Florida Senate - 2022 COMMITTEE AMENDMENT
Bill No. CS for SB 1222
Ì874244+Î874244
LEGISLATIVE ACTION
Senate . House
Comm: RS .
02/07/2022 .
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The Committee on Judiciary (Bean) recommended the following:
1 Senate Amendment (with title amendment)
2
3 Delete everything after the enacting clause
4 and insert:
5 Section 1. Present subsections (1) through (22) of section
6 401.23, Florida Statutes, are redesignated as subsections (2)
7 through (23), respectively, a new subsection (1) is added to
8 that section, and present subsection (19) of that section is
9 amended, to read:
10 401.23 Definitions.—As used in this part, the term:
11 (1) “Acute hospital care at home” means acute and post
12 acute health care services provided in a clinically qualified
13 patient’s permanent residence, as defined in s. 196.012(17),
14 through a program approved by the Centers for Medicare and
15 Medicaid Services and the Agency for Health Care Administration.
16 (20)(19) “Physician” means a practitioner who is licensed
17 under the provisions of chapter 458 or chapter 459. For the
18 purpose of providing medical direction “medical direction” as
19 defined in subsection (14) for the treatment of patients
20 immediately before prior to or during transportation to a United
21 States Department of Veterans Affairs medical facility,
22 “physician” also means a practitioner employed by the United
23 States Department of Veterans Affairs.
24 Section 2. Paragraph (c) is added to subsection (2) of
25 section 401.272, Florida Statutes, to read:
26 401.272 Emergency medical services community health care.—
27 (2) Notwithstanding any other provision of law to the
28 contrary:
29 (c) Paramedics may provide basic life support services and
30 advanced life support services to patients receiving acute
31 hospital care at home as specified in the paramedic’s
32 supervisory relationship with a physician or standing orders as
33 described in s. 401.265, s. 458.348, or s. 459.025. A physician
34 who supervises or provides medical direction to a paramedic who
35 provides basic life support services or advanced life support
36 services to patients receiving acute hospital care at home
37 pursuant to a formal supervisory relationship or standing orders
38 is liable for any act or omission of the paramedic acting under
39 the physician’s supervision or medical direction when providing
40 such services. The department may adopt and enforce rules
41 necessary to implement this paragraph.
42 Section 3. Section 465.003, Florida Statutes, is reordered
43 and amended to read:
44 465.003 Definitions.—As used in this chapter, the term:
45 (1) “Acute hospital care at home” means acute and post
46 acute health care services provided in a clinically qualified
47 patient’s permanent residence, as defined in s. 196.012(17),
48 through a program approved by the Centers for Medicare and
49 Medicaid Services and the Agency for Health Care Administration.
50 (2)(1) “Administration” means the obtaining and giving of a
51 single dose of medicinal drugs by a legally authorized person to
52 a patient for her or his consumption.
53 (4)(2) “Board” means the Board of Pharmacy.
54 (10)(3) “Consultant pharmacist” means a pharmacist licensed
55 by the department and certified as a consultant pharmacist
56 pursuant to s. 465.0125.
57 (11)(4) “Data communication device” means an electronic
58 device that receives electronic information from one source and
59 transmits or routes it to another, including, but not limited
60 to, any such bridge, router, switch, or gateway.
61 (12)(5) “Department” means the Department of Health.
62 (13)(6) “Dispense” means the transfer of possession of one
63 or more doses of a medicinal drug by a pharmacist to the
64 ultimate consumer or her or his agent. As an element of
65 dispensing, the pharmacist shall, prior to the actual physical
66 transfer, interpret and assess the prescription order for
67 potential adverse reactions, interactions, and dosage regimen
68 she or he deems appropriate in the exercise of her or his
69 professional judgment, and the pharmacist shall certify that the
70 medicinal drug called for by the prescription is ready for
71 transfer. The pharmacist shall also provide counseling on proper
72 drug usage, either orally or in writing, if in the exercise of
73 her or his professional judgment counseling is necessary. The
74 actual sales transaction and delivery of such drug shall not be
75 considered dispensing. The administration shall not be
76 considered dispensing.
77 (14)(7) “Institutional formulary system” means a method
78 whereby the medical staff evaluates, appraises, and selects
79 those medicinal drugs or proprietary preparations which in the
80 medical staff’s clinical judgment are most useful in patient
81 care, and which are available for dispensing by a practicing
82 pharmacist in a Class II or Class III institutional pharmacy.
83 (15)(8) “Medicinal drugs” or “drugs” means those substances
84 or preparations commonly known as “prescription” or “legend”
85 drugs which are required by federal or state law to be dispensed
86 only on a prescription, but shall not include patents or
87 proprietary preparations as hereafter defined.
