing, storing, dispensing, concentrating, and using
32 adult human nonembryonic stem cells and HCT/Ps.—
33 (1) DEFINITIONS.—As used in this section, the term:
34 (a) “Adult human nonembryonic stem cells” means cells and
35 cellular material that are derived from autologous or allogeneic
36 human tissue intended for implantation, transplantation,
37 infusion, or transfer into a human recipient.
38 (b) “Agency” means the Agency for Health Care
39 Administration.
40 (c) “Allogeneic use” means the collection of human cells or
41 tissue from one person and the implantation, transplantation,
42 infusion, or transfer of those human cells or tissue into
43 another person.
44 (d) “Autologous use” means the implantation,
45 transplantation, infusion, or transfer of human cells or tissue
46 back into the individual from which they were collected.
47 (e) “Dispense” has the same meaning as in s. 465.003(6).
48 (f) “Establishment” means a place of business that is at
49 one general physical location and may extend to one or more
50 contiguous suites, units, floors, or buildings operated and
51 controlled exclusively by entities under common operation and
52 control. The term includes multiple buildings with an
53 intervening thoroughfare if the buildings are under common
54 exclusive ownership, operation, and control. For purposes of
55 permitting, each suite, unit, floor, or building must be
56 identified in the most recent permit application.
57 (g) “FD&C Act” means the Federal Food, Drug, and Cosmetic
58 Act, 21 U.S.C. ss. 301 et seq.; 52 Stat. 1040 et seq.
59 (h) “HCT/Ps” means human cells, tissues, or cellular or
60 tissue-based products that are intended for implantation,
61 transplantation, infusion, or transfer into a human recipient.
62 This term includes adult human nonembryonic stem cells, but does
63 not include any of the following:
64 1. Vascularized human organs for transplantation.
65 2. Whole blood, blood components, blood derivative
66 products, or platelet-rich plasma that are exempt under 21
67 C.F.R. s. 607.65.
68 3. Human secretions, including milk, collagen, and cell
69 factors, but not semen.
70 4. Minimally manipulated bone marrow that is for homologous
71 use only and that is not combined with any other article except
72 water, crystalloids, or sterilizing, preserving, or storage
73 agents.
74 5. Ancillary products used in the manufacture of
75 nonembryonic adult human allogeneic or autologous HCT/Ps.
76 6. Cells, tissue, or organs derived from animals.
77 7. In vitro diagnostic products.
78 8. Blood vessels recovered with an organ for
79 transplantation.
80 (i) “Homologous use” means the repair, reconstruction, or
81 supplementation of a recipient’s cells or tissues with adult
82 human nonembryonic stem cells or adult human nonembryonic HCT/Ps
83 that perform the same basic function or functions in the
84 recipient as in the donor.
85 (j) “Manufacture” means the preparing, deriving,
86 compounding, propagating, processing, producing, or fabricating
87 of any drug, device, or cosmetic.
88 (k) “Minimally manipulated” means:
89 1. For structural tissues, processing that does not alter
90 the original relevant characteristics of the tissue which relate
91 to the tissue’s utility for reconstruction, repair, or
92 replacement.
93 2. For cells or nonstructural tissues, processing that does
94 not alter the relevant biological characteristics of the cells
95 or tissues.
96 3. The washing, rinsing, cleaning, sizing, shaping, or
97 concentrating of adult human nonembryonic HCT/Ps which does not
98 alter the relevant characteristics or basic functions of the
99 tissue or cell.
100 (l) “Nonembryonic stem cell bank” means a publicly or
101 privately owned establishment that operates its own
102 laboratories, retains control over all aspects of processing and
103 storage, is managed by a single entity, and performs any of the
104 following activities in the course of its business:
105 1. Engages in the manufacture, use, implantation,
106 transplantation, infusion, dispensing, transfer, or storage of
107 adult human allogeneic and autologous nonembryonic stem cells.
108 2. Accepts, receives, carries, or delivers human allogeneic
109 and autologous nonembryonic stem cells, drugs, or products that
110 are approved by United States Food and Drug Administration and
111 regulated as drugs, devices, or biological products by the FD&C
112 Act, s. 351 of the PHS Act, or part I of chapter 499.
113 3. Recovers, collects, screens, and tests, in the facility,
114 adult human autologous nonembryonic HCT/Ps from a specific
115 patient for implantation, transplantation, infusion, or transfer
116 back into the same patient during a single surgery within the
117 facility.
