Florida Senate - 2022 COMMITTEE AMENDMENT
Bill No. CS for SB 1222
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LEGISLATIVE ACTION
Senate . House
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The Committee on Judiciary (Bean) recommended the following:
1 Senate Substitute for Amendment (874244) (with title
2 amendment)
3
4 Delete everything after the enacting clause
5 and insert:
6 Section 1. Present subsections (1) through (22) of section
7 401.23, Florida Statutes, are redesignated as subsections (2)
8 through (23), respectively, a new subsection (1) is added to
9 that section, and present subsection (19) of that section is
10 amended, to read:
11 401.23 Definitions.—As used in this part, the term:
12 (1) “Acute and post-acute hospital care at home” means
13 acute and post-acute health care services provided in a
14 clinically qualified patient’s permanent residence, as defined
15 in s. 196.012(17), through a program approved by the Centers for
16 Medicare and Medicaid Services and the Agency for Health Care
17 Administration.
18 (20)(19) “Physician” means a practitioner who is licensed
19 under the provisions of chapter 458 or chapter 459. For the
20 purpose of providing medical direction “medical direction” as
21 defined in subsection (14) for the treatment of patients
22 immediately before prior to or during transportation to a United
23 States Department of Veterans Affairs medical facility,
24 “physician” also means a practitioner employed by the United
25 States Department of Veterans Affairs.
26 Section 2. Paragraph (c) is added to subsection (2) of
27 section 401.272, Florida Statutes, to read:
28 401.272 Emergency medical services community health care.—
29 (2) Notwithstanding any other provision of law to the
30 contrary:
31 (c) Paramedics may provide basic life support services and
32 advanced life support services to patients receiving acute and
33 post-acute hospital care at home as specified in the paramedic’s
34 supervisory relationship with a physician or standing orders as
35 described in s. 401.265, s. 458.348, or s. 459.025. A physician
36 who supervises or provides medical direction to a paramedic who
37 provides basic life support services or advanced life support
38 services to patients receiving acute and post-acute hospital
39 care at home pursuant to a formal supervisory relationship or
40 standing orders is liable for any act or omission of the
41 paramedic acting under the physician’s supervision or medical
42 direction when providing such services. The department may adopt
43 and enforce rules necessary to implement this paragraph.
44 Section 3. Section 465.003, Florida Statutes, is reordered
45 and amended to read:
46 465.003 Definitions.—As used in this chapter, the term:
47 (1) “Acute and post-acute hospital care at home” means
48 acute and post-acute health care services provided in a
49 clinically qualified patient’s permanent residence, as defined
50 in s. 196.012(17), through a program approved by the Centers for
51 Medicare and Medicaid Services and the Agency for Health Care
52 Administration.
53 (2)(1) “Administration” means the obtaining and giving of a
54 single dose of medicinal drugs by a legally authorized person to
55 a patient for her or his consumption.
56 (4)(2) “Board” means the Board of Pharmacy.
57 (10)(3) “Consultant pharmacist” means a pharmacist licensed
58 by the department and certified as a consultant pharmacist
59 pursuant to s. 465.0125.
60 (11)(4) “Data communication device” means an electronic
61 device that receives electronic information from one source and
62 transmits or routes it to another, including, but not limited
63 to, any such bridge, router, switch, or gateway.
64 (12)(5) “Department” means the Department of Health.
65 (13)(6) “Dispense” means the transfer of possession of one
66 or more doses of a medicinal drug by a pharmacist to the
67 ultimate consumer or her or his agent. As an element of
68 dispensing, the pharmacist shall, prior to the actual physical
69 transfer, interpret and assess the prescription order for
70 potential adverse reactions, interactions, and dosage regimen
71 she or he deems appropriate in the exercise of her or his
72 professional judgment, and the pharmacist shall certify that the
73 medicinal drug called for by the prescription is ready for
74 transfer. The pharmacist shall also provide counseling on proper
75 drug usage, either orally or in writing, if in the exercise of
76 her or his professional judgment counseling is necessary. The
77 actual sales transaction and delivery of such drug shall not be
78 considered dispensing. The administration shall not be
79 considered dispensing.
80 (14)(7) “Institutional formulary system” means a method
81 whereby the medical staff evaluates, appraises, and selects
82 those medicinal drugs or proprietary preparations which in the
83 medical staff’s clinical judgment are most useful in patient
84 care, and which are available for dispensing by a practicing
85 pharmacist in a Class II or Class III institutional pharmacy.
86 (15)(8) “Medicinal drugs” or “drugs” means those substances
87 or preparations commonly known as “prescription” or “legend”
88 drugs which are required by federal or state law to be dispensed
89 only on a prescription, but shall not include patents or
90 proprietary preparations as hereafter defined.
