CS for CS for CS for SB 512 Second Engrossed
2020512e2
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; amending s.
24 499.012, F.S.; authorizing the Department of Business
25 and Professional Regulation to issue a prescription
26 drug manufacturer permit to a certain nonembryonic
27 stem cell bank; providing an effective date.
28
29 Be It Enacted by the Legislature of the State of Florida:
30
31 Section 1. Section 381.06017, Florida Statutes, is created
32 to read:
33 381.06017 Nonembryonic stem cell banks; collecting,
34 manufacturing, storing, dispensing, concentrating, and using
35 adult human nonembryonic stem cells and HCT/Ps.—
36 (1) DEFINITIONS.—As used in this section, the term:
37 (a) “Adult human nonembryonic stem cells” means cells and
38 cellular material that are derived from autologous or allogeneic
39 human tissue intended for implantation, transplantation,
40 infusion, or transfer into a human recipient.
41 (b) “Agency” means the Agency for Health Care
42 Administration.
43 (c) “Allogeneic 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 This term includes adult human nonembryonic stem cells, but does
66 not include any of the following:
67 1. Vascularized human organs for transplantation.
68 2. Whole blood, blood components, blood derivative
69 products, or platelet-rich plasma that are exempt under 21
70 C.F.R. s. 607.65.
71 3. Human secretions, including milk, collagen, and cell
72 factors, but not semen.
73 4. Minimally manipulated bone marrow that is for homologous
74 use only and that is not combined with any other article except
75 water, crystalloids, or sterilizing, preserving, or storage
76 agents.
77 5. Ancillary products used in the manufacture of
78 nonembryonic adult human allogeneic or autologous HCT/Ps.
79 6. Cells, tissue, or organs derived from animals.
80 7. In vitro diagnostic products.
81 8. Blood vessels recovered with an organ for
82 transplantation.
83 (i) “Homologous use” means the repair, reconstruction, or
84 supplementation of a recipient’s cells or tissues with adult
85 human nonembryonic stem cells or adult human nonembryonic HCT/Ps
86 that perform the same basic function or functions in the
87 recipient as in the donor.
88 (j) “Manufacture” means the preparing, deriving,
89 compounding, propagating, processing, producing, or fabricating
90 of any drug, device, or cosmetic.
91 (k) “Minimally manipulated” means:
92 1. For structural tissues, processing that does not alter
93 the original relevant characteristics of the tissue which relate
94 to the tissue’s utility for reconstruction, repair, or
95 replacement.
96 2. For cells or nonstructural tissues, processing that does
97 not alter the relevant biological characteristics of the cells
98 or tissues.
99 3. The washing, rinsing, cleaning, sizing, shaping, or
100 concentrating of adult human nonembryonic HCT/Ps which does not
101 alter the relevant characteristics or basic functions of the
102 tissue or cell.
103 (l) “Nonembryonic stem cell bank” means a publicly or
104 privately owned establishment that operates its own
105 laboratories, retains control over all aspects of processing and
106 storage, is managed by a single entity, and performs any of the
107 following activities in the course of its business:
108 1. Engages in the manufacture, use, implantation,
109 transplantation, infusion, dispensing, transfer, or storage of
110 adult human allogeneic and autologous nonembryonic stem cells.
111 2. Accepts, receives, carries, or delivers human allogeneic
112 and autologous nonembryonic stem cells, drugs, or products that
113 are approved by United States Food and Drug Administration and
114 regulated as drugs, devices, or biological products by the FD&C
115 Act, s. 351 of the PHS Act, or part I of chapter 499.
116 3. Recovers, collects, screens, and tests, in the facility,
117 adult human autologous nonembryonic HCT/Ps from a specific
118 patient for implantation, transplantation, infusion, or transfer
119 back into the same patient during a single surgery within the
120 facility.
121 4. Provides patient-specific health care services using
122 adult human autologous nonembryonic HCT/Ps in the facility
123 during a single procedure.
124 5. Advertises adult human nonembryonic stem cell services
125 or adult human autologous nonembryonic HCT/P services,
126 including, but not limited to, the collection, manufacture
127 implantation, transplantation, infusion, transfer, storage,
128 dispensing, use, or purported use of United States Food and Drug
129 Administration-approved adult human autologous nonembryonic stem
130 cells or adult human autologous nonembryonic HCT/Ps that are
131 intended to diagnose, cure, mitigate, treat, provide therapy
132 for, or prevent an injury or a disease.
