Florida Senate - 2022 CS for CS for SB 1222
By the Committees on Judiciary; and Health Policy; and Senators
Bean and Gibson
590-02781-22 20221222c2
1 A bill to be entitled
2 An act relating to acute and post-acute hospital care
3 at home; amending s. 401.23, F.S.; defining the term
4 “acute and post-acute hospital care at home”; amending
5 s. 401.272, F.S.; authorizing paramedics to perform
6 certain life support services to patients receiving
7 acute and post-acute hospital care at home under
8 certain circumstances; providing that a physician or
9 medical director who supervises or directs the
10 provision of such services by a paramedic is liable
11 for any act or omission during the provision of such
12 services; authorizing the Department of Health to
13 adopt and enforce rules; amending s. 465.003, F.S.;
14 defining the term “acute and post-acute hospital care
15 at home”; amending s. 465.019, F.S.; specifying that
16 Class III institutional pharmacies may dispense,
17 distribute, compound, and fill prescriptions for
18 medicinal drugs for inpatient treatment and patients
19 receiving acute and post-acute hospital care at home;
20 amending ss. 14.33, 125.01045, 166.0446, 252.515,
21 395.1027, 400.143, 401.245, 401.27, 409.9201, 458.331,
22 459.015, 465.014, 465.015, 465.0156, 465.016,
23 465.0197, 465.022, 465.023, 465.1901, 465.1902,
24 499.003, and 893.02, F.S.; conforming cross
25 references; providing an effective date.
26
27 Be It Enacted by the Legislature of the State of Florida:
28
29 Section 1. Present subsections (1) through (22) of section
30 401.23, Florida Statutes, are redesignated as subsections (2)
31 through (23), respectively, a new subsection (1) is added to
32 that section, and present subsection (19) of that section is
33 amended, to read:
34 401.23 Definitions.—As used in this part, the term:
35 (1) “Acute and post-acute hospital care at home” means
36 acute and post-acute health care services provided in a
37 clinically qualified patient’s permanent residence, as defined
38 in s. 196.012(17), through a program approved by the Centers for
39 Medicare and Medicaid Services and the Agency for Health Care
40 Administration.
41 (20)(19) “Physician” means a practitioner who is licensed
42 under the provisions of chapter 458 or chapter 459. For the
43 purpose of providing medical direction “medical direction” as
44 defined in subsection (14) for the treatment of patients
45 immediately before prior to or during transportation to a United
46 States Department of Veterans Affairs medical facility,
47 “physician” also means a practitioner employed by the United
48 States Department of Veterans Affairs.
49 Section 2. Paragraph (c) is added to subsection (2) of
50 section 401.272, Florida Statutes, to read:
51 401.272 Emergency medical services community health care.—
52 (2) Notwithstanding any other provision of law to the
53 contrary:
54 (c) Paramedics may provide basic life support services and
55 advanced life support services to patients receiving acute and
56 post-acute hospital care at home as specified in the paramedic’s
57 supervisory relationship with a physician or standing orders as
58 described in s. 401.265, s. 458.348, or s. 459.025. A physician
59 who supervises or provides medical direction to a paramedic who
60 provides basic life support services or advanced life support
61 services to patients receiving acute and post-acute hospital
62 care at home pursuant to a formal supervisory relationship or
63 standing orders is liable for any act or omission of the
64 paramedic acting under the physician’s supervision or medical
65 direction when providing such services. The department may adopt
66 and enforce rules necessary to implement this paragraph.
67 Section 3. Section 465.003, Florida Statutes, is reordered
68 and amended to read:
69 465.003 Definitions.—As used in this chapter, the term:
70 (1) “Acute and post-acute hospital care at home” means
71 acute and post-acute health care services provided in a
72 clinically qualified patient’s permanent residence, as defined
73 in s. 196.012(17), through a program approved by the Centers for
74 Medicare and Medicaid Services and the Agency for Health Care
75 Administration.
76 (2)(1) “Administration” means the obtaining and giving of a
77 single dose of medicinal drugs by a legally authorized person to
78 a patient for her or his consumption.
79 (4)(2) “Board” means the Board of Pharmacy.
80 (10)(3) “Consultant pharmacist” means a pharmacist licensed
81 by the department and certified as a consultant pharmacist
82 pursuant to s. 465.0125.
83 (11)(4) “Data communication device” means an electronic
84 device that receives electronic information from one source and
85 transmits or routes it to another, including, but not limited
86 to, any such bridge, router, switch, or gateway.
87 (12)(5) “Department” means the Department of Health.
