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A bill to be entitled 1
An act relating to acute hospital care at home; 2
amending s. 401.23, F.S.; defining the term "acute 3
hospital care at home"; amending s. 401.272, F.S.; 4
authorizing paramedics to provide certain life support 5
services to patients receiving acute hospital care at 6
home under certain circumstances; providing that a 7
physician or medical director who supervises or 8
directs the provision of such services by a paramedic 9
is liable for any act or omission during the provision 10
of such services; authorizing the Department of Health 11
to adopt rules; amending s. 465.003, F.S.; defining 12
the term "acute hospital care at home"; amending s. 13
465.019, F.S.; providing that Class III institu tional 14
pharmacies may dispense, distribute, compound, and 15
fill prescriptions for medicinal drugs for inpatient 16
treatment and patients receiving acute hospital care 17
at home; amending ss. 14.33, 125.01045, 166.0446, 18
252.515, 395.1027, 400.143, 401.245, 401.2 7, 409.9201, 19
458.331, 459.015, 465.014, 465.015, 465.0156, 465.016, 20
465.0197, 465.022, 465.023, 465.1901, 465.1902, 21
499.003, 893.02, F.S.; conforming cross -references; 22
providing an effective date. 23
24
Be It Enacted by the Legislature of the State of Flori da: 25
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Section 1. Subsections (1) through (22) of section 401.23, 27
Florida Statutes, are renumbered as subsections (2) through 28
(23), respectively, present subsection (19) is amended, and a 29
new subsection (1) is added to that section, to read: 30
401.23 Definitions.—As used in this part, the term: 31
(1) "Acute hospital care at home" means acute and post -32
acute health care services provided in a clinically qualified 33
patient's permanent residence, as defined in s. 196.012, through 34
a program approved by the Cent ers for Medicare and Medicaid 35
Services and the Agency for Health Care Administration. 36
(20)(19) "Physician" means a practitioner who is licensed 37
under the provisions of chapter 458 or chapter 459. For the 38
purpose of providing "medical direction" as defined in 39
subsection (14) for the treatment of patients immediately before 40
prior to or during transportation to a United States Department 41
of Veterans Affairs medical facility, "physician" also means a 42
practitioner employed by the United States Department of 43
Veterans Affairs. 44
Section 2. Paragraph (c) is added to subsection (2) of 45
section 401.272, Florida Statutes, to read: 46
401.272 Emergency medical services community health care. — 47
(2) Notwithstanding any other provision of law to the 48
contrary: 49
(c) Paramedics may provide basic life support services and 50
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advanced life support services to patients receiving acute 51
hospital care at home as specified in the paramedic's 52
supervisory relationship with a physician or standing orders as 53
described in s. 401.265, s. 458.348, or s. 459.025. A physician 54
who supervises or provides medical direction to a paramedic who 55
provides basic life support services or advanced life support 56
services to patients receiving acute hospital care at home 57
pursuant to a formal supervisory re lationship or standing orders 58
is liable for any act or omission of the paramedic acting under 59
the physician's supervision or medical direction when providing 60
such services. The department may adopt and enforce rules 61
necessary to implement this paragraph. 62
Section 3. Section 465.003, Florida Statutes, is amended 63
to read: 64
465.003 Definitions. —As used in this chapter, the term: 65
(1) "Acute hospital care at home" means acute and post -66
acute health care services provided in a clinically qualified 67
patient's permanent residence, as defined in s. 196.012, through 68
a program approved by the Centers for Medicare and Medicaid 69
Services and the Agency for Health Care Administration. 70
(2)(1) "Administration" means the obtaining and giving of 71
a single dose of medicina l drugs by a legally authorized person 72
to a patient for her or his consumption. 73
(3)(17) "Automated pharmacy system" means a mechanical 74
system that delivers prescription drugs received from a Florida 75
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licensed pharmacy and maintains related transaction inf ormation. 76
(4)(2) "Board" means the Board of Pharmacy. 77
(5)(21) "Central distribution facility" means a facility 78
under common control with a hospital holding a Class III 79
institutional pharmacy permit that may dispense, distribute, 80
compound, or fill presc riptions for medicinal drugs; prepare 81
prepackaged drug products; and conduct other pharmaceutical 82
services. 83
(6)(16) "Centralized prescription filling" means the 84
filling of a prescription by one pharmacy upon request by 85
another pharmacy to fill or refill the prescription. The term 86
includes the performance by one pharmacy for another pharmacy of 87
other pharmacy duties such as drug utilization review, 88
therapeutic drug utilization review, claims adjudication, and 89
