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| 9 | 9 | | Page 1 of 10 |
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| 10 | 10 | | 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 |
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| 14 | 14 | | A bill to be entitled 1 |
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| 15 | 15 | | An act relating to pharmacy; amending s. 465.003, 2 |
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| 16 | 16 | | F.S.; revising the definition of the term "pharmacy" 3 |
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| 17 | 17 | | to include remote-site pharmacies; revising 4 |
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| 18 | 18 | | construction of the term "not present and on duty"; 5 |
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| 19 | 19 | | amending s. 465.014, F.S.; authorizing registered 6 |
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| 20 | 20 | | pharmacy technicians to handle the sales transactions 7 |
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| 21 | 21 | | and delivery of dispensed drugs under certain 8 |
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| 22 | 22 | | circumstances; providing an exception to certain 9 |
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| 23 | 23 | | supervision limitations; amending s. 465.015, F.S.; 10 |
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| 24 | 24 | | providing applicability; exempting certain registered 11 |
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| 25 | 25 | | pharmacy technicians from specified prohibitions; 12 |
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| 26 | 26 | | creating s. 465.0198, F.S.; defining terms; providing 13 |
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| 27 | 27 | | for the permitting of remote -site pharmacies; 14 |
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| 28 | 28 | | requiring that a licensed or consultant pharmacist 15 |
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| 29 | 29 | | serve as the prescription department manager of a 16 |
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| 30 | 30 | | remote-site pharmacy; requiring remote -site pharmacies 17 |
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| 31 | 31 | | to notify the Department of Health of a change in the 18 |
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| 32 | 32 | | pharmacy's prescription department manager within a 19 |
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| 33 | 33 | | specified timeframe; providing requirements for 20 |
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| 34 | 34 | | remote-site pharmacies; authorizing remote -site 21 |
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| 35 | 35 | | pharmacies to store, hold, and dispense medicinal 22 |
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| 36 | 36 | | drugs; prohibiting the dispensing of Schedule II 23 |
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| 37 | 37 | | medications at remote -site pharmacies unless a 24 |
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| 38 | 38 | | pharmacist is present; requiring prescription 25 |
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| 40 | 40 | | HB 273 2025 |
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| 46 | 46 | | Page 2 of 10 |
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| 47 | 47 | | 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 |
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| 50 | 50 | | |
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| 51 | 51 | | department managers to visit remote -site pharmacies, 26 |
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| 52 | 52 | | based on a certain sche dule, to perform specified 27 |
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| 53 | 53 | | tasks; prohibiting remote -site pharmacies from being 28 |
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| 54 | 54 | | open when the supervising pharmacy is closed unless a 29 |
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| 55 | 55 | | certain pharmacist is present or providing remote 30 |
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| 56 | 56 | | supervision at the remote -site pharmacy; authorizing 31 |
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| 57 | 57 | | the Board of Pharmacy to adopt specified rules; 32 |
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| 58 | 58 | | amending s. 465.022, F.S.; exempting registered 33 |
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| 59 | 59 | | pharmacists serving as prescription department 34 |
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| 60 | 60 | | managers for remote-site pharmacies from certain 35 |
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| 61 | 61 | | practice limitations; providing an effective date. 36 |
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| 62 | 62 | | 37 |
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| 63 | 63 | | Be It Enacted by the Legisl ature of the State of Florida: 38 |
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| 64 | 64 | | 39 |
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| 65 | 65 | | Section 1. Subsection (20) of section 465.003, Florida 40 |
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| 66 | 66 | | Statutes, is amended to read: 41 |
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| 67 | 67 | | 465.003 Definitions. —As used in this chapter, the term: 42 |
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| 68 | 68 | | (20)(a) "Pharmacy" includes a community pharmacy, an 43 |
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| 69 | 69 | | institutional pharmacy , a nuclear pharmacy, a special pharmacy, 44 |
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| 70 | 70 | | and an Internet pharmacy , and a remote-site pharmacy. 45 |
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| 71 | 71 | | 1. The term "community pharmacy" includes every location 46 |
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| 72 | 72 | | where medicinal drugs are compounded, dispensed, stored, or sold 47 |
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| 73 | 73 | | or where prescriptions are filled or dispensed on an outpatient 48 |
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| 74 | 74 | | basis. 49 |
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| 75 | 75 | | 2. The term "institutional pharmacy" includes every 50 |
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| 84 | 84 | | 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 |
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| 87 | 87 | | |
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| 88 | 88 | | location in a hospital, clinic, nursing home, dispensary, 51 |
