Florida 2025 Regular Session

Florida Senate Bill S0906 Latest Draft

Bill / Introduced Version Filed 02/19/2025

 Florida Senate - 2025 SB 906  By Senator Collins 14-00110B-25 2025906__ 1 A bill to be entitled 2 An act relating to pharmacy; amending s. 465.003, 3 F.S.; revising the definition of the term pharmacy 4 to include remote-site pharmacies; revising 5 construction of the term not present and on duty; 6 amending s. 465.014, F.S.; authorizing registered 7 pharmacy technicians to handle the sales transactions 8 and delivery of dispensed drugs under certain 9 circumstances; providing an exception to certain 10 supervision limitations; amending s. 465.015, F.S.; 11 providing applicability; exempting certain registered 12 pharmacy technicians from specified prohibitions; 13 creating s. 465.0198, F.S.; defining terms; providing 14 for the permitting of remote-site pharmacies; 15 requiring that a licensed or consultant pharmacist 16 serve as the prescription department manager of a 17 remote-site pharmacy; requiring remote-site pharmacies 18 to notify the Department of Health of a change in the 19 pharmacys prescription department manager within a 20 specified timeframe; providing requirements for 21 remote-site pharmacies; authorizing 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 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; authorizing 32 the Board of Pharmacy to adopt specified rules; 33 amending s. 465.022, F.S.; exempting registered 34 pharmacists serving as prescription department 35 managers for remote-site pharmacies from certain 36 practice limitations; providing an effective date. 37 38 Be It Enacted by the Legislature of the State of Florida: 39 40 Section 1.Subsection (20) of section 465.003, Florida 41 Statutes, is amended to read: 42 465.003Definitions.As used in this chapter, the term: 43 (20)(a)Pharmacy includes a community pharmacy, an 44 institutional pharmacy, a nuclear pharmacy, a special pharmacy, 45 and an Internet pharmacy, and a remote-site pharmacy. 46 1.The term community pharmacy includes every location 47 where medicinal drugs are compounded, dispensed, stored, or sold 48 or where prescriptions are filled or dispensed on an outpatient 49 basis. 50 2.The term institutional pharmacy includes every 51 location in a hospital, clinic, nursing home, dispensary, 52 sanitarium, extended care facility, or other facility, 53 hereinafter referred to as health care institutions, where 54 medicinal drugs are compounded, dispensed, stored, or sold. 55 3.The term nuclear pharmacy includes every location 56 where radioactive drugs and chemicals within the classification 57 of medicinal drugs are compounded, dispensed, stored, or sold. 58 The term nuclear pharmacy does not include hospitals licensed 59 under chapter 395 or the nuclear medicine facilities of such 60 hospitals. 61 4.The term special pharmacy includes every location 62 where medicinal drugs are compounded, dispensed, stored, or sold 63 if such locations are not otherwise defined in this subsection. 64 5.The term Internet pharmacy includes locations not 65 otherwise licensed or issued a permit under this chapter, within 66 or outside this state, which use the Internet to communicate 67 with or obtain information from consumers in this state and use 68 such communication or information to fill or refill 69 prescriptions or to dispense, distribute, or otherwise engage in 70 the practice of pharmacy in this state. Any act described in 71 this definition constitutes the practice of the profession of 72 pharmacy. 73 6.The term remote-site pharmacy includes every location 74 where medicinal drugs are dispensed by a supervising pharmacist 75 as defined in s. 465.0198 who is 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 pharmacists responsibility to provide pharmacy services. 90 4.A supervising pharmacist as defined in s. 465.0198, 91 acting in the capacity of a prescription department manager, 92 from remotely supervising a registered pharmacy technician at a 93 remote-site pharmacy. 94 Section 2.Subsection (1) of section 465.014, Florida 95 Statutes, is amended to read: 96 465.014Pharmacy technician. 97 (1)A person other than a licensed pharmacist or pharmacy 98 intern may not engage in the practice of the profession of 99 pharmacy, except that a licensed pharmacist may delegate to 100 pharmacy technicians who are registered pursuant to this section 101 those duties, tasks, and functions that do not fall within the 102 purview of s. 465.003, and a registered pharmacy technician 103 operating under remote supervision of a supervising pharmacist 104 as defined in s. 465.0198 may handle the sales transactions and 105 delivery of the dispensed drugs. All such delegated acts must be 106 performed under the direct supervision of a licensed pharmacist 107 who is responsible for all such acts performed by persons under 108 his or her supervision. A registered pharmacy technician, under 109 the supervision of a pharmacist, may initiate or receive 110 communications with a practitioner or his or her agent, on 111 behalf of a patient, regarding refill authorization requests. A 112 licensed pharmacist may not supervise more than one registered 113 pharmacy technician, except as provided in s. 465.0198 or unless 114 otherwise permitted by the guidelines adopted by the board. The 115 board shall establish guidelines to be followed by licensees or 116 permittees in determining the circumstances under which a 117 licensed pharmacist may supervise more than one pharmacy 118 technician. 119 Section 3.Paragraph (b) of subsection (1) and paragraph 120 (b) of subsection (2) of section 465.015, Florida Statutes, are 121 amended to read: 122 465.015Violations and penalties. 123 (1)It is unlawful for any person to own, operate, 124 maintain, open, establish, conduct, or have charge of, either 125 alone or with another person or persons, a pharmacy: 126 (b)In which a person not licensed as a pharmacist in this 127 state or not registered as an intern in this state or in which 128 an intern who is not acting under the direct and immediate 129 personal supervision of a licensed pharmacist fills, compounds, 130 or dispenses any prescription or dispenses medicinal drugs. This 131 paragraph does not apply to any person who owns, operates, 132 maintains, opens, establishes, conducts, or has charge of a 133 remote-site pharmacy under s. 465.0198. 