118 4. Provides patient-specific health care services using
119 adult human autologous nonembryonic HCT/Ps in the facility
120 during a single procedure.
121 5. Advertises adult human nonembryonic stem cell services
122 or adult human autologous nonembryonic HCT/P services,
123 including, but not limited to, the collection, manufacture
124 implantation, transplantation, infusion, transfer, storage,
125 dispensing, use, or purported use of United States Food and Drug
126 Administration-approved adult human autologous nonembryonic stem
127 cells or adult human autologous nonembryonic HCT/Ps that are
128 intended to diagnose, cure, mitigate, treat, provide therapy
129 for, or prevent an injury or a disease.
130 6. Performs any procedure that is intended to:
131 a. Collect or store adult human autologous nonembryonic
132 HCT/Ps for autonomous homologous use; or
133 b. Diagnose, cure, mitigate, treat, provide therapy for, or
134 prevent an injury or a disease through the use or purported use
135 of adult human autologous nonembryonic HCT/Ps.
136 7. Compounds patient-specific adult human autologous
137 nonembryonic HCT/Ps into a drug product by combining or mixing
138 the patient-specific adult human nonembryonic HCT/Ps, at the
139 prescriptive direction of a licensed physician authorized within
140 the scope of his or her license to prescribe and administer
141 adult human autologous nonembryonic HCT/Ps with one or more
142 drugs or products to create a patient-specific drug or product.
143 8. Dispenses adult human autologous nonembryonic stem cells
144 or HCT/Ps to any of the following for a specific patient
145 pursuant to a valid order from a licensed physician authorized
146 within the scope of his or her license to prescribe and
147 administer adult human autologous nonembryonic HCT/Ps:
148 a. The specific patient’s physician with privileges to
149 practice at the nonembryonic stem cell bank.
150 b. For office use, the specific patient’s physician’s
151 office or a health care facility or treatment setting where the
152 physician has privileges to administer adult human autologous
153 nonembryonic HCT/Ps.
154 (m) “Office use” includes the provision and administration
155 of any United States Food and Drug Administration-approved adult
156 human nonembryonic stem cell drug, compounded drug, or
157 compounded product regulated as a drug, device, or any
158 biological product under the FD&C Act, s. 351 of the PHS Act, or
159 part I of chapter 499, to a patient’s physician in the
160 physician’s office or in a health care facility or treatment
161 setting, including a hospital, an ambulatory surgical center, or
162 a health care clinic licensed under chapter 395 or chapter 400.
163 The term also includes the patient-specific dispensing,
164 provision, or administration of the patient’s adult human
165 autologous nonembryonic HCT/Ps.
166 (n) “PHS Act” means the Public Health and Safety Act, 42
167 U.S.C. ss. 262 et seq., and applicable regulations, including 21
168 C.F.R. parts 1270 and 1271.
169 (o) “Physician” means a person who is licensed to practice
170 medicine under chapter 458 or osteopathic medicine under chapter
171 459.
172 (2) DUTIES AND REGISTRATION.—
173 (a) Establishments that manufacture adult human
174 nonembryonic HCT/Ps are regulated by either s. 351 or s. 361 of
175 the PHS Act and part I of chapter 499.
176 (b) Establishments that are regulated by s. 361 of the PHS
177 Act must register with and submit a list of all HCT/Ps
178 manufactured to the Food and Drug Administration and obtain a
179 permit from the Department of Business and Professional
180 Regulation if the HCT/P manufactured:
181 1. Is minimally manipulated;
182 2. Is intended only for homologous use;
183 3. Is manufactured through a process that does not involve
184 the combination of the cells or tissue with another article,
185 except water, crystalloids, or a sterilizing, preserving, or
186 storing agent; and
187 4. For an adult human nonembryonic HCT/P, either:
188 a. Does not have a systemic effect and is not dependent
189 upon the metabolic activity of living cells for their primary
190 function; or
191 b. Has a systemic effect or is dependent upon the metabolic
192 activity of living cells for its primary function and is for
193 autologous use or for allogeneic use in a first-degree or
194 second-degree blood relative.
