CS/HB 493 2024
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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 pharmacy; amending s. 465.003, 2
F.S.; revising the definition of the term "pharmacy" 3
to include remote-site pharmacies; revising 4
construction of the term "not present and on duty"; 5
amending s. 465.014, F.S.; authorizing registered 6
pharmacy technicians to perform certain delegated 7
tasks at a remote-site pharmacy under remote 8
supervision; establishing the maximum number of 9
registered pharmacy technicians that a pharmacist may 10
remotely supervise; creating s. 465.0198, F.S.; 11
defining the terms "supervising pharmacist" and 12
"supervising pharmacy"; providing for the permitting 13
of remote-site pharmacies; requiring a licensed or 14
consultant pharmacist to serve as the prescription 15
department manager of a remote -site pharmacy; 16
requiring remote-site pharmacies to notify the 17
Department of Health of a change in the pharmacy's 18
prescription department manager within a specified 19
timeframe; providing requirements for remote -site 20
pharmacies; authorizing remote -site pharmacies to 21
store, hold, and dispense medici nal drugs; prohibiting 22
the dispensing of Schedule II medications at remote -23
site pharmacies unless a pharmacist is present; 24
requiring prescription department managers to visit 25
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remote-site pharmacies, based on a certain schedule, 26
to perform specified tasks; prohibiting remote-site 27
pharmacies from being open when the supervising 28
pharmacy is closed unless a supervising pharmacist is 29
present or providing remote supervision at the remote -30
site pharmacy; authorizing the Board of Pharmacy to 31
adopt specified rules; a mending s. 465.022, F.S.; 32
exempting registered pharmacists serving as 33
prescription department managers for remote -site 34
pharmacies from certain practice limitations; 35
providing an effective date. 36
37
Be It Enacted by the Legislature of the State of Florida: 38
39
Section 1. Subsection (20) of section 465.003, Florida 40
Statutes, is amended to read: 41
465.003 Definitions. —As used in this chapter, the term: 42
(20)(a) "Pharmacy" includes a community pharmacy, an 43
institutional pharmacy, a nuclear pharmacy, a specia l pharmacy, 44
and an Internet pharmacy , and a remote-site pharmacy. 45
1. The term "community pharmacy" includes every location 46
where medicinal drugs are compounded, dispensed, stored, or sold 47
or where prescriptions are filled or dispensed on an outpatient 48
basis. 49
2. The term "institutional pharmacy" includes every 50
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location in a hospital, clinic, nursing home, dispensary, 51
sanitarium, extended care facility, or other facility, 52
hereinafter referred to as "health care institutions," where 53
medicinal drugs are com pounded, dispensed, stored, or sold. 54
3. The term "nuclear pharmacy" includes every location 55
where radioactive drugs and chemicals within the classification 56
of medicinal drugs are compounded, dispensed, stored, or sold. 57
The term "nuclear pharmacy" does no t include hospitals licensed 58
under chapter 395 or the nuclear medicine facilities of such 59
hospitals. 60
4. The term "special pharmacy" includes every location 61
where medicinal drugs are compounded, dispensed, stored, or sold 62
if such locations are not otherwi se defined in this subsection. 63
5. The term "Internet pharmacy" includes locations not 64
otherwise licensed or issued a permit under this chapter, within 65
or outside this state, which use the Internet to communicate 66
with or obtain information from consumers in this state and use 67
such communication or information to fill or refill 68
prescriptions or to dispense, distribute, or otherwise engage in 69
the practice of pharmacy in this state. Any act described in 70
this definition constitutes the practice of the professi on of 71
pharmacy. 72
6. The term "remote -site pharmacy" means a location where 73
medicinal drugs are dispensed by a supervising pharmacist as 74
defined in s. 465.0198(1) who is acting in the capacity of a 75
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prescription department manager and remotely supervising a 76
registered pharmacy technician handling the sales transactions 77
and delivery of the drugs. 78
(b) The pharmacy department of any permittee is shall be 79
considered closed whenever a Florida licensed pharmacist is not 80
present and on duty. The term "not present and on duty" may 81
shall not be construed to prevent any of the following: 82
1. A pharmacist from exiting the prescription department 83
for the purposes of consulting or responding to inquiries or 84
providing assistance to patients or customers . 85
2. A pharmacist from, attending to personal hygiene needs . 86
3. A pharmacist from , or performing any other function for 87
which the pharmacist is responsible, provided that such 88
activities are conducted in a manner consistent with the 89
pharmacist's responsibility to provide pharmacy services. 90
4. A supervising pharmacist as defined in s. 465 .0198(1) 91
who is acting in the capacity of a prescription department 92
manager from remotely supervising a registered pharmacy 93
technician at a remote -site pharmacy. 94
Section 2. Subsection (1) of section 465.014, Florida 95
Statutes, is amended, and subsection (10) is added to that 96
section, to read: 97
465.014 Pharmacy technician. — 98
(1) A person other than a licensed pharmacist or pharmacy 99
intern may not engage in the practice of the profession of 100
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pharmacy as defined in s. 465.003 , except that a licensed 101
pharmacist may delegate to pharmacy technicians who are 102
registered pursuant to this section those duties, tasks, and 103
functions that do not fall within the purview of s. 465.003. 104
Except as otherwise provided in this section, all such delegated 105
acts must be performed under the direct supervision of a 106