134 (2)It is unlawful for any person: 135 (b)To fill, compound, or dispense prescriptions or to 136 dispense medicinal drugs if such person does not hold an active 137 license as a pharmacist in this state, is not registered as an 138 intern in this state, or is an intern not acting under the 139 direct and immediate personal supervision of a licensed 140 pharmacist, or is not a registered pharmacy technician at a 141 remote-site pharmacy who is acting under remote supervision of a 142 licensed pharmacist pursuant to s. 465.0198. 143 Section 4.Section 465.0198, Florida Statutes, is created 144 to read: 145 465.0198Remote-site pharmacy permits. 146 (1)As used in this section, the term: 147 (a)Supervising pharmacist means a pharmacist licensed in 148 this state who is employed by or under contract with a pharmacy 149 licensed in this state and who remotely supervises registered 150 pharmacy technicians at a remote-site pharmacy at a maximum 151 ratio of one pharmacist to up to six registered pharmacy 152 technicians. 153 (b)Supervising pharmacy means a pharmacy licensed in 154 this state which employs or contracts with a pharmacist licensed 155 in this state who remotely supervises a registered pharmacy 156 technician at a remote-site pharmacy at a maximum ratio of one 157 pharmacist to up to six registered pharmacy technicians. 158 (c)Telepharmacy means the practice of pharmacy by a 159 pharmacist located in this state using telecommunications or 160 other automations and technologies to provide or supervise the 161 provision of pharmacy services to patients and their agents who 162 are located at sites other than where the pharmacist is located, 163 including dispensing of prescriptions to and counseling of 164 patients. 165 (2)Any person desiring a permit to operate a remote-site 166 pharmacy must apply to the department. If the board certifies 167 that the application complies with the laws and rules of the 168 board, the department must issue the permit. A permit may not be 169 issued unless a licensed pharmacist or consultant pharmacist is 170 designated as the prescription department manager responsible 171 for the oversight of the remote-site pharmacy. The permittee 172 must notify the department within 10 days after any change of 173 the prescription department manager. 174 (3)A remote-site pharmacy must comply with all of the 175 following: 176 (a)Be jointly owned by or operated under a contract with a 177 supervising pharmacy. 178 (b)Operate only between the hours of 7 p.m. and 9 a.m., in 179 accordance with subsection (6). 180 (c)Maintain a video surveillance system that records 181 continuously 24 hours a day, 7 days a week, and retain video 182 surveillance recordings for at least 30 days. 183 (d)Display a sign visible to the public indicating that 184 the location is a remote-site pharmacy and that the facility is 185 under 24-hour video surveillance. 186 (e)Maintain a policies and procedures manual, which must 187 be made available to the board or its agent upon request and 188 must include, but need not be limited to, all of the following: 189 1.A description of how the remote-site pharmacy will 190 comply with federal and state laws and rules. 191 2.The procedures for supervising the remote-site pharmacy 192 and counseling its patients. 193 3.The procedures for reviewing the prescription drug 194 inventory and drug records maintained by the remote-site 195 pharmacy. 196 4.The policies and procedures for providing security 197 adequate to protect the confidentiality and integrity of patient 198 information. 199 5.The written plan for recovery from an event that 200 interrupts or prevents the prescription department manager from 201 supervising the remote-site pharmacys operation. 202 6.The procedures for use of the state prescription drug 203 monitoring program by the prescription department manager before 204 he or she may authorize the dispensing of any controlled 205 substance. 206 7.The procedures for maintaining a perpetual inventory of 207 the controlled substances listed in Schedule II of s. 893.03. 208 8.The specific duties, tasks, and functions that 209 registered pharmacy technicians are authorized to perform at the 210 remote-site pharmacy. 211 (4)A remote-site pharmacy may store, hold, or dispense any 212 medicinal drug, including proprietary drugs and controlled 213 substances. However, a remote-site pharmacy may not dispense 214 Schedule II controlled substances listed in s. 893.03 unless a 215 pharmacist is present at the remote-site pharmacy. 216 (5)The prescription department manager must visit the 217 remote-site pharmacy, based on a schedule determined by the 218 board, to inspect the pharmacy, address personnel matters, and 219 provide clinical services for patients. 220 (6)A remote-site pharmacy may only be open when the 221 supervising pharmacy is open, unless a pharmacist employed by or 222 under contract with the supervising pharmacy, or a pharmacy 223 under contract with the supervising pharmacy, is present at the 224 remote-site pharmacy or is providing remote supervision as 225 required under this section. 226 (7)The board may adopt rules as necessary to specify 227 additional criteria for a remote-site pharmacy. Any additional 228 criteria adopted by the board must be limited to rules 229 concerning one or more of the following: 230 (a)Application requirements. 231 (b)Structural and equipment requirements. 232 (c)Training requirements. 233 (d)Inventory recordkeeping and storage requirements. 234 Section 5.Paragraph (c) of subsection (11) of section 235 465.022, Florida Statutes, is amended to read: 236 465.022Pharmacies; general requirements; fees. 237 (11)A permittee must notify the department of the identity 238 of the prescription department manager within 10 days after 239 employment. The prescription department manager must comply with 240 the following requirements: 241 (c)A registered pharmacist may not serve as the 242 prescription department manager in more than one location, 243 except when acting as a prescription department manager under s. 244 465.0198, unless approved by the board. 245 Section 6.This act shall take effect July 1, 2025.