91 (18)(9) “Patent or proprietary preparation” means a
92 medicine in its unbroken, original package which is sold to the
93 public by, or under the authority of, the manufacturer or
94 primary distributor thereof and which is not misbranded under
95 the provisions of the Florida Drug and Cosmetic Act.
96 (19)(10) “Pharmacist” means any person licensed pursuant to
97 this chapter to practice the profession of pharmacy.
98 (20)(a)(11)(a) “Pharmacy” includes a community pharmacy, an
99 institutional pharmacy, a nuclear pharmacy, a special pharmacy,
100 and an Internet pharmacy.
101 1. The term “community pharmacy” includes every location
102 where medicinal drugs are compounded, dispensed, stored, or sold
103 or where prescriptions are filled or dispensed on an outpatient
104 basis.
105 2. The term “institutional pharmacy” includes every
106 location in a hospital, clinic, nursing home, dispensary,
107 sanitarium, extended care facility, or other facility,
108 hereinafter referred to as “health care institutions,” where
109 medicinal drugs are compounded, dispensed, stored, or sold.
110 3. The term “nuclear pharmacy” includes every location
111 where radioactive drugs and chemicals within the classification
112 of medicinal drugs are compounded, dispensed, stored, or sold.
113 The term “nuclear pharmacy” does not include hospitals licensed
114 under chapter 395 or the nuclear medicine facilities of such
115 hospitals.
116 4. The term “special pharmacy” includes every location
117 where medicinal drugs are compounded, dispensed, stored, or sold
118 if such locations are not otherwise defined in this subsection.
119 5. The term “Internet pharmacy” includes locations not
120 otherwise licensed or issued a permit under this chapter, within
121 or outside this state, which use the Internet to communicate
122 with or obtain information from consumers in this state and use
123 such communication or information to fill or refill
124 prescriptions or to dispense, distribute, or otherwise engage in
125 the practice of pharmacy in this state. Any act described in
126 this definition constitutes the practice of the profession of
127 pharmacy as defined in subsection (13).
128 (b) The pharmacy department of any permittee shall be
129 considered closed whenever a Florida licensed pharmacist is not
130 present and on duty. The term “not present and on duty” shall
131 not be construed to prevent a pharmacist from exiting the
132 prescription department for the purposes of consulting or
133 responding to inquiries or providing assistance to patients or
134 customers, attending to personal hygiene needs, or performing
135 any other function for which the pharmacist is responsible,
136 provided that such activities are conducted in a manner
137 consistent with the pharmacist’s responsibility to provide
138 pharmacy services.
139 (21)(12) “Pharmacy intern” means a person who is currently
140 registered in, and attending, a duly accredited college or
141 school of pharmacy, or who is a graduate of such a school or
142 college of pharmacy, and who is duly and properly registered
143 with the department as provided for under its rules.
144 (22)(13) “Practice of the profession of pharmacy” includes
145 compounding, dispensing, and consulting concerning contents,
146 therapeutic values, and uses of any medicinal drug; consulting
147 concerning therapeutic values and interactions of patent or
148 proprietary preparations, whether pursuant to prescriptions or
149 in the absence and entirely independent of such prescriptions or
150 orders; and conducting other pharmaceutical services. For
151 purposes of this subsection, the term “other pharmaceutical
152 services” means monitoring the patient’s drug therapy and
153 assisting the patient in the management of his or her drug
154 therapy, and includes reviewing, and making recommendations
155 regarding, the patient’s drug therapy and health care status in
156 communication with the patient’s prescribing health care
157 provider as licensed under chapter 458, chapter 459, chapter
158 461, or chapter 466, or a similar statutory provision in another
159 jurisdiction, or such provider’s agent or such other persons as
160 specifically authorized by the patient; and initiating,
161 modifying, or discontinuing drug therapy for a chronic health
162 condition under a collaborative pharmacy practice agreement.
163 This subsection may not be interpreted to permit an alteration
164 of a prescriber’s directions, the diagnosis or treatment of any
165 disease, the initiation of any drug therapy, the practice of
166 medicine, or the practice of osteopathic medicine, unless
167 otherwise permitted by law or specifically authorized by s.
