| 16 | | - | F.S.; revising the definition of the term "pharmacy" 3 |
|---|
| 17 | | - | to include remote-site pharmacies; revising 4 |
|---|
| 18 | | - | construction of the term "not present and on duty"; 5 |
|---|
| 19 | | - | amending s. 465.014, F.S.; authorizing registered 6 |
|---|
| 20 | | - | pharmacy technicians to perform certain delegated 7 |
|---|
| 21 | | - | tasks at a remote-site pharmacy under remote 8 |
|---|
| 22 | | - | supervision; establishing the maximum number of 9 |
|---|
| 23 | | - | registered pharmacy technicians that a pharmacist may 10 |
|---|
| 24 | | - | remotely supervise; creating s. 465.0198, F.S.; 11 |
|---|
| 25 | | - | defining the terms "supervising pharmacist" and 12 |
|---|
| 26 | | - | "supervising pharmacy"; providing for the permitting 13 |
|---|
| 27 | | - | of remote-site pharmacies; requiring a licensed or 14 |
|---|
| 28 | | - | consultant pharmacist to serve as the prescription 15 |
|---|
| 29 | | - | department manager of a remote -site pharmacy; 16 |
|---|
| 30 | | - | requiring remote-site pharmacies to notify the 17 |
|---|
| 31 | | - | Department of Health of a change in the pharmacy's 18 |
|---|
| 32 | | - | prescription department manager within a specified 19 |
|---|
| 33 | | - | timeframe; providing requirements for remote -site 20 |
|---|
| 34 | | - | pharmacies; authorizing remote -site pharmacies to 21 |
|---|
| 35 | | - | store, hold, and dispense medici nal drugs; prohibiting 22 |
|---|
| 36 | | - | the dispensing of Schedule II medications at remote -23 |
|---|
| 37 | | - | site pharmacies unless a pharmacist is present; 24 |
|---|
| 38 | | - | requiring prescription department managers to visit 25 |
|---|
| 16 | + | F.S.; revising the definition of the term "dispense"; 3 |
|---|
| 17 | + | revising the definition of the term "pharmacy" to 4 |
|---|
| 18 | + | include remote-site pharmacies; revising construction 5 |
|---|
| 19 | + | of the term "not present and on duty"; amending s. 6 |
|---|
| 20 | + | 465.014, F.S.; authorizi ng registered pharmacy 7 |
|---|
| 21 | + | technicians to dispense medicinal drugs under certain 8 |
|---|
| 22 | + | circumstances; providing an exception to certain 9 |
|---|
| 23 | + | supervision limitations; amending s. 465.015, F.S.; 10 |
|---|
| 24 | + | providing applicability; exempting certain registered 11 |
|---|
| 25 | + | pharmacy technicians fro m specified prohibitions; 12 |
|---|
| 26 | + | creating s. 465.0198, F.S.; defining the terms 13 |
|---|
| 27 | + | "supervising pharmacy" and "telepharmacy"; providing 14 |
|---|
| 28 | + | for the permitting of remote -site pharmacies; 15 |
|---|
| 29 | + | requiring a licensed or consultant pharmacist to serve 16 |
|---|
| 30 | + | as the prescription departmen t manager of a remote -17 |
|---|
| 31 | + | site pharmacy; requiring remote -site pharmacies to 18 |
|---|
| 32 | + | notify the Department of Health of a change in the 19 |
|---|
| 33 | + | pharmacy's prescription department manager within a 20 |
|---|
| 34 | + | specified timeframe; providing requirements for 21 |
|---|
| 35 | + | remote-site pharmacies; authoriz ing remote-site 22 |
|---|
| 36 | + | pharmacies to store, hold, and dispense medicinal 23 |
|---|
| 37 | + | drugs; prohibiting the dispensing of Schedule II 24 |
|---|
| 38 | + | medications at remote -site pharmacies unless a 25 |
|---|
| 51 | | - | remote-site pharmacies, based on a certain schedule, 26 |
|---|
| 52 | | - | to perform specified tasks; prohibiting remote-site 27 |
|---|
| 53 | | - | pharmacies from being open when the supervising 28 |
|---|
| 54 | | - | pharmacy is closed unless a supervising pharmacist is 29 |
|---|
| 55 | | - | present or providing remote supervision at the remote -30 |
|---|
| 56 | | - | site pharmacy; authorizing the Board of Pharmacy to 31 |
|---|
| 57 | | - | adopt specified rules; a mending s. 465.022, F.S.; 32 |
|---|
| 58 | | - | exempting registered pharmacists serving as 33 |
|---|