the obtaining of refill authorizations. 90
(7)(22) "Common control" means the power to direct or 91
cause the direction of the management and policies of a person 92
or an organization, whether by ownership of stock, voting 93
rights, contract, or otherwise. 94
(8)(20) "Compounded sterile product" means a drug th at is 95
intended for parenteral administration, an ophthalmic or oral 96
inhalation drug in aqueous format, or a drug or product that is 97
required to be sterile under federal or state law or rule, which 98
is produced through compounding, but is not approved by the 99
United States Food and Drug Administration. 100
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(9)(18) "Compounding" means combining, mixing, or altering 101
the ingredients of one or more drugs or products to create 102
another drug or product. 103
(10)(3) "Consultant pharmacist" means a pharmacist 104
licensed by the department and certified as a consultant 105
pharmacist pursuant to s. 465.0125. 106
(11)(4) "Data communication device" means an electronic 107
device that receives electronic information from one source and 108
transmits or routes it to another, including, but not limited 109
to, any such bridge, router, switch, or gateway. 110
(12)(5) "Department" means the Department of Health. 111
(13)(6) "Dispense" means the transfer of possession of one 112
or more doses of a medici nal drug by a pharmacist to the 113
ultimate consumer or her or his agent. As an element of 114
dispensing, the pharmacist shall, prior to the actual physical 115
transfer, interpret and assess the prescription order for 116
potential adverse reactions, interactions, and dosage regimen 117
she or he deems appropriate in the exercise of her or his 118
professional judgment, and the pharmacist shall certify that the 119
medicinal drug called for by the prescription is ready for 120
transfer. The pharmacist shall also provide counseling on p roper 121
drug usage, either orally or in writing, if in the exercise of 122
her or his professional judgment counseling is necessary. The 123
actual sales transaction and delivery of such drug shall not be 124
considered dispensing. The administration shall not be 125
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considered dispensing. 126
(14)(7) "Institutional formulary system" means a method 127
whereby the medical staff evaluates, appraises, and selects 128
those medicinal drugs or proprietary preparations which in the 129
medical staff's clinical judgment are most useful in patie nt 130
care, and which are available for dispensing by a practicing 131
pharmacist in a Class II or Class III institutional pharmacy. 132
(15)(8) "Medicinal drugs" or "drugs" means those 133
substances or preparations commonly known as "prescription" or 134
"legend" drugs which are required by federal or state law to be 135
dispensed only on a prescription, but shall not include patents 136
or proprietary preparations as hereafter defined. 137
(16)(15) "Nuclear pharmacist" means a pharmacist licensed 138
by the department and certified as a nuclear pharmacist pursuant 139
to s. 465.0126. 140
(17)(19) "Outsourcing facility" means a single physical 141
location registered as an outsourcing facility under the federal 142
Drug Quality and Security Act, Pub. L. No. 113 -54, at which 143
sterile compounding of a d rug or product is conducted. 144
(18)(9) "Patent or proprietary preparation" means a 145
medicine in its unbroken, original package which is sold to the 146
public by, or under the authority of, the manufacturer or 147
primary distributor thereof and which is not misbra nded under 148
the provisions of the Florida Drug and Cosmetic Act. 149
(19)(10) "Pharmacist" means any person licensed pursuant 150
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to this chapter to practice the profession of pharmacy. 151
(20)(11)(a) "Pharmacy" includes a community pharmacy, an 152
institutional pharmacy, a nuclear pharmacy, a special pharmacy, 153
and an Internet pharmacy. 154
1. The term "community pharmacy" includes every location 155
where medicinal drugs are compounded, dispensed, stored, or sold 156
or where prescriptions are filled or dispensed on an out patient 157
basis. 158
2. The term "institutional pharmacy" includes every 159
location in a hospital, clinic, nursing home, dispensary, 160
sanitarium, extended care facility, or other facility, 161
hereinafter referred to as "health care institutions," where 162
medicinal drugs are compounded, dispensed, stored, or sold. 163
3. The term "nuclear pharmacy" includes every location 164
where radioactive drugs and chemicals within the classification 165
of medicinal drugs are compounded, dispensed, stored, or sold. 166
The term "nuclear pharmac y" does not include hospitals licensed 167
under chapter 395 or the nuclear medicine facilities of such 168
hospitals. 169
4. The term "special pharmacy" includes every location 170
where medicinal drugs are compounded, dispensed, stored, or sold 171
if such locations are n ot otherwise defined in this subsection. 172
5. The term "Internet pharmacy" includes locations not 173
otherwise licensed or issued a permit under this chapter, within 174