88 (13)(6) “Dispense” means the transfer of possession of one
89 or more doses of a medicinal drug by a pharmacist to the
90 ultimate consumer or her or his agent. As an element of
91 dispensing, the pharmacist shall, prior to the actual physical
92 transfer, interpret and assess the prescription order for
93 potential adverse reactions, interactions, and dosage regimen
94 she or he deems appropriate in the exercise of her or his
95 professional judgment, and the pharmacist shall certify that the
96 medicinal drug called for by the prescription is ready for
97 transfer. The pharmacist shall also provide counseling on proper
98 drug usage, either orally or in writing, if in the exercise of
99 her or his professional judgment counseling is necessary. The
100 actual sales transaction and delivery of such drug shall not be
101 considered dispensing. The administration shall not be
102 considered dispensing.
103 (14)(7) “Institutional formulary system” means a method
104 whereby the medical staff evaluates, appraises, and selects
105 those medicinal drugs or proprietary preparations which in the
106 medical staff’s clinical judgment are most useful in patient
107 care, and which are available for dispensing by a practicing
108 pharmacist in a Class II or Class III institutional pharmacy.
109 (15)(8) “Medicinal drugs” or “drugs” means those substances
110 or preparations commonly known as “prescription” or “legend”
111 drugs which are required by federal or state law to be dispensed
112 only on a prescription, but shall not include patents or
113 proprietary preparations as hereafter defined.
114 (18)(9) “Patent or proprietary preparation” means a
115 medicine in its unbroken, original package which is sold to the
116 public by, or under the authority of, the manufacturer or
117 primary distributor thereof and which is not misbranded under
118 the provisions of the Florida Drug and Cosmetic Act.
119 (19)(10) “Pharmacist” means any person licensed pursuant to
120 this chapter to practice the profession of pharmacy.
121 (20)(a)(11)(a) “Pharmacy” includes a community pharmacy, an
122 institutional pharmacy, a nuclear pharmacy, a special pharmacy,
123 and an Internet pharmacy.
124 1. The term “community pharmacy” includes every location
125 where medicinal drugs are compounded, dispensed, stored, or sold
126 or where prescriptions are filled or dispensed on an outpatient
127 basis.
128 2. The term “institutional pharmacy” includes every
129 location in a hospital, clinic, nursing home, dispensary,
130 sanitarium, extended care facility, or other facility,
131 hereinafter referred to as “health care institutions,” where
132 medicinal drugs are compounded, dispensed, stored, or sold.
133 3. The term “nuclear pharmacy” includes every location
134 where radioactive drugs and chemicals within the classification
135 of medicinal drugs are compounded, dispensed, stored, or sold.
136 The term “nuclear pharmacy” does not include hospitals licensed
137 under chapter 395 or the nuclear medicine facilities of such
138 hospitals.
139 4. The term “special pharmacy” includes every location
140 where medicinal drugs are compounded, dispensed, stored, or sold
141 if such locations are not otherwise defined in this subsection.
142 5. The term “Internet pharmacy” includes locations not
143 otherwise licensed or issued a permit under this chapter, within
144 or outside this state, which use the Internet to communicate
145 with or obtain information from consumers in this state and use
146 such communication or information to fill or refill
147 prescriptions or to dispense, distribute, or otherwise engage in
148 the practice of pharmacy in this state. Any act described in
149 this definition constitutes the practice of the profession of
150 pharmacy as defined in subsection (13).
151 (b) The pharmacy department of any permittee shall be
152 considered closed whenever a Florida licensed pharmacist is not
153 present and on duty. The term “not present and on duty” shall
154 not be construed to prevent a pharmacist from exiting the
155 prescription department for the purposes of consulting or
156 responding to inquiries or providing assistance to patients or
157 customers, attending to personal hygiene needs, or performing
158 any other function for which the pharmacist is responsible,
159 provided that such activities are conducted in a manner
160 consistent with the pharmacist’s responsibility to provide
161 pharmacy services.
162 (21)(12) “Pharmacy intern” means a person who is currently
163 registered in, and attending, a duly accredited college or
164 school of pharmacy, or who is a graduate of such a school or
165 college of pharmacy, and who is duly and properly registered
166 with the department as provided for under its rules.
167 (22)(13) “Practice of the profession of pharmacy” includes
168 compounding, dispensing, and consulting concerning contents,
169 therapeutic values, and uses of any medicinal drug; consulting
170 concerning therapeutic values and interactions of patent or
171 proprietary preparations, whether pursuant to prescriptions or
172 in the absence and entirely independent of such prescriptions or
173 orders; and conducting other pharmaceutical services. For
174 purposes of this subsection, the term “other pharmaceutical
175 services” means monitoring the patient’s drug therapy and
176 assisting the patient in the management of his or her drug
177 therapy, and includes reviewing, and making recommendations
178 regarding, the patient’s drug therapy and health care status in
179 communication with the patient’s prescribing health care
180 provider as licensed under chapter 458, chapter 459, chapter
181 461, or chapter 466, or a similar statutory provision in another
182 jurisdiction, or such provider’s agent or such other persons as
183 specifically authorized by the patient; and initiating,
184 modifying, or discontinuing drug therapy for a chronic health
185 condition under a collaborative pharmacy practice agreement.