| 59 | | - | prescription department managers for remote -site 34 |
|---|
| 60 | | - | pharmacies from certain practice limitations; 35 |
|---|
| 61 | | - | providing an effective date. 36 |
|---|
| 62 | | - | 37 |
|---|
| 63 | | - | Be It Enacted by the Legislature of the State of Florida: 38 |
|---|
| 64 | | - | 39 |
|---|
| 65 | | - | Section 1. Subsection (20) of section 465.003, Florida 40 |
|---|
| 66 | | - | Statutes, is amended to read: 41 |
|---|
| 67 | | - | 465.003 Definitions. —As used in this chapter, the term: 42 |
|---|
| 68 | | - | (20)(a) "Pharmacy" includes a community pharmacy, an 43 |
|---|
| 69 | | - | institutional pharmacy, a nuclear pharmacy, a specia l pharmacy, 44 |
|---|
| 70 | | - | and an Internet pharmacy , and a remote-site pharmacy. 45 |
|---|
| 71 | | - | 1. The term "community pharmacy" includes every location 46 |
|---|
| 72 | | - | where medicinal drugs are compounded, dispensed, stored, or sold 47 |
|---|
| 73 | | - | or where prescriptions are filled or dispensed on an outpatient 48 |
|---|
| 74 | | - | basis. 49 |
|---|
| 75 | | - | 2. The term "institutional pharmacy" includes every 50 |
|---|
| 51 | + | pharmacist is present; requiring prescription 26 |
|---|
| 52 | + | department managers to visit remote -site pharmacies, 27 |
|---|
| 53 | + | based on a certain schedule, to perform specified 28 |
|---|
| 54 | + | tasks; prohibiting remote -site pharmacies from being 29 |
|---|
| 55 | + | open when the supervising pharmacy is closed unless a 30 |
|---|
| 56 | + | certain pharmacist is present or providing remote 31 |
|---|
| 57 | + | supervision at the remote -site pharmacy; prohibiting 32 |
|---|
| 58 | + | registered pharmacists from serving as prescription 33 |
|---|
| 59 | + | department managers for more than three remote -site 34 |
|---|
| 60 | + | pharmacies under certain circumstances; authorizing 35 |
|---|
| 61 | + | the Board of Pharmacy to adopt specified rules; 36 |
|---|
| 62 | + | amending s. 465.022, F.S.; exempting regist ered 37 |
|---|
| 63 | + | pharmacists serving as prescription department 38 |
|---|
| 64 | + | managers for remote-site pharmacies from certain 39 |
|---|
| 65 | + | practice limitations; providing an effective date. 40 |
|---|
| 66 | + | 41 |
|---|
| 67 | + | Be It Enacted by the Legislature of the State of Florida: 42 |
|---|
| 68 | + | 43 |
|---|
| 69 | + | Section 1. Subsections (13) and (20) of section 465.003, 44 |
|---|
| 70 | + | Florida Statutes, are amended to read: 45 |
|---|
| 71 | + | 465.003 Definitions. —As used in this chapter, the term: 46 |
|---|
| 72 | + | (13) "Dispense" means the transfer of possession of one or 47 |
|---|
| 73 | + | more doses of a medicinal drug by a pharmacist , or by a 48 |
|---|
| 74 | + | registered pharmacy t echnician who is remotely supervised by an 49 |
|---|
| 75 | + | offsite pharmacist, to the ultimate consumer or her or his 50 |
|---|
| 88 | | - | location in a hospital, clinic, nursing home, dispensary, 51 |
|---|
| 89 | | - | sanitarium, extended care facility, or other facility, 52 |
|---|
| 90 | | - | hereinafter referred to as "health care institutions," where 53 |
|---|
| 91 | | - | medicinal drugs are com pounded, dispensed, stored, or sold. 54 |
|---|
| 92 | | - | 3. The term "nuclear pharmacy" includes every location 55 |
|---|
| 93 | | - | where radioactive drugs and chemicals within the classification 56 |
|---|
| 94 | | - | of medicinal drugs are compounded, dispensed, stored, or sold. 57 |
|---|
| 95 | | - | The term "nuclear pharmacy" does no t include hospitals licensed 58 |
|---|
| 96 | | - | under chapter 395 or the nuclear medicine facilities of such 59 |
|---|
| 97 | | - | hospitals. 60 |
|---|
| 98 | | - | 4. The term "special pharmacy" includes every location 61 |
|---|
| 99 | | - | where medicinal drugs are compounded, dispensed, stored, or sold 62 |
|---|
| 100 | | - | if such locations are not otherwi se defined in this subsection. 63 |
|---|
| 101 | | - | 5. The term "Internet pharmacy" includes locations not 64 |
