Florida Senate - 2020 CS for CS for CS for SB 512
By the Committees on Rules; Appropriations; and Health Policy;
and Senator Hutson
595-04240-20 2020512c3
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 requirements for certain establishments;
5 prohibiting a nonembryonic stem cell bank from more
6 than minimally manipulating adult human nonembryonic
7 stem cells or HCT/Ps under certain circumstances;
8 providing that a nonembryonic stem cell bank that
9 performs certain functions is deemed a clinic;
10 requiring such nonembryonic stem cell banks to comply
11 with specified requirements; prohibiting an entity
12 other than certain nonembryonic stem cell banks and
13 pharmacists from dispensing certain compounded drugs
14 or products, with exceptions; prohibiting certain
15 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, and using adult human
32 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 that
35 are derived from adult human nonembryonic HCT/Ps through
36 enzymatic digestion, mechanical disruption, or similar
37 processing. The term includes only drugs, devices, or biological
38 products that are approved by the United States Food and Drug
39 Administration and are regulated by the FD&C Act, s. 351 of the
40 PHS Act, or part I of chapter 499.
41 (b) “Agency” means the Agency for Health Care
42 Administration.
43 (c) “Allogenic use” means the collection of human cells or
44 tissue from one person and the implantation, transplantation,
45 infusion, or transfer of those human cells or tissue into
46 another person.
47 (d) “Autologous use” means the implantation,
48 transplantation, infusion, or transfer of human cells or tissue
49 back into the individual from which they were collected.
50 (e) “Dispense” has the same meaning as in s. 465.003(6).
51 (f) “Establishment” means a place of business that is at
52 one general physical location and may extend to one or more
53 contiguous suites, units, floors, or buildings operated and
54 controlled exclusively by entities under common operation and
55 control. The term includes multiple buildings with an
56 intervening thoroughfare if the buildings are under common
57 exclusive ownership, operation, and control. For purposes of
58 permitting, each suite, unit, floor, or building must be
59 identified in the most recent permit application.
60 (g) “FD&C Act” means the Federal Food, Drug, and Cosmetic
61 Act, 21 U.S.C. ss. 301 et seq.; 52 Stat. 1040 et seq.
62 (h) ”HCT/Ps“ means human cells, tissues, or cellular or
63 tissue-based products that are intended for implantation,
64 transplantation, infusion, or transfer into a human recipient.
65 The term does not include any of the following:
66 1. Vascularized human organs for transplantation.
67 2. Whole blood, blood components, blood derivative
68 products, or platelet-rich plasma that are exempt under 21 C.F.R
69 607.65.
70 3. Human secretions, including milk, collagen, and cell
71 factors, but not semen.
72 4. Minimally manipulated bone marrow that is for homologous
73 use only and that is not combined with any other article except
74 water, crystalloids, or sterilizing, preserving, or storage
75 agents.
76 5. Ancillary products used in the manufacture of
77 nonembryonic adult human allogenic or autologous HCT/Ps.
78 6. Cells, tissue, or organs derived from animals.
79 7. In vitro diagnostic products.
80 8. Blood vessels recovered with an organ for
81 transplantation.
82 (i) “Homologous use” means the repair, reconstruction, or
83 supplementation of a recipient’s cells or tissues with adult
84 human nonembryonic stem cells or adult human nonembryonic HCT/Ps
85 that perform the same basic function or functions in the
86 recipient as in the donor.
87 (j) “Manufacture” means the preparing, deriving,
88 compounding, propagating, processing, producing, or fabricating
89 of any drug, device, or cosmetic.
90 (k) “Minimally manipulated” means:
91 1. For structural tissues, processing that does not alter
92 the original relevant characteristics of the tissue which relate
93 to the tissue’s utility for reconstruction, repair, or
94 replacement.
95 2. For cells or nonstructural tissues, processing that does
96 not alter the relevant biological characteristics of the cells
97 or tissues.
98 3. The washing, rinsing, cleaning, sizing, shaping, or
99 concentrating of adult human nonembryonic HCT/Ps which does not
100 alter the relevant characteristics or basic functions of the
101 tissue or cell.