133 6. Performs any procedure that is intended to:
134 a. Collect or store adult human autologous nonembryonic
135 HCT/Ps for autonomous homologous use; or
136 b. Diagnose, cure, mitigate, treat, provide therapy for, or
137 prevent an injury or a disease through the use or purported use
138 of adult human autologous nonembryonic HCT/Ps.
139 7. Compounds patient-specific adult human autologous
140 nonembryonic HCT/Ps into a drug product by combining or mixing
141 the patient-specific adult human nonembryonic HCT/Ps, at the
142 prescriptive direction of a licensed physician authorized within
143 the scope of his or her license to prescribe and administer
144 adult human autologous nonembryonic HCT/Ps with one or more
145 drugs or products to create a patient-specific drug or product.
146 8. Dispenses adult human autologous nonembryonic stem cells
147 or HCT/Ps to any of the following for a specific patient
148 pursuant to a valid order from a licensed physician authorized
149 within the scope of his or her license to prescribe and
150 administer adult human autologous nonembryonic HCT/Ps:
151 a. The specific patient’s physician with privileges to
152 practice at the nonembryonic stem cell bank.
153 b. For office use, the specific patient’s physician’s
154 office or a health care facility or treatment setting where the
155 physician has privileges to administer adult human autologous
156 nonembryonic HCT/Ps.
157 (m) “Office use” includes the provision and administration
158 of any United States Food and Drug Administration-approved adult
159 human nonembryonic stem cell drug, compounded drug, or
160 compounded product regulated as a drug, device, or any
161 biological product under the FD&C Act, s. 351 of the PHS Act, or
162 part I of chapter 499, to a patient’s physician in the
163 physician’s office or in a health care facility or treatment
164 setting, including a hospital, an ambulatory surgical center, or
165 a health care clinic licensed under chapter 395 or chapter 400.
166 The term also includes the patient-specific dispensing,
167 provision, or administration of the patient’s adult human
168 autologous nonembryonic HCT/Ps.
169 (n) “PHS Act” means the Public Health and Safety Act, 42
170 U.S.C. ss. 262 et seq., and applicable regulations, including 21
171 C.F.R. parts 1270 and 1271.
172 (o) “Physician” means a person who is licensed to practice
173 medicine under chapter 458 or osteopathic medicine under chapter
174 459.
175 (2) DUTIES AND REGISTRATION.—
176 (a) Establishments that manufacture adult human
177 nonembryonic HCT/Ps are regulated by either s. 351 or s. 361 of
178 the PHS Act and part I of chapter 499.
179 (b) Establishments that are regulated by s. 361 of the PHS
180 Act must register with and submit a list of all HCT/Ps
181 manufactured to the Food and Drug Administration and obtain a
182 permit from the Department of Business and Professional
183 Regulation if the HCT/P manufactured:
184 1. Is minimally manipulated;
185 2. Is intended only for homologous use;
186 3. Is manufactured through a process that does not involve
187 the combination of the cells or tissue with another article,
188 except water, crystalloids, or a sterilizing, preserving, or
189 storing agent; and
190 4. For an adult human nonembryonic HCT/P, either:
191 a. Does not have a systemic effect and is not dependent
192 upon the metabolic activity of living cells for their primary
193 function; or
194 b. Has a systemic effect or is dependent upon the metabolic
195 activity of living cells for its primary function and is for
196 autologous use or for allogeneic use in a first-degree or
197 second-degree blood relative.
198 (c) Establishments that are regulated by s. 351 of the PHS
199 Act must obtain approval from the United States Food and Drug
200 Administration in the form of an approved investigational new
201 drug application or a biological license application and must
202 obtain a prescription drug manufacturing permit pursuant to s.
203 499.01(2)(a).
204 (d) Establishments that manufacture adult human
205 nonembryonic HCT/Ps that do not meet the criteria described in
206 paragraph (a) are exempt from the registration and listing
207 requirements of s. 361 of the PHS Act, but must obtain a permit
208 from, and submit a list of all HCT/Ps manufactured to, the
209 Department of Business and Professional Regulation if the
210 establishment:
211 1. Uses the adult human nonembryonic HCT/Ps for
212 nonmedicinal scientific purposes; or
213 2. Removes human adult nonembryonic HCT/Ps from a patient,
214 through a surgical procedure performed by a physician on that
215 patient, and implants the same HCT/Ps into the same patient
216 during that same surgical procedure, with the HCT/Ps being only
217 minimal manipulated through washing, rinsing, cleaning, sizing,
218 shaping, or concentrating that does not alter the original
219 structural or relevant biological characteristics of the cells
220 or tissues.