|---|
| 102 | | - | otherwise licensed or issued a permit under this chapter, within 65 |
|---|
| 103 | | - | or outside this state, which use the Internet to communicate 66 |
|---|
| 104 | | - | with or obtain information from consumers in this state and use 67 |
|---|
| 105 | | - | such communication or information to fill or refill 68 |
|---|
| 106 | | - | prescriptions or to dispense, distribute, or otherwise engage in 69 |
|---|
| 107 | | - | the practice of pharmacy in this state. Any act described in 70 |
|---|
| 108 | | - | this definition constitutes the practice of the professi on of 71 |
|---|
| 109 | | - | pharmacy. 72 |
|---|
| 110 | | - | 6. The term "remote -site pharmacy" means a location where 73 |
|---|
| 111 | | - | medicinal drugs are dispensed by a supervising pharmacist as 74 |
|---|
| 112 | | - | defined in s. 465.0198(1) who is acting in the capacity of a 75 |
|---|
| 88 | + | agent. As an element of dispensing, the pharmacist shall, prior 51 |
|---|
| 89 | + | to the actual physical transfer, interpret and assess the 52 |
|---|
| 90 | + | prescription order for potential adverse reactions, 53 |
|---|
| 91 | + | interactions, and dosage regimen she or he deems appropriate in 54 |
|---|
| 92 | + | the exercise of her or his professional judgment, and the 55 |
|---|
| 93 | + | pharmacist shall certify that the medicinal drug called for by 56 |
|---|
| 94 | + | the prescription is ready for transfer. The pharmac ist shall 57 |
|---|
| 95 | + | also provide counseling on proper drug usage, either orally or 58 |
|---|
| 96 | + | in writing, if in the exercise of her or his professional 59 |
|---|
| 97 | + | judgment counseling is necessary. The actual sales transaction 60 |
|---|
| 98 | + | and delivery of such drug shall not be considered dispensing. 61 |
|---|
| 99 | + | The administration shall not be considered dispensing. 62 |
|---|
| 100 | + | (20)(a) "Pharmacy" includes a community pharmacy, an 63 |
|---|
| 101 | + | institutional pharmacy, a nuclear pharmacy, a special pharmacy, 64 |
|---|
| 102 | + | and an Internet pharmacy , and a remote-site pharmacy. 65 |
|---|
| 103 | + | 1. The term "community pha rmacy" includes every location 66 |
|---|
| 104 | + | where medicinal drugs are compounded, dispensed, stored, or sold 67 |
|---|
| 105 | + | or where prescriptions are filled or dispensed on an outpatient 68 |
|---|
| 106 | + | basis. 69 |
|---|
| 107 | + | 2. The term "institutional pharmacy" includes every 70 |
|---|
| 108 | + | location in a hospital, clinic, nur sing home, dispensary, 71 |
|---|
| 109 | + | sanitarium, extended care facility, or other facility, 72 |
|---|
| 110 | + | hereinafter referred to as "health care institutions," where 73 |
|---|
| 111 | + | medicinal drugs are compounded, dispensed, stored, or sold. 74 |
|---|
| 112 | + | 3. The term "nuclear pharmacy" includes every location 75 |
|---|
| 125 | | - | prescription department manager and remotely supervising a 76 |
|---|
| 126 | | - | registered pharmacy technician handling the sales transactions 77 |
|---|
| 127 | | - | and delivery of the drugs. 78 |
|---|
| 128 | | - | (b) The pharmacy department of any permittee is shall be 79 |
|---|
| 129 | | - | considered closed whenever a Florida licensed pharmacist is not 80 |
|---|
| 130 | | - | present and on duty. The term "not present and on duty" may 81 |
|---|
| 131 | | - | shall not be construed to prevent any of the following: 82 |
|---|
| 132 | | - | 1. A pharmacist from exiting the prescription department 83 |
|---|
| 133 | | - | for the purposes of consulting or responding to inquiries or 84 |
|---|
| 134 | | - | providing assistance to patients or customers . 85 |
|---|
| 135 | | - | 2. A pharmacist from, attending to personal hygiene needs . 86 |
|---|
| 136 | | - | 3. A pharmacist from , or performing any other function for 87 |
|---|
| 137 | | - | which the pharmacist is responsible, provided that such 88 |
|---|
