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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 medicinal 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 r eceived from a Florida 75
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licensed pharmacy and maintains related transaction information. 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 prescriptions 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 re view, 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 that 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 informat ion 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 medicinal 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 pro vide counseling on proper 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 patient 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 drug 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 misbranded 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, a n 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 dis pensed on an outpatient 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 pharmacy" 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 not 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
(b) The pharmacy department of any permittee shall be 182
considered closed whenever a Florida licensed pharmacist is not 183
present and on duty. The term "not present and on duty" shall 184
not be construed to prevent a pharmacist from exiting the 185
prescription department for the purposes of consulting or 186
responding to inquiries or providing assistance to patients or 187
customers, attending to personal hygiene needs, or performing 188
any other function for which the pharmacist is responsible, 189
provided that such activities are conducted in a manner 190
consistent with the pharmacist's responsibility to provide 191
pharmacy services. 192
(21)(12) "Pharmacy intern" means a person who is currently 193
registered in, and attending, a duly accredited college or 194
school of pharmacy, or who is a graduate of such a school or 195
college of pharmacy, and who is duly and properly registered 196
with the department as provided for under its rules. 197
(22)(13) "Practice of the professio n of pharmacy" includes 198
compounding, dispensing, and consulting concerning contents, 199
therapeutic values, and uses of any medicinal drug; consulting 200
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concerning therapeutic values and interactions of patent or 201
proprietary preparations, whether pursuant to pr escriptions or 202
in the absence and entirely independent of such prescriptions or 203
orders; and conducting other pharmaceutical services. For 204
purposes of this subsection, the term "other pharmaceutical 205
services" means monitoring the patient's drug therapy and 206
assisting the patient in the management of his or her drug 207
therapy, and includes reviewing, and making recommendations 208
regarding, the patient's drug therapy and health care status in 209
communication with the patient's prescribing health care 210
provider as licensed under chapter 458, chapter 459, chapter 211
461, or chapter 466, or a similar statutory provision in another 212
jurisdiction, or such provider's agent or such other persons as 213
specifically authorized by the patient; and initiating, 214
modifying, or discontinuin g drug therapy for a chronic health 215
condition under a collaborative pharmacy practice agreement. 216
This subsection may not be interpreted to permit an alteration 217
of a prescriber's directions, the diagnosis or treatment of any 218
disease, the initiation of any d rug therapy, the practice of 219
medicine, or the practice of osteopathic medicine, unless 220
otherwise permitted by law or specifically authorized by s. 221
465.1865 or s. 465.1895. The term "practice of the profession of 222
pharmacy" also includes any other act, servi ce, operation, 223
research, or transaction incidental to, or forming a part of, 224
any of the foregoing acts, requiring, involving, or employing 225
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the science or art of any branch of the pharmaceutical 226
profession, study, or training, and shall expressly permit a 227
pharmacist to transmit information from persons authorized to 228
prescribe medicinal drugs to their patients. The practice of the 229
profession of pharmacy also includes the administration of 230
vaccines to adults pursuant to s. 465.189, the testing or 231
screening for and treatment of minor, nonchronic health 232
conditions pursuant to s. 465.1895, and the preparation of 233