or outside this state, which use the Internet to communicate 175
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with or obtain information from consumers in this state and use 176
such communication or information to fill or refill 177
prescriptions or to dispense, distribute, or otherwise engage in 178
the practice of pharmacy in this state. Any act described in 179
this definition constitutes the practice of the profession of 180
pharmacy as defined in subsection (13) . 181
(21)(12) "Pharmacy intern" means a person who is currently 182
registered in, and attending, a duly accredited college or 183
school of pharmacy, or who is a graduate of such a school or 184
college of pharmacy, and who is duly and properly registered 185
with the department as provided for under its rules. 186
(22)(13) "Practice of the profession of pharmacy" includes 187
compounding, dispensing, and consulting concerning contents, 188
therapeutic values, and uses of any med icinal drug; consulting 189
concerning therapeutic values and interactions of patent or 190
proprietary preparations, whether pursuant to prescriptions or 191
in the absence and entirely independent of such prescriptions or 192
orders; and conducting other pharmaceutical services. For 193
purposes of this subsection, the term "other pharmaceutical 194
services" means monitoring the patient's drug therapy and 195
assisting the patient in the management of his or her drug 196
therapy, and includes reviewing, and making recommendations 197
regarding, the patient's drug therapy and health care status in 198
communication with the patient's prescribing health care 199
provider as licensed under chapter 458, chapter 459, chapter 200
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461, or chapter 466, or a similar statutory provision in another 201
jurisdiction, or such provider's agent or such other persons as 202
specifically authorized by the patient; and initiating, 203
modifying, or discontinuing drug therapy for a chronic health 204
condition under a collaborative pharmacy practice agreement. 205
This subsection may not be interpreted to permit an alteration 206
of a prescriber's directions, the diagnosis or treatment of any 207
disease, the initiation of any drug therapy, the practice of 208
medicine, or the practice of osteopathic medicine, unless 209
otherwise permitted by law or specifi cally authorized by s. 210
465.1865 or s. 465.1895. The term "practice of the profession of 211
pharmacy" also includes any other act, service, operation, 212
research, or transaction incidental to, or forming a part of, 213
any of the foregoing acts, requiring, involving , or employing 214
the science or art of any branch of the pharmaceutical 215
profession, study, or training, and shall expressly permit a 216
pharmacist to transmit information from persons authorized to 217
prescribe medicinal drugs to their patients. The practice of th e 218
profession of pharmacy also includes the administration of 219
vaccines to adults pursuant to s. 465.189, the testing or 220
screening for and treatment of minor, nonchronic health 221
conditions pursuant to s. 465.1895, and the preparation of 222
prepackaged drug produ cts in facilities holding Class III 223
institutional pharmacy permits. The term also includes the 224
ordering and evaluating of any laboratory or clinical testing; 225
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conducting patient assessments; and modifying, discontinuing, or 226
administering medicinal drugs pur suant to s. 465.0125 by a 227
consultant pharmacist. 228
(23)(14) "Prescription" includes any order for drugs or 229
medicinal supplies written or transmitted by any means of 230
communication by a duly licensed practitioner authorized by the 231
laws of the state to prescr ibe such drugs or medicinal supplies 232
and intended to be dispensed by a pharmacist. The term also 233
includes an orally transmitted order by the lawfully designated 234
agent of such practitioner. The term also includes an order 235
written or transmitted by a practit ioner licensed to practice in 236
a jurisdiction other than this state, but only if the pharmacist 237
called upon to dispense such order determines, in the exercise 238
of her or his professional judgment, that the order is valid and 239
necessary for the treatment of a chronic or recurrent illness. 240
The term "prescription" also includes a pharmacist's order for a 241
product selected from the formulary created pursuant to s. 242
465.186. Prescriptions may be retained in written form or the 243
pharmacist may cause them to be recorded in a data processing 244
system, provided that such order can be produced in printed form 245
upon lawful request. 246
Section 4. Paragraph (d) of subsection (2) and paragraph 247
(a) of subsection (4) of section 465.019, Florida Statutes, are 248
amended to read: 249
465.019 Institutional pharmacies; permits. — 250
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(2) The following classes of institutional pharmacies are 251
established: 252
(d)1. "Class III institutional pharmacies" are those 253