| 138 | | - | activities are conducted in a manner consistent with the 89 |
|---|
| 139 | | - | pharmacist's responsibility to provide pharmacy services. 90 |
|---|
| 140 | | - | 4. A supervising pharmacist as defined in s. 465 .0198(1) 91 |
|---|
| 141 | | - | who is acting in the capacity of a prescription department 92 |
|---|
| 142 | | - | manager from remotely supervising a registered pharmacy 93 |
|---|
| 143 | | - | technician at a remote -site pharmacy. 94 |
|---|
| 144 | | - | Section 2. Subsection (1) of section 465.014, Florida 95 |
|---|
| 145 | | - | Statutes, is amended, and subsection (10) is added to that 96 |
|---|
| 146 | | - | section, to read: 97 |
|---|
| 147 | | - | 465.014 Pharmacy technician. — 98 |
|---|
| 148 | | - | (1) A person other than a licensed pharmacist or pharmacy 99 |
|---|
| 149 | | - | intern may not engage in the practice of the profession of 100 |
|---|
| 125 | + | where radioactive drugs and chemicals within the classification 76 |
|---|
| 126 | + | of medicinal drugs are compounded, dispensed, stored, or sold. 77 |
|---|
| 127 | + | The term "nuclear pharmacy" does not include hospitals licensed 78 |
|---|
| 128 | + | under chapter 395 or the nuclear medicine facilities of such 79 |
|---|
| 129 | + | hospitals. 80 |
|---|
| 130 | + | 4. The term "special pharmacy" includes every location 81 |
|---|
| 131 | + | where medicinal drugs are compounded, dispensed, stored, or sold 82 |
|---|
| 132 | + | if such locations are not otherwise defined in this subsection. 83 |
|---|
| 133 | + | 5. The term "Internet pharmacy" includes locations not 84 |
|---|
| 134 | + | otherwise licensed or issued a permit under this chapter, within 85 |
|---|
| 135 | + | or outside this state, which use the Internet to communicate 86 |
|---|
| 136 | + | with or obtain information from consumers in this state and use 87 |
|---|
| 137 | + | such communication or information to fill or refill 88 |
|---|
| 138 | + | prescriptions or to dispense, distribute, or otherwise engage in 89 |
|---|
| 139 | + | the practice of pharmacy in this state. Any act described in 90 |
|---|
| 140 | + | this definition constitutes the practice of the profession of 91 |
|---|
| 141 | + | pharmacy. 92 |
|---|
| 142 | + | 6. The term "remote -site pharmacy" includes every location 93 |
|---|
| 143 | + | where medicinal drugs are dispensed by a registered pharmacy 94 |
|---|
| 144 | + | technician who is remotely supervised by an offsite pharmacist 95 |
|---|
| 145 | + | acting in the capacity of a prescription department manager. 96 |
|---|
| 146 | + | (b) The pharmacy department of any permittee is shall be 97 |
|---|
| 147 | + | considered closed whenever a Florida licensed pharmacist is not 98 |
|---|
| 148 | + | present and on duty. The term "not present and on duty" may 99 |
|---|
| 149 | + | shall not be construed to prevent any of the following: 100 |
|---|
| 162 | | - | pharmacy as defined in s. 465.003 , except that a licensed 101 |
|---|
| 163 | | - | pharmacist may delegate to pharmacy technicians who are 102 |
|---|
| 164 | | - | registered pursuant to this section those duties, tasks, and 103 |
|---|
| 165 | | - | functions that do not fall within the purview of s. 465.003. 104 |
|---|
| 166 | | - | Except as otherwise provided in this section, all such delegated 105 |
|---|
| 167 | | - | acts must be performed under the direct supervision of a 106 |
|---|
| 168 | | - | licensed pharmacist who is responsible for all such acts 107 |
|---|
| 169 | | - | performed by persons under his or her supervision. A registered 108 |
|---|
| 170 | | - | pharmacy technician, under the supervision of a pharmacist, may 109 |
|---|
| 171 | | - | initiate or receive communication s with a practitioner or his or 110 |
|---|
| 172 | | - | her agent, on behalf of a patient, regarding refill 111 |
|---|
| 173 | | - | authorization requests. A licensed pharmacist may not supervise 112 |
|---|
| 174 | | - | more than one registered pharmacy technician unless otherwise 113 |