prepackaged drug products in facilities holding Class III 234
institutional pharmacy permits. The term also includes the 235
ordering and evaluating of any labora tory or clinical testing; 236
conducting patient assessments; and modifying, discontinuing, or 237
administering medicinal drugs pursuant to s. 465.0125 by a 238
consultant pharmacist. 239
(23)(14) "Prescription" includes any order for drugs or 240
medicinal supplies writte n or transmitted by any means of 241
communication by a duly licensed practitioner authorized by the 242
laws of the state to prescribe such drugs or medicinal supplies 243
and intended to be dispensed by a pharmacist. The term also 244
includes an orally transmitted orde r by the lawfully designated 245
agent of such practitioner. The term also includes an order 246
written or transmitted by a practitioner licensed to practice in 247
a jurisdiction other than this state, but only if the pharmacist 248
called upon to dispense such order de termines, in the exercise 249
of her or his professional judgment, that the order is valid and 250
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necessary for the treatment of a chronic or recurrent illness. 251
The term "prescription" also includes a pharmacist's order for a 252
product selected from the formulary c reated pursuant to s. 253
465.186. Prescriptions may be retained in written form or the 254
pharmacist may cause them to be recorded in a data processing 255
system, provided that such order can be produced in printed form 256
upon lawful request. 257
Section 4. Paragraph (d) of subsection (2) and paragraph 258
(a) of subsection (4) of section 465.019, Florida Statutes, are 259
amended to read: 260
465.019 Institutional pharmacies; permits. — 261
(2) The following classes of institutional pharmacies are 262
established: 263
(d)1. "Class III institutional pharmacies" are those 264
institutional pharmacies, including central distribution 265
facilities, affiliated with a hospital which that provide the 266
same services that are authorized by a Class II institutional 267
pharmacy permit. Class III institutiona l pharmacies may also: 268
a. Dispense, distribute, compound, and fill prescriptions 269
for medicinal drugs for inpatient treatment or for patients 270
receiving acute hospital care at home . 271
b. Prepare prepackaged drug products. 272
c. Conduct other pharmaceutical services for the 273
affiliated hospital and for entities under common control that 274
are each permitted under this chapter to possess medicinal 275
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drugs. 276
d. Provide the services in sub -subparagraphs a.-c. to an 277
entity under common control which holds an active h ealth care 278
clinic establishment permit as required under s. 499.01(2)(r). 279
2. A Class III institutional pharmacy shall maintain 280
policies and procedures addressing: 281
a. The consultant pharmacist responsible for 282
pharmaceutical services. 283
b. Safe practices for the preparation, dispensing, 284
prepackaging, distribution, and transportation of medicinal 285
drugs and prepackaged drug products. 286
c. Recordkeeping to monitor the movement, distribution, 287
and transportation of medicinal drugs and prepackaged drug 288
products. 289
d. Recordkeeping of pharmacy staff responsible for each 290
step in the preparation, dispensing, prepackaging, 291
transportation, and distribution of medicinal drugs and 292
prepackaged drug products. 293
e. Medicinal drugs and prepackaged drug products that may 294
not be safely distributed among Class III institutional 295
pharmacies. 296
(4)(a) Medicinal drugs shall be dispensed by in an 297
institutional pharmacy to outpatients only when that institution 298
has secured a community pharmacy permit from the department. 299
However, medicinal drugs may be dispensed by a hospital that 300
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operates a Class II or Class III institutional pharmacy to a 301
patient of the hospital's emergency department or a hospital 302
inpatient upon discharge if a prescriber, as defined in s. 303
465.025(1), treating the patient in such hospital determines 304
that the medicinal drug is warranted and that community pharmacy 305
services are not readily accessible, geographically or 306
otherwise, to the patient. Such prescribing and dispensing must 307
be for a supply of the drug that wil l last for the greater of 308
the following: 309
1. Up to 48 hours; or 310
2. Through the end of the next business day. 311
Section 5. Subsection (1) of section 14.33, Florida 312
Statutes, is amended to read: 313
14.33 Medal of Heroism. — 314