221 (e) A nonembryonic stem cell bank that manufactures adult
222 human nonembryonic HCT/Ps may not perform enzymatic digestion on
223 or mechanical disruption of or similarly process any adult human
224 nonembryonic stem cell or HCT/P to alter the HCT/P’s original
225 structural characteristics or relevant biological
226 characteristics or to isolate differentiated cells from
227 undifferentiated cells that have lost their original structural
228 function, so that the undifferentiated cells can be
229 differentiated into a specialized cell type, unless the
230 nonembryonic stem cell bank has first registered the HCT/P with
231 the United States Food and Drug Administration and registered
232 with the Department of Business and Professional Regulation as a
233 drug, device, or biological product manufacturer and complies
234 with all applicable regulations under the FD&C Act, s. 351 of
235 the PHS Act, 21 C.F.R. parts 1-1299, and part I of chapter 499.
236 (f) A nonembryonic stem cell bank that advertises,
237 collects, stores, manufactures, dispenses, compounds, uses, or
238 purports to use adult human nonembryonic stem cells or adult
239 human autologous nonembryonic HCT/Ps is deemed a clinic as
240 defined in s. 400.9905 and must comply with all of the following
241 requirements:
242 1. Adhere to the applicable current good tissue practices
243 for the collecting, removing, manufacturing, processing, using,
244 concentrating, and implanting of adult human nonembryonic stem
245 cells or products containing adult human nonembryonic stem cells
246 pursuant to the FD&C Act, the PHS Act, 21 C.F.R. part 1271, and
247 part I of chapter 499.
248 2. Adhere to the applicable current good manufacturing
249 practices for the collecting, removing, manufacturing,
250 processing, using, concentrating, compounding, and implanting of
251 adult human autologous nonembryonic HCT/Ps so that it does not
252 alter the relevant tissue or cellular characteristics or basic
253 functions.
254 3. Obtain a health care clinic license from the agency
255 pursuant to s. 400.991 and part II of chapter 408 and register
256 each establishment separately, unless:
257 a. The clinic is a facility licensed under chapter 395; or
258 b. The clinic is affiliated with an accredited medical
259 school that provides training to medical students, residents, or
260 fellows.
261 4. Have a physician medical director who is responsible for
262 the establishment’s compliance with all requirements related to
263 licensure, operation of a nonembryonic stem cell bank, and
264 current good manufacturing practices under this section, part X
265 of chapter 400, and the FD&C Act, the PHS Act, 21 C.F.R. parts
266 1-1299, and part I of chapter 499.
267 5. Notify the agency, in writing, on a form approved by the
268 agency, within 10 days after termination of a physician medical
269 director and notify the agency within 10 days after such
270 termination of the identity of the physician medical director
271 who has assumed responsibility for that nonembryonic stem cell
272 bank. Failure to have a physician medical director practicing at
273 the location of the licensed nonembryonic stem cell bank is the
274 basis for a summary suspension of the nonembryonic stem cell
275 bank’s license pursuant to s. 120.60(6) or s. 400.607.
276 6. Require a physician medical director with a full,
277 active, and unencumbered license to actively practice at the
278 nonembryonic stem cell bank location for which he or she has
279 assumed responsibility.
280 7. Maintain commercial and professional liability insurance
281 in an amount not less than $250,000 per claim.
282 8. Operate each establishment using the same name as the
283 one used to obtain the health care clinic license from the
284 agency. All invoices, packing slips, and other business records
285 must list the same name.
286 9. Obtain a pharmacy permit for each person and
287 establishment before dispensing, offering office use of, or
288 compounding adult human nonembryonic stem cells with any other
289 drug, compound, or product.
290 (3) DISPENSING OF DRUGS OR COMPOUNDED DRUGS OR PRODUCTS.—
291 (a) A pharmacist at a nonembryonic stem cell bank that is
292 also permitted as a pharmacy under chapter 465 may dispense for
293 office use only any of the following to a stem cell bank within
294 this state:
295 1. Adult human nonembryonic stem cells.
296 2. A compounded drug containing adult human nonembryonic
297 stem cells.
298 3. A compounded product containing adult human nonembryonic
299 stem cells.