102 (l) “Nonembryonic stem cell bank” means a publicly or
103 privately owned establishment that operates its own
104 laboratories, retains control over all aspects of processing and
105 storage, is managed by a single entity, and performs any of the
106 following activities in the course of its business:
107 1. Engages in the manufacture, use, implantation,
108 transplantation, infusion, dispensing, transfer, or storage of
109 adult human allogenic and autologous nonembryonic stem cells.
110 2. Accepts, receives, carries, or delivers human allogenic
111 and autologous nonembryonic stem cells, drugs, or products that
112 are approved by United States Food and Drug Administration and
113 regulated as drugs, devices, or biological products by the FD&C
114 Act, s. 351 of the PHS Act, or part I of chapter 499.
115 3. Recovers, collects, screens, and tests, in the facility,
116 adult human autologous nonembryonic HCT/Ps from a specific
117 patient for implantation, transplantation, infusion, or transfer
118 back into the same patient during a single surgery within the
119 facility.
120 4. Provides patient-specific health care services using
121 adult human autologous nonembryonic HCT/Ps in the facility
122 during a single procedure.
123 5. Advertises adult human nonembryonic stem cell services
124 or adult human autologous nonembryonic HCT/P services,
125 including, but not limited to, the collection, manufacture
126 implantation, transplantation, infusion, transfer, storage,
127 dispensing, use, or purported use of United States Food and Drug
128 Administration-approved adult human autologous nonembryonic stem
129 cells or adult human autologous nonembryonic HCT/Ps that are
130 intended to diagnose, cure, mitigate, treat, provide therapy
131 for, or prevent an injury or a disease.
132 6. Performs any procedure that is intended to:
133 a. Collect or store adult human autologous nonembryonic
134 HCT/Ps for autonomous homologous use; or
135 b. Diagnose, cure, mitigate, treat, provide therapy for, or
136 prevent an injury or a disease through the use or purported use
137 of adult human autologous nonembryonic HCT/Ps.
138 7. Compounds patient-specific adult human autologous
139 nonembryonic HCT/Ps into a drug product by combining or mixing
140 the patient-specific adult human nonembryonic HCT/Ps, at the
141 prescriptive direction of a licensed physician authorized within
142 the scope of his or her license to prescribe and administer
143 adult human autologous nonembryonic HCT/Ps with one or more
144 drugs or products to create a patient-specific drug or product.
145 8. Dispenses adult human autologous nonembryonic stem cells
146 or HCT/Ps to any of the following for a specific patient
147 pursuant to a valid order from a licensed physician authorized
148 within the scope of his or her license to prescribe and
149 administer adult human autologous nonembryonic HCT/Ps:
150 a. The specific patient’s physician with privileges to
151 practice at the nonembryonic stem cell bank.
152 b. For office use, the specific patient’s physician’s
153 office or a health care facility or treatment setting where the
154 physician has privileges to administer adult human autologous
155 nonembryonic HCT/Ps.
156 (m) “Office use” includes the provision and administration
157 of any United States Food and Drug Administration-approved adult
158 human nonembryonic stem cell drug, compounded drug, or
159 compounded product regulated as a drug, device, or any
160 biological product under the FD&C Act, s. 351 of the PHS Act, or
161 part I of chapter 499, to a patient’s physician in the
162 physician’s office or in a health care facility or treatment
163 setting, including a hospital, an ambulatory surgical center, or
164 a health care clinic licensed under chapter 395 or chapter 400.
165 The term also includes the patient-specific dispensing,
166 provision, or administration of the patient’s adult human
167 autologous nonembryonic HCT/Ps.
168 (n) “PHS Act” means the Public Health and Safety Act, 42
169 U.S.C. ss. 262 et seq., and applicable regulations, including 21
170 C.F.R. part 1271.
171 (o) “Physician” means a person who is licensed to practice
172 medicine under chapter 458 or osteopathic medicine under chapter
173 459.
174 (2) DUTIES AND REGISTRATION.—
175 (a) Establishments that manufacture adult human
176 nonembryonic HCT/Ps are regulated by s. 361 of the PHS Act and
177 part I of chapter 499. Such establishments must register with
178 and submit a list of all HCT/Ps manufactured to the Food and
179 Drug Administration and obtain a permit from the Department of
180 Business and Professional 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 allogenic use in a first-degree or second
194 degree blood relative.