(1) The Governor may award a Medal of Heroism of 315
appropriate design, with ribbons and appurtenances, to a law 316
enforcement, correctional, or correctional probation officer , as 317
defined in s. 943.10(14); a firefighter, as defined in s. 318
112.191(1)(b); an emergency medical technician, as d efined in s. 319
401.23 s. 401.23(11); or a paramedic, as defined in s. 401.23 s. 320
401.23(17). A recipient must have distinguished himself or 321
herself conspicuously by gallantry and intrepidity, must have 322
risked his or her life deliberately above and beyond the call of 323
duty while performing duty in his or her respective position, 324
and must have engaged in hazardous or perilous activities to 325
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preserve lives with the knowledge that such activities might 326
result in great personal harm. 327
Section 6. Subsection (1) of section 125.01045, Florida 328
Statutes, is amended to read: 329
125.01045 Prohibition of fees for first responder 330
services.— 331
(1) A county may not impose a fee or seek reimbursement 332
for any costs or expenses that may be incurred for services 333
provided by a first responder, including costs or expenses 334
related to personnel, supplies, motor vehicles, or equipment in 335
response to a motor vehicle accident, except for costs to 336
contain or clean up hazardous materials in quantities reportable 337
to the Florida State Warning Point at the Division of Emergency 338
Management, and costs for transportation and treatme nt provided 339
by ambulance services licensed pursuant to s. 401.23 s. 340
401.23(4) and (5). 341
Section 7. Subsection (1) of section 166.0446, Florida 342
Statutes, is amended to read: 343
166.0446 Prohibition of fees for first responder 344
services.— 345
(1) A municipality may not impose a fee or seek 346
reimbursement for any costs or expenses that may be incurred for 347
services provided by a first responder, including costs or 348
expenses related to personnel, supplies, motor vehicles, or 349
equipment in response to a motor vehicle accident, except for 350
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costs to contain or clean up hazardous materials in quantities 351
reportable to the Florida State Warning Point at the Division of 352
Emergency Management, and costs for transportation and treatment 353
provided by ambulance services licensed p ursuant to s. 401.23 s. 354
401.23(4) and (5). 355
Section 8. Paragraph (a) of subsection (3) of section 356
252.515, Florida Statutes, is amended to read: 357
252.515 Postdisaster Relief Assistance Act; immunity from 358
civil liability.— 359
(3) As used in this section, the term: 360
(a) "Emergency first responder" means: 361
1. A physician licensed under chapter 458. 362
2. An osteopathic physician licensed under chapter 459. 363
3. A chiropractic physician licensed under chapter 460. 364
4. A podiatric physician licensed under c hapter 461. 365
5. A dentist licensed under chapter 466. 366
6. An advanced practice registered nurse licensed under s. 367
464.012. 368
7. A physician assistant licensed under s. 458.347 or s. 369
459.022. 370
8. A worker employed by a public or private hospital in 371
the state. 372
9. A paramedic as defined in s. 401.23 s. 401.23(17). 373
10. An emergency medical technician as defined in s. 374
401.23 s. 401.23(11). 375
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11. A firefighter as defined in s. 633.102. 376
12. A law enforcement officer as defined in s. 943.10. 377
13. A member of the Florida National Guard. 378
14. Any other personnel designated as emergency personnel 379
by the Governor pursuant to a declared emergency. 380
Section 9. Subsection (5) of section 395.1027, Florida 381
Statutes, is amended to read: 382
395.1027 Regional poiso n control centers.— 383
(5) By October 1, 1999, each regional poison control 384
center shall develop a prehospital emergency dispatch protocol 385
with each licensee as defined in s. 401.23 by s. 401.23(13) in 386
the geographic area covered by the regional poison cont rol 387
center. The prehospital emergency dispatch protocol shall be 388
developed by each licensee's medical director in conjunction 389
with the designated regional poison control center responsible 390
for the geographic area in which the licensee operates. The 391
protocol shall define toxic substances and describe the 392
procedure by which the designated regional poison control center 393
may be consulted by the licensee. If a call is transferred to 394
the designated regional poison control center in accordance with 395