institutional pharmacies, including central distribution 254
facilities, affiliated wit h a hospital which that provide the 255
same services that are authorized by a Class II institutional 256
pharmacy permit. Class III institutional pharmacies may also: 257
a. Dispense, distribute, compound, and fill prescriptions 258
for medicinal drugs for inpatient treatment or for patients 259
receiving acute hospital care at home . 260
b. Prepare prepackaged drug products. 261
c. Conduct other pharmaceutical services for the 262
affiliated hospital and for entities under common control that 263
are each permitted under this chapter t o possess medicinal 264
drugs. 265
d. Provide the services in sub -subparagraphs a.-c. to an 266
entity under common control which holds an active health care 267
clinic establishment permit as required under s. 499.01(2)(r). 268
2. A Class III institutional pharmacy shall maintain 269
policies and procedures addressing: 270
a. The consultant pharmacist responsible for 271
pharmaceutical services. 272
b. Safe practices for the preparation, dispensing, 273
prepackaging, distribution, and transportation of medicinal 274
drugs and prepackaged dru g products. 275
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c. Recordkeeping to monitor the movement, distribution, 276
and transportation of medicinal drugs and prepackaged drug 277
products. 278
d. Recordkeeping of pharmacy staff responsible for each 279
step in the preparation, dispensing, prepackaging, 280
transportation, and distribution of medicinal drugs and 281
prepackaged drug products. 282
e. Medicinal drugs and prepackaged drug products that may 283
not be safely distributed among Class III institutional 284
pharmacies. 285
(4)(a) Medicinal drugs shall be dispensed by in an 286
institutional pharmacy to outpatients only when that institution 287
has secured a community pharmacy permit from the department. 288
However, medicinal drugs may be dispensed by a hospital that 289
operates a Class II or Class III institutional pharmacy to a 290
patient of the hospital's emergency department or a hospital 291
inpatient upon discharge if a prescriber, as defined in s. 292
465.025(1), treating the patient in such hospital determines 293
that the medicinal drug is warranted and that community pharmacy 294
services are not readily accessible, geographically or 295
otherwise, to the patient. Such prescribing and dispensing must 296
be for a supply of the drug that will last for the greater of 297
the following: 298
1. Up to 48 hours; or 299
2. Through the end of the next business day. 300
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Section 5. Subsection (1) of section 14.33, Florida 301
Statutes, is amended to read: 302
14.33 Medal of Heroism. — 303
(1) The Governor may award a Medal of Heroism of 304
appropriate design, with ribbons and appurtenances, to a law 305
enforcement, correctional, or correcti onal probation officer , as 306
defined in s. 943.10(14); a firefighter, as defined in s. 307
112.191(1)(b); an emergency medical technician, as defined in s. 308
401.23 s. 401.23(11); or a paramedic, as defined in s. 401.23 s. 309
401.23(17). A recipient must have distinguished himself or 310
herself conspicuously by gallantry and intrepidity, must have 311
risked his or her life deliberately above and beyond the call of 312
duty while performing duty in his or her respective position, 313
and must have engaged in hazardous or peri lous activities to 314
preserve lives with the knowledge that such activities might 315
result in great personal harm. 316
Section 6. Subsection (1) of section 125.01045, Florida 317
Statutes, is amended to read: 318
125.01045 Prohibition of fees for first responder 319
services.— 320
(1) A county may not impose a fee or seek reimbursement 321
for any costs or expenses that may be incurred for services 322
provided by a first responder, including costs or expenses 323
related to personnel, supplies, motor vehicles, or equipment in 324
response to a motor vehicle accident, except for costs to 325
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contain or clean up hazardous materials in quantities reportable 326
to the Florida State Warning Point at the Division of Emergency 327
Management, and costs for transportation and treatment provided 328
by ambulance services licensed pursuant to s. 401.23 s. 329
401.23(4) and (5). 330
Section 7. Subsection (1) of section 166.0446, Florida 331
Statutes, is amended to read: 332
166.0446 Prohibition of fees for first responder 333
services.— 334
(1) A municipality may not impose a fee or seek 335
reimbursement for any costs or expenses that may be incurred for 336
services provided by a first responder, including costs or 337
expenses related to personnel, supplies, motor vehicles, or 338
equipment in response to a motor vehicle accident, except for 339
costs to contain or clean up hazardous materials in quantities 340
reportable to the Florida State Warning Point at the Division of 341
Emergency Management, and costs for transportation and treatment 342
provided by ambulance services licensed pursuant to s. 401.23 s. 343
401.23(4) and (5). 344