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| 89 | 89 | | sanitarium, extended care facility, or other facility, 52 |
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| 90 | 90 | | hereinafter referred to as "health care institutions," where 53 |
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| 91 | 91 | | medicinal drugs are compounded, dispensed, stored, or sold. 54 |
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| 92 | 92 | | 3. The term "nuclear pharmacy" includes every location 55 |
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| 93 | 93 | | where radioactive drugs and chemicals within the classification 56 |
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| 94 | 94 | | of medicinal drugs are compounded, dispensed, stored, or sold. 57 |
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| 95 | 95 | | The term "nuclear pharmacy" does not include hospitals licensed 58 |
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| 96 | 96 | | under chapter 395 or the nuclear medicine facilities of such 59 |
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| 97 | 97 | | hospitals. 60 |
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| 98 | 98 | | 4. The term "special pharmacy" includes every location 61 |
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| 99 | 99 | | where medicinal drugs are compounded, dispensed, stored, or sold 62 |
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| 100 | 100 | | if such locations are not otherwise defined in this subsection. 63 |
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| 101 | 101 | | 5. The term "Internet pharmacy" includes locations not 64 |
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| 102 | 102 | | otherwise licensed or issued a permit under this chapter, within 65 |
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| 103 | 103 | | or outside this state, which use the Internet to communicate 66 |
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| 104 | 104 | | with or obtain information from consumers in this state and use 67 |
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| 105 | 105 | | such communication or information to fill or refill 68 |
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| 106 | 106 | | prescriptions or to dispense, distribute, or otherwise engage in 69 |
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| 107 | 107 | | the practice of pharmacy in this state. Any act described in 70 |
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| 108 | 108 | | this definition constitute s the practice of the profession of 71 |
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| 109 | 109 | | pharmacy. 72 |
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| 110 | 110 | | 6. The term "remote -site pharmacy" includes every location 73 |
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| 111 | 111 | | where medicinal drugs are dispensed by a supervising pharmacist 74 |
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| 112 | 112 | | as defined in s. 465.0198 who is remotely supervising a 75 |
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| 121 | 121 | | 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 |
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| 122 | 122 | | |
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| 123 | 123 | | |
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| 124 | 124 | | |
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| 125 | 125 | | registered pharmacy technicia n handling the sales transactions 76 |
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| 126 | 126 | | and delivery of the drugs. 77 |
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| 127 | 127 | | (b) The pharmacy department of any permittee is shall be 78 |
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| 128 | 128 | | considered closed whenever a Florida licensed pharmacist is not 79 |
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| 129 | 129 | | present and on duty. The term "not present and on duty" may 80 |
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| 130 | 130 | | shall not be construed to prevent any of the following: 81 |
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| 131 | 131 | | 1. A pharmacist from exiting the prescription department 82 |
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| 132 | 132 | | for the purposes of consulting or responding to inquiries or 83 |
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| 133 | 133 | | providing assistance to patients or customers . 84 |
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| 134 | 134 | | 2. A pharmacist from , attending to personal hygiene needs. 85 |
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| 135 | 135 | | 3. A pharmacist from , or performing any other function for 86 |
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| 136 | 136 | | which the pharmacist is responsible, provided that such 87 |
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| 137 | 137 | | activities are conducted in a manner consistent with the 88 |
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| 138 | 138 | | pharmacist's responsibility to provide pharmacy services. 89 |
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| 139 | 139 | | 4. A supervising pharmacist as defined in s. 465.0198, 90 |
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| 140 | 140 | | acting in the capacity of a prescription department manager, 91 |
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| 141 | 141 | | from remotely supervising a registered pharmacy technician at a 92 |
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| 142 | 142 | | remote-site pharmacy. 93 |
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| 143 | 143 | | Section 2. Subsection (1) of section 465.014, Florida 94 |
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| 144 | 144 | | Statutes, is amended to read: 95 |
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| 145 | 145 | | 465.014 Pharmacy technician. — 96 |
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| 146 | 146 | | (1) A person other than a licensed pharmacist or pharmacy 97 |
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| 147 | 147 | | intern may not engage in the practice of the profession of 98 |
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| 148 | 148 | | pharmacy, except that a licensed pharmacist may delegate to 99 |
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| 149 | 149 | | pharmacy technicians who are registered pursuant to this section 100 |
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| 158 | 158 | | 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 |