186 This subsection may not be interpreted to permit an alteration
187 of a prescriber’s directions, the diagnosis or treatment of any
188 disease, the initiation of any drug therapy, the practice of
189 medicine, or the practice of osteopathic medicine, unless
190 otherwise permitted by law or specifically authorized by s.
191 465.1865 or s. 465.1895. The term “practice of the profession of
192 pharmacy” also includes any other act, service, operation,
193 research, or transaction incidental to, or forming a part of,
194 any of the foregoing acts, requiring, involving, or employing
195 the science or art of any branch of the pharmaceutical
196 profession, study, or training, and shall expressly permit a
197 pharmacist to transmit information from persons authorized to
198 prescribe medicinal drugs to their patients. The practice of the
199 profession of pharmacy also includes the administration of
200 vaccines to adults pursuant to s. 465.189, the testing or
201 screening for and treatment of minor, nonchronic health
202 conditions pursuant to s. 465.1895, and the preparation of
203 prepackaged drug products in facilities holding Class III
204 institutional pharmacy permits. The term also includes the
205 ordering and evaluating of any laboratory or clinical testing;
206 conducting patient assessments; and modifying, discontinuing, or
207 administering medicinal drugs pursuant to s. 465.0125 by a
208 consultant pharmacist.
209 (23)(14) “Prescription” includes any order for drugs or
210 medicinal supplies written or transmitted by any means of
211 communication by a duly licensed practitioner authorized by the
212 laws of the state to prescribe such drugs or medicinal supplies
213 and intended to be dispensed by a pharmacist. The term also
214 includes an orally transmitted order by the lawfully designated
215 agent of such practitioner. The term also includes an order
216 written or transmitted by a practitioner licensed to practice in
217 a jurisdiction other than this state, but only if the pharmacist
218 called upon to dispense such order determines, in the exercise
219 of her or his professional judgment, that the order is valid and
220 necessary for the treatment of a chronic or recurrent illness.
221 The term “prescription” also includes a pharmacist’s order for a
222 product selected from the formulary created pursuant to s.
223 465.186. Prescriptions may be retained in written form or the
224 pharmacist may cause them to be recorded in a data processing
225 system, provided that such order can be produced in printed form
226 upon lawful request.
227 (16)(15) “Nuclear pharmacist” means a pharmacist licensed
228 by the department and certified as a nuclear pharmacist pursuant
229 to s. 465.0126.
230 (6)(16) “Centralized prescription filling” means the
231 filling of a prescription by one pharmacy upon request by
232 another pharmacy to fill or refill the prescription. The term
233 includes the performance by one pharmacy for another pharmacy of
234 other pharmacy duties such as drug utilization review,
235 therapeutic drug utilization review, claims adjudication, and
236 the obtaining of refill authorizations.
237 (3)(17) “Automated pharmacy system” means a mechanical
238 system that delivers prescription drugs received from a Florida
239 licensed pharmacy and maintains related transaction information.
240 (9)(18) “Compounding” means combining, mixing, or altering
241 the ingredients of one or more drugs or products to create
242 another drug or product.
243 (17)(19) “Outsourcing facility” means a single physical
244 location registered as an outsourcing facility under the federal
245 Drug Quality and Security Act, Pub. L. No. 113-54, at which
246 sterile compounding of a drug or product is conducted.
247 (8)(20) “Compounded sterile product” means a drug that is
248 intended for parenteral administration, an ophthalmic or oral
249 inhalation drug in aqueous format, or a drug or product that is
250 required to be sterile under federal or state law or rule, which
251 is produced through compounding, but is not approved by the
252 United States Food and Drug Administration.
253 (5)(21) “Central distribution facility” means a facility
254 under common control with a hospital holding a Class III
255 institutional pharmacy permit that may dispense, distribute,
256 compound, or fill prescriptions for medicinal drugs; prepare
257 prepackaged drug products; and conduct other pharmaceutical
258 services.
259 (7)(22) “Common control” means the power to direct or cause
260 the direction of the management and policies of a person or an
261 organization, whether by ownership of stock, voting rights,
262 contract, or otherwise.