Section 8. Paragraph (a) of subsection (3) of section 345
252.515, Florida Statutes, is amended to read: 346
252.515 Postdisaster Relief Assistance Act; immunity from 347
civil liability.— 348
(3) As used in this section, the term: 349
(a) "Emergency first responder" means: 350
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1. A physician licensed under chapter 458. 351
2. An osteopathic physician licensed under chapter 459. 352
3. A chiropractic physician licensed under chapter 460. 353
4. A podiatric physician licensed under chapter 461. 354
5. A dentist licensed under chapter 466. 355
6. An advanced practice registered nurse licensed under s. 356
464.012. 357
7. A physician assistant licensed under s. 458.347 or s. 358
459.022. 359
8. A worker employed by a public or private hospital in 360
the state. 361
9. A paramedic as defined in s. 401.23 s. 401.23(17). 362
10. An emergency medical technician as defined in s. 363
401.23 s. 401.23(11). 364
11. A firefighter as defined in s. 633.102. 365
12. A law enforcement officer as defined in s. 943.10. 366
13. A member of the Florida N ational Guard. 367
14. Any other personnel designated as emergency personnel 368
by the Governor pursuant to a declared emergency. 369
Section 9. Subsection (5) of section 395.1027, Florida 370
Statutes, is amended to read: 371
395.1027 Regional poison control centers .— 372
(5) By October 1, 1999, each regional poison control 373
center shall develop a prehospital emergency dispatch protocol 374
with each licensee as defined in s. 401.23 by s. 401.23(13) in 375
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the geographic area covered by the regional poison control 376
center. The prehospital emergency dispatch protocol shall be 377
developed by each licensee's medical director in conjunction 378
with the designated regional poison control center responsible 379
for the geographic area in which the licensee operates. The 380
protocol shall define to xic substances and describe the 381
procedure by which the designated regional poison control center 382
may be consulted by the licensee. If a call is transferred to 383
the designated regional poison control center in accordance with 384
the protocol established under t his section and s. 401.268, the 385
designated regional poison control center shall assume 386
responsibility and liability for the call. 387
Section 10. Paragraph (b) of subsection (1) of section 388
400.143, Florida Statutes, is amended to read: 389
400.143 Institutional formularies established by nursing 390
home facilities.— 391
(1) For purposes of this section, the term: 392
(b) "Medicinal drug" has the same meaning as provided in 393
s. 465.003 s. 465.003(8). 394
Section 11. Paragraph (b) of subsection (2) of section 395
401.245, Florida Statutes, is amended to read: 396
401.245 Emergency Medical Services Advisory Council. — 397
(2) 398
(b) Representation on the Emergency Medical Services 399
Advisory Council shall include : two licensed physicians who are 400
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medical directors "medical directors" as defined in s. 401.23 s. 401
401.23(15) or whose medical practice is closely related to 402
emergency medical services; two emergency medical service 403
administrators, one of whom is employed by a fire service; two 404
certified paramedics, one of whom is em ployed by a fire service; 405
two certified emergency medical technicians, one of whom is 406
employed by a fire service; one emergency medical services 407
educator; one emergency nurse; one hospital administrator; one 408
representative of air ambulance services; one re presentative of 409
a commercial ambulance operator; and two laypersons who are in 410
no way connected with emergency medical services, one of whom is 411
a representative of the elderly. Ex officio members of the 412
advisory council from state agencies shall include, b ut are 413
shall not be limited to, representatives from the Department of 414
Education, the Department of Management Services, the State Fire 415
Marshal, the Department of Highway Safety and Motor Vehicles, 416
the Department of Transportation, and the Division of Emer gency 417
Management. 418
Section 12. Subsection (2) of section 401.27, Florida 419
Statutes, is amended to read: 420
401.27 Personnel; standards and certification. — 421
(2) The department shall establish by rule educational and 422
training criteria and examinations for the certification and 423
recertification of emergency medical technicians and paramedics. 424
Such rules must require, but need not be limited to: 425
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(a) For emergency medical technicians, proficiency in 426
techniques identified in s. 401.23 s. 401.23(7) and in rules of 427
the department. 428
(b) For paramedics, proficiency in techniques identified 429
in s. 401.23 s. 401.23(1) and in rules of the department. 430
Section 13. Paragraph (a) of subsection (1) of section 431
409.9201, Florida Statutes, is amended to read: 432
409.9201 Medicaid fraud.— 433
(1) As used in this section, the term: 434
(a) "Prescription drug" means any drug, including, but not 435
