Florida 2025 2025 Regular Session

Florida House Bill H0273 Introduced / Bill

Filed 01/28/2025

                       
 
HB 273   	2025 
 
 
 
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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 handle the sales transactions 7 
and delivery of dispensed 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 from specified prohibitions; 12 
creating s. 465.0198, F.S.; defining terms; providing 13 
for the permitting of remote -site pharmacies; 14 
requiring that a licensed or consultant pharmacist 15 
serve as the prescription department manager of a 16 
remote-site pharmacy; requiring remote -site pharmacies 17 
to notify the Department of Health of a change in the 18 
pharmacy's prescription department manager within a 19 
specified timeframe; providing requirements for 20 
remote-site pharmacies; authorizing remote -site 21 
pharmacies to store, hold, and dispense medicinal 22 
drugs; prohibiting the dispensing of Schedule II 23 
medications at remote -site pharmacies unless a 24 
pharmacist is present; requiring prescription 25     
 
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department managers to visit remote -site pharmacies, 26 
based on a certain sche dule, to perform specified 27 
tasks; prohibiting remote -site pharmacies from being 28 
open when the supervising pharmacy is closed unless a 29 
certain pharmacist is present or providing remote 30 
supervision at the remote -site pharmacy; authorizing 31 
the Board of Pharmacy to adopt specified rules; 32 
amending s. 465.022, F.S.; exempting registered 33 
pharmacists serving as prescription department 34 
managers for remote-site pharmacies from certain 35 
practice limitations; providing an effective date. 36 
 37 
Be It Enacted by the Legisl ature 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 special 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 compounded, 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 not 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 otherwise 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 constitute s the practice of the profession of 71 
pharmacy. 72 
 6.  The term "remote -site pharmacy" includes every location 73 
where medicinal drugs are dispensed by a supervising pharmacist 74 
as defined in s. 465.0198 who is remotely supervising a 75     
 
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registered pharmacy technicia n handling the sales transactions 76 
and delivery of the drugs. 77 
 (b)  The pharmacy department of any permittee is shall be 78 
considered closed whenever a Florida licensed pharmacist is not 79 
present and on duty. The term "not present and on duty" may 80 
shall not be construed to prevent any of the following: 81 
 1. A pharmacist from exiting the prescription department 82 
for the purposes of consulting or responding to inquiries or 83 
providing assistance to patients or customers . 84 
 2.  A pharmacist from , attending to personal hygiene needs. 85 
 3.  A pharmacist from , or performing any other function for 86 
which the pharmacist is responsible, provided that such 87 
activities are conducted in a manner consistent with the 88 
pharmacist's responsibility to provide pharmacy services. 89 
 4.  A supervising pharmacist as defined in s. 465.0198, 90 
acting in the capacity of a prescription department manager, 91 
from remotely supervising a registered pharmacy technician at a 92 
remote-site pharmacy. 93 
 Section 2.  Subsection (1) of section 465.014, Florida 94 
Statutes, is amended to read: 95 
 465.014  Pharmacy technician. — 96 
 (1)  A person other than a licensed pharmacist or pharmacy 97 
intern may not engage in the practice of the profession of 98 
pharmacy, except that a licensed pharmacist may delegate to 99 
pharmacy technicians who are registered pursuant to this section 100     
 
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those duties, tasks, and functions that do not fall within the 101 
purview of s. 465.003 , and a registered pharmacy technician 102 
operating under remote supervision of a supervising pharmacist 103 
as defined in s. 465. 0198 may handle the sales transactions and 104 
delivery of the dispensed drugs . All such delegated acts must be 105 
performed under the direct supervision of a licensed pharmacist 106 
who is responsible for all such acts performed by persons under 107 
his or her supervisi on. A registered pharmacy technician, under 108 
the supervision of a pharmacist, may initiate or receive 109 
communications with a practitioner or his or her agent, on 110 
behalf of a patient, regarding refill authorization requests. A 111 
licensed pharmacist may not supe rvise more than one registered 112 
pharmacy technician, except as provided in s. 465.0198 or unless 113 
otherwise permitted by the guidelines adopted by the board. The 114 
board shall establish guidelines to be followed by licensees or 115 
permittees in determining the ci rcumstances under which a 116 
licensed pharmacist may supervise more than one pharmacy 117 
technician. 118 
 Section 3.  Paragraph (b) of subsection (1) and paragraph 119 
(b) of subsection (2) of section 465.015, Florida Statutes, are 120 
amended to read: 121 
 465.015  Violations and penalties.— 122 
 (1)  It is unlawful for any person to own, operate, 123 
maintain, open, establish, conduct, or have charge of, either 124 
alone or with another person or persons, a pharmacy: 125     
 
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 (b)  In which a person not licensed as a pharmacist in this 126 
state or not registered as an intern in this state or in which 127 
an intern who is not acting under the direct and immediate 128 
personal supervision of a licensed pharmacist fills, compounds, 129 
or dispenses any prescription or dispenses medicinal drugs. This 130 
paragraph does not apply to any person who owns, operates, 131 
maintains, opens, establishes, conducts, or has charge of a 132 
remote-site pharmacy under s. 465.0198. 133 
 (2)  It is unlawful for any person: 134 
 (b)  To fill, compound, or dispense prescriptions or to 135 
dispense medicinal drugs if such person does not hold an active 136 
license as a pharmacist in this state, is not registered as an 137 
intern in this state, or is an intern not acting under the 138 
direct and immediate personal supervision of a licensed 139 
pharmacist, or is not a registe red pharmacy technician at a 140 
remote-site pharmacy who is acting under remote supervision of a 141 
licensed pharmacist pursuant to s. 465.0198 . 142 
 Section 4.  Section 465.0198, Florida Statutes, is created 143 
to read: 144 
 465.0198  Remote-site pharmacy permits. — 145 
 (1) As used in this section, the term: 146 
 (a)  "Supervising pharmacist" means a pharmacist licensed 147 
in this state who is employed by or under contract with a 148 
pharmacy licensed in this state and who remotely supervises 149 
registered pharmacy technicians at a remot e-site pharmacy at a 150     
 