the protocol established under this section and s. 401.268, the 396
designated regional poison control center shall assume 397
responsibility and liability for the call. 398
Section 10. Paragraph (b) of subsection (1) of section 399
400.143, Florida Statutes, is amended to read: 400
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400.143 Institutional formularies established by nursing 401
home facilities.— 402
(1) For purposes of this section, the term: 403
(b) "Medicinal drug" has the same meaning as provided in 404
s. 465.003 s. 465.003(8). 405
Section 11. Paragraph (b) of subsection (2) of section 406
401.245, Florida Statutes, is amended to read: 407
401.245 Emergency Medical Services Advisory Council. — 408
(2) 409
(b) Representation on the Emergency Medical Services 410
Advisory Council shall include : two licensed physicians who are 411
medical directors "medical directors" as defined in s. 401.23 s. 412
401.23(15) or whose medical practice is closely related to 413
emergency medical services; two emergency medical service 414
administrators, one of whom is employed by a fire service; two 415
certified paramedics, one of who m is employed by a fire service; 416
two certified emergency medical technicians, one of whom is 417
employed by a fire service; one emergency medical services 418
educator; one emergency nurse; one hospital administrator; one 419
representative of air ambulance services; one representative of 420
a commercial ambulance operator; and two laypersons who are in 421
no way connected with emergency medical services, one of whom is 422
a representative of the elderly. Ex officio members of the 423
advisory council from state agencies shall inc lude, but are 424
shall not be limited to, representatives from the Department of 425
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Education, the Department of Management Services, the State Fire 426
Marshal, the Department of Highway Safety and Motor Vehicles, 427
the Department of Transportation, and the Division of Emergency 428
Management. 429
Section 12. Subsection (2) of section 401.27, Florida 430
Statutes, is amended to read: 431
401.27 Personnel; standards and certification. — 432
(2) The department shall establish by rule educational and 433
training criteria and examinations for the certification and 434
recertification of emergency medical technicians and paramedics. 435
Such rules must require, but need not be limited to: 436
(a) For emergency medical technicians, proficiency in 437
techniques identified in s. 401.23 s. 401.23(7) and in rules of 438
the department. 439
(b) For paramedics, proficiency in techniques identified 440
in s. 401.23 s. 401.23(1) and in rules of the department. 441
Section 13. Paragraph (a) of subsection (1) of section 442
409.9201, Florida Statutes, is amended to r ead: 443
409.9201 Medicaid fraud. — 444
(1) As used in this section, the term: 445
(a) "Prescription drug" means any drug, including, but not 446
limited to, finished dosage forms or active ingredients that are 447
subject to, defined in, or described in s. 503(b) of the Federal 448
Food, Drug, and Cosmetic Act or in s. 465.003 s. 465.003(8), s. 449
499.003(17), s. 499.007(13), or s. 499.82(10). 450
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451
The value of individual items of the legend drugs or goods or 452
services involved in distinct transactions committed during a 453
single scheme or course of conduct, whether involving a single 454
person or several persons, may be aggregated when determining 455
the punishment for the offense. 456
Section 14. Paragraph (pp) of subsection (1) of section 457
458.331, Florida Statutes, is amended to read: 458
458.331 Grounds for disciplinary action; action by the 459
board and department. — 460
(1) The following acts constitute grounds for denial of a 461
license or disciplinary action, as specified in s. 456.072(2): 462
(pp) Applicable to a licensee who serves as the design ated 463
physician of a pain-management clinic as defined in s. 458.3265 464
or s. 459.0137: 465
1. Registering a pain -management clinic through 466
misrepresentation or fraud; 467
2. Procuring, or attempting to procure, the registration 468
of a pain-management clinic for an y other person by making or 469
causing to be made, any false representation; 470
3. Failing to comply with any requirement of chapter 499, 471
the Florida Drug and Cosmetic Act; 21 U.S.C. ss. 301 -392, the 472
Federal Food, Drug, and Cosmetic Act; 21 U.S.C. ss. 821 et s eq., 473
the Drug Abuse Prevention and Control Act; or chapter 893, the 474
Florida Comprehensive Drug Abuse Prevention and Control Act; 475