300 (b) Adult human nonembryonic stem cells, compounded drugs
301 containing adult human nonembryonic stem cells, or products
302 containing adult human nonembryonic stem cells may not be sold
303 or dispensed by any person or establishment other than the adult
304 human nonembryonic stem cell bank or a pharmacist at the
305 nonembryonic stem cell bank that dispenses or receives the adult
306 human nonembryonic stem cells or the compounded drug or product
307 containing adult human nonembryonic stem cells, except that:
308 1. A physician who requests the dispensing of adult human
309 nonembryonic stem cells, a compounded drug, or a compounded
310 product from the manufacturing nonembryonic stem cell bank may
311 administer such items to his or her patient if the physician is
312 authorized within the scope of his or her license to prescribe
313 and administer adult human nonembryonic stem cells; or
314 2. A pharmacist, a pharmacy, or an establishment that
315 receives or carries adult human nonembryonic stem cells, a
316 compounded drug, or a compounded product that was manufactured
317 by a nonembryonic stem cell bank may sell or dispense such items
318 to a physician who is authorized within the scope of his or her
319 license to prescribe and administer adult human nonembryonic
320 stem cells to patients.
321 (4) HEALTH CARE PRACTITIONER RESPONSIBILITIES.—
322 (a) A physician, an advanced practice registered nurse
323 licensed under chapter 464, or a physician assistant licensed
324 under chapter 458 or chapter 459 may not practice in a
325 nonembryonic stem cell bank that is not licensed by the agency
326 as required by the rules adopted pursuant to s. 400.9925. The
327 license of a health care practitioner who violates this
328 paragraph is subject to disciplinary action by the appropriate
329 regulatory board.
330 (b) In the performance of any procedure collecting,
331 storing, using, or purporting to use adult human nonembryonic
332 stem cells or products containing adult human nonembryonic stem
333 cells, a health care practitioner must adhere to the applicable
334 current good tissue practices for the collecting, removing,
335 manufacturing, processing, using, concentrating, compounding,
336 and implanting of stem cells or products containing stem cells
337 pursuant to the FD&C Act, the PHS Act, 21 C.F.R. part 1271, and
338 part I of chapter 499.
339 (5) RULEMAKING.—The agency, in consultation with the
340 Department of Health and the Department of Business and
341 Professional Regulation, shall adopt rules to administer the
342 licensure, inspection, and regulation of nonembryonic stem cell
343 banks, including, but not limited to, rules regarding all of the
344 following which must be consistent with the best practices
345 specified in the FD&C Act, the PHS Act, 21 C.F.R. parts 1270
346 1271, and part I of chapter 499:
347 (a) Advertising.
348 (b) Nonembryonic stem cell bank procedures and protocols
349 for the collecting, removing, manufacturing, storing,
350 dispensing, concentrating, and using of adult human nonembryonic
351 stem cells, other drugs containing adult human nonembryonic stem
352 cells, and products containing adult human nonembryonic stem
353 cells, in accordance with applicable current best practices.
354 (c) Adverse incident reporting.
355 (d) Informed consent.
356 (e) Recordkeeping, record retention, and availability of
357 records for inspection.
358 Section 2. Paragraph (d) of subsection (1) of section
359 499.012, Florida Statutes, is amended to read:
360 499.012 Permit application requirements.—
361 (1)
362 (d) A permit for a prescription drug manufacturer,
363 prescription drug repackager, prescription drug wholesale
364 distributor, limited prescription drug veterinary wholesale
365 distributor, or retail pharmacy drug wholesale distributor may
366 not be issued to the address of a health care entity or to a
367 pharmacy licensed under chapter 465, except as provided in this
368 paragraph. The department may issue a prescription drug
369 manufacturer permit to a nonembryonic stem cell bank that is
370 licensed by the Agency for Health Care Administration pursuant
371 to s. 400.991 and part II of chapter 408. The department may
372 issue a prescription drug manufacturer permit to an applicant at
373 the same address as a licensed nuclear pharmacy, which is a
374 health care entity, even if the nuclear pharmacy holds a special
375 sterile compounding permit under chapter 465, for the purpose of
376 manufacturing prescription drugs used in positron emission
377 tomography or other radiopharmaceuticals, as listed in a rule
378 adopted by the department pursuant to this paragraph. The
379 purpose of this exemption is to assure availability of state-of
380 the-art pharmaceuticals that would pose a significant danger to
381 the public health if manufactured at a separate establishment
382 address from the nuclear pharmacy from which the prescription
383 drugs are dispensed. The department may also issue a retail
384 pharmacy drug wholesale distributor permit to the address of a
385 community pharmacy licensed under chapter 465, even if the
386 community pharmacy holds a special sterile compounding permit
387 under chapter 465, as long as the community pharmacy does not
388 meet the definition of a closed pharmacy in s. 499.003.
389 Section 3. This act shall take effect July 1, 2020.