195 (c) Establishments that are regulated by s. 351 of the PHS
196 Act must obtain approval from the United States Food and Drug
197 Administration in the form of an approved investigational new
198 drug application or a biological license application and must
199 obtain a prescription drug manufacturing permit pursuant to s.
200 499.01(2)(a).
201 (d) Establishments that manufacture adult human
202 nonembryonic HCT/Ps that do not meet the criteria described in
203 paragraph (a) are exempt from the registration and listing
204 requirements of s. 361 of the PHS Act, but must obtain a permit
205 from, and submit a list of all HCT/Ps manufactured to, the
206 Department of Business and Professional Regulation if the
207 establishment:
208 1. Uses the adult human nonembryonic HCT/Ps for
209 nonmedicinal scientific purposes; or
210 2. Removes human adult nonembryonic HCT/Ps from a patient,
211 through a surgical procedure performed by a physician on that
212 patient, and implants the same HCT/Ps into the same patient
213 during that same surgical procedure, with the HCT/Ps being only
214 minimal manipulated through washing, rinsing, cleaning, sizing,
215 shaping, or concentrating that does not alter the original
216 structural or relevant biological characteristics of the cells
217 or tissues.
218 (e) A nonembryonic stem cell bank that manufactures adult
219 human nonembryonic HCT/Ps may not perform enzymatic digestion on
220 or mechanical disruption of or similarly process any adult human
221 nonembryonic stem cell or HCT/P to alter the HCT/P’s original
222 structural characteristics or relevant biological
223 characteristics or to isolate differentiated cells from
224 undifferentiated cells that have lost their original structural
225 function, so that the undifferentiated cells can be
226 differentiated into a specialized cell type, unless the
227 nonembryonic stem cell bank has first registered the HCT/P with
228 the United States Food and Drug Administration and registered
229 with the Department of Business and Professional Regulation as a
230 drug, device, or biological product manufacturer and complies
231 with all applicable regulations under the FD&C Act, s. 351 of
232 the PHS Act, 21 C.F.R. parts 1-1299, and part I of chapter 499.
233 (f) A nonembryonic stem cell bank that advertises,
234 collects, stores, manufactures, dispenses, compounds, uses, or
235 purports to use adult human nonembryonic stem cells or adult
236 human autologous nonembryonic HCT/Ps is deemed a clinic as
237 defined in s. 400.9905 and must comply with all of the following
238 requirements:
239 1. Adhere to the applicable current good tissue practices
240 for the collecting, removing, manufacturing, processing, using,
241 concentrating, and implanting of adult human nonembryonic stem
242 cells or products containing adult human nonembryonic stem cells
243 pursuant to the FD&C Act, the PHS Act, 21 C.F.R. part 1271, and
244 part I of chapter 499.
245 2. Adhere to the applicable current good manufacturing
246 practices for the collecting, removing, manufacturing,
247 processing, using, concentrating, compounding, and implanting of
248 adult human autologous nonembryonic HCT/Ps so that it does not
249 alter the relevant tissue or cellular characteristics or basic
250 functions.
251 3. Obtain a health care clinic license from the agency
252 pursuant to s. 400.991 and part II of chapter 408 and register
253 each establishment separately, unless:
254 a. The clinic is a facility licensed under chapter 395; or
255 b. The clinic is affiliated with an accredited medical
256 school that provides training to medical students, residents, or
257 fellows.
258 4. Have a physician medical director who is responsible for
259 the establishment’s compliance with all requirements related to
260 licensure, operation of a nonembryonic stem cell bank, and
261 current good manufacturing practices under this section, part X
262 of chapter 400, and the FD&C Act, the PHS Act, 21 C.F.R. parts
263 1-1299, and part I of chapter 499.
264 5. Notify the agency, in writing, on a form approved by the
265 agency, within 10 days after termination of a physician medical
266 director and notify the agency within 10 days after such
267 termination of the identity of the physician medical director
268 who has assumed responsibility for that nonembryonic stem cell
269 bank. Failure to have a physician medical director practicing at
270 the location of the licensed nonembryonic stem cell bank is the
271 basis for a summary suspension of the nonembryonic stem cell
272 bank’s license pursuant to s. 120.60(6) or s. 400.607.