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| 159 | 159 | | |
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| 160 | 160 | | |
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| 161 | 161 | | |
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| 162 | 162 | | those duties, tasks, and functions that do not fall within the 101 |
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| 163 | 163 | | purview of s. 465.003 , and a registered pharmacy technician 102 |
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| 164 | 164 | | operating under remote supervision of a supervising pharmacist 103 |
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| 165 | 165 | | as defined in s. 465. 0198 may handle the sales transactions and 104 |
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| 166 | 166 | | delivery of the dispensed drugs . All such delegated acts must be 105 |
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| 167 | 167 | | performed under the direct supervision of a licensed pharmacist 106 |
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| 168 | 168 | | who is responsible for all such acts performed by persons under 107 |
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| 169 | 169 | | his or her supervisi on. A registered pharmacy technician, under 108 |
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| 170 | 170 | | the supervision of a pharmacist, may initiate or receive 109 |
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| 171 | 171 | | communications with a practitioner or his or her agent, on 110 |
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| 172 | 172 | | behalf of a patient, regarding refill authorization requests. A 111 |
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| 173 | 173 | | licensed pharmacist may not supe rvise more than one registered 112 |
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| 174 | 174 | | pharmacy technician, except as provided in s. 465.0198 or unless 113 |
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| 175 | 175 | | otherwise permitted by the guidelines adopted by the board. The 114 |
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| 176 | 176 | | board shall establish guidelines to be followed by licensees or 115 |
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| 177 | 177 | | permittees in determining the ci rcumstances under which a 116 |
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| 178 | 178 | | licensed pharmacist may supervise more than one pharmacy 117 |
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| 179 | 179 | | technician. 118 |
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| 180 | 180 | | Section 3. Paragraph (b) of subsection (1) and paragraph 119 |
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| 181 | 181 | | (b) of subsection (2) of section 465.015, Florida Statutes, are 120 |
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| 182 | 182 | | amended to read: 121 |
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| 183 | 183 | | 465.015 Violations and penalties.— 122 |
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| 184 | 184 | | (1) It is unlawful for any person to own, operate, 123 |
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| 185 | 185 | | maintain, open, establish, conduct, or have charge of, either 124 |
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| 186 | 186 | | alone or with another person or persons, a pharmacy: 125 |
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| 195 | 195 | | 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 |
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| 196 | 196 | | |
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| 197 | 197 | | |
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| 198 | 198 | | |
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| 199 | 199 | | (b) In which a person not licensed as a pharmacist in this 126 |
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| 200 | 200 | | state or not registered as an intern in this state or in which 127 |
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| 201 | 201 | | an intern who is not acting under the direct and immediate 128 |
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| 202 | 202 | | personal supervision of a licensed pharmacist fills, compounds, 129 |
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| 203 | 203 | | or dispenses any prescription or dispenses medicinal drugs. This 130 |
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| 204 | 204 | | paragraph does not apply to any person who owns, operates, 131 |
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| 205 | 205 | | maintains, opens, establishes, conducts, or has charge of a 132 |
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| 206 | 206 | | remote-site pharmacy under s. 465.0198. 133 |
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| 207 | 207 | | (2) It is unlawful for any person: 134 |
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| 208 | 208 | | (b) To fill, compound, or dispense prescriptions or to 135 |
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| 209 | 209 | | dispense medicinal drugs if such person does not hold an active 136 |
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| 210 | 210 | | license as a pharmacist in this state, is not registered as an 137 |
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| 211 | 211 | | intern in this state, or is an intern not acting under the 138 |
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| 212 | 212 | | direct and immediate personal supervision of a licensed 139 |
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| 213 | 213 | | pharmacist, or is not a registe red pharmacy technician at a 140 |
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| 214 | 214 | | remote-site pharmacy who is acting under remote supervision of a 141 |
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| 215 | 215 | | licensed pharmacist pursuant to s. 465.0198 . 142 |
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| 216 | 216 | | Section 4. Section 465.0198, Florida Statutes, is created 143 |
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| 217 | 217 | | to read: 144 |
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| 218 | 218 | | 465.0198 Remote-site pharmacy permits. — 145 |
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| 219 | 219 | | (1) As used in this section, the term: 146 |
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| 220 | 220 | | (a) "Supervising pharmacist" means a pharmacist licensed 147 |
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| 221 | 221 | | in this state who is employed by or under contract with a 148 |
