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F L O R I D A H O U S E O F R E P R E S E N T A T I V E S
A bill to be entitled 1
An act relating to pharmac y; amending s. 465.003, 2
F.S.; revising the definition of the term "dispense"; 3
revising the definition of the term "pharmacy" to 4
include remote-site pharmacies; revising construction 5
of the term "not present and on duty"; amending s. 6
465.014, F.S.; authorizi ng registered pharmacy 7
technicians to dispense medicinal drugs under certain 8
circumstances; providing an exception to certain 9
supervision limitations; amending s. 465.015, F.S.; 10
providing applicability; exempting certain registered 11
pharmacy technicians fro m specified prohibitions; 12
creating s. 465.0198, F.S.; defining the terms 13
"supervising pharmacy" and "telepharmacy"; providing 14
for the permitting of remote -site pharmacies; 15
requiring a licensed or consultant pharmacist to serve 16
as the prescription departmen t manager of a remote -17
site pharmacy; requiring remote -site pharmacies to 18
notify the Department of Health of a change in the 19
pharmacy's prescription department manager within a 20
specified timeframe; providing requirements for 21
remote-site pharmacies; authoriz ing remote-site 22
pharmacies to store, hold, and dispense medicinal 23
drugs; prohibiting the dispensing of Schedule II 24
medications at remote -site pharmacies unless a 25
HB 493 2024
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pharmacist is present; requiring prescription 26
department managers to visit remote -site pharmacies, 27
based on a certain schedule, to perform specified 28
tasks; prohibiting remote -site pharmacies from being 29
open when the supervising pharmacy is closed unless a 30
certain pharmacist is present or providing remote 31
supervision at the remote -site pharmacy; prohibiting 32
registered pharmacists from serving as prescription 33
department managers for more than three remote -site 34
pharmacies under certain circumstances; authorizing 35
the Board of Pharmacy to adopt specified rules; 36
amending s. 465.022, F.S.; exempting regist ered 37
pharmacists serving as prescription department 38
managers for remote-site pharmacies from certain 39
practice limitations; providing an effective date. 40
41
Be It Enacted by the Legislature of the State of Florida: 42
43
Section 1. Subsections (13) and (20) of section 465.003, 44
Florida Statutes, are amended to read: 45
465.003 Definitions. —As used in this chapter, the term: 46
(13) "Dispense" means the transfer of possession of one or 47
more doses of a medicinal drug by a pharmacist , or by a 48
registered pharmacy t echnician who is remotely supervised by an 49
offsite pharmacist, to the ultimate consumer or her or his 50
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agent. As an element of dispensing, the pharmacist shall, prior 51
to the actual physical transfer, interpret and assess the 52
prescription order for potential adverse reactions, 53
interactions, and dosage regimen she or he deems appropriate in 54
the exercise of her or his professional judgment, and the 55
pharmacist shall certify that the medicinal drug called for by 56
the prescription is ready for transfer. The pharmac ist shall 57
also provide counseling on proper drug usage, either orally or 58
in writing, if in the exercise of her or his professional 59
judgment counseling is necessary. The actual sales transaction 60
and delivery of such drug shall not be considered dispensing. 61
The administration shall not be considered dispensing. 62
(20)(a) "Pharmacy" includes a community pharmacy, an 63
institutional pharmacy, a nuclear pharmacy, a special pharmacy, 64
and an Internet pharmacy , and a remote-site pharmacy. 65
1. The term "community pha rmacy" includes every location 66
where medicinal drugs are compounded, dispensed, stored, or sold 67
or where prescriptions are filled or dispensed on an outpatient 68
basis. 69
2. The term "institutional pharmacy" includes every 70
location in a hospital, clinic, nur sing home, dispensary, 71
sanitarium, extended care facility, or other facility, 72
hereinafter referred to as "health care institutions," where 73
medicinal drugs are compounded, dispensed, stored, or sold. 74
3. The term "nuclear pharmacy" includes every location 75
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where radioactive drugs and chemicals within the classification 76
of medicinal drugs are compounded, dispensed, stored, or sold. 77
The term "nuclear pharmacy" does not include hospitals licensed 78
under chapter 395 or the nuclear medicine facilities of such 79
hospitals. 80
4. The term "special pharmacy" includes every location 81
where medicinal drugs are compounded, dispensed, stored, or sold 82
if such locations are not otherwise defined in this subsection. 83
5. The term "Internet pharmacy" includes locations not 84
otherwise licensed or issued a permit under this chapter, within 85
or outside this state, which use the Internet to communicate 86
with or obtain information from consumers in this state and use 87