263 Section 4. Paragraph (d) of subsection (2) and paragraph
264 (a) of subsection (4) of section 465.019, Florida Statutes, are
265 amended to read:
266 465.019 Institutional pharmacies; permits.—
267 (2) The following classes of institutional pharmacies are
268 established:
269 (d)1. “Class III institutional pharmacies” are those
270 institutional pharmacies, including central distribution
271 facilities, affiliated with a hospital which that provide the
272 same services that are authorized by a Class II institutional
273 pharmacy permit. Class III institutional pharmacies may also:
274 a. Dispense, distribute, compound, and fill prescriptions
275 for medicinal drugs for inpatient treatment or for patients
276 receiving acute and post-acute hospital care at home.
277 b. Prepare prepackaged drug products.
278 c. Conduct other pharmaceutical services for the affiliated
279 hospital and for entities under common control that are each
280 permitted under this chapter to possess medicinal drugs.
281 d. Provide the services in sub-subparagraphs a.-c. to an
282 entity under common control which holds an active health care
283 clinic establishment permit as required under s. 499.01(2)(r).
284 2. A Class III institutional pharmacy shall maintain
285 policies and procedures addressing:
286 a. The consultant pharmacist responsible for pharmaceutical
287 services.
288 b. Safe practices for the preparation, dispensing,
289 prepackaging, distribution, and transportation of medicinal
290 drugs and prepackaged drug products.
291 c. Recordkeeping to monitor the movement, distribution, and
292 transportation of medicinal drugs and prepackaged drug products.
293 d. Recordkeeping of pharmacy staff responsible for each
294 step in the preparation, dispensing, prepackaging,
295 transportation, and distribution of medicinal drugs and
296 prepackaged drug products.
297 e. Medicinal drugs and prepackaged drug products that may
298 not be safely distributed among Class III institutional
299 pharmacies.
300 (4)(a) Medicinal drugs shall be dispensed by in an
301 institutional pharmacy to outpatients only when that institution
302 has secured a community pharmacy permit from the department.
303 However, medicinal drugs may be dispensed by a hospital that
304 operates a Class II or Class III institutional pharmacy to a
305 patient of the hospital’s emergency department or a hospital
306 inpatient upon discharge if a prescriber, as defined in s.
307 465.025(1), treating the patient in such hospital determines
308 that the medicinal drug is warranted and that community pharmacy
309 services are not readily accessible, geographically or
310 otherwise, to the patient. Such prescribing and dispensing must
311 be for a supply of the drug that will last for the greater of
312 the following:
313 1. Up to 48 hours; or
314 2. Through the end of the next business day.
315 Section 5. Subsection (1) of section 14.33, Florida
316 Statutes, is amended to read:
317 14.33 Medal of Heroism.—
318 (1) The Governor may award a Medal of Heroism of
319 appropriate design, with ribbons and appurtenances, to a law
320 enforcement, correctional, or correctional probation officer, as
321 defined in s. 943.10(14); a firefighter, as defined in s.
322 112.191(1)(b); an emergency medical technician, as defined in s.
323 401.23 s. 401.23(11); or a paramedic, as defined in s. 401.23 s.
324 401.23(17). A recipient must have distinguished himself or
325 herself conspicuously by gallantry and intrepidity, must have
326 risked his or her life deliberately above and beyond the call of
327 duty while performing duty in his or her respective position,
328 and must have engaged in hazardous or perilous activities to
329 preserve lives with the knowledge that such activities might
330 result in great personal harm.
331 Section 6. Subsection (1) of section 125.01045, Florida
332 Statutes, is amended to read:
333 125.01045 Prohibition of fees for first responder
334 services.—
335 (1) A county may not impose a fee or seek reimbursement for
336 any costs or expenses that may be incurred for services provided
337 by a first responder, including costs or expenses related to
338 personnel, supplies, motor vehicles, or equipment in response to
339 a motor vehicle accident, except for costs to contain or clean
340 up hazardous materials in quantities reportable to the Florida
341 State Warning Point at the Division of Emergency Management, and
342 costs for transportation and treatment provided by air ambulance
343 services or emergency medical services vehicles, as those terms
344 are defined in s. 401.23 ambulance services licensed pursuant to
345 s. 401.23(4) and (5).
346 Section 7. Subsection (1) of section 166.0446, Florida
347 Statutes, is amended to read:
348 166.0446 Prohibition of fees for first responder services.—
349 (1) A municipality may not impose a fee or seek
350 reimbursement for any costs or expenses that may be incurred for
351 services provided by a first responder, including costs or
352 expenses related to personnel, supplies, motor vehicles, or
353 equipment in response to a motor vehicle accident, except for
354 costs to contain or clean up hazardous materials in quantities
355 reportable to the Florida State Warning Point at the Division of
356 Emergency Management, and costs for transportation and treatment
357 provided by air ambulance services or emergency medical services
358 vehicles, as those terms are defined in s. 401.23 ambulance
359 services licensed pursuant to s. 401.23(4) and (5).