168 465.1865 or s. 465.1895. The term “practice of the profession of
169 pharmacy” also includes any other act, service, operation,
170 research, or transaction incidental to, or forming a part of,
171 any of the foregoing acts, requiring, involving, or employing
172 the science or art of any branch of the pharmaceutical
173 profession, study, or training, and shall expressly permit a
174 pharmacist to transmit information from persons authorized to
175 prescribe medicinal drugs to their patients. The practice of the
176 profession of pharmacy also includes the administration of
177 vaccines to adults pursuant to s. 465.189, the testing or
178 screening for and treatment of minor, nonchronic health
179 conditions pursuant to s. 465.1895, and the preparation of
180 prepackaged drug products in facilities holding Class III
181 institutional pharmacy permits. The term also includes the
182 ordering and evaluating of any laboratory or clinical testing;
183 conducting patient assessments; and modifying, discontinuing, or
184 administering medicinal drugs pursuant to s. 465.0125 by a
185 consultant pharmacist.
186 (23)(14) “Prescription” includes any order for drugs or
187 medicinal supplies written or transmitted by any means of
188 communication by a duly licensed practitioner authorized by the
189 laws of the state to prescribe such drugs or medicinal supplies
190 and intended to be dispensed by a pharmacist. The term also
191 includes an orally transmitted order by the lawfully designated
192 agent of such practitioner. The term also includes an order
193 written or transmitted by a practitioner licensed to practice in
194 a jurisdiction other than this state, but only if the pharmacist
195 called upon to dispense such order determines, in the exercise
196 of her or his professional judgment, that the order is valid and
197 necessary for the treatment of a chronic or recurrent illness.
198 The term “prescription” also includes a pharmacist’s order for a
199 product selected from the formulary created pursuant to s.
200 465.186. Prescriptions may be retained in written form or the
201 pharmacist may cause them to be recorded in a data processing
202 system, provided that such order can be produced in printed form
203 upon lawful request.
204 (16)(15) “Nuclear pharmacist” means a pharmacist licensed
205 by the department and certified as a nuclear pharmacist pursuant
206 to s. 465.0126.
207 (6)(16) “Centralized prescription filling” means the
208 filling of a prescription by one pharmacy upon request by
209 another pharmacy to fill or refill the prescription. The term
210 includes the performance by one pharmacy for another pharmacy of
211 other pharmacy duties such as drug utilization review,
212 therapeutic drug utilization review, claims adjudication, and
213 the obtaining of refill authorizations.
214 (3)(17) “Automated pharmacy system” means a mechanical
215 system that delivers prescription drugs received from a Florida
216 licensed pharmacy and maintains related transaction information.
217 (9)(18) “Compounding” means combining, mixing, or altering
218 the ingredients of one or more drugs or products to create
219 another drug or product.
220 (17)(19) “Outsourcing facility” means a single physical
221 location registered as an outsourcing facility under the federal
222 Drug Quality and Security Act, Pub. L. No. 113-54, at which
223 sterile compounding of a drug or product is conducted.
224 (8)(20) “Compounded sterile product” means a drug that is
225 intended for parenteral administration, an ophthalmic or oral
226 inhalation drug in aqueous format, or a drug or product that is
227 required to be sterile under federal or state law or rule, which
228 is produced through compounding, but is not approved by the
229 United States Food and Drug Administration.
230 (5)(21) “Central distribution facility” means a facility
231 under common control with a hospital holding a Class III
232 institutional pharmacy permit that may dispense, distribute,
233 compound, or fill prescriptions for medicinal drugs; prepare
234 prepackaged drug products; and conduct other pharmaceutical
235 services.
236 (7)(22) “Common control” means the power to direct or cause
237 the direction of the management and policies of a person or an
238 organization, whether by ownership of stock, voting rights,
239 contract, or otherwise.
240 Section 4. Paragraph (d) of subsection (2) and paragraph
241 (a) of subsection (4) of section 465.019, Florida Statutes, are
242 amended to read:
243 465.019 Institutional pharmacies; permits.—
244 (2) The following classes of institutional pharmacies are
245 established:
246 (d)1. “Class III institutional pharmacies” are those
247 institutional pharmacies, including central distribution
248 facilities, affiliated with a hospital which that provide the
249 same services that are authorized by a Class II institutional
250 pharmacy permit. Class III institutional pharmacies may also:
251 a. Dispense, distribute, compound, and fill prescriptions
252 for medicinal drugs for inpatient treatment or for patients
253 receiving acute and post-acute hospital care at home.
254 b. Prepare prepackaged drug products.
255 c. Conduct other pharmaceutical services for the affiliated
256 hospital and for entities under common control that are each
257 permitted under this chapter to possess medicinal drugs.
258 d. Provide the services in sub-subparagraphs a.-c. to an
259 entity under common control which holds an active health care
260 clinic establishment permit as required under s. 499.01(2)(r).
261 2. A Class III institutional pharmacy shall maintain
262 policies and procedures addressing:
263 a. The consultant pharmacist responsible for pharmaceutical
264 services.
265 b. Safe practices for the preparation, dispensing,
266 prepackaging, distribution, and transportation of medicinal
267 drugs and prepackaged drug products.