such communication or information to fill or refill 88
prescriptions or to dispense, distribute, or otherwise engage in 89
the practice of pharmacy in this state. Any act described in 90
this definition constitutes the practice of the profession of 91
pharmacy. 92
6. The term "remote -site pharmacy" includes every location 93
where medicinal drugs are dispensed by a registered pharmacy 94
technician who is remotely supervised by an offsite pharmacist 95
acting in the capacity of a prescription department manager. 96
(b) The pharmacy department of any permittee is shall be 97
considered closed whenever a Florida licensed pharmacist is not 98
present and on duty. The term "not present and on duty" may 99
shall not be construed to prevent any of the following: 100
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1. A pharmacist from exiting the prescription department 101
for the purposes of consulting or responding t o inquiries or 102
providing assistance to patients or customers . 103
2. A pharmacist from , attending to personal hygiene needs . 104
3. A pharmacist from , or performing any other function for 105
which the pharmacist is responsible, provided that such 106
activities are conducted in a manner consistent with the 107
pharmacist's responsibility to provide pharmacy services. 108
4. An offsite pharmacist, acting in the capacity of a 109
prescription department manager, from remotely supervising a 110
registered pharmacy technician at a remote -site pharmacy. 111
Section 2. Subsection (1) of section 465.014, Florida 112
Statutes, is amended to read: 113
465.014 Pharmacy technician. — 114
(1) A person other than a licensed pharmacist or pharmacy 115
intern may not engage in the practice of the profession of 116
pharmacy, except that a licensed pharmacist may delegate to 117
pharmacy technicians who are registered pursuant to this section 118
those duties, tasks, an d functions that do not fall within the 119
purview of s. 465.003 , and a registered pharmacy technician 120
operating under remote supervision of an offsite pharmacist 121
under s. 465.0198 may dispense medicinal drugs under such 122
supervision. All such delegated acts m ust be performed under the 123
direct supervision of a licensed pharmacist who is responsible 124
for all such acts performed by persons under his or her 125
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supervision. A registered pharmacy technician, under the 126
supervision of a pharmacist, may initiate or receive 127
communications with a practitioner or his or her agent, on 128
behalf of a patient, regarding refill authorization requests. A 129
licensed pharmacist may not supervise more than one registered 130
pharmacy technician, except as provided in s. 465.0198 or unless 131
otherwise permitted by the guidelines adopted by the board. The 132
board shall establish guidelines to be followed by licensees or 133
permittees in determining the circumstances under which a 134
licensed pharmacist may supervise more than one pharmacy 135
technician. 136
Section 3. Paragraph (b) of subsection (1) and paragraph 137
(b) of subsection (2) of section 465.015, Florida Statutes, are 138
amended to read: 139
465.015 Violations and penalties. — 140
(1) It is unlawful for any person to own, operate, 141
maintain, open, establish, con duct, or have charge of, either 142
alone or with another person or persons, a pharmacy: 143
(b) In which a person not licensed as a pharmacist in this 144
state or not registered as an intern in this state or in which 145
an intern who is not acting under the direct an d immediate 146
personal supervision of a licensed pharmacist fills, compounds, 147
or dispenses any prescription or dispenses medicinal drugs. This 148
paragraph does not apply to any person who owns, operates, 149
maintains, opens, establishes, conducts, or has charge o f a 150
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remote-site pharmacy under s. 465.0198. 151
(2) It is unlawful for any person: 152
(b) To fill, compound, or dispense prescriptions or to 153
dispense medicinal drugs if such person does not hold an active 154
license as a pharmacist in this state, is not register ed as an 155
intern in this state, or is an intern not acting under the 156
direct and immediate personal supervision of a licensed 157
pharmacist, or is not a registered pharmacy technician at a 158
remote-site pharmacy who is acting under remote supervision of a 159
licensed pharmacist pursuant to s. 465.0198 . 160
Section 4. Section 465.0198, Florida Statutes, is created 161
to read: 162
465.0198 Remote-site pharmacy permits. — 163
(1) As used in this section, the term: 164
(a) "Supervising pharmacy" means a pharmacy licensed in 165
this state which employs or contracts with a pharmacist licensed 166
in this state who remotely supervises a registered pharmacy 167
technician at a remote -site pharmacy at a ratio of one 168
pharmacist to up to six registered pharmacy technicians. 169
(b) "Telepharmacy" mean s the practice of pharmacy by a 170
pharmacist located in this state using telecommunications or 171