273 6. Require a physician medical director with a full,
274 active, and unencumbered license to actively practice at the
275 nonembryonic stem cell bank location for which he or she has
276 assumed responsibility.
277 7. Maintain commercial and professional liability insurance
278 in an amount not less than $250,000 per claim.
279 8. Operate each establishment using the same name as the
280 one used to obtain the health care clinic license from the
281 agency. All invoices, packing slips, and other business records
282 must list the same name.
283 9. Obtain a pharmacy permit for each person and
284 establishment before dispensing, offering office use of, or
285 compounding adult human nonembryonic stem cells with any other
286 drug, compound, or product.
287 (3) DISPENSING OF DRUGS OR COMPOUNDED DRUGS OR PRODUCTS.—
288 (a) A pharmacist at a nonembryonic stem cell bank that is
289 also permitted as a pharmacy under chapter 465 may dispense for
290 office use only any of the following to a stem cell bank within
291 this state:
292 1. Adult human nonembryonic stem cells.
293 2. A compounded drug containing adult human nonembryonic
294 stem cells.
295 3. A compounded product containing adult human nonembryonic
296 stem cells.
297 (b) Adult human nonembryonic stem cells, compounded drugs
298 containing adult human nonembryonic stem cells, or products
299 containing adult human nonembryonic stem cells may not be sold
300 or dispensed by any person or establishment other than the adult
301 human nonembryonic stem cell bank or a pharmacist at the
302 nonembryonic stem cell bank that dispenses or receives the adult
303 human nonembryonic stem cells or the compounded drug or product
304 containing adult human nonembryonic stem cells, except that:
305 1. A physician who requests the dispensing of adult human
306 nonembryonic stem cells, a compounded drug, or a compounded
307 product from the manufacturing nonembryonic stem cell bank may
308 administer such items to his or her patient if the physician is
309 authorized within the scope of his or her license to prescribe
310 and administer adult human nonembryonic stem cells; or
311 2. A pharmacist, a pharmacy, or an establishment that
312 receives or carries adult human nonembryonic stem cells, a
313 compounded drug, or a compounded product that was manufactured
314 by a nonembryonic stem cell bank may sell or dispense such items
315 to a physician who is authorized within the scope of his or her
316 license to prescribe and administer adult human nonembryonic
317 stem cells to patients.
318 (4) HEALTH CARE PRACTITIONER RESPONSIBILITIES.—
319 (a) A physician, an advanced practice registered nurse
320 licensed under chapter 464, or a physician assistant licensed
321 under chapter 458 or chapter 459 may not practice in a
322 nonembryonic stem cell bank that is not licensed by the agency
323 as required by the rules adopted pursuant to s. 400.9925. The
324 license of a health care practitioner who violates this
325 paragraph is subject to disciplinary action by the appropriate
326 regulatory board.
327 (b) In the performance of any procedure collecting,
328 storing, using, or purporting to use adult human nonembryonic
329 stem cells or products containing adult human nonembryonic stem
330 cells, a health care practitioner must adhere to the applicable
331 current good tissue practices for the collecting, removing,
332 manufacturing, processing, using, concentrating, compounding,
333 and implanting of stem cells or products containing stem cells
334 pursuant to the FD&C Act, the PHS Act, 21 C.F.R. part 1271, and
335 part I of chapter 499.
336 (5) RULEMAKING.—The agency, in consultation with the
337 Department of Health and the Department of Business and
338 Professional Regulation, shall adopt rules to administer the
339 licensure, inspection, and regulation of nonembryonic stem cell
340 banks, including, but not limited to, rules regarding all of the
341 following which must be consistent with the best practices
342 specified in the FD&C Act, the PHS Act, 21 C.F.R. parts 1270
343 1271, and part I of chapter 499:
344 (a) Advertising.
345 (b) Nonembryonic stem cell bank procedures and protocols
346 for the collecting, removing, manufacturing, storing,
347 dispensing, concentrating, and using of adult human nonembryonic
348 stem cells, other drugs containing adult human nonembryonic stem
349 cells, and products containing adult human nonembryonic stem
350 cells, in accordance with applicable current best practices.
351 (c) Adverse incident reporting.
352 (d) Informed consent.
353 (e) Recordkeeping, record retention, and availability of
354 records for inspection.
355 Section 2. This act shall take effect July 1, 2020.