88 (18)(9) “Patent or proprietary preparation” means a
89 medicine in its unbroken, original package which is sold to the
90 public by, or under the authority of, the manufacturer or
91 primary distributor thereof and which is not misbranded under
92 the provisions of the Florida Drug and Cosmetic Act.
93 (19)(10) “Pharmacist” means any person licensed pursuant to
94 this chapter to practice the profession of pharmacy.
95 (20)(a)(11)(a) “Pharmacy” includes a community pharmacy, an
96 institutional pharmacy, a nuclear pharmacy, a special pharmacy,
97 and an Internet pharmacy.
98 1. The term “community pharmacy” includes every location
99 where medicinal drugs are compounded, dispensed, stored, or sold
100 or where prescriptions are filled or dispensed on an outpatient
101 basis.
102 2. The term “institutional pharmacy” includes every
103 location in a hospital, clinic, nursing home, dispensary,
104 sanitarium, extended care facility, or other facility,
105 hereinafter referred to as “health care institutions,” where
106 medicinal drugs are compounded, dispensed, stored, or sold.
107 3. The term “nuclear pharmacy” includes every location
108 where radioactive drugs and chemicals within the classification
109 of medicinal drugs are compounded, dispensed, stored, or sold.
110 The term “nuclear pharmacy” does not include hospitals licensed
111 under chapter 395 or the nuclear medicine facilities of such
112 hospitals.
113 4. The term “special pharmacy” includes every location
114 where medicinal drugs are compounded, dispensed, stored, or sold
115 if such locations are not otherwise defined in this subsection.
116 5. The term “Internet pharmacy” includes locations not
117 otherwise licensed or issued a permit under this chapter, within
118 or outside this state, which use the Internet to communicate
119 with or obtain information from consumers in this state and use
120 such communication or information to fill or refill
121 prescriptions or to dispense, distribute, or otherwise engage in
122 the practice of pharmacy in this state. Any act described in
123 this definition constitutes the practice of the profession of
124 pharmacy as defined in subsection (13).
125 (b) The pharmacy department of any permittee shall be
126 considered closed whenever a Florida licensed pharmacist is not
127 present and on duty. The term “not present and on duty” shall
128 not be construed to prevent a pharmacist from exiting the
129 prescription department for the purposes of consulting or
130 responding to inquiries or providing assistance to patients or
131 customers, attending to personal hygiene needs, or performing
132 any other function for which the pharmacist is responsible,
133 provided that such activities are conducted in a manner
134 consistent with the pharmacist’s responsibility to provide
135 pharmacy services.
136 (21)(12) “Pharmacy intern” means a person who is currently
137 registered in, and attending, a duly accredited college or
138 school of pharmacy, or who is a graduate of such a school or
139 college of pharmacy, and who is duly and properly registered
140 with the department as provided for under its rules.
141 (22)(13) “Practice of the profession of pharmacy” includes
142 compounding, dispensing, and consulting concerning contents,
143 therapeutic values, and uses of any medicinal drug; consulting
144 concerning therapeutic values and interactions of patent or
145 proprietary preparations, whether pursuant to prescriptions or
146 in the absence and entirely independent of such prescriptions or
147 orders; and conducting other pharmaceutical services. For
148 purposes of this subsection, the term “other pharmaceutical
149 services” means monitoring the patient’s drug therapy and
150 assisting the patient in the management of his or her drug
151 therapy, and includes reviewing, and making recommendations
152 regarding, the patient’s drug therapy and health care status in
153 communication with the patient’s prescribing health care
154 provider as licensed under chapter 458, chapter 459, chapter
155 461, or chapter 466, or a similar statutory provision in another
156 jurisdiction, or such provider’s agent or such other persons as
157 specifically authorized by the patient; and initiating,
158 modifying, or discontinuing drug therapy for a chronic health
159 condition under a collaborative pharmacy practice agreement.
160 This subsection may not be interpreted to permit an alteration
161 of a prescriber’s directions, the diagnosis or treatment of any
162 disease, the initiation of any drug therapy, the practice of
163 medicine, or the practice of osteopathic medicine, unless
164 otherwise permitted by law or specifically authorized by s.