360 Section 8. Paragraph (a) of subsection (3) of section
361 252.515, Florida Statutes, is amended to read:
362 252.515 Postdisaster Relief Assistance Act; immunity from
363 civil liability.—
364 (3) As used in this section, the term:
365 (a) “Emergency first responder” means:
366 1. A physician licensed under chapter 458.
367 2. An osteopathic physician licensed under chapter 459.
368 3. A chiropractic physician licensed under chapter 460.
369 4. A podiatric physician licensed under chapter 461.
370 5. A dentist licensed under chapter 466.
371 6. An advanced practice registered nurse licensed under s.
372 464.012.
373 7. A physician assistant licensed under s. 458.347 or s.
374 459.022.
375 8. A worker employed by a public or private hospital in the
376 state.
377 9. A paramedic as defined in s. 401.23 s. 401.23(17).
378 10. An emergency medical technician as defined in s. 401.23
379 s. 401.23(11).
380 11. A firefighter as defined in s. 633.102.
381 12. A law enforcement officer as defined in s. 943.10.
382 13. A member of the Florida National Guard.
383 14. Any other personnel designated as emergency personnel
384 by the Governor pursuant to a declared emergency.
385 Section 9. Subsection (5) of section 395.1027, Florida
386 Statutes, is amended to read:
387 395.1027 Regional poison control centers.—
388 (5) By October 1, 1999, each regional poison control center
389 shall develop a prehospital emergency dispatch protocol with
390 each licensee as defined in s. 401.23 by s. 401.23(13) in the
391 geographic area covered by the regional poison control center.
392 The prehospital emergency dispatch protocol shall be developed
393 by each licensee’s medical director in conjunction with the
394 designated regional poison control center responsible for the
395 geographic area in which the licensee operates. The protocol
396 shall define toxic substances and describe the procedure by
397 which the designated regional poison control center may be
398 consulted by the licensee. If a call is transferred to the
399 designated regional poison control center in accordance with the
400 protocol established under this section and s. 401.268, the
401 designated regional poison control center shall assume
402 responsibility and liability for the call.
403 Section 10. Paragraph (b) of subsection (1) of section
404 400.143, Florida Statutes, is amended to read:
405 400.143 Institutional formularies established by nursing
406 home facilities.—
407 (1) For purposes of this section, the term:
408 (b) “Medicinal drug” has the same meaning as provided in s.
409 465.003 s. 465.003(8).
410 Section 11. Paragraph (b) of subsection (2) of section
411 401.245, Florida Statutes, is amended to read:
412 401.245 Emergency Medical Services Advisory Council.—
413 (2)(b) Representation on the Emergency Medical Services
414 Advisory Council shall include: two licensed physicians who are
415 medical directors “medical directors” as defined in s. 401.23 s.
416 401.23(15) or whose medical practice is closely related to
417 emergency medical services; two emergency medical service
418 administrators, one of whom is employed by a fire service; two
419 certified paramedics, one of whom is employed by a fire service;
420 two certified emergency medical technicians, one of whom is
421 employed by a fire service; one emergency medical services
422 educator; one emergency nurse; one hospital administrator; one
423 representative of air ambulance services; one representative of
424 a commercial ambulance operator; and two laypersons who are in
425 no way connected with emergency medical services, one of whom is
426 a representative of the elderly. Ex officio members of the
427 advisory council from state agencies shall include, but are
428 shall not be limited to, representatives from the Department of
429 Education, the Department of Management Services, the State Fire
430 Marshal, the Department of Highway Safety and Motor Vehicles,
431 the Department of Transportation, and the Division of Emergency
432 Management.
433 Section 12. Subsection (2) of section 401.27, Florida
434 Statutes, is amended to read:
435 401.27 Personnel; standards and certification.—
436 (2) The department shall establish by rule educational and
437 training criteria and examinations for the certification and
438 recertification of emergency medical technicians and paramedics.
439 Such rules must require, but need not be limited to:
440 (a) For emergency medical technicians, proficiency in basic
441 life support as defined techniques identified in s. 401.23 s.
442 401.23(7) and in rules of the department.
443 (b) For paramedics, proficiency in advanced life support as
444 defined techniques identified in s. 401.23 s. 401.23(1) and in
445 rules of the department.