195 (b) Establishments that manufacture adult human
196 nonembryonic HCT/Ps that do not meet the criteria described in
197 paragraph (a) are exempt from the registration and listing
198 requirements of s. 361 of the PHS Act, but must obtain a permit
199 from, and submit a list of all HCT/Ps manufactured to, the
200 Department of Business and Professional Regulation if the
201 establishment:
202 1. Uses the adult human nonembryonic HCT/Ps for
203 nonmedicinal scientific purposes; or
204 2. Removes human adult nonembryonic HCT/Ps from a patient
205 and implants the same HCT/Ps into the same patient during the
206 same surgical procedure with only minimal manipulation of the
207 HCT/Ps which does not alter the original relevant biological
208 characteristics of the cells or tissues.
209 (c) A nonembryonic stem cell bank that manufactures adult
210 human nonembryonic HCT/Ps may not more than minimally
211 manipulate, through enzymatic digestion, mechanical disruption,
212 or similar processing, any adult human nonembryonic stem cell or
213 HCT/P to alter the HCT/P’s original structural characteristics
214 or relevant biological characteristics or to isolate
215 differentiated cells from undifferentiated cells that have lost
216 their original structural function, so that the undifferentiated
217 cells can be differentiated into a specialized cell type, unless
218 the nonembryonic stem cell bank has first registered the HCT/P
219 with the United States Food and Drug Administration and
220 registered with the Department of Business and Professional
221 Regulation as a drug, device, or biological product manufacturer
222 and complies with all applicable regulations under the FD&C Act,
223 s. 351 of the PHS Act, 21 C.F.R. parts 1-1299, and part I of
224 chapter 499.
225 (d) A nonembryonic stem cell bank that advertises,
226 collects, stores, manufactures, dispenses, compounds, uses, or
227 purports to use adult human nonembryonic stem cells or adult
228 human autologous nonembryonic HCT/Ps is deemed a clinic as
229 defined in s. 400.9905 and must comply with all of the following
230 requirements:
231 1. Adhere to the applicable current good manufacturing
232 practices for the collecting, removing, manufacturing,
233 processing, using, compounding, and implanting of adult human
234 nonembryonic stem cells or products containing adult human
235 nonembryonic stem cells pursuant to the FD&C Act, the PHS Act,
236 21 C.F.R. parts 1270-1271, and part I of chapter 499.
237 2. Adhere to the applicable current good manufacturing
238 practices for the collecting, removing, manufacturing,
239 processing, using, compounding, and implanting of adult human
240 autologous nonembryonic HCT/Ps so that it does not alter the
241 relevant tissue or cellular characteristics or basic functions.
242 3. Obtain a health care clinic license from the agency
243 pursuant to s. 400.991 and part II of chapter 408 and register
244 each establishment separately, unless:
245 a. The clinic is a facility licensed under chapter 395; or
246 b. The clinic is affiliated with an accredited medical
247 school that provides training to medical students, residents, or
248 fellows.
249 4. Have a physician medical director who is responsible for
250 the establishment’s compliance with all requirements related to
251 licensure, operation of a nonembryonic stem cell bank, and
252 current good manufacturing practices under this section, part X
253 of chapter 400, and the FD&C Act, the PHS Act, 21 C.F.R. parts
254 1-1299, and part I of chapter 499.
255 5. Notify the agency, in writing, on a form approved by the
256 agency, within 10 days after termination of a physician medical
257 director and notify the agency within 10 days after such
258 termination of the identity of the physician medical director
259 who has assumed responsibility for that nonembryonic stem cell
260 bank. Failure to have a physician medical director practicing at
261 the location of the licensed nonembryonic stem cell bank is the
262 basis for a summary suspension of the nonembryonic stem cell
263 bank’s license pursuant to s. 120.60(6) or s. 400.607.
264 6. Require a physician medical director with a full,
265 active, and unencumbered license to actively practice at the
266 nonembryonic stem cell bank location for which he or she has
267 assumed responsibility.