165 465.1865 or s. 465.1895. The term “practice of the profession of
166 pharmacy” also includes any other act, service, operation,
167 research, or transaction incidental to, or forming a part of,
168 any of the foregoing acts, requiring, involving, or employing
169 the science or art of any branch of the pharmaceutical
170 profession, study, or training, and shall expressly permit a
171 pharmacist to transmit information from persons authorized to
172 prescribe medicinal drugs to their patients. The practice of the
173 profession of pharmacy also includes the administration of
174 vaccines to adults pursuant to s. 465.189, the testing or
175 screening for and treatment of minor, nonchronic health
176 conditions pursuant to s. 465.1895, and the preparation of
177 prepackaged drug products in facilities holding Class III
178 institutional pharmacy permits. The term also includes the
179 ordering and evaluating of any laboratory or clinical testing;
180 conducting patient assessments; and modifying, discontinuing, or
181 administering medicinal drugs pursuant to s. 465.0125 by a
182 consultant pharmacist.
183 (23)(14) “Prescription” includes any order for drugs or
184 medicinal supplies written or transmitted by any means of
185 communication by a duly licensed practitioner authorized by the
186 laws of the state to prescribe such drugs or medicinal supplies
187 and intended to be dispensed by a pharmacist. The term also
188 includes an orally transmitted order by the lawfully designated
189 agent of such practitioner. The term also includes an order
190 written or transmitted by a practitioner licensed to practice in
191 a jurisdiction other than this state, but only if the pharmacist
192 called upon to dispense such order determines, in the exercise
193 of her or his professional judgment, that the order is valid and
194 necessary for the treatment of a chronic or recurrent illness.
195 The term “prescription” also includes a pharmacist’s order for a
196 product selected from the formulary created pursuant to s.
197 465.186. Prescriptions may be retained in written form or the
198 pharmacist may cause them to be recorded in a data processing
199 system, provided that such order can be produced in printed form
200 upon lawful request.
201 (16)(15) “Nuclear pharmacist” means a pharmacist licensed
202 by the department and certified as a nuclear pharmacist pursuant
203 to s. 465.0126.
204 (6)(16) “Centralized prescription filling” means the
205 filling of a prescription by one pharmacy upon request by
206 another pharmacy to fill or refill the prescription. The term
207 includes the performance by one pharmacy for another pharmacy of
208 other pharmacy duties such as drug utilization review,
209 therapeutic drug utilization review, claims adjudication, and
210 the obtaining of refill authorizations.
211 (3)(17) “Automated pharmacy system” means a mechanical
212 system that delivers prescription drugs received from a Florida
213 licensed pharmacy and maintains related transaction information.
214 (9)(18) “Compounding” means combining, mixing, or altering
215 the ingredients of one or more drugs or products to create
216 another drug or product.
217 (17)(19) “Outsourcing facility” means a single physical
218 location registered as an outsourcing facility under the federal
219 Drug Quality and Security Act, Pub. L. No. 113-54, at which
220 sterile compounding of a drug or product is conducted.
221 (8)(20) “Compounded sterile product” means a drug that is
222 intended for parenteral administration, an ophthalmic or oral
223 inhalation drug in aqueous format, or a drug or product that is
224 required to be sterile under federal or state law or rule, which
225 is produced through compounding, but is not approved by the
226 United States Food and Drug Administration.
227 (5)(21) “Central distribution facility” means a facility
228 under common control with a hospital holding a Class III
229 institutional pharmacy permit that may dispense, distribute,
230 compound, or fill prescriptions for medicinal drugs; prepare
231 prepackaged drug products; and conduct other pharmaceutical
232 services.
233 (7)(22) “Common control” means the power to direct or cause
234 the direction of the management and policies of a person or an
235 organization, whether by ownership of stock, voting rights,
236 contract, or otherwise.
237 Section 4. Paragraph (d) of subsection (2) and paragraph
238 (a) of subsection (4) of section 465.019, Florida Statutes, are
239 amended to read:
240 465.019 Institutional pharmacies; permits.—
241 (2) The following classes of institutional pharmacies are
242 established:
243 (d)1. “Class III institutional pharmacies” are those
244 institutional pharmacies, including central distribution
245 facilities, affiliated with a hospital which that provide the
246 same services that are authorized by a Class II institutional
247 pharmacy permit. Class III institutional pharmacies may also:
248 a. Dispense, distribute, compound, and fill prescriptions
249 for medicinal drugs for inpatient treatment or for patients
250 receiving acute hospital care at home.
251 b. Prepare prepackaged drug products.
252 c. Conduct other pharmaceutical services for the affiliated
253 hospital and for entities under common control that are each
254 permitted under this chapter to possess medicinal drugs.
255 d. Provide the services in sub-subparagraphs a.-c. to an
256 entity under common control which holds an active health care
257 clinic establishment permit as required under s. 499.01(2)(r).