|---|
| 175 | | - | permitted by the guidelines adopted by the boa rd. The board 114 |
|---|
| 176 | | - | shall establish guidelines to be followed by licensees or 115 |
|---|
| 177 | | - | permittees in determining the circumstances under which a 116 |
|---|
| 178 | | - | licensed pharmacist may supervise more than one pharmacy 117 |
|---|
| 179 | | - | technician. 118 |
|---|
| 180 | | - | (10) A registered pharmacy technician may perform the 119 |
|---|
| 181 | | - | delegated acts authorized by this section at a remote -site 120 |
|---|
| 182 | | - | pharmacy under the remote supervision of a supervising 121 |
|---|
| 183 | | - | pharmacist as defined in s. 465.0198(1). A supervising 122 |
|---|
| 184 | | - | pharmacist may not remotely supervise more than six registered 123 |
|---|
| 185 | | - | pharmacy technicians. 124 |
|---|
| 186 | | - | Section 3. Section 465.0198, Florida Statutes, is created 125 |
|---|
| 162 | + | 1. A pharmacist from exiting the prescription department 101 |
|---|
| 163 | + | for the purposes of consulting or responding t o inquiries or 102 |
|---|
| 164 | + | providing assistance to patients or customers . 103 |
|---|
| 165 | + | 2. A pharmacist from , attending to personal hygiene needs . 104 |
|---|
| 166 | + | 3. A pharmacist from , or performing any other function for 105 |
|---|
| 167 | + | which the pharmacist is responsible, provided that such 106 |
|---|
| 168 | + | activities are conducted in a manner consistent with the 107 |
|---|
| 169 | + | pharmacist's responsibility to provide pharmacy services. 108 |
|---|
| 170 | + | 4. An offsite pharmacist, acting in the capacity of a 109 |
|---|
| 171 | + | prescription department manager, from remotely supervising a 110 |
|---|
| 172 | + | registered pharmacy technician at a remote -site pharmacy. 111 |
|---|
| 173 | + | Section 2. Subsection (1) of section 465.014, Florida 112 |
|---|
| 174 | + | Statutes, is amended to read: 113 |
|---|
| 175 | + | 465.014 Pharmacy technician. — 114 |
|---|
| 176 | + | (1) A person other than a licensed pharmacist or pharmacy 115 |
|---|
| 177 | + | intern may not engage in the practice of the profession of 116 |
|---|
| 178 | + | pharmacy, except that a licensed pharmacist may delegate to 117 |
|---|
| 179 | + | pharmacy technicians who are registered pursuant to this section 118 |
|---|
| 180 | + | those duties, tasks, an d functions that do not fall within the 119 |
|---|
| 181 | + | purview of s. 465.003 , and a registered pharmacy technician 120 |
|---|
| 182 | + | operating under remote supervision of an offsite pharmacist 121 |
|---|
| 183 | + | under s. 465.0198 may dispense medicinal drugs under such 122 |
|---|
| 184 | + | supervision. All such delegated acts m ust be performed under the 123 |
|---|
| 185 | + | direct supervision of a licensed pharmacist who is responsible 124 |
|---|
| 186 | + | for all such acts performed by persons under his or her 125 |
|---|
| 199 | | - | to read: 126 |
|---|
| 200 | | - | 465.0198 Remote-site pharmacy permits. — 127 |
|---|
| 201 | | - | (1) As used in this section, the term: 128 |
|---|
| 202 | | - | (a) "Supervising pharmacist" means a pharmacist licensed 129 |
|---|
| 203 | | - | in this state employed by or under contract wi th a pharmacy 130 |
|---|
| 204 | | - | licensed in this state who remotely supervises registered 131 |
|---|
| 205 | | - | pharmacy technicians at a remote -site pharmacy. 132 |
|---|
| 206 | | - | (b) "Supervising pharmacy" means a pharmacy licensed in 133 |
|---|
| 207 | | - | this state which employs or contracts with a pharmacist licensed 134 |
|---|
| 208 | | - | in this state to serve as the supervising pharmacist for a 135 |
|---|
| 209 | | - | remote-site pharmacy that is jointly owned by or operated under 136 |
|---|
| 210 | | - | a contract with the pharmacy. 137 |
|---|
| 211 | | - | (2) Any person desiring a permit to operate a remote -site 138 |
|---|