268 7. Maintain commercial and professional liability insurance
269 in an amount not less than $250,000 per claim.
270 8. Operate each establishment using the same name as the
271 one used to obtain the health care clinic license from the
272 agency. All invoices, packing slips, and other business records
273 must list the same name.
274 9. Obtain a pharmacy permit for each person and
275 establishment before dispensing, offering office use of, or
276 compounding adult human nonembryonic stem cells with any other
277 drug, compound, or product.
278 (3) DISPENSING OF DRUGS OR COMPOUNDED DRUGS OR PRODUCTS.—
279 (a) A pharmacist at a nonembryonic stem cell bank that is
280 also permitted as a pharmacy under chapter 465 may dispense for
281 office use only any of the following to a stem cell bank within
282 this state:
283 1. Adult human nonembryonic stem cells.
284 2. A compounded drug containing adult human nonembryonic
285 stem cells.
286 3. A compounded product containing adult human nonembryonic
287 stem cells.
288 (b) Adult human nonembryonic stem cells, compounded drugs
289 containing adult human nonembryonic stem cells, or products
290 containing adult human nonembryonic stem cells may not be sold
291 or dispensed by any person or establishment other than the adult
292 human nonembryonic stem cell bank or a pharmacist at the
293 nonembryonic stem cell bank that dispenses or receives the adult
294 human nonembryonic stem cells or the compounded drug or product
295 containing adult human nonembryonic stem cells, except that:
296 1. A physician who requests the dispensing of adult human
297 nonembryonic stem cells, a compounded drug, or a compounded
298 product from the manufacturing nonembryonic stem cell bank may
299 administer such items to his or her patient if the physician is
300 authorized within the scope of his or her license to prescribe
301 and administer adult human nonembryonic stem cells; or
302 2. A pharmacist, a pharmacy, or an establishment that
303 receives or carries adult human nonembryonic stem cells, a
304 compounded drug, or a compounded product that was manufactured
305 by a nonembryonic stem cell bank may sell or dispense such items
306 to a physician who is authorized within the scope of his or her
307 license to prescribe and administer adult human nonembryonic
308 stem cells to patients.
309 (4) HEALTH CARE PRACTITIONER RESPONSIBILITIES.—
310 (a) A physician, an advanced practice registered nurse
311 licensed under chapter 464, or a physician assistant licensed
312 under chapter 458 or chapter 459 may not practice in a
313 nonembryonic stem cell bank that is not licensed by the agency
314 as required by the rules adopted pursuant to s. 400.9925. The
315 license of a health care practitioner who violates this
316 paragraph is subject to disciplinary action by the appropriate
317 regulatory board.
318 (b) In the performance of any procedure collecting,
319 storing, using, or purporting to use adult human nonembryonic
320 stem cells or products containing adult human nonembryonic stem
321 cells, a health care practitioner must adhere to the applicable
322 current good manufacturing practices for the collecting,
323 removing, manufacturing, processing, using, compounding, and
324 implanting of stem cells or products containing stem cells
325 pursuant to the FD&C Act, the PHS Act, 21 C.F.R. parts 1270
326 1271, and part I of chapter 499.
327 (5) RULEMAKING.—The agency, in consultation with the
328 Department of Health and the Department of Business and
329 Professional Regulation, shall adopt rules to administer the
330 licensure, inspection, and regulation of nonembryonic stem cell
331 banks, including, but not limited to, rules regarding all of the
332 following which must be consistent with the best practices
333 specified in the FD&C Act, the PHS Act, 21 C.F.R. parts 1270
334 1271, and part I of chapter 499:
335 (a) Advertising.
336 (b) Nonembryonic stem cell bank procedures and protocols
337 for the collecting, removing, manufacturing, storing,
338 dispensing, and using of adult human nonembryonic stem cells,
339 other drugs containing adult human nonembryonic stem cells, and
340 products containing adult human nonembryonic stem cells, in
341 accordance with applicable current best practices.
342 (c) Adverse incident reporting.
343 (d) Informed consent.
344 (e) Recordkeeping, record retention, and availability of
345 records for inspection.
346 Section 2. This act shall take effect July 1, 2020.