258 2. A Class III institutional pharmacy shall maintain
259 policies and procedures addressing:
260 a. The consultant pharmacist responsible for pharmaceutical
261 services.
262 b. Safe practices for the preparation, dispensing,
263 prepackaging, distribution, and transportation of medicinal
264 drugs and prepackaged drug products.
265 c. Recordkeeping to monitor the movement, distribution, and
266 transportation of medicinal drugs and prepackaged drug products.
267 d. Recordkeeping of pharmacy staff responsible for each
268 step in the preparation, dispensing, prepackaging,
269 transportation, and distribution of medicinal drugs and
270 prepackaged drug products.
271 e. Medicinal drugs and prepackaged drug products that may
272 not be safely distributed among Class III institutional
273 pharmacies.
274 (4)(a) Medicinal drugs shall be dispensed by in an
275 institutional pharmacy to outpatients only when that institution
276 has secured a community pharmacy permit from the department.
277 However, medicinal drugs may be dispensed by a hospital that
278 operates a Class II or Class III institutional pharmacy to a
279 patient of the hospital’s emergency department or a hospital
280 inpatient upon discharge if a prescriber, as defined in s.
281 465.025(1), treating the patient in such hospital determines
282 that the medicinal drug is warranted and that community pharmacy
283 services are not readily accessible, geographically or
284 otherwise, to the patient. Such prescribing and dispensing must
285 be for a supply of the drug that will last for the greater of
286 the following:
287 1. Up to 48 hours; or
288 2. Through the end of the next business day.
289 Section 5. Subsection (1) of section 14.33, Florida
290 Statutes, is amended to read:
291 14.33 Medal of Heroism.—
292 (1) The Governor may award a Medal of Heroism of
293 appropriate design, with ribbons and appurtenances, to a law
294 enforcement, correctional, or correctional probation officer, as
295 defined in s. 943.10(14); a firefighter, as defined in s.
296 112.191(1)(b); an emergency medical technician, as defined in s.
297 401.23 s. 401.23(11); or a paramedic, as defined in s. 401.23 s.
298 401.23(17). A recipient must have distinguished himself or
299 herself conspicuously by gallantry and intrepidity, must have
300 risked his or her life deliberately above and beyond the call of
301 duty while performing duty in his or her respective position,
302 and must have engaged in hazardous or perilous activities to
303 preserve lives with the knowledge that such activities might
304 result in great personal harm.
305 Section 6. Subsection (1) of section 125.01045, Florida
306 Statutes, is amended to read:
307 125.01045 Prohibition of fees for first responder
308 services.—
309 (1) A county may not impose a fee or seek reimbursement for
310 any costs or expenses that may be incurred for services provided
311 by a first responder, including costs or expenses related to
312 personnel, supplies, motor vehicles, or equipment in response to
313 a motor vehicle accident, except for costs to contain or clean
314 up hazardous materials in quantities reportable to the Florida
315 State Warning Point at the Division of Emergency Management, and
316 costs for transportation and treatment provided by ambulance
317 services licensed pursuant to part III of chapter 401 s.
318 401.23(4) and (5).
319 Section 7. Subsection (1) of section 166.0446, Florida
320 Statutes, is amended to read:
321 166.0446 Prohibition of fees for first responder services.—
322 (1) A municipality may not impose a fee or seek
323 reimbursement for any costs or expenses that may be incurred for
324 services provided by a first responder, including costs or
325 expenses related to personnel, supplies, motor vehicles, or
326 equipment in response to a motor vehicle accident, except for
327 costs to contain or clean up hazardous materials in quantities
328 reportable to the Florida State Warning Point at the Division of
329 Emergency Management, and costs for transportation and treatment
330 provided by ambulance services licensed pursuant to part III of
331 chapter 401 s. 401.23(4) and (5).
332 Section 8. Paragraph (a) of subsection (3) of section
333 252.515, Florida Statutes, is amended to read:
334 252.515 Postdisaster Relief Assistance Act; immunity from
335 civil liability.—
336 (3) As used in this section, the term:
337 (a) “Emergency first responder” means:
338 1. A physician licensed under chapter 458.
339 2. An osteopathic physician licensed under chapter 459.
340 3. A chiropractic physician licensed under chapter 460.
341 4. A podiatric physician licensed under chapter 461.
342 5. A dentist licensed under chapter 466.
343 6. An advanced practice registered nurse licensed under s.
344 464.012.
345 7. A physician assistant licensed under s. 458.347 or s.
346 459.022.
347 8. A worker employed by a public or private hospital in the
348 state.
349 9. A paramedic as defined in s. 401.23 s. 401.23(17).