limited to, finished dosage forms or active ingredients that are 436
subject to, defined in, or described in s. 503(b) of the Federal 437
Food, Drug, and Cosmetic Act or in s. 465.003 s. 465.003(8), s. 438
499.003(17), s. 499.007(13), or s. 499.82(10). 439
440
The value of individual items of the legend drugs or goods or 441
services involved in distinct transactions committed during a 442
single scheme or course of c onduct, whether involving a single 443
person or several persons, may be aggregated when determining 444
the punishment for the offense. 445
Section 14. Paragraph (pp) of subsection (1) of section 446
458.331, Florida Statutes, is amended to read: 447
458.331 Grounds for disciplinary action; action by the 448
board and department. — 449
(1) The following acts constitute grounds for denial of a 450
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license or disciplinary action, as specified in s. 456.072(2): 451
(pp) Applicable to a licensee who serves as the designated 452
physician of a pain-management clinic as defined in s. 458.3265 453
or s. 459.0137: 454
1. Registering a pain -management clinic through 455
misrepresentation or fraud; 456
2. Procuring, or attempting to procure, the registration 457
of a pain-management clinic for any other person by making or 458
causing to be made, any false representation; 459
3. Failing to comply with any requirement of chapter 499, 460
the Florida Drug and Cosmetic Act; 21 U.S.C. ss. 301 -392, the 461
Federal Food, Drug, and Cosmetic Act; 21 U.S.C. ss. 821 et seq., 462
the Drug Abuse Prevention and Control Act; or chapter 893, the 463
Florida Comprehensive Drug Abuse Prevention and Control Act; 464
4. Being convicted or found guilty of, regardless of 465
adjudication to, a felony or any other crime involving moral 466
turpitude, fraud, dishonesty , or deceit in any jurisdiction of 467
the courts of this state, of any other state, or of the United 468
States; 469
5. Being convicted of, or disciplined by a regulatory 470
agency of the Federal Government or a regulatory agency of 471
another state for, any offense that would constitute a violation 472
of this chapter; 473
6. Being convicted of, or entering a plea of guilty or 474
nolo contendere to, regardless of adjudication, a crime in any 475
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jurisdiction of the courts of this state, of any other state, or 476
of the United States whi ch relates to the practice of, or the 477
ability to practice, a licensed health care profession; 478
7. Being convicted of, or entering a plea of guilty or 479
nolo contendere to, regardless of adjudication, a crime in any 480
jurisdiction of the courts of this state, of any other state, or 481
of the United States which relates to health care fraud; 482
8. Dispensing any medicinal drug based upon a 483
communication that purports to be a prescription as defined in 484
s. 465.003 s. 465.003(14) or s. 893.02 if the dispensing 485
practitioner knows or has reason to believe that the purported 486
prescription is not based upon a valid practitioner -patient 487
relationship; or 488
9. Failing to timely notify the board of the date of his 489
or her termination from a pain -management clinic as required by 490
s. 458.3265(3). 491
Section 15. Paragraph (rr) of subsection (1) of section 492
459.015, Florida Statutes, is amended to read: 493
459.015 Grounds for disciplinary action; action by the 494
board and department. — 495
(1) The following acts constitute grounds for denial of a 496
license or disciplinary action, as specified in s. 456.072(2): 497
(rr) Applicable to a licensee who serves as the designated 498
physician of a pain-management clinic as defined in s. 458.3265 499
or s. 459.0137: 500
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1. Registering a pain -management clinic thro ugh 501
misrepresentation or fraud; 502
2. Procuring, or attempting to procure, the registration 503
of a pain-management clinic for any other person by making or 504
causing to be made, any false representation; 505
3. Failing to comply with any requirement of chapter 499, 506
the Florida Drug and Cosmetic Act; 21 U.S.C. ss. 301 -392, the 507
Federal Food, Drug, and Cosmetic Act; 21 U.S.C. ss. 821 et seq., 508
the Drug Abuse Prevention and Control Act; or chapter 893, the 509
Florida Comprehensive Drug Abuse Prevention and Control Act; 510
4. Being convicted or found guilty of, regardless of 511
adjudication to, a felony or any other crime involving moral 512
turpitude, fraud, dishonesty, or deceit in any jurisdiction of 513
the courts of this state, of any other state, or of the United 514
States; 515
5. Being convicted of, or disciplined by a regulatory 516
agency of the Federal Government or a regulatory agency of 517
another state for, any offense that would constitute a violation 518
of this chapter; 519
6. Being convicted of, or entering a plea of guilty or 520
nolo contendere to, regardless of adjudication, a crime in any 521
jurisdiction of the courts of this state, of any other state, or 522
of the United States which relates to the practice of, or the 523
ability to practice, a licensed health care profession; 524