| 212 | | - | pharmacy must apply to the department. If the board cert ifies 139 |
|---|
| 213 | | - | that the application complies with the laws and rules of the 140 |
|---|
| 214 | | - | board, the department must issue the permit. A permit may not be 141 |
|---|
| 215 | | - | issued unless a licensed pharmacist or consultant pharmacist is 142 |
|---|
| 216 | | - | designated as the prescription department manager responsibl e 143 |
|---|
| 217 | | - | for the oversight of the remote -site pharmacy. The permittee 144 |
|---|
| 218 | | - | must notify the department within 10 days after any change of 145 |
|---|
| 219 | | - | the prescription department manager. 146 |
|---|
| 220 | | - | (3) A remote-site pharmacy must comply with all of the 147 |
|---|
| 221 | | - | following: 148 |
|---|
| 222 | | - | (a) Be jointly owned by or operated under a contract with 149 |
|---|
| 223 | | - | a supervising pharmacy. 150 |
|---|
| 199 | + | supervision. A registered pharmacy technician, under the 126 |
|---|
| 200 | + | supervision of a pharmacist, may initiate or receive 127 |
|---|
| 201 | + | communications with a practitioner or his or her agent, on 128 |
|---|
| 202 | + | behalf of a patient, regarding refill authorization requests. A 129 |
|---|
| 203 | + | licensed pharmacist may not supervise more than one registered 130 |
|---|
| 204 | + | pharmacy technician, except as provided in s. 465.0198 or unless 131 |
|---|
| 205 | + | otherwise permitted by the guidelines adopted by the board. The 132 |
|---|
| 206 | + | board shall establish guidelines to be followed by licensees or 133 |
|---|
| 207 | + | permittees in determining the circumstances under which a 134 |
|---|
| 208 | + | licensed pharmacist may supervise more than one pharmacy 135 |
|---|
| 209 | + | technician. 136 |
|---|
| 210 | + | Section 3. Paragraph (b) of subsection (1) and paragraph 137 |
|---|
| 211 | + | (b) of subsection (2) of section 465.015, Florida Statutes, are 138 |
|---|
| 212 | + | amended to read: 139 |
|---|
| 213 | + | 465.015 Violations and penalties. — 140 |
|---|
| 214 | + | (1) It is unlawful for any person to own, operate, 141 |
|---|
| 215 | + | maintain, open, establish, con duct, or have charge of, either 142 |
|---|
| 216 | + | alone or with another person or persons, a pharmacy: 143 |
|---|
| 217 | + | (b) In which a person not licensed as a pharmacist in this 144 |
|---|
| 218 | + | state or not registered as an intern in this state or in which 145 |
|---|
| 219 | + | an intern who is not acting under the direct an d immediate 146 |
|---|
| 220 | + | personal supervision of a licensed pharmacist fills, compounds, 147 |
|---|
| 221 | + | or dispenses any prescription or dispenses medicinal drugs. This 148 |
|---|
| 222 | + | paragraph does not apply to any person who owns, operates, 149 |
|---|
| 223 | + | maintains, opens, establishes, conducts, or has charge o f a 150 |
|---|
| 236 | | - | (b) Maintain a video surveillance system that records 151 |
|---|
| 237 | | - | continuously 24 hours per day and retain video surveillance 152 |
|---|
| 238 | | - | recordings for at least 30 days. 153 |
|---|
| 239 | | - | (c) Display a sign visible to the public indica ting that 154 |
|---|
| 240 | | - | the location is a remote -site pharmacy and that the facility is 155 |
|---|
| 241 | | - | under 24-hour video surveillance. 156 |
|---|
| 242 | | - | (d) Maintain a policies and procedures manual, which must 157 |
|---|
| 243 | | - | be made available to the board or its agent upon request and 158 |
|---|
| 244 | | - | must include, but need not be limited to, all of the following: 159 |
|---|
| 245 | | - | 1. A description of how the pharmacy will comply with 160 |
|---|
| 246 | | - | federal and state laws and rules. 161 |
|---|
| 247 | | - | 2. The procedures for supervising the remote -site pharmacy 162 |
|---|
| 248 | | - | and counseling its patients. 163 |
|---|
| 249 | | - | 3. The procedures for reviewing the p rescription drug 164 |