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4. Being convicted or found guilty of, regardless of 476
adjudication to, a felony or any other crime involving moral 477
turpitude, fraud, dishonesty, or deceit in any jurisdiction of 478
the courts of this state, of any other state, or of the United 479
States; 480
5. Being convicted of, or disciplined by a regulatory 481
agency of the Federal Government or a regulatory agency of 482
another state for, any offense that would constitute a violation 483
of this chapter; 484
6. Being convicted of, or entering a plea of guilty or 485
nolo contendere to, regardless of adjudication, a crime in any 486
jurisdiction of the courts of this state, of any other state, or 487
of the United States which relates to the practice of, or the 488
ability to practice, a licensed health care profession; 489
7. Being convicted of, or entering a plea of guilty or 490
nolo contendere to, regardless of adjudication, a crime in any 491
jurisdiction of the court s of this state, of any other state, or 492
of the United States which relates to health care fraud; 493
8. Dispensing any medicinal drug based upon a 494
communication that purports to be a prescription as defined in 495
s. 465.003 s. 465.003(14) or s. 893.02 if the di spensing 496
practitioner knows or has reason to believe that the purported 497
prescription is not based upon a valid practitioner -patient 498
relationship; or 499
9. Failing to timely notify the board of the date of his 500
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or her termination from a pain -management clinic as required by 501
s. 458.3265(3). 502
Section 15. Paragraph (rr) of subsection (1) of section 503
459.015, Florida Statutes, is amended to read: 504
459.015 Grounds for disciplinary action; action by the 505
board and department. — 506
(1) The following acts constitute g rounds for denial of a 507
license or disciplinary action, as specified in s. 456.072(2): 508
(rr) Applicable to a licensee who serves as the designated 509
physician of a pain-management clinic as defined in s. 458.3265 510
or s. 459.0137: 511
1. Registering a pain -management clinic through 512
misrepresentation or fraud; 513
2. Procuring, or attempting to procure, the registration 514
of a pain-management clinic for any other person by making or 515
causing to be made, any false representation; 516
3. Failing to comply with any requirement of chapter 499, 517
the Florida Drug and Cosmetic Act; 21 U.S.C. ss. 301 -392, the 518
Federal Food, Drug, and Cosmetic Act; 21 U.S.C. ss. 821 et seq., 519
the Drug Abuse Prevention and Control Act; or chapter 893, the 520
Florida Comprehensive Drug Abuse Preve ntion and Control Act; 521
4. Being convicted or found guilty of, regardless of 522
adjudication to, a felony or any other crime involving moral 523
turpitude, fraud, dishonesty, or deceit in any jurisdiction of 524
the courts of this state, of any other state, or of th e United 525
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States; 526
5. Being convicted of, or disciplined by a regulatory 527
agency of the Federal Government or a regulatory agency of 528
another state for, any offense that would constitute a violation 529
of this chapter; 530
6. Being convicted of, or entering a ple a of guilty or 531
nolo contendere to, regardless of adjudication, a crime in any 532
jurisdiction of the courts of this state, of any other state, or 533
of the United States which relates to the practice of, or the 534
ability to practice, a licensed health care profess ion; 535
7. Being convicted of, or entering a plea of guilty or 536
nolo contendere to, regardless of adjudication, a crime in any 537
jurisdiction of the courts of this state, of any other state, or 538
of the United States which relates to health care fraud; 539
8. Dispensing any medicinal drug based upon a 540
communication that purports to be a prescription as defined in 541
s. 465.003 s. 465.003(14) or s. 893.02 if the dispensing 542
practitioner knows or has reason to believe that the purported 543
prescription is not based upon a v alid practitioner-patient 544
relationship; or 545
9. Failing to timely notify the board of the date of his 546
or her termination from a pain -management clinic as required by 547
s. 459.0137(3). 548
Section 16. Subsection (1) of section 465.014, Florida 549
Statutes, is amended to read: 550
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465.014 Pharmacy technician. — 551
(1) A person other than a licensed pharmacist or pharmacy 552
intern may not engage in the practice of the profession of 553