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| 222 | 222 | | pharmacy licensed in this state and who remotely supervises 149 |
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| 223 | 223 | | registered pharmacy technicians at a remot e-site pharmacy at a 150 |
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| 232 | 232 | | 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 |
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| 233 | 233 | | |
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| 234 | 234 | | |
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| 235 | 235 | | |
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| 236 | 236 | | maximum ratio of one pharmacist to up to six registered pharmacy 151 |
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| 237 | 237 | | technicians. 152 |
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| 238 | 238 | | (b) "Supervising pharmacy" means a pharmacy licensed in 153 |
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| 239 | 239 | | this state which employs or contracts with a pharmacist licensed 154 |
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| 240 | 240 | | in this state who remotely supervi ses a registered pharmacy 155 |
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| 241 | 241 | | technician at a remote -site pharmacy at a ratio of one 156 |
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| 242 | 242 | | pharmacist to up to six registered pharmacy technicians. 157 |
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| 243 | 243 | | (c) "Telepharmacy" means the practice of pharmacy by a 158 |
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| 244 | 244 | | pharmacist located in this state using telecommunications or 159 |
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| 245 | 245 | | other automations and technologies to provide or supervise the 160 |
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| 246 | 246 | | provision of pharmacy services to patients and their agents who 161 |
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| 247 | 247 | | are located at sites other than where the pharmacist is located, 162 |
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| 248 | 248 | | including dispensing of prescriptions to and counseling of 163 |
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| 249 | 249 | | patients. 164 |
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| 250 | 250 | | (2) Any person desiring a permit to operate a remote -site 165 |
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| 251 | 251 | | pharmacy must apply to the department. If the board certifies 166 |
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| 252 | 252 | | that the application complies with the laws and rules of the 167 |
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| 253 | 253 | | board, the department must issue the permit. A permit may not be 168 |
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| 254 | 254 | | issued unless a licensed pharmacist or consultant pharmacist is 169 |
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| 255 | 255 | | designated as the prescription department manager responsible 170 |
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| 256 | 256 | | for the oversight of the remote -site pharmacy. The permittee 171 |
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| 257 | 257 | | must notify the department within 10 days after any change of 172 |
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| 258 | 258 | | the prescription department manager. 173 |
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| 259 | 259 | | (3) A remote-site pharmacy must comply with all of the 174 |
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| 260 | 260 | | following: 175 |
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| 269 | 269 | | 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 |
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| 270 | 270 | | |
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| 271 | 271 | | |
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| 272 | 272 | | |
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| 273 | 273 | | (a) Be jointly owned by or operated under a contract with 176 |
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| 274 | 274 | | a supervising pharmacy. 177 |
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| 275 | 275 | | (b) Be open between the hours of 7 p.m. to 9 a.m., in 178 |
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| 276 | 276 | | accordance with subse ction (6). 179 |
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| 277 | 277 | | (c) Maintain a video surveillance system that records 180 |
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| 278 | 278 | | continuously 24 hours a day, 7 days a week, and retain video 181 |
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| 279 | 279 | | surveillance recordings for at least 30 days. 182 |
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| 280 | 280 | | (d) Display a sign visible to the public indicating that 183 |
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| 281 | 281 | | the location is a remot e-site pharmacy and that the facility is 184 |
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| 282 | 282 | | under 24-hour video surveillance. 185 |
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| 283 | 283 | | (e) Maintain a policies and procedures manual, which must 186 |
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| 284 | 284 | | be made available to the board or its agent upon request and 187 |
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| 285 | 285 | | must include, but need not be limited to, all of the following: 188 |
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| 286 | 286 | | 1. A description of how the remote -site pharmacy will 189 |
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| 287 | 287 | | comply with federal and state laws and rules. 190 |
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| 288 | 288 | | 2. The procedures for supervising the remote -site pharmacy 191 |
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| 289 | 289 | | and counseling its patients. 192 |
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| 290 | 290 | | 3. The procedures for reviewing the prescription dr ug 193 |
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| 291 | 291 | | inventory and drug records maintained by the remote -site 194 |
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| 292 | 292 | | pharmacy. 195 |
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| 293 | 293 | | 4. The policies and procedures for providing security 196 |