|---|
| 250 | | - | inventory and drug records maintained by the remote -site 165 |
|---|
| 251 | | - | pharmacy. 166 |
|---|
| 252 | | - | 4. The policies and procedures for providing security 167 |
|---|
| 253 | | - | adequate to protect the confidentiality and integrity of patient 168 |
|---|
| 254 | | - | information. 169 |
|---|
| 255 | | - | 5. The written plan for recovery fro m an event that 170 |
|---|
| 256 | | - | interrupts or prevents the prescription department manager from 171 |
|---|
| 257 | | - | supervising the remote -site pharmacy's operation. 172 |
|---|
| 258 | | - | 6. The procedures for use of the state prescription drug 173 |
|---|
| 259 | | - | monitoring program by the prescription department manager before 174 |
|---|
| 260 | | - | he or she may authorize the dispensing of any controlled 175 |
|---|
| 236 | + | remote-site pharmacy under s. 465.0198. 151 |
|---|
| 237 | + | (2) It is unlawful for any person: 152 |
|---|
| 238 | + | (b) To fill, compound, or dispense prescriptions or to 153 |
|---|
| 239 | + | dispense medicinal drugs if such person does not hold an active 154 |
|---|
| 240 | + | license as a pharmacist in this state, is not register ed as an 155 |
|---|
| 241 | + | intern in this state, or is an intern not acting under the 156 |
|---|
| 242 | + | direct and immediate personal supervision of a licensed 157 |
|---|
| 243 | + | pharmacist, or is not a registered pharmacy technician at a 158 |
|---|
| 244 | + | remote-site pharmacy who is acting under remote supervision of a 159 |
|---|
| 245 | + | licensed pharmacist pursuant to s. 465.0198 . 160 |
|---|
| 246 | + | Section 4. Section 465.0198, Florida Statutes, is created 161 |
|---|
| 247 | + | to read: 162 |
|---|
| 248 | + | 465.0198 Remote-site pharmacy permits. — 163 |
|---|
| 249 | + | (1) As used in this section, the term: 164 |
|---|
| 250 | + | (a) "Supervising pharmacy" means a pharmacy licensed in 165 |
|---|
| 251 | + | this state which employs or contracts with a pharmacist licensed 166 |
|---|
| 252 | + | in this state who remotely supervises a registered pharmacy 167 |
|---|
| 253 | + | technician at a remote -site pharmacy at a ratio of one 168 |
|---|
| 254 | + | pharmacist to up to six registered pharmacy technicians. 169 |
|---|
| 255 | + | (b) "Telepharmacy" mean s the practice of pharmacy by a 170 |
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| 256 | + | pharmacist located in this state using telecommunications or 171 |
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| 257 | + | other automations and technologies to provide or supervise the 172 |
|---|
| 258 | + | provision of pharmacy services to patients and their agents who 173 |
|---|
| 259 | + | are located at sites other than wher e the pharmacist is located, 174 |
|---|
| 260 | + | including dispensing of prescriptions to and counseling of 175 |
|---|
| 273 | | - | substance. 176 |
|---|
| 274 | | - | 7. The procedures for maintaining a perpetual inventory of 177 |
|---|
| 275 | | - | the controlled substances listed in Schedule II of s. 893.03. 178 |
|---|
| 276 | | - | 8. The specific duties, tasks, and functions that 179 |
|---|
| 277 | | - | registered pharmacy technicians are authorized to perform at the 180 |
|---|
| 278 | | - | remote-site pharmacy. 181 |
|---|
| 279 | | - | (4) A remote-site pharmacy may store, hold, or dispense 182 |
|---|
| 280 | | - | any medicinal drug, including proprietary drugs and controlled 183 |
|---|
| 281 | | - | substances. However, a remote -site pharmacy may not dispense 184 |
|---|
| 282 | | - | Schedule II controlled substances listed in s. 893.03 unless a 185 |
|---|
| 283 | | - | pharmacist is present at the remote -site pharmacy. 186 |
|---|
| 284 | | - | (5) The prescription department manager must visit the 187 |
|---|
| 285 | | - | remote-site pharmacy, based on a schedule determined by the 188 |
|---|
| 286 | | - | board, to inspect the pharm acy, address personnel matters, and 189 |