268 c. Recordkeeping to monitor the movement, distribution, and
269 transportation of medicinal drugs and prepackaged drug products.
270 d. Recordkeeping of pharmacy staff responsible for each
271 step in the preparation, dispensing, prepackaging,
272 transportation, and distribution of medicinal drugs and
273 prepackaged drug products.
274 e. Medicinal drugs and prepackaged drug products that may
275 not be safely distributed among Class III institutional
276 pharmacies.
277 (4)(a) Medicinal drugs shall be dispensed by in an
278 institutional pharmacy to outpatients only when that institution
279 has secured a community pharmacy permit from the department.
280 However, medicinal drugs may be dispensed by a hospital that
281 operates a Class II or Class III institutional pharmacy to a
282 patient of the hospital’s emergency department or a hospital
283 inpatient upon discharge if a prescriber, as defined in s.
284 465.025(1), treating the patient in such hospital determines
285 that the medicinal drug is warranted and that community pharmacy
286 services are not readily accessible, geographically or
287 otherwise, to the patient. Such prescribing and dispensing must
288 be for a supply of the drug that will last for the greater of
289 the following:
290 1. Up to 48 hours; or
291 2. Through the end of the next business day.
292 Section 5. Subsection (1) of section 14.33, Florida
293 Statutes, is amended to read:
294 14.33 Medal of Heroism.—
295 (1) The Governor may award a Medal of Heroism of
296 appropriate design, with ribbons and appurtenances, to a law
297 enforcement, correctional, or correctional probation officer, as
298 defined in s. 943.10(14); a firefighter, as defined in s.
299 112.191(1)(b); an emergency medical technician, as defined in s.
300 401.23 s. 401.23(11); or a paramedic, as defined in s. 401.23 s.
301 401.23(17). A recipient must have distinguished himself or
302 herself conspicuously by gallantry and intrepidity, must have
303 risked his or her life deliberately above and beyond the call of
304 duty while performing duty in his or her respective position,
305 and must have engaged in hazardous or perilous activities to
306 preserve lives with the knowledge that such activities might
307 result in great personal harm.
308 Section 6. Subsection (1) of section 125.01045, Florida
309 Statutes, is amended to read:
310 125.01045 Prohibition of fees for first responder
311 services.—
312 (1) A county may not impose a fee or seek reimbursement for
313 any costs or expenses that may be incurred for services provided
314 by a first responder, including costs or expenses related to
315 personnel, supplies, motor vehicles, or equipment in response to
316 a motor vehicle accident, except for costs to contain or clean
317 up hazardous materials in quantities reportable to the Florida
318 State Warning Point at the Division of Emergency Management, and
319 costs for transportation and treatment provided by air ambulance
320 services or emergency medical services vehicles, as those terms
321 are defined in s. 401.23 ambulance services licensed pursuant to
322 s. 401.23(4) and (5).
323 Section 7. Subsection (1) of section 166.0446, Florida
324 Statutes, is amended to read:
325 166.0446 Prohibition of fees for first responder services.—
326 (1) A municipality may not impose a fee or seek
327 reimbursement for any costs or expenses that may be incurred for
328 services provided by a first responder, including costs or
329 expenses related to personnel, supplies, motor vehicles, or
330 equipment in response to a motor vehicle accident, except for
331 costs to contain or clean up hazardous materials in quantities
332 reportable to the Florida State Warning Point at the Division of
333 Emergency Management, and costs for transportation and treatment
334 provided by air ambulance services or emergency medical services
335 vehicles, as those terms are defined in s. 401.23 ambulance
336 services licensed pursuant to s. 401.23(4) and (5).
337 Section 8. Paragraph (a) of subsection (3) of section
338 252.515, Florida Statutes, is amended to read:
339 252.515 Postdisaster Relief Assistance Act; immunity from
340 civil liability.—
341 (3) As used in this section, the term:
342 (a) “Emergency first responder” means:
343 1. A physician licensed under chapter 458.
344 2. An osteopathic physician licensed under chapter 459.
345 3. A chiropractic physician licensed under chapter 460.
346 4. A podiatric physician licensed under chapter 461.
347 5. A dentist licensed under chapter 466.
348 6. An advanced practice registered nurse licensed under s.
349 464.012.
350 7. A physician assistant licensed under s. 458.347 or s.
351 459.022.
352 8. A worker employed by a public or private hospital in the
353 state.
354 9. A paramedic as defined in s. 401.23 s. 401.23(17).
355 10. An emergency medical technician as defined in s. 401.23
356 s. 401.23(11).
357 11. A firefighter as defined in s. 633.102.