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| 294 | 294 | | adequate to protect the confidentiality and integrity of patient 197 |
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| 295 | 295 | | information. 198 |
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| 296 | 296 | | 5. The written plan for recovery from an event tha t 199 |
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| 297 | 297 | | interrupts or prevents the prescription department manager from 200 |
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| 306 | 306 | | 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 |
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| 307 | 307 | | |
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| 308 | 308 | | |
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| 309 | 309 | | |
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| 310 | 310 | | supervising the remote -site pharmacy's operation. 201 |
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| 311 | 311 | | 6. The procedures for use of the state prescription drug 202 |
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| 312 | 312 | | monitoring program by the prescription department manager before 203 |
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| 313 | 313 | | he or she may authorize the dispensing of any controlled 204 |
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| 314 | 314 | | substance. 205 |
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| 315 | 315 | | 7. The procedures for maintaining a perpetual inventory of 206 |
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| 316 | 316 | | the controlled substances listed in Schedule II of s. 893.03. 207 |
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| 317 | 317 | | 8. The specific duties, tasks, and functions that 208 |
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| 318 | 318 | | registered pharmacy technicians are authorized to perform at the 209 |
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| 319 | 319 | | remote-site pharmacy. 210 |
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| 320 | 320 | | (4) A remote-site pharmacy may store, hold, or dispense 211 |
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| 321 | 321 | | any medicinal drug, including proprietary drugs and controlled 212 |
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| 322 | 322 | | substances. However, a remote -site pharmacy may not dispense 213 |
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| 323 | 323 | | Schedule II controlled substances listed in s. 893.03 unless a 214 |
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| 324 | 324 | | pharmacist is present at the remote -site pharmacy. 215 |
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| 325 | 325 | | (5) The prescription department manager must visit the 216 |
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| 326 | 326 | | remote-site pharmacy, based on a schedule determined by the 217 |
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| 327 | 327 | | board, to inspect the pharmacy, address personnel matters, and 218 |
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| 328 | 328 | | provide clinical services for patients. 219 |
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| 329 | 329 | | (6) A remote-site pharmacy may only be open when the 220 |
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| 330 | 330 | | supervising pharmacy is open, unless a pharmacist employed by or 221 |
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| 331 | 331 | | under contract with the supervising pharmacy, or a pharmacy 222 |
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| 332 | 332 | | under contract with the supervising pharmacy, is present at the 223 |
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| 333 | 333 | | remote-site pharmacy or is providing remote supervision as 224 |
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| 334 | 334 | | required under this section. 225 |
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| 343 | 343 | | 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 |
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| 345 | 345 | | |
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| 346 | 346 | | |
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| 347 | 347 | | (7) The board may adopt rules as necessary to specify 226 |
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| 348 | 348 | | additional criteria for a remote -site pharmacy. Any a dditional 227 |
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| 349 | 349 | | criteria adopted by the board must be limited to rules 228 |
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| 350 | 350 | | concerning one or more of the following: 229 |
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| 351 | 351 | | (a) Application requirements. 230 |
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| 352 | 352 | | (b) Structural and equipment requirements. 231 |
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| 353 | 353 | | (c) Training requirements. 232 |
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| 354 | 354 | | (d) Inventory recordkeeping and storage re quirements. 233 |
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| 355 | 355 | | Section 5. Paragraph (c) of subsection (11) of section 234 |
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| 356 | 356 | | 465.022, Florida Statutes, is amended to read: 235 |
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| 357 | 357 | | 465.022 Pharmacies; general requirements; fees. — 236 |
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| 358 | 358 | | (11) A permittee must notify the department of the 237 |
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| 359 | 359 | | identity of the prescription depar tment manager within 10 days 238 |
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| 360 | 360 | | after employment. The prescription department manager must 239 |
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| 361 | 361 | | comply with the following requirements: 240 |
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| 362 | 362 | | (c) A registered pharmacist may not serve as the 241 |
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| 363 | 363 | | prescription department manager in more than one location , 242 |
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| 364 | 364 | | except when acting as a prescription department manager under s. 243 |
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| 365 | 365 | | 465.0198, unless approved by the board. 244 |
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| 366 | 366 | | Section 6. This act shall take effect July 1, 2025. 245 |
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