other automations and technologies to provide or supervise the 172
provision of pharmacy services to patients and their agents who 173
are located at sites other than wher e the pharmacist is located, 174
including dispensing of prescriptions to and counseling of 175
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patients. 176
(2) Any person desiring a permit to operate a remote -site 177
pharmacy must apply to the department. If the board certifies 178
that the application complies with t he laws and rules of the 179
board, the department must issue the permit. A permit may not be 180
issued unless a licensed pharmacist or consultant pharmacist is 181
designated as the prescription department manager responsible 182
for the oversight of the remote -site pharmacy. The permittee 183
must notify the department within 10 days after any change of 184
the prescription department manager. 185
(3) A remote-site pharmacy must comply with all of the 186
following: 187
(a) Be jointly owned by or operated under a contract with 188
a supervising pharmacy. 189
(b) Maintain a video surveillance system that records 190
continuously 24 hours per day and retain video surveillance 191
recordings for at least 30 days. 192
(c) Display a sign visible to the public indicating that 193
the location is a remote -site pharmacy and that the facility is 194
under 24-hour video surveillance. 195
(d) Maintain a policies and procedures manual, which must 196
be made available to the board or its agent upon request and 197
must include, but need not be limited to, all of the following: 198
1. A description of how the pharmacy will comply with 199
federal and state laws and rules. 200
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2. The procedures for supervising the remote -site pharmacy 201
and counseling its patients. 202
3. The procedures for reviewing the prescription drug 203
inventory and drug record s maintained by the remote -site 204
pharmacy. 205
4. The policies and procedures for providing security 206
adequate to protect the confidentiality and integrity of patient 207
information. 208
5. The written plan for recovery from an event that 209
interrupts or prevents the prescription department manager from 210
supervising the remote -site pharmacy's operation. 211
6. The procedures for use of the state prescription drug 212
monitoring program by the prescription department manager before 213
he or she may authorize the dispensing of an y controlled 214
substance. 215
7. The procedures for maintaining a perpetual inventory of 216
the controlled substances listed in Schedule II of s. 893.03. 217
8. The specific duties, tasks, and functions that 218
registered pharmacy technicians are authorized to perform at the 219
remote-site pharmacy. 220
(4) A remote-site pharmacy may store, hold, or dispense 221
any medicinal drug, including proprietary drugs and controlled 222
substances. However, a remote -site pharmacy may not dispense 223
Schedule II controlled substances listed in s. 893.03 unless a 224
pharmacist is present at the remote -site pharmacy. 225
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(5) The prescription department manager must visit the 226
remote-site pharmacy, based on a schedule determined by the 227
board, to inspect the pharmacy, address personnel matters, and 228
provide clinical services for patients. 229
(6) A remote-site pharmacy may not be open when the 230
supervising pharmacy is closed, unless a pharmacist employed by 231
or under contract with the supervising pharmacy, or a pharmacy 232
under contract with the supervising pharm acy, is present at the 233
remote-site pharmacy or is providing remote supervision as 234
required under this section. 235
(7) A registered pharmacist may not serve as the 236
prescription department manager for more than three remote -site 237
pharmacies that are under comm on control of the same supervising 238
pharmacy, at a ratio of one pharmacist to up to six registered 239
pharmacy technicians at each remote -site pharmacy. 240
(8) The board may adopt rules as necessary to specify 241
additional criteria for a remote -site pharmacy. Any additional 242
criteria adopted by the board must be limited to rules 243
concerning one or more of the following: 244
(a) Application requirements. 245
(b) Structural and equipment requirements. 246
(c) Training requirements. 247
(d) Inventory recordkeeping and storage requirements. 248
Section 5. Paragraph (c) of subsection (11) of section 249
465.022, Florida Statutes, is amended to read: 250
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465.022 Pharmacies; general requirements; fees. — 251
(11) A permittee must notify the department of the 252
identity of the prescription dep artment manager within 10 days 253
after employment. The prescription department manager must 254
comply with the following requirements: 255
(c) A registered pharmacist may not serve as the 256
prescription department manager in more than one location , 257
except as authorized under s. 465.0198, unless approved by the 258
board. 259
Section 6. This act shall take effect July 1, 2024. 260