licensed pharmacist who is responsible for all such acts 107
performed by persons under his or her supervision. A registered 108
pharmacy technician, under the supervision of a pharmacist, may 109
initiate or receive communication s with a practitioner or his or 110
her agent, on behalf of a patient, regarding refill 111
authorization requests. A licensed pharmacist may not supervise 112
more than one registered pharmacy technician unless otherwise 113
permitted by the guidelines adopted by the boa rd. The board 114
shall establish guidelines to be followed by licensees or 115
permittees in determining the circumstances under which a 116
licensed pharmacist may supervise more than one pharmacy 117
technician. 118
(10) A registered pharmacy technician may perform the 119
delegated acts authorized by this section at a remote -site 120
pharmacy under the remote supervision of a supervising 121
pharmacist as defined in s. 465.0198(1). A supervising 122
pharmacist may not remotely supervise more than six registered 123
pharmacy technicians. 124
Section 3. Section 465.0198, Florida Statutes, is created 125
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to read: 126
465.0198 Remote-site pharmacy permits. — 127
(1) As used in this section, the term: 128
(a) "Supervising pharmacist" means a pharmacist licensed 129
in this state employed by or under contract wi th a pharmacy 130
licensed in this state who remotely supervises registered 131
pharmacy technicians at a remote -site pharmacy. 132
(b) "Supervising pharmacy" means a pharmacy licensed in 133
this state which employs or contracts with a pharmacist licensed 134
in this state to serve as the supervising pharmacist for a 135
remote-site pharmacy that is jointly owned by or operated under 136
a contract with the pharmacy. 137
(2) Any person desiring a permit to operate a remote -site 138
pharmacy must apply to the department. If the board cert ifies 139
that the application complies with the laws and rules of the 140
board, the department must issue the permit. A permit may not be 141
issued unless a licensed pharmacist or consultant pharmacist is 142
designated as the prescription department manager responsibl e 143
for the oversight of the remote -site pharmacy. The permittee 144
must notify the department within 10 days after any change of 145
the prescription department manager. 146
(3) A remote-site pharmacy must comply with all of the 147
following: 148
(a) Be jointly owned by or operated under a contract with 149
a supervising pharmacy. 150
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(b) Maintain a video surveillance system that records 151
continuously 24 hours per day and retain video surveillance 152
recordings for at least 30 days. 153
(c) Display a sign visible to the public indica ting that 154
the location is a remote -site pharmacy and that the facility is 155
under 24-hour video surveillance. 156
(d) Maintain a policies and procedures manual, which must 157
be made available to the board or its agent upon request and 158
must include, but need not be limited to, all of the following: 159
1. A description of how the pharmacy will comply with 160
federal and state laws and rules. 161
2. The procedures for supervising the remote -site pharmacy 162
and counseling its patients. 163
3. The procedures for reviewing the p rescription drug 164
inventory and drug records maintained by the remote -site 165
pharmacy. 166
4. The policies and procedures for providing security 167
adequate to protect the confidentiality and integrity of patient 168
information. 169
5. The written plan for recovery fro m an event that 170
interrupts or prevents the prescription department manager from 171
supervising the remote -site pharmacy's operation. 172
6. The procedures for use of the state prescription drug 173
monitoring program by the prescription department manager before 174
he or she may authorize the dispensing of any controlled 175
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substance. 176
7. The procedures for maintaining a perpetual inventory of 177
the controlled substances listed in Schedule II of s. 893.03. 178
8. The specific duties, tasks, and functions that 179
registered pharmacy technicians are authorized to perform at the 180
remote-site pharmacy. 181
(4) A remote-site pharmacy may store, hold, or dispense 182
any medicinal drug, including proprietary drugs and controlled 183
substances. However, a remote -site pharmacy may not dispense 184
Schedule II controlled substances listed in s. 893.03 unless a 185
pharmacist is present at the remote -site pharmacy. 186
(5) The prescription department manager must visit the 187
remote-site pharmacy, based on a schedule determined by the 188
board, to inspect the pharm acy, address personnel matters, and 189
provide clinical services for patients. 190
(6) A remote-site pharmacy may not be open when the 191
supervising pharmacy is closed, unless a supervising pharmacist 192
is present at the remote -site pharmacy or is providing remote 193
supervision as required under this section. 194
(7) The board may adopt rules as necessary to specify 195
additional criteria for a remote -site pharmacy related to: 196
(a) Application requirements. 197
(b) Structural and equipment requirements. 198
(c) Training requirements. 199
(d) Inventory recordkeeping and storage requirements. 200
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Section 4. Paragraph (c) of subsection (11) of section 201
465.022, Florida Statutes, is amended to read: 202
465.022 Pharmacies; general requirements; fees. — 203
(11) A permittee must notif y the department of the 204
identity of the prescription department manager within 10 days 205
after employment. The prescription department manager must 206
comply with the following requirements: 207
(c) A registered pharmacist may not serve as the 208
prescription department manager in more than one location , 209
except as authorized under s. 465.0198, unless approved by the 210
board. 211
Section 5. This act shall take effect July 1, 2024. 212