pharmacy, except that a licensed pharmacist may delegate to 554
pharmacy technicians who are r egistered pursuant to this section 555
those duties, tasks, and functions that do not fall within the 556
purview of s. 465.003 s. 465.003(13). All such delegated acts 557
must be performed under the direct supervision of a licensed 558
pharmacist who is responsible for a ll such acts performed by 559
persons under his or her supervision. A registered pharmacy 560
technician, under the supervision of a pharmacist, may initiate 561
or receive communications with a practitioner or his or her 562
agent, on behalf of a patient, regarding refil l authorization 563
requests. A licensed pharmacist may not supervise more than one 564
registered pharmacy technician unless otherwise permitted by the 565
guidelines adopted by the board. The board shall establish 566
guidelines to be followed by licensees or permittees in 567
determining the circumstances under which a licensed pharmacist 568
may supervise more than one pharmacy technician. 569
Section 17. Paragraph (c) of subsection (2) of section 570
465.015, Florida Statutes, is amended to read: 571
465.015 Violations and penaltie s.— 572
(2) It is unlawful for any person: 573
(c) To sell or dispense drugs as defined in s. 465.003 s. 574
465.003(8) without first being furnished with a prescription. 575
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Section 18. Subsection (9) of section 465.0156, Florida 576
Statutes, is amended to read: 577
465.0156 Registration of nonresident pharmacies. — 578
(9) Notwithstanding s. 465.003 s. 465.003(10), for 579
purposes of this section, the registered pharmacy and the 580
pharmacist designated by the registered pharmacy as the 581
prescription department manager or the e quivalent must be 582
licensed in the state of location in order to dispense into this 583
state. 584
Section 19. Paragraph (s) of subsection (1) of section 585
465.016, Florida Statutes, is amended to read: 586
465.016 Disciplinary actions. — 587
(1) The following acts co nstitute grounds for denial of a 588
license or disciplinary action, as specified in s. 456.072(2): 589
(s) Dispensing any medicinal drug based upon a 590
communication that purports to be a prescription as defined in 591
s. 465.003 by s. 465.003(14) or s. 893.02 when the pharmacist 592
knows or has reason to believe that the purported prescription 593
is not based upon a valid practitioner -patient relationship. 594
Section 20. Subsection (4) of section 465.0197, Florida 595
Statutes, is amended to read: 596
465.0197 Internet pharmacy permits. — 597
(4) Notwithstanding s. 465.003 s. 465.003(10), for 598
purposes of this section, the Internet pharmacy and the 599
pharmacist designated by the Internet pharmacy as the 600
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prescription department manager or the equivalent must be 601
licensed in the state of location in order to dispense into this 602
state. 603
Section 21. Paragraph (j) of subsection (5) of section 604
465.022, Florida Statutes, is amended to read: 605
465.022 Pharmacies; general requirements; fees. — 606
(5) The department or board s hall deny an application for 607
a pharmacy permit if the applicant or an affiliated person, 608
partner, officer, director, or prescription department manager 609
or consultant pharmacist of record of the applicant: 610
(j) Has dispensed any medicinal drug based upon a 611
communication that purports to be a prescription as defined in 612
s. 465.003 by s. 465.003(14) or s. 893.02 when the pharmacist 613
knows or has reason to believe that the purported prescription 614
is not based upon a valid practitioner -patient relationship that 615
includes a documented patient evaluation, including history and 616
a physical examination adequate to establish the diagnosis for 617
which any drug is prescribed and any other requirement 618
established by board rule under chapter 458, chapter 459, 619
chapter 461, chapter 463, chapter 464, or chapter 466. 620
621
For felonies in which the defendant entered a plea of guilty or 622
nolo contendere in an agreement with the court to enter a 623
pretrial intervention or drug diversion program, the department 624
shall deny the application if upon final resolution of the case 625
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the licensee has failed to successfully complete the program. 626
Section 22. Paragraph (h) of subsection (1) of section 627
465.023, Florida Statutes, is amended to read: 628
465.023 Pharmacy permittee; disciplinary action. — 629
(1) The department or the board may revo ke or suspend the 630