350 10. An emergency medical technician as defined in s. 401.23
351 s. 401.23(11).
352 11. A firefighter as defined in s. 633.102.
353 12. A law enforcement officer as defined in s. 943.10.
354 13. A member of the Florida National Guard.
355 14. Any other personnel designated as emergency personnel
356 by the Governor pursuant to a declared emergency.
357 Section 9. Subsection (5) of section 395.1027, Florida
358 Statutes, is amended to read:
359 395.1027 Regional poison control centers.—
360 (5) By October 1, 1999, each regional poison control center
361 shall develop a prehospital emergency dispatch protocol with
362 each licensee as defined in s. 401.23 by s. 401.23(13) in the
363 geographic area covered by the regional poison control center.
364 The prehospital emergency dispatch protocol shall be developed
365 by each licensee’s medical director in conjunction with the
366 designated regional poison control center responsible for the
367 geographic area in which the licensee operates. The protocol
368 shall define toxic substances and describe the procedure by
369 which the designated regional poison control center may be
370 consulted by the licensee. If a call is transferred to the
371 designated regional poison control center in accordance with the
372 protocol established under this section and s. 401.268, the
373 designated regional poison control center shall assume
374 responsibility and liability for the call.
375 Section 10. Paragraph (b) of subsection (1) of section
376 400.143, Florida Statutes, is amended to read:
377 400.143 Institutional formularies established by nursing
378 home facilities.—
379 (1) For purposes of this section, the term:
380 (b) “Medicinal drug” has the same meaning as provided in s.
381 465.003 s. 465.003(8).
382 Section 11. Paragraph (b) of subsection (2) of section
383 401.245, Florida Statutes, is amended to read:
384 401.245 Emergency Medical Services Advisory Council.—
385 (2)(b) Representation on the Emergency Medical Services
386 Advisory Council shall include: two licensed physicians who are
387 medical directors “medical directors” as defined in s. 401.23 s.
388 401.23(15) or whose medical practice is closely related to
389 emergency medical services; two emergency medical service
390 administrators, one of whom is employed by a fire service; two
391 certified paramedics, one of whom is employed by a fire service;
392 two certified emergency medical technicians, one of whom is
393 employed by a fire service; one emergency medical services
394 educator; one emergency nurse; one hospital administrator; one
395 representative of air ambulance services; one representative of
396 a commercial ambulance operator; and two laypersons who are in
397 no way connected with emergency medical services, one of whom is
398 a representative of the elderly. Ex officio members of the
399 advisory council from state agencies shall include, but are
400 shall not be limited to, representatives from the Department of
401 Education, the Department of Management Services, the State Fire
402 Marshal, the Department of Highway Safety and Motor Vehicles,
403 the Department of Transportation, and the Division of Emergency
404 Management.
405 Section 12. Subsection (2) of section 401.27, Florida
406 Statutes, is amended to read:
407 401.27 Personnel; standards and certification.—
408 (2) The department shall establish by rule educational and
409 training criteria and examinations for the certification and
410 recertification of emergency medical technicians and paramedics.
411 Such rules must require, but need not be limited to:
412 (a) For emergency medical technicians, proficiency in basic
413 life support as defined techniques identified in s. 401.23 s.
414 401.23(7) and in rules of the department.
415 (b) For paramedics, proficiency in advanced life support as
416 defined techniques identified in s. 401.23 s. 401.23(1) and in
417 rules of the department.
418 Section 13. Paragraph (a) of subsection (1) of section
419 409.9201, Florida Statutes, is amended to read:
420 409.9201 Medicaid fraud.—
421 (1) As used in this section, the term:
422 (a) “Prescription drug” means any drug, including, but not
423 limited to, finished dosage forms or active ingredients that are
424 subject to, defined in, or described in s. 503(b) of the Federal
425 Food, Drug, and Cosmetic Act or in s. 465.003 s. 465.003(8), s.
426 499.003(17), s. 499.007(13), or s. 499.82(10).
427
428 The value of individual items of the legend drugs or goods or
429 services involved in distinct transactions committed during a
430 single scheme or course of conduct, whether involving a single
431 person or several persons, may be aggregated when determining
432 the punishment for the offense.