7. Being convicted of, or entering a plea of guilty or 525
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nolo contendere to, regardless of adjudication, a crime in any 526
jurisdiction of the courts of this state, of any other state, or 527
of the United States which relates to health care fraud; 528
8. Dispensing any medicinal dr ug based upon a 529
communication that purports to be a prescription as defined in 530
s. 465.003 s. 465.003(14) or s. 893.02 if the dispensing 531
practitioner knows or has reason to believe that the purported 532
prescription is not based upon a valid practitioner -patient 533
relationship; or 534
9. Failing to timely notify the board of the date of his 535
or her termination from a pain -management clinic as required by 536
s. 459.0137(3). 537
Section 16. Subsection (1) of section 465.014, Florida 538
Statutes, is amended to read: 539
465.014 Pharmacy technician. — 540
(1) A person other than a licensed pharmacist or pharmacy 541
intern may not engage in the practice of the profession of 542
pharmacy, except that a licensed pharmacist may delegate to 543
pharmacy technicians who are registered pursuant to t his section 544
those duties, tasks, and functions that do not fall within the 545
purview of s. 465.003 s. 465.003(13). All such delegated acts 546
must be performed under the direct supervision of a licensed 547
pharmacist who is responsible for all such acts performed by 548
persons under his or her supervision. A registered pharmacy 549
technician, under the supervision of a pharmacist, may initiate 550
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or receive communications with a practitioner or his or her 551
agent, on behalf of a patient, regarding refill authorization 552
requests. A licensed pharmacist may not supervise more than one 553
registered pharmacy technician unless otherwise permitted by the 554
guidelines adopted by the board. The board shall establish 555
guidelines to be followed by licensees or permittees in 556
determining the circumstances under which a licensed pharmacist 557
may supervise more than one pharmacy technician. 558
Section 17. Paragraph (c) of subsection (2) of section 559
465.015, Florida Statutes, is amended to read: 560
465.015 Violations and penalties. — 561
(2) It is unlawful for any person: 562
(c) To sell or dispense drugs as defined in s. 465.003 s. 563
465.003(8) without first being furnished with a prescription. 564
Section 18. Subsection (9) of section 465.0156, Florida 565
Statutes, is amended to read: 566
465.0156 Registration of nonresident pharmacies. — 567
(9) Notwithstanding s. 465.003 s. 465.003(10), for 568
purposes of this section, the registered pharmacy and the 569
pharmacist designated by the registered pharmacy as the 570
prescription department manager or the equivalent must be 571
licensed in the state of location in order to dispense into this 572
state. 573
Section 19. Paragraph (s) of subsection (1) of section 574
465.016, Florida Statutes, is amended to read: 575
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465.016 Disciplinary actions. — 576
(1) The following acts constitute grounds for de nial of a 577
license or disciplinary action, as specified in s. 456.072(2): 578
(s) Dispensing any medicinal drug based upon a 579
communication that purports to be a prescription as defined in 580
s. 465.003 by s. 465.003(14) or s. 893.02 when the pharmacist 581
knows or has reason to believe that the purported prescription 582
is not based upon a valid practitioner -patient relationship. 583
Section 20. Subsection (4) of section 465.0197, Florida 584
Statutes, is amended to read: 585
465.0197 Internet pharmacy permits. — 586
(4) Notwithstanding s. 465.003 s. 465.003(10), for 587
purposes of this section, the Internet pharmacy and the 588
pharmacist designated by the Internet pharmacy as the 589
prescription department manager or the equivalent must be 590
licensed in the state of location in order to dispense into this 591
state. 592
Section 21. Paragraph (j) of subsection (5) of section 593
465.022, Florida Statutes, is amended to read: 594
465.022 Pharmacies; general requirements; fees. — 595
(5) The department or board s hall deny an application for 596
a pharmacy permit if the applicant or an affiliated person, 597
partner, officer, director, or prescription department manager 598
or consultant pharmacist of record of the applicant: 599
(j) Has dispensed any medicinal drug based upon a 600
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communication that purports to be a prescription as defined in 601
s. 465.003 by s. 465.003(14) or s. 893.02 when the pharmacist 602
knows or has reason to b elieve that the purported prescription 603
is not based upon a valid practitioner -patient relationship that 604
includes a documented patient evaluation, including history and 605
a physical examination adequate to establish the diagnosis for 606
which any drug is prescri bed and any other requirement 607
established by board rule under chapter 458, chapter 459, 608
chapter 461, chapter 463, chapter 464, or chapter 466. 609
610
For felonies in which the defendant entered a plea of guilty or 611