358 12. A law enforcement officer as defined in s. 943.10.
359 13. A member of the Florida National Guard.
360 14. Any other personnel designated as emergency personnel
361 by the Governor pursuant to a declared emergency.
362 Section 9. Subsection (5) of section 395.1027, Florida
363 Statutes, is amended to read:
364 395.1027 Regional poison control centers.—
365 (5) By October 1, 1999, each regional poison control center
366 shall develop a prehospital emergency dispatch protocol with
367 each licensee as defined in s. 401.23 by s. 401.23(13) in the
368 geographic area covered by the regional poison control center.
369 The prehospital emergency dispatch protocol shall be developed
370 by each licensee’s medical director in conjunction with the
371 designated regional poison control center responsible for the
372 geographic area in which the licensee operates. The protocol
373 shall define toxic substances and describe the procedure by
374 which the designated regional poison control center may be
375 consulted by the licensee. If a call is transferred to the
376 designated regional poison control center in accordance with the
377 protocol established under this section and s. 401.268, the
378 designated regional poison control center shall assume
379 responsibility and liability for the call.
380 Section 10. Paragraph (b) of subsection (1) of section
381 400.143, Florida Statutes, is amended to read:
382 400.143 Institutional formularies established by nursing
383 home facilities.—
384 (1) For purposes of this section, the term:
385 (b) “Medicinal drug” has the same meaning as provided in s.
386 465.003 s. 465.003(8).
387 Section 11. Paragraph (b) of subsection (2) of section
388 401.245, Florida Statutes, is amended to read:
389 401.245 Emergency Medical Services Advisory Council.—
390 (2)(b) Representation on the Emergency Medical Services
391 Advisory Council shall include: two licensed physicians who are
392 medical directors “medical directors” as defined in s. 401.23 s.
393 401.23(15) or whose medical practice is closely related to
394 emergency medical services; two emergency medical service
395 administrators, one of whom is employed by a fire service; two
396 certified paramedics, one of whom is employed by a fire service;
397 two certified emergency medical technicians, one of whom is
398 employed by a fire service; one emergency medical services
399 educator; one emergency nurse; one hospital administrator; one
400 representative of air ambulance services; one representative of
401 a commercial ambulance operator; and two laypersons who are in
402 no way connected with emergency medical services, one of whom is
403 a representative of the elderly. Ex officio members of the
404 advisory council from state agencies shall include, but are
405 shall not be limited to, representatives from the Department of
406 Education, the Department of Management Services, the State Fire
407 Marshal, the Department of Highway Safety and Motor Vehicles,
408 the Department of Transportation, and the Division of Emergency
409 Management.
410 Section 12. Subsection (2) of section 401.27, Florida
411 Statutes, is amended to read:
412 401.27 Personnel; standards and certification.—
413 (2) The department shall establish by rule educational and
414 training criteria and examinations for the certification and
415 recertification of emergency medical technicians and paramedics.
416 Such rules must require, but need not be limited to:
417 (a) For emergency medical technicians, proficiency in basic
418 life support as defined techniques identified in s. 401.23 s.
419 401.23(7) and in rules of the department.
420 (b) For paramedics, proficiency in advanced life support as
421 defined techniques identified in s. 401.23 s. 401.23(1) and in
422 rules of the department.
423 Section 13. Paragraph (a) of subsection (1) of section
424 409.9201, Florida Statutes, is amended to read:
425 409.9201 Medicaid fraud.—
426 (1) As used in this section, the term:
427 (a) “Prescription drug” means any drug, including, but not
428 limited to, finished dosage forms or active ingredients that are
429 subject to, defined in, or described in s. 503(b) of the Federal
430 Food, Drug, and Cosmetic Act or in s. 465.003 s. 465.003(8), s.
431 499.003(17), s. 499.007(13), or s. 499.82(10).
432
433 The value of individual items of the legend drugs or goods or
434 services involved in distinct transactions committed during a
435 single scheme or course of conduct, whether involving a single
436 person or several persons, may be aggregated when determining
437 the punishment for the offense.