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maximum ratio of one pharmacist to up to six registered pharmacy 151 
technicians. 152 
 (b)  "Supervising pharmacy" means a pharmacy licensed in 153 
this state which employs or contracts with a pharmacist licensed 154 
in this state who remotely supervi ses a registered pharmacy 155 
technician at a remote -site pharmacy at a ratio of one 156 
pharmacist to up to six registered pharmacy technicians. 157 
 (c)  "Telepharmacy" means the practice of pharmacy by a 158 
pharmacist located in this state using telecommunications or 159 
other automations and technologies to provide or supervise the 160 
provision of pharmacy services to patients and their agents who 161 
are located at sites other than where the pharmacist is located, 162 
including dispensing of prescriptions to and counseling of 163 
patients. 164 
 (2)  Any person desiring a permit to operate a remote -site 165 
pharmacy must apply to the department. If the board certifies 166 
that the application complies with the laws and rules of the 167 
board, the department must issue the permit. A permit may not be 168 
issued unless a licensed pharmacist or consultant pharmacist is 169 
designated as the prescription department manager responsible 170 
for the oversight of the remote -site pharmacy. The permittee 171 
must notify the department within 10 days after any change of 172 
the prescription department manager. 173 
 (3)  A remote-site pharmacy must comply with all of the 174 
following: 175     
 
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 (a)  Be jointly owned by or operated under a contract with 176 
a supervising pharmacy. 177 
 (b)  Be open between the hours of 7 p.m. to 9 a.m., in 178 
accordance with subse ction (6). 179 
 (c)  Maintain a video surveillance system that records 180 
continuously 24 hours a day, 7 days a week, and retain video 181 
surveillance recordings for at least 30 days. 182 
 (d)  Display a sign visible to the public indicating that 183 
the location is a remot e-site pharmacy and that the facility is 184 
under 24-hour video surveillance. 185 
 (e)  Maintain a policies and procedures manual, which must 186 
be made available to the board or its agent upon request and 187 
must include, but need not be limited to, all of the following: 188 
 1.  A description of how the remote -site pharmacy will 189 
comply with federal and state laws and rules. 190 
 2.  The procedures for supervising the remote -site pharmacy 191 
and counseling its patients. 192 
 3.  The procedures for reviewing the prescription dr ug 193 
inventory and drug records maintained by the remote -site 194 
pharmacy. 195 
 4.  The policies and procedures for providing security 196 
adequate to protect the confidentiality and integrity of patient 197 
information. 198 
 5.  The written plan for recovery from an event tha t 199 
interrupts or prevents the prescription department manager from 200     
 
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supervising the remote -site pharmacy's operation. 201 
 6.  The procedures for use of the state prescription drug 202 
monitoring program by the prescription department manager before 203 
he or she may authorize the dispensing of any controlled 204 
substance. 205 
 7.  The procedures for maintaining a perpetual inventory of 206 
the controlled substances listed in Schedule II of s. 893.03. 207 
 8.  The specific duties, tasks, and functions that 208 
registered pharmacy technicians are authorized to perform at the 209 
remote-site pharmacy. 210 
 (4)  A remote-site pharmacy may store, hold, or dispense 211 
any medicinal drug, including proprietary drugs and controlled 212 
substances. However, a remote -site pharmacy may not dispense 213 
Schedule II controlled substances listed in s. 893.03 unless a 214 
pharmacist is present at the remote -site pharmacy. 215 
 (5)  The prescription department manager must visit the 216 
remote-site pharmacy, based on a schedule determined by the 217 
board, to inspect the pharmacy, address personnel matters, and 218 
provide clinical services for patients. 219 
 (6)  A remote-site pharmacy may only be open when the 220 
supervising pharmacy is open, unless a pharmacist employed by or 221 
under contract with the supervising pharmacy, or a pharmacy 222 
under contract with the supervising pharmacy, is present at the 223 
remote-site pharmacy or is providing remote supervision as 224 
required under this section. 225     
 
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 (7)  The board may adopt rules as necessary to specify 226 
additional criteria for a remote -site pharmacy. Any a dditional 227 
criteria adopted by the board must be limited to rules 228 
concerning one or more of the following: 229 
 (a)  Application requirements. 230 
 (b)  Structural and equipment requirements. 231 
 (c)  Training requirements. 232 
 (d)  Inventory recordkeeping and storage re quirements. 233 
 Section 5.  Paragraph (c) of subsection (11) of section 234 
465.022, Florida Statutes, is amended to read: 235 
 465.022  Pharmacies; general requirements; fees. — 236 
 (11)  A permittee must notify the department of the 237 
identity of the prescription depar tment manager within 10 days 238 
after employment. The prescription department manager must 239 
comply with the following requirements: 240 
 (c)  A registered pharmacist may not serve as the 241 
prescription department manager in more than one location , 242 
except when acting as a prescription department manager under s. 243 
465.0198, unless approved by the board. 244 
 Section 6. This act shall take effect July 1, 2025. 245