433 Section 14. Paragraph (pp) of subsection (1) of section
434 458.331, Florida Statutes, is amended to read:
435 458.331 Grounds for disciplinary action; action by the
436 board and department.—
437 (1) The following acts constitute grounds for denial of a
438 license or disciplinary action, as specified in s. 456.072(2):
439 (pp) Applicable to a licensee who serves as the designated
440 physician of a pain-management clinic as defined in s. 458.3265
441 or s. 459.0137:
442 1. Registering a pain-management clinic through
443 misrepresentation or fraud;
444 2. Procuring, or attempting to procure, the registration of
445 a pain-management clinic for any other person by making or
446 causing to be made, any false representation;
447 3. Failing to comply with any requirement of chapter 499,
448 the Florida Drug and Cosmetic Act; 21 U.S.C. ss. 301-392, the
449 Federal Food, Drug, and Cosmetic Act; 21 U.S.C. ss. 821 et seq.,
450 the Drug Abuse Prevention and Control Act; or chapter 893, the
451 Florida Comprehensive Drug Abuse Prevention and Control Act;
452 4. Being convicted or found guilty of, regardless of
453 adjudication to, a felony or any other crime involving moral
454 turpitude, fraud, dishonesty, or deceit in any jurisdiction of
455 the courts of this state, of any other state, or of the United
456 States;
457 5. Being convicted of, or disciplined by a regulatory
458 agency of the Federal Government or a regulatory agency of
459 another state for, any offense that would constitute a violation
460 of this chapter;
461 6. Being convicted of, or entering a plea of guilty or nolo
462 contendere to, regardless of adjudication, a crime in any
463 jurisdiction of the courts of this state, of any other state, or
464 of the United States which relates to the practice of, or the
465 ability to practice, a licensed health care profession;
466 7. 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 health care fraud;
470 8. Dispensing any medicinal drug based upon a communication
471 that purports to be a prescription as defined in s. 465.003 s.
472 465.003(14) or s. 893.02 if the dispensing practitioner knows or
473 has reason to believe that the purported prescription is not
474 based upon a valid practitioner-patient relationship; or
475 9. Failing to timely notify the board of the date of his or
476 her termination from a pain-management clinic as required by s.
477 458.3265(3).
478 Section 15. Paragraph (rr) of subsection (1) of section
479 459.015, Florida Statutes, is amended to read:
480 459.015 Grounds for disciplinary action; action by the
481 board and department.—
482 (1) The following acts constitute grounds for denial of a
483 license or disciplinary action, as specified in s. 456.072(2):
484 (rr) Applicable to a licensee who serves as the designated
485 physician of a pain-management clinic as defined in s. 458.3265
486 or s. 459.0137:
487 1. Registering a pain-management clinic through
488 misrepresentation or fraud;
489 2. Procuring, or attempting to procure, the registration of
490 a pain-management clinic for any other person by making or
491 causing to be made, any false representation;
492 3. Failing to comply with any requirement of chapter 499,
493 the Florida Drug and Cosmetic Act; 21 U.S.C. ss. 301-392, the
494 Federal Food, Drug, and Cosmetic Act; 21 U.S.C. ss. 821 et seq.,
495 the Drug Abuse Prevention and Control Act; or chapter 893, the
496 Florida Comprehensive Drug Abuse Prevention and Control Act;
497 4. Being convicted or found guilty of, regardless of
498 adjudication to, a felony or any other crime involving moral
499 turpitude, fraud, dishonesty, or deceit in any jurisdiction of
500 the courts of this state, of any other state, or of the United
501 States;
502 5. Being convicted of, or disciplined by a regulatory
503 agency of the Federal Government or a regulatory agency of
504 another state for, any offense that would constitute a violation
505 of this chapter;
506 6. Being convicted of, or entering a plea of guilty or nolo
507 contendere to, regardless of adjudication, a crime in any
508 jurisdiction of the courts of this state, of any other state, or
509 of the United States which relates to the practice of, or the
510 ability to practice, a licensed health care profession;
511 7. 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 health care fraud;
515 8. Dispensing any medicinal drug based upon a communication
516 that purports to be a prescription as defined in s. 465.003 s.
517 465.003(14) or s. 893.02 if the dispensing practitioner knows or
518 has reason to believe that the purported prescription is not
519 based upon a valid practitioner-patient relationship; or
520 9. Failing to timely notify the board of the date of his or
521 her termination from a pain-management clinic as required by s.
522 459.0137(3).
523 Section 16. Subsection (1) of section 465.014, Florida
524 Statutes, is amended to read:
525 465.014 Pharmacy technician.—
526 (1) A person other than a licensed pharmacist or pharmacy
527 intern may not engage in the practice of the profession of
528 pharmacy, except that a licensed pharmacist may delegate to
529 pharmacy technicians who are registered pursuant to this section
530 those duties, tasks, and functions that do not fall within the
531 purview of s. 465.003 s. 465.003(13). All such delegated acts
532 must be performed under the direct supervision of a licensed
533 pharmacist who is responsible for all such acts performed by
534 persons under his or her supervision. A registered pharmacy
535 technician, under the supervision of a pharmacist, may initiate
536 or receive communications with a practitioner or his or her
537 agent, on behalf of a patient, regarding refill authorization
538 requests. A licensed pharmacist may not supervise more than one
539 registered pharmacy technician unless otherwise permitted by the
540 guidelines adopted by the board. The board shall establish
541 guidelines to be followed by licensees or permittees in
542 determining the circumstances under which a licensed pharmacist
543 may supervise more than one pharmacy technician.