446 Section 13. Paragraph (a) of subsection (1) of section
447 409.9201, Florida Statutes, is amended to read:
448 409.9201 Medicaid fraud.—
449 (1) As used in this section, the term:
450 (a) “Prescription drug” means any drug, including, but not
451 limited to, finished dosage forms or active ingredients that are
452 subject to, defined in, or described in s. 503(b) of the Federal
453 Food, Drug, and Cosmetic Act or in s. 465.003 s. 465.003(8), s.
454 499.003(17), s. 499.007(13), or s. 499.82(10).
455
456 The value of individual items of the legend drugs or goods or
457 services involved in distinct transactions committed during a
458 single scheme or course of conduct, whether involving a single
459 person or several persons, may be aggregated when determining
460 the punishment for the offense.
461 Section 14. Paragraph (pp) of subsection (1) of section
462 458.331, Florida Statutes, is amended to read:
463 458.331 Grounds for disciplinary action; action by the
464 board and department.—
465 (1) The following acts constitute grounds for denial of a
466 license or disciplinary action, as specified in s. 456.072(2):
467 (pp) Applicable to a licensee who serves as the designated
468 physician of a pain-management clinic as defined in s. 458.3265
469 or s. 459.0137:
470 1. Registering a pain-management clinic through
471 misrepresentation or fraud;
472 2. Procuring, or attempting to procure, the registration of
473 a pain-management clinic for any other person by making or
474 causing to be made, any false representation;
475 3. Failing to comply with any requirement of chapter 499,
476 the Florida Drug and Cosmetic Act; 21 U.S.C. ss. 301-392, the
477 Federal Food, Drug, and Cosmetic Act; 21 U.S.C. ss. 821 et seq.,
478 the Drug Abuse Prevention and Control Act; or chapter 893, the
479 Florida Comprehensive Drug Abuse Prevention and Control Act;
480 4. Being convicted or found guilty of, regardless of
481 adjudication to, a felony or any other crime involving moral
482 turpitude, fraud, dishonesty, or deceit in any jurisdiction of
483 the courts of this state, of any other state, or of the United
484 States;
485 5. Being convicted of, or disciplined by a regulatory
486 agency of the Federal Government or a regulatory agency of
487 another state for, any offense that would constitute a violation
488 of this chapter;
489 6. Being convicted of, or entering a plea of guilty or nolo
490 contendere to, regardless of adjudication, a crime in any
491 jurisdiction of the courts of this state, of any other state, or
492 of the United States which relates to the practice of, or the
493 ability to practice, a licensed health care profession;
494 7. Being convicted of, or entering a plea of guilty or nolo
495 contendere to, regardless of adjudication, a crime in any
496 jurisdiction of the courts of this state, of any other state, or
497 of the United States which relates to health care fraud;
498 8. Dispensing any medicinal drug based upon a communication
499 that purports to be a prescription as defined in s. 465.003 s.
500 465.003(14) or s. 893.02 if the dispensing practitioner knows or
501 has reason to believe that the purported prescription is not
502 based upon a valid practitioner-patient relationship; or
503 9. Failing to timely notify the board of the date of his or
504 her termination from a pain-management clinic as required by s.
505 458.3265(3).
506 Section 15. Paragraph (rr) of subsection (1) of section
507 459.015, Florida Statutes, is amended to read:
508 459.015 Grounds for disciplinary action; action by the
509 board and department.—
510 (1) The following acts constitute grounds for denial of a
511 license or disciplinary action, as specified in s. 456.072(2):
512 (rr) Applicable to a licensee who serves as the designated
513 physician of a pain-management clinic as defined in s. 458.3265
514 or s. 459.0137:
515 1. Registering a pain-management clinic through
516 misrepresentation or fraud;
517 2. Procuring, or attempting to procure, the registration of
518 a pain-management clinic for any other person by making or
519 causing to be made, any false representation;
520 3. Failing to comply with any requirement of chapter 499,
521 the Florida Drug and Cosmetic Act; 21 U.S.C. ss. 301-392, the
522 Federal Food, Drug, and Cosmetic Act; 21 U.S.C. ss. 821 et seq.,
523 the Drug Abuse Prevention and Control Act; or chapter 893, the
524 Florida Comprehensive Drug Abuse Prevention and Control Act;
525 4. Being convicted or found guilty of, regardless of
526 adjudication to, a felony or any other crime involving moral
527 turpitude, fraud, dishonesty, or deceit in any jurisdiction of
528 the courts of this state, of any other state, or of the United
529 States;
530 5. Being convicted of, or disciplined by a regulatory
531 agency of the Federal Government or a regulatory agency of
532 another state for, any offense that would constitute a violation
533 of this chapter;
534 6. Being convicted of, or entering a plea of guilty or nolo
535 contendere to, regardless of adjudication, a crime in any
536 jurisdiction of the courts of this state, of any other state, or
537 of the United States which relates to the practice of, or the
538 ability to practice, a licensed health care profession;
539 7. Being convicted of, or entering a plea of guilty or nolo
540 contendere to, regardless of adjudication, a crime in any
541 jurisdiction of the courts of this state, of any other state, or
542 of the United States which relates to health care fraud;
543 8. Dispensing any medicinal drug based upon a communication
544 that purports to be a prescription as defined in s. 465.003 s.