permit of any pharmacy permittee, and may fine, place on 631
probation, or otherwise discipline any pharmacy permittee if the 632
permittee, or any affiliated person, partner, officer, director, 633
or agent of the permittee, including a person finge rprinted 634
under s. 465.022(3), has: 635
(h) Dispensed any medicinal drug based upon a 636
communication that purports to be a prescription as defined in 637
s. 465.003 by s. 465.003(14) or s. 893.02 when the pharmacist 638
knows or has reason to believe that the purporte d prescription 639
is not based upon a valid practitioner -patient relationship that 640
includes a documented patient evaluation, including history and 641
a physical examination adequate to establish the diagnosis for 642
which any drug is prescribed and any other requir ement 643
established by board rule under chapter 458, chapter 459, 644
chapter 461, chapter 463, chapter 464, or chapter 466. 645
Section 23. Section 465.1901, Florida Statutes, is amended 646
to read: 647
465.1901 Practice of orthotics and pedorthics. —The 648
provisions of chapter 468 relating to orthotics or pedorthics do 649
not apply to any licensed pharmacist or to any person acting 650
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under the supervision of a licensed pharmacist. The practice of 651
orthotics or pedorthics by a pharmacist or any of the 652
pharmacist's employees a cting under the supervision of a 653
pharmacist shall be construed to be within the meaning of the 654
term "practice of the profession of pharmacy" as defined set 655
forth in s. 465.003 s. 465.003(13), and shall be subject to 656
regulation in the same manner as any oth er pharmacy practice. 657
The Board of Pharmacy shall develop rules regarding the practice 658
of orthotics and pedorthics by a pharmacist. Any pharmacist or 659
person under the supervision of a pharmacist engaged in the 660
practice of orthotics or pedorthics is not pre cluded from 661
continuing that practice pending adoption of these rules. 662
Section 24. Paragraph (j) of subsection (2) of section 663
465.1902, Florida Statutes, is amended to read: 664
465.1902 Prescription Drug Donation Repository Program. — 665
(2) DEFINITIONS.—As used in this section, the term: 666
(j) "Prescription drug" has the same meaning as the term 667
"medicinal drugs" or "drugs," as those terms are defined in s. 668
465.003 s. 465.003(8), but does not include controlled 669
substances, cancer drugs donated under s. 499 .029, or drugs with 670
an approved United States Food and Drug Administration risk 671
evaluation and mitigation strategy that includes elements to 672
assure safe use. 673
Section 25. Subsection (40) of section 499.003, Florida 674
Statutes, is amended to read: 675
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499.003 Definitions of terms used in this part. —As used in 676
this part, the term: 677
(40) "Prescription drug" means a prescription, medicinal, 678
or legend drug, including, but not limited to, finished dosage 679
forms or active pharmaceutical ingredients subject to, defi ned 680
by, or described by s. 503(b) of the federal act or s. 465.003 681
s. 465.003(8), s. 499.007(13), subsection (31), or subsection 682
(47), except that an active pharmaceutical ingredient is a 683
prescription drug only if substantially all finished dosage 684
forms in which it may be lawfully dispensed or administered in 685
this state are also prescription drugs. 686
Section 26. Paragraph (c) of subsection (24) of section 687
893.02, Florida Statutes, is amended to read: 688
893.02 Definitions. —The following words and phrases a s 689
used in this chapter shall have the following meanings, unless 690
the context otherwise requires: 691
(24) "Prescription" includes any order for drugs or 692
medicinal supplies which is written or transmitted by any means 693
of communication by a licensed practition er authorized by the 694
laws of this state to prescribe such drugs or medicinal 695
supplies, is issued in good faith and in the course of 696
professional practice, is intended to be dispensed by a person 697
authorized by the laws of this state to do so, and meets the 698
requirements of s. 893.04. 699
(c) A prescription for a controlled substance may not be 700
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issued on the same prescription blank with another prescription 701
for a controlled substance that is named or described in a 702
different schedule or with another prescription for a medicinal 703
drug, as defined in s. 465.003 s. 465.003(8), that is not a 704
controlled substance. 705
Section 27. This act shall take effect July 1, 2022. 706