544 Section 17. Paragraph (c) of subsection (2) of section
545 465.015, Florida Statutes, is amended to read:
546 465.015 Violations and penalties.—
547 (2) It is unlawful for any person:
548 (c) To sell or dispense drugs as defined in s. 465.003 s.
549 465.003(8) without first being furnished with a prescription.
550 Section 18. Subsection (9) of section 465.0156, Florida
551 Statutes, is amended to read:
552 465.0156 Registration of nonresident pharmacies.—
553 (9) Notwithstanding s. 465.003 s. 465.003(10), for purposes
554 of this section, the registered pharmacy and the pharmacist
555 designated by the registered pharmacy as the prescription
556 department manager or the equivalent must be licensed in the
557 state of location in order to dispense into this state.
558 Section 19. Paragraph (s) of subsection (1) of section
559 465.016, Florida Statutes, is amended to read:
560 465.016 Disciplinary actions.—
561 (1) The following acts constitute grounds for denial of a
562 license or disciplinary action, as specified in s. 456.072(2):
563 (s) Dispensing any medicinal drug based upon a
564 communication that purports to be a prescription as defined in
565 s. 465.003 by s. 465.003(14) or s. 893.02 when the pharmacist
566 knows or has reason to believe that the purported prescription
567 is not based upon a valid practitioner-patient relationship.
568 Section 20. Subsection (4) of section 465.0197, Florida
569 Statutes, is amended to read:
570 465.0197 Internet pharmacy permits.—
571 (4) Notwithstanding s. 465.003 s. 465.003(10), for purposes
572 of this section, the Internet pharmacy and the pharmacist
573 designated by the Internet pharmacy as the prescription
574 department manager or the equivalent must be licensed in the
575 state of location in order to dispense into this state.
576 Section 21. Paragraph (j) of subsection (5) of section
577 465.022, Florida Statutes, is amended to read:
578 465.022 Pharmacies; general requirements; fees.—
579 (5) The department or board shall deny an application for a
580 pharmacy permit if the applicant or an affiliated person,
581 partner, officer, director, or prescription department manager
582 or consultant pharmacist of record of the applicant:
583 (j) Has dispensed any medicinal drug based upon a
584 communication that purports to be a prescription as defined in
585 s. 465.003 by s. 465.003(14) or s. 893.02 when the pharmacist
586 knows or has reason to believe that the purported prescription
587 is not based upon a valid practitioner-patient relationship that
588 includes a documented patient evaluation, including history and
589 a physical examination adequate to establish the diagnosis for
590 which any drug is prescribed and any other requirement
591 established by board rule under chapter 458, chapter 459,
592 chapter 461, chapter 463, chapter 464, or chapter 466.
593
594 For felonies in which the defendant entered a plea of guilty or
595 nolo contendere in an agreement with the court to enter a
596 pretrial intervention or drug diversion program, the department
597 shall deny the application if upon final resolution of the case
598 the licensee has failed to successfully complete the program.
599 Section 22. Paragraph (h) of subsection (1) of section
600 465.023, Florida Statutes, is amended to read:
601 465.023 Pharmacy permittee; disciplinary action.—
602 (1) The department or the board may revoke or suspend the
603 permit of any pharmacy permittee, and may fine, place on
604 probation, or otherwise discipline any pharmacy permittee if the
605 permittee, or any affiliated person, partner, officer, director,
606 or agent of the permittee, including a person fingerprinted
607 under s. 465.022(3), has:
608 (h) Dispensed any medicinal drug based upon a communication
609 that purports to be a prescription as defined in s. 465.003 by
610 s. 465.003(14) or s. 893.02 when the pharmacist knows or has
611 reason to believe that the purported prescription is not based
612 upon a valid practitioner-patient relationship that includes a
613 documented patient evaluation, including history and a physical
614 examination adequate to establish the diagnosis for which any
615 drug is prescribed and any other requirement established by
616 board rule under chapter 458, chapter 459, chapter 461, chapter
617 463, chapter 464, or chapter 466.