|---|
| 287 | | - | provide clinical services for patients. 190 |
|---|
| 288 | | - | (6) A remote-site pharmacy may not be open when the 191 |
|---|
| 289 | | - | supervising pharmacy is closed, unless a supervising pharmacist 192 |
|---|
| 290 | | - | is present at the remote -site pharmacy or is providing remote 193 |
|---|
| 291 | | - | supervision as required under this section. 194 |
|---|
| 292 | | - | (7) The board may adopt rules as necessary to specify 195 |
|---|
| 293 | | - | additional criteria for a remote -site pharmacy related to: 196 |
|---|
| 294 | | - | (a) Application requirements. 197 |
|---|
| 295 | | - | (b) Structural and equipment requirements. 198 |
|---|
| 296 | | - | (c) Training requirements. 199 |
|---|
| 297 | | - | (d) Inventory recordkeeping and storage requirements. 200 |
|---|
| 273 | + | patients. 176 |
|---|
| 274 | + | (2) Any person desiring a permit to operate a remote -site 177 |
|---|
| 275 | + | pharmacy must apply to the department. If the board certifies 178 |
|---|
| 276 | + | that the application complies with t he laws and rules of the 179 |
|---|
| 277 | + | board, the department must issue the permit. A permit may not be 180 |
|---|
| 278 | + | issued unless a licensed pharmacist or consultant pharmacist is 181 |
|---|
| 279 | + | designated as the prescription department manager responsible 182 |
|---|
| 280 | + | for the oversight of the remote -site pharmacy. The permittee 183 |
|---|
| 281 | + | must notify the department within 10 days after any change of 184 |
|---|
| 282 | + | the prescription department manager. 185 |
|---|
| 283 | + | (3) A remote-site pharmacy must comply with all of the 186 |
|---|
| 284 | + | following: 187 |
|---|
| 285 | + | (a) Be jointly owned by or operated under a contract with 188 |
|---|
| 286 | + | a supervising pharmacy. 189 |
|---|
| 287 | + | (b) Maintain a video surveillance system that records 190 |
|---|
| 288 | + | continuously 24 hours per day and retain video surveillance 191 |
|---|
| 289 | + | recordings for at least 30 days. 192 |
|---|
| 290 | + | (c) Display a sign visible to the public indicating that 193 |
|---|
| 291 | + | the location is a remote -site pharmacy and that the facility is 194 |
|---|
| 292 | + | under 24-hour video surveillance. 195 |
|---|
| 293 | + | (d) Maintain a policies and procedures manual, which must 196 |
|---|
| 294 | + | be made available to the board or its agent upon request and 197 |
|---|
| 295 | + | must include, but need not be limited to, all of the following: 198 |
|---|
| 296 | + | 1. A description of how the pharmacy will comply with 199 |
|---|
| 297 | + | federal and state laws and rules. 200 |
|---|
| 310 | | - | Section 4. Paragraph (c) of subsection (11) of section 201 |
|---|
| 311 | | - | 465.022, Florida Statutes, is amended to read: 202 |
|---|
| 312 | | - | 465.022 Pharmacies; general requirements; fees. — 203 |
|---|
| 313 | | - | (11) A permittee must notif y the department of the 204 |
|---|
| 314 | | - | identity of the prescription department manager within 10 days 205 |
|---|
| 315 | | - | after employment. The prescription department manager must 206 |
|---|
| 316 | | - | comply with the following requirements: 207 |
|---|
| 317 | | - | (c) A registered pharmacist may not serve as the 208 |
|---|
| 318 | | - | prescription department manager in more than one location , 209 |
|---|
| 319 | | - | except as authorized under s. 465.0198, unless approved by the 210 |
|---|
| 320 | | - | board. 211 |
|---|
| 321 | | - | Section 5. This act shall take effect July 1, 2024. 212 |
|---|
| 310 | + | 2. The procedures for supervising the remote -site pharmacy 201 |
|---|
| 311 | + | and counseling its patients. 202 |
|---|
| 312 | + | 3. The procedures for reviewing the prescription drug 203 |
|---|
| 313 | + | inventory and drug record s maintained by the remote -site 204 |
|---|
| 314 | + | pharmacy. 205 |
|---|
| 315 | + | 4. The policies and procedures for providing