nolo contendere in an agreement with the court to enter a 612
pretrial intervention or drug diversion program, the department 613
shall deny the application if upon final resolution of the case 614
the licensee has failed to successfully complete the program. 615
Section 22. Paragraph (h) of subsection (1) of sect ion 616
465.023, Florida Statutes, is amended to read: 617
465.023 Pharmacy permittee; disciplinary action. — 618
(1) The department or the board may revoke or suspend the 619
permit of any pharmacy permittee, and may fine, place on 620
probation, or otherwise discipline a ny pharmacy permittee if the 621
permittee, or any affiliated person, partner, officer, director, 622
or agent of the permittee, including a person fingerprinted 623
under s. 465.022(3), has: 624
(h) Dispensed any medicinal drug based upon a 625
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communication that purports to be a prescription as defined in 626
s. 465.003 by s. 465.003(14) or s. 893.02 when the pharmacist 627
knows or has reason to believe that the purported prescription 628
is not based upon a valid practitioner -patient relationship that 629
includes a documented patient e valuation, including history and 630
a physical examination adequate to establish the diagnosis for 631
which any drug is prescribed and any other requirement 632
established by board rule under chapter 458, chapter 459, 633
chapter 461, chapter 463, chapter 464, or chapt er 466. 634
Section 23. Section 465.1901, Florida Statutes, is amended 635
to read: 636
465.1901 Practice of orthotics and pedorthics. —The 637
provisions of chapter 468 relating to orthotics or pedorthics do 638
not apply to any licensed pharmacist or to any person acti ng 639
under the supervision of a licensed pharmacist. The practice of 640
orthotics or pedorthics by a pharmacist or any of the 641
pharmacist's employees acting under the supervision of a 642
pharmacist shall be construed to be within the meaning of the 643
term "practice of the profession of pharmacy" as defined set 644
forth in s. 465.003 s. 465.003(13), and shall be subject to 645
regulation in the same manner as any other pharmacy practice. 646
The Board of Pharmacy shall develop rules regarding the practice 647
of orthotics and pedorth ics by a pharmacist. Any pharmacist or 648
person under the supervision of a pharmacist engaged in the 649
practice of orthotics or pedorthics is not precluded from 650
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continuing that practice pending adoption of these rules. 651
Section 24. Paragraph (j) of subsecti on (2) of section 652
465.1902, Florida Statutes, is amended to read: 653
465.1902 Prescription Drug Donation Repository Program. — 654
(2) DEFINITIONS.—As used in this section, the term: 655
(j) "Prescription drug" has the same meaning as the term 656
"medicinal drugs" or "drugs," as those terms are defined in s. 657
465.003 s. 465.003(8), but does not include controlled 658
substances, cancer drugs donated under s. 499.029, or drugs with 659
an approved United States Food and Drug Administration risk 660
evaluation and mitigation strat egy that includes elements to 661
assure safe use. 662
Section 25. Subsection (40) of section 499.003, Florida 663
Statutes, is amended to read: 664
499.003 Definitions of terms used in this part. —As used in 665
this part, the term: 666
(40) "Prescription drug" means a pr escription, medicinal, 667
or legend drug, including, but not limited to, finished dosage 668
forms or active pharmaceutical ingredients subject to, defined 669
by, or described by s. 503(b) of the federal act or s. 465.003 670
s. 465.003(8), s. 499.007(13), subsection (3 1), or subsection 671
(47), except that an active pharmaceutical ingredient is a 672
prescription drug only if substantially all finished dosage 673
forms in which it may be lawfully dispensed or administered in 674
this state are also prescription drugs. 675
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Section 26. Paragraph (c) of subsection (24) of section 676
893.02, Florida Statutes, is amended to read: 677
893.02 Definitions. —The following words and phrases as 678
used in this chapter shall have the following meanings, unless 679
the context otherwise requires: 680
(24) "Prescription" includes any order for drugs or 681
medicinal supplies which is written or transmitted by any means 682
of communication by a licensed practitioner authorized by the 683
laws of this state to prescribe such drugs or medicinal 684
supplies, is issued in good faith and in the course of 685
professional practice, is intended to be dispensed by a person 686
authorized by the laws of this state to do so, and meets the 687
requirements of s. 893.04. 688
(c) A prescription for a controlled substance may not be 689
issued on the same prescr iption blank with another prescription 690
for a controlled substance that is named or described in a 691
different schedule or with another prescription for a medicinal 692
drug, as defined in s. 465.003 s. 465.003(8), that is not a 693
controlled substance. 694
Section 27. This act shall take effect July 1, 2022. 695