545 465.003(14) or s. 893.02 if the dispensing practitioner knows or
546 has reason to believe that the purported prescription is not
547 based upon a valid practitioner-patient relationship; or
548 9. Failing to timely notify the board of the date of his or
549 her termination from a pain-management clinic as required by s.
550 459.0137(3).
551 Section 16. Subsection (1) of section 465.014, Florida
552 Statutes, is amended to read:
553 465.014 Pharmacy technician.—
554 (1) A person other than a licensed pharmacist or pharmacy
555 intern may not engage in the practice of the profession of
556 pharmacy, except that a licensed pharmacist may delegate to
557 pharmacy technicians who are registered pursuant to this section
558 those duties, tasks, and functions that do not fall within the
559 purview of s. 465.003 s. 465.003(13). All such delegated acts
560 must be performed under the direct supervision of a licensed
561 pharmacist who is responsible for all such acts performed by
562 persons under his or her supervision. A registered pharmacy
563 technician, under the supervision of a pharmacist, may initiate
564 or receive communications with a practitioner or his or her
565 agent, on behalf of a patient, regarding refill authorization
566 requests. A licensed pharmacist may not supervise more than one
567 registered pharmacy technician unless otherwise permitted by the
568 guidelines adopted by the board. The board shall establish
569 guidelines to be followed by licensees or permittees in
570 determining the circumstances under which a licensed pharmacist
571 may supervise more than one pharmacy technician.
572 Section 17. Paragraph (c) of subsection (2) of section
573 465.015, Florida Statutes, is amended to read:
574 465.015 Violations and penalties.—
575 (2) It is unlawful for any person:
576 (c) To sell or dispense drugs as defined in s. 465.003 s.
577 465.003(8) without first being furnished with a prescription.
578 Section 18. Subsection (9) of section 465.0156, Florida
579 Statutes, is amended to read:
580 465.0156 Registration of nonresident pharmacies.—
581 (9) Notwithstanding s. 465.003 s. 465.003(10), for purposes
582 of this section, the registered pharmacy and the pharmacist
583 designated by the registered pharmacy as the prescription
584 department manager or the equivalent must be licensed in the
585 state of location in order to dispense into this state.
586 Section 19. Paragraph (s) of subsection (1) of section
587 465.016, Florida Statutes, is amended to read:
588 465.016 Disciplinary actions.—
589 (1) The following acts constitute grounds for denial of a
590 license or disciplinary action, as specified in s. 456.072(2):
591 (s) Dispensing any medicinal drug based upon a
592 communication that purports to be a prescription as defined in
593 s. 465.003 by s. 465.003(14) or s. 893.02 when the pharmacist
594 knows or has reason to believe that the purported prescription
595 is not based upon a valid practitioner-patient relationship.
596 Section 20. Subsection (4) of section 465.0197, Florida
597 Statutes, is amended to read:
598 465.0197 Internet pharmacy permits.—
599 (4) Notwithstanding s. 465.003 s. 465.003(10), for purposes
600 of this section, the Internet pharmacy and the pharmacist
601 designated by the Internet pharmacy as the prescription
602 department manager or the equivalent must be licensed in the
603 state of location in order to dispense into this state.
604 Section 21. Paragraph (j) of subsection (5) of section
605 465.022, Florida Statutes, is amended to read:
606 465.022 Pharmacies; general requirements; fees.—
607 (5) The department or board shall deny an application for a
608 pharmacy permit if the applicant or an affiliated person,
609 partner, officer, director, or prescription department manager
610 or consultant pharmacist of record of the applicant:
611 (j) Has dispensed any medicinal drug based upon a
612 communication that purports to be a prescription as defined in
613 s. 465.003 by s. 465.003(14) or s. 893.02 when the pharmacist
614 knows or has reason to believe that the purported prescription
615 is not based upon a valid practitioner-patient relationship that
616 includes a documented patient evaluation, including history and
617 a physical examination adequate to establish the diagnosis for
618 which any drug is prescribed and any other requirement
619 established by board rule under chapter 458, chapter 459,
620 chapter 461, chapter 463, chapter 464, or chapter 466.