438 Section 14. Paragraph (pp) of subsection (1) of section
439 458.331, Florida Statutes, is amended to read:
440 458.331 Grounds for disciplinary action; action by the
441 board and department.—
442 (1) The following acts constitute grounds for denial of a
443 license or disciplinary action, as specified in s. 456.072(2):
444 (pp) Applicable to a licensee who serves as the designated
445 physician of a pain-management clinic as defined in s. 458.3265
446 or s. 459.0137:
447 1. Registering a pain-management clinic through
448 misrepresentation or fraud;
449 2. Procuring, or attempting to procure, the registration of
450 a pain-management clinic for any other person by making or
451 causing to be made, any false representation;
452 3. Failing to comply with any requirement of chapter 499,
453 the Florida Drug and Cosmetic Act; 21 U.S.C. ss. 301-392, the
454 Federal Food, Drug, and Cosmetic Act; 21 U.S.C. ss. 821 et seq.,
455 the Drug Abuse Prevention and Control Act; or chapter 893, the
456 Florida Comprehensive Drug Abuse Prevention and Control Act;
457 4. Being convicted or found guilty of, regardless of
458 adjudication to, a felony or any other crime involving moral
459 turpitude, fraud, dishonesty, or deceit in any jurisdiction of
460 the courts of this state, of any other state, or of the United
461 States;
462 5. Being convicted of, or disciplined by a regulatory
463 agency of the Federal Government or a regulatory agency of
464 another state for, any offense that would constitute a violation
465 of this chapter;
466 6. Being convicted of, or entering a plea of guilty or nolo
467 contendere to, regardless of adjudication, a crime in any
468 jurisdiction of the courts of this state, of any other state, or
469 of the United States which relates to the practice of, or the
470 ability to practice, a licensed health care profession;
471 7. Being convicted of, or entering a plea of guilty or nolo
472 contendere to, regardless of adjudication, a crime in any
473 jurisdiction of the courts of this state, of any other state, or
474 of the United States which relates to health care fraud;
475 8. Dispensing any medicinal drug based upon a communication
476 that purports to be a prescription as defined in s. 465.003 s.
477 465.003(14) or s. 893.02 if the dispensing practitioner knows or
478 has reason to believe that the purported prescription is not
479 based upon a valid practitioner-patient relationship; or
480 9. Failing to timely notify the board of the date of his or
481 her termination from a pain-management clinic as required by s.
482 458.3265(3).
483 Section 15. Paragraph (rr) of subsection (1) of section
484 459.015, Florida Statutes, is amended to read:
485 459.015 Grounds for disciplinary action; action by the
486 board and department.—
487 (1) The following acts constitute grounds for denial of a
488 license or disciplinary action, as specified in s. 456.072(2):
489 (rr) Applicable to a licensee who serves as the designated
490 physician of a pain-management clinic as defined in s. 458.3265
491 or s. 459.0137:
492 1. Registering a pain-management clinic through
493 misrepresentation or fraud;
494 2. Procuring, or attempting to procure, the registration of
495 a pain-management clinic for any other person by making or
496 causing to be made, any false representation;
497 3. Failing to comply with any requirement of chapter 499,
498 the Florida Drug and Cosmetic Act; 21 U.S.C. ss. 301-392, the
499 Federal Food, Drug, and Cosmetic Act; 21 U.S.C. ss. 821 et seq.,
500 the Drug Abuse Prevention and Control Act; or chapter 893, the
501 Florida Comprehensive Drug Abuse Prevention and Control Act;
502 4. Being convicted or found guilty of, regardless of
503 adjudication to, a felony or any other crime involving moral
504 turpitude, fraud, dishonesty, or deceit in any jurisdiction of
505 the courts of this state, of any other state, or of the United
506 States;
507 5. Being convicted of, or disciplined by a regulatory
508 agency of the Federal Government or a regulatory agency of
509 another state for, any offense that would constitute a violation
510 of this chapter;
511 6. Being convicted of, or entering a plea of guilty or nolo
512 contendere to, regardless of adjudication, a crime in any
513 jurisdiction of the courts of this state, of any other state, or
514 of the United States which relates to the practice of, or the
515 ability to practice, a licensed health care profession;
516 7. Being convicted of, or entering a plea of guilty or nolo
517 contendere to, regardless of adjudication, a crime in any
518 jurisdiction of the courts of this state, of any other state, or
519 of the United States which relates to health care fraud;
520 8. Dispensing any medicinal drug based upon a communication
521 that purports to be a prescription as defined in s. 465.003 s.
522 465.003(14) or s. 893.02 if the dispensing practitioner knows or
523 has reason to believe that the purported prescription is not
524 based upon a valid practitioner-patient relationship; or
525 9. Failing to timely notify the board of the date of his or
526 her termination from a pain-management clinic as required by s.
527 459.0137(3).
528 Section 16. Subsection (1) of section 465.014, Florida
529 Statutes, is amended to read:
530 465.014 Pharmacy technician.—
531 (1) A person other than a licensed pharmacist or pharmacy
532 intern may not engage in the practice of the profession of
533 pharmacy, except that a licensed pharmacist may delegate to
534 pharmacy technicians who are registered pursuant to this section
535 those duties, tasks, and functions that do not fall within the
536 purview of s. 465.003 s. 465.003(13). All such delegated acts
537 must be performed under the direct supervision of a licensed
538 pharmacist who is responsible for all such acts performed by
539 persons under his or her supervision. A registered pharmacy
540 technician, under the supervision of a pharmacist, may initiate
541 or receive communications with a practitioner or his or her
542 agent, on behalf of a patient, regarding refill authorization
543 requests. A licensed pharmacist may not supervise more than one
544 registered pharmacy technician unless otherwise permitted by the
545 guidelines adopted by the board. The board shall establish
546 guidelines to be followed by licensees or permittees in
547 determining the circumstances under which a licensed pharmacist
548 may supervise more than one pharmacy technician.
549 Section 17. Paragraph (c) of subsection (2) of section
550 465.015, Florida Statutes, is amended to read:
551 465.015 Violations and penalties.—
552 (2) It is unlawful for any person:
553 (c) To sell or dispense drugs as defined in s. 465.003 s.
554 465.003(8) without first being furnished with a prescription.
555 Section 18. Subsection (9) of section 465.0156, Florida
556 Statutes, is amended to read:
557 465.0156 Registration of nonresident pharmacies.—
558 (9) Notwithstanding s. 465.003 s. 465.003(10), for purposes
559 of this section, the registered pharmacy and the pharmacist
560 designated by the registered pharmacy as the prescription
561 department manager or the equivalent must be licensed in the
562 state of location in order to dispense into this state.
563 Section 19. Paragraph (s) of subsection (1) of section
564 465.016, Florida Statutes, is amended to read:
565 465.016 Disciplinary actions.—
566 (1) The following acts constitute grounds for denial of a
567 license or disciplinary action, as specified in s. 456.072(2):
568 (s) Dispensing any medicinal drug based upon a
569 communication that purports to be a prescription as defined in
570 s. 465.003 by s. 465.003(14) or s. 893.02 when the pharmacist
571 knows or has reason to believe that the purported prescription
572 is not based upon a valid practitioner-patient relationship.
573 Section 20. Subsection (4) of section 465.0197, Florida
574 Statutes, is amended to read:
575 465.0197 Internet pharmacy permits.—
576 (4) Notwithstanding s. 465.003 s. 465.003(10), for purposes
577 of this section, the Internet pharmacy and the pharmacist
578 designated by the Internet pharmacy as the prescription
579 department manager or the equivalent must be licensed in the
580 state of location in order to dispense into this state.
581 Section 21. Paragraph (j) of subsection (5) of section
582 465.022, Florida Statutes, is amended to read:
583 465.022 Pharmacies; general requirements; fees.—
584 (5) The department or board shall deny an application for a
585 pharmacy permit if the applicant or an affiliated person,
586 partner, officer, director, or prescription department manager
587 or consultant pharmacist of record of the applicant:
588 (j) Has dispensed any medicinal drug based upon a
589 communication that purports to be a prescription as defined in
590 s. 465.003 by s. 465.003(14) or s. 893.02 when the pharmacist
591 knows or has reason to believe that the purported prescription
592 is not based upon a valid practitioner-patient relationship that
593 includes a documented patient evaluation, including history and
594 a physical examination adequate to establish the diagnosis for
595 which any drug is prescribed and any other requirement
596 established by board rule under chapter 458, chapter 459,
597 chapter 461, chapter 463, chapter 464, or chapter 466.
598
599 For felonies in which the defendant entered a plea of guilty or
600 nolo contendere in an agreement with the court to enter a
601 pretrial intervention or drug diversion program, the department
602 shall deny the application if upon final resolution of the case
603 the licensee has failed to successfully complete the program.
604 Section 22. Paragraph (h) of subsection (1) of section
605 465.023, Florida Statutes, is amended to read:
606 465.023 Pharmacy permittee; disciplinary action.—
607 (1) The department or the board may revoke or suspend the
608 permit of any pharmacy permittee, and may fine, place on
609 probation, or otherwise discipline any pharmacy permittee if the
610 permittee, or any affiliated person, partner, officer, director,
611 or agent of the permittee, including a person fingerprinted
612 under s. 465.022(3), has:
613 (h) Dispensed any medicinal drug based upon a communication
614 that purports to be a prescription as defined in s. 465.003 by
615 s. 465.003(14) or s. 893.02 when the pharmacist knows or has
616 reason to believe that the purported prescription is not based
617 upon a valid practitioner-patient relationship that includes a
618 documented patient evaluation, including history and a physical
619 examination adequate to establish the diagnosis for which any
620 drug is prescribed and any other requirement established by
621 board rule under chapter 458, chapter 459, chapter 461, chapter
622 463, chapter 464, or chapter 466.
623 Section 23. Section 465.1901, Florida Statutes, is amended
624 to read:
625 465.1901 Practice of orthotics and pedorthics.—The
626 provisions of chapter 468 relating to orthotics or pedorthics do
627 not apply to any licensed pharmacist or to any person acting
628 under the supervision of a licensed pharmacist. The practice of
629 orthotics or pedorthics by a pharmacist or any of the
630 pharmacist’s employees acting under the supervision of a
631 pharmacist shall be construed to be within the meaning of the
632 term “practice of the profession of pharmacy” as defined set
633 forth in s. 465.003 s. 465.003(13), and shall be subject to
634 regulation in the same manner as any other pharmacy practice.
635 The Board of Pharmacy shall develop rules regarding the practice
636 of orthotics and pedorthics by a pharmacist. Any pharmacist or
637 person under the supervision of a pharmacist engaged in the
638 practice of orthotics or pedorthics is not precluded from
639 continuing that practice pending adoption of these rules.
640 Section 24. Paragraph (j) of subsection (2) of section
641 465.1902, Florida Statutes, is amended to read:
642 465.1902 Prescription Drug Donation Repository Program.—
643 (2) DEFINITIONS.—As used in this section, the term:
644 (j) “Prescription drug” has the same meaning as the term
645 “medicinal drugs” or “drugs,” as those terms are defined in s.
646 465.003 s. 465.003(8), but does not include controlled
647 substances, cancer drugs donated under s. 499.029, or drugs with
648 an approved United States Food and Drug Administration risk
649 evaluation and mitigation strategy that includes elements to
650 assure safe use.
651 Section 25. Subsection (40) of section 499.003, Florida
652 Statutes, is amended to read:
653 499.003 Definitions of terms used in this part.—As used in
654 this part, the term:
655 (40) “Prescription drug” means a prescription, medicinal,
656 or legend drug, including, but not limited to, finished dosage
657 forms or active pharmaceutical ingredients subject to, defined
658 by, or described by s. 503(b) of the federal act or s. 465.003
659 s. 465.003(8), s. 499.007(13), subsection (31), or subsection
660 (47), except that an active pharmaceutical ingredient is a
661 prescription drug only if substantially all finished dosage
662 forms in which it may be lawfully dispensed or administered in
663 this state are also prescription drugs.
664 Section 26. Paragraph (c) of subsection (24) of section
665 893.02, Florida Statutes, is amended to read:
666 893.02 Definitions.—The following words and phrases as used
667 in this chapter shall have the following meanings, unless the
668 context otherwise requires:
669 (24) “Prescription” includes any order for drugs or
670 medicinal supplies which is written or transmitted by any means
671 of communication by a licensed practitioner authorized by the
672 laws of this state to prescribe such drugs or medicinal
673 supplies, is issued in good faith and in the course of
674 professional practice, is intended to be dispensed by a person
675 authorized by the laws of this state to do so, and meets the
676 requirements of s. 893.04.
677 (c) A prescription for a controlled substance may not be
678 issued on the same prescription blank with another prescription
679 for a controlled substance that is named or described in a
680 different schedule or with another prescription for a medicinal
681 drug, as defined in s. 465.003 s. 465.003(8), that is not a
682 controlled substance.
683 Section 27. This act shall take effect July 1, 2022.
684
685 ================= T I T L E A M E N D M E N T ================
686 And the title is amended as follows:
687 Delete everything before the enacting clause
688 and insert:
689 A bill to be entitled
690 An act relating to acute and post-acute hospital care
691 at home; amending s. 401.23, F.S.; defining the term
692 “acute and post-acute hospital care at home”; amending
693 s. 401.272, F.S.; authorizing paramedics to perform
694 certain life support services to patients receiving
695 acute and post-acute hospital care at home under
696 certain circumstances; providing that a physician or
697 medical director who supervises or directs the
698 provision of such services by a paramedic is liable
699 for any act or omission during the provision of such
700 services; authorizing the Department of Health to
701 adopt and enforce rules; amending s. 465.003, F.S.;
702 defining the term “acute and post-acute hospital care
703 at home”; amending s. 465.019, F.S.; specifying that
704 Class III institutional pharmacies may dispense,
705 distribute, compound, and fill prescriptions for
706 medicinal drugs for inpatient treatment and patients
707 receiving acute and post-acute hospital care at home;
708 amending ss. 14.33, 125.01045, 166.0446, 252.515,
709 395.1027, 400.143, 401.245, 401.27, 409.9201, 458.331,
710 459.015, 465.014, 465.015, 465.0156, 465.016,
711 465.0197, 465.022, 465.023, 465.1901, 465.1902,
712 499.003, and 893.02, F.S.; conforming cross
713 references; providing an effective date.