618 Section 23. Section 465.1901, Florida Statutes, is amended
619 to read:
620 465.1901 Practice of orthotics and pedorthics.—The
621 provisions of chapter 468 relating to orthotics or pedorthics do
622 not apply to any licensed pharmacist or to any person acting
623 under the supervision of a licensed pharmacist. The practice of
624 orthotics or pedorthics by a pharmacist or any of the
625 pharmacist’s employees acting under the supervision of a
626 pharmacist shall be construed to be within the meaning of the
627 term “practice of the profession of pharmacy” as defined set
628 forth in s. 465.003 s. 465.003(13), and shall be subject to
629 regulation in the same manner as any other pharmacy practice.
630 The Board of Pharmacy shall develop rules regarding the practice
631 of orthotics and pedorthics by a pharmacist. Any pharmacist or
632 person under the supervision of a pharmacist engaged in the
633 practice of orthotics or pedorthics is not precluded from
634 continuing that practice pending adoption of these rules.
635 Section 24. Paragraph (j) of subsection (2) of section
636 465.1902, Florida Statutes, is amended to read:
637 465.1902 Prescription Drug Donation Repository Program.—
638 (2) DEFINITIONS.—As used in this section, the term:
639 (j) “Prescription drug” has the same meaning as the term
640 “medicinal drugs” or “drugs,” as those terms are defined in s.
641 465.003 s. 465.003(8), but does not include controlled
642 substances, cancer drugs donated under s. 499.029, or drugs with
643 an approved United States Food and Drug Administration risk
644 evaluation and mitigation strategy that includes elements to
645 assure safe use.
646 Section 25. Subsection (40) of section 499.003, Florida
647 Statutes, is amended to read:
648 499.003 Definitions of terms used in this part.—As used in
649 this part, the term:
650 (40) “Prescription drug” means a prescription, medicinal,
651 or legend drug, including, but not limited to, finished dosage
652 forms or active pharmaceutical ingredients subject to, defined
653 by, or described by s. 503(b) of the federal act or s. 465.003
654 s. 465.003(8), s. 499.007(13), subsection (31), or subsection
655 (47), except that an active pharmaceutical ingredient is a
656 prescription drug only if substantially all finished dosage
657 forms in which it may be lawfully dispensed or administered in
658 this state are also prescription drugs.
659 Section 26. Paragraph (c) of subsection (24) of section
660 893.02, Florida Statutes, is amended to read:
661 893.02 Definitions.—The following words and phrases as used
662 in this chapter shall have the following meanings, unless the
663 context otherwise requires:
664 (24) “Prescription” includes any order for drugs or
665 medicinal supplies which is written or transmitted by any means
666 of communication by a licensed practitioner authorized by the
667 laws of this state to prescribe such drugs or medicinal
668 supplies, is issued in good faith and in the course of
669 professional practice, is intended to be dispensed by a person
670 authorized by the laws of this state to do so, and meets the
671 requirements of s. 893.04.
672 (c) A prescription for a controlled substance may not be
673 issued on the same prescription blank with another prescription
674 for a controlled substance that is named or described in a
675 different schedule or with another prescription for a medicinal
676 drug, as defined in s. 465.003 s. 465.003(8), that is not a
677 controlled substance.
678 Section 27. This act shall take effect July 1, 2022.
679
680 ================= T I T L E A M E N D M E N T ================
681 And the title is amended as follows:
682 Delete everything before the enacting clause
683 and insert:
684 A bill to be entitled
685 An act relating to acute hospital care at home;
686 amending s. 401.23, F.S.; defining the term “acute
687 hospital care at home”; amending s. 401.272, F.S.;
688 authorizing paramedics to perform certain life support
689 services to patients receiving acute hospital care at
690 home under certain circumstances; providing that a
691 physician or medical director who supervises or
692 directs the provision of such services by a paramedic
693 is liable for any act or omission during the provision
694 of such services; authorizing the Department of Health
695 to adopt and enforce rules; amending s. 465.003, F.S.;
696 defining the term “acute hospital care at home”;
697 amending s. 465.019, F.S.; specifying that Class III
698 institutional pharmacies may dispense, distribute,
699 compound, and fill prescriptions for medicinal drugs
700 for inpatient treatment and patients receiving acute
701 hospital care at home; amending ss. 14.33, 125.01045,
702 166.0446, 252.515, 395.1027, 400.143, 401.245, 401.27,
703 409.9201, 458.331, 459.015, 465.014, 465.015,
704 465.0156, 465.016, 465.0197, 465.022, 465.023,
705 465.1901, 465.1902, 499.003, and 893.02, F.S.;
706 conforming cross-references; providing an effective
707 date.