621
622 For felonies in which the defendant entered a plea of guilty or
623 nolo contendere in an agreement with the court to enter a
624 pretrial intervention or drug diversion program, the department
625 shall deny the application if upon final resolution of the case
626 the licensee has failed to successfully complete the program.
627 Section 22. Paragraph (h) of subsection (1) of section
628 465.023, Florida Statutes, is amended to read:
629 465.023 Pharmacy permittee; disciplinary action.—
630 (1) The department or the board may revoke or suspend the
631 permit of any pharmacy permittee, and may fine, place on
632 probation, or otherwise discipline any pharmacy permittee if the
633 permittee, or any affiliated person, partner, officer, director,
634 or agent of the permittee, including a person fingerprinted
635 under s. 465.022(3), has:
636 (h) Dispensed any medicinal drug based upon a communication
637 that purports to be a prescription as defined in s. 465.003 by
638 s. 465.003(14) or s. 893.02 when the pharmacist knows or has
639 reason to believe that the purported prescription is not based
640 upon a valid practitioner-patient relationship that includes a
641 documented patient evaluation, including history and a physical
642 examination adequate to establish the diagnosis for which any
643 drug is prescribed and any other requirement established by
644 board rule under chapter 458, chapter 459, chapter 461, chapter
645 463, chapter 464, or chapter 466.
646 Section 23. Section 465.1901, Florida Statutes, is amended
647 to read:
648 465.1901 Practice of orthotics and pedorthics.—The
649 provisions of chapter 468 relating to orthotics or pedorthics do
650 not apply to any licensed pharmacist or to any person acting
651 under the supervision of a licensed pharmacist. The practice of
652 orthotics or pedorthics by a pharmacist or any of the
653 pharmacist’s employees acting under the supervision of a
654 pharmacist shall be construed to be within the meaning of the
655 term “practice of the profession of pharmacy” as defined set
656 forth in s. 465.003 s. 465.003(13), and shall be subject to
657 regulation in the same manner as any other pharmacy practice.
658 The Board of Pharmacy shall develop rules regarding the practice
659 of orthotics and pedorthics by a pharmacist. Any pharmacist or
660 person under the supervision of a pharmacist engaged in the
661 practice of orthotics or pedorthics is not precluded from
662 continuing that practice pending adoption of these rules.
663 Section 24. Paragraph (j) of subsection (2) of section
664 465.1902, Florida Statutes, is amended to read:
665 465.1902 Prescription Drug Donation Repository Program.—
666 (2) DEFINITIONS.—As used in this section, the term:
667 (j) “Prescription drug” has the same meaning as the term
668 “medicinal drugs” or “drugs,” as those terms are defined in s.
669 465.003 s. 465.003(8), but does not include controlled
670 substances, cancer drugs donated under s. 499.029, or drugs with
671 an approved United States Food and Drug Administration risk
672 evaluation and mitigation strategy that includes elements to
673 assure safe use.
674 Section 25. Subsection (40) of section 499.003, Florida
675 Statutes, is amended to read:
676 499.003 Definitions of terms used in this part.—As used in
677 this part, the term:
678 (40) “Prescription drug” means a prescription, medicinal,
679 or legend drug, including, but not limited to, finished dosage
680 forms or active pharmaceutical ingredients subject to, defined
681 by, or described by s. 503(b) of the federal act or s. 465.003
682 s. 465.003(8), s. 499.007(13), subsection (31), or subsection
683 (47), except that an active pharmaceutical ingredient is a
684 prescription drug only if substantially all finished dosage
685 forms in which it may be lawfully dispensed or administered in
686 this state are also prescription drugs.
687 Section 26. Paragraph (c) of subsection (24) of section
688 893.02, Florida Statutes, is amended to read:
689 893.02 Definitions.—The following words and phrases as used
690 in this chapter shall have the following meanings, unless the
691 context otherwise requires:
692 (24) “Prescription” includes any order for drugs or
693 medicinal supplies which is written or transmitted by any means
694 of communication by a licensed practitioner authorized by the
695 laws of this state to prescribe such drugs or medicinal
696 supplies, is issued in good faith and in the course of
697 professional practice, is intended to be dispensed by a person
698 authorized by the laws of this state to do so, and meets the
699 requirements of s. 893.04.
700 (c) A prescription for a controlled substance may not be
701 issued on the same prescription blank with another prescription
702 for a controlled substance that is named or described in a
703 different schedule or with another prescription for a medicinal
704 drug, as defined in s. 465.003 s. 465.003(8), that is not a
705 controlled substance.
706 Section 27. This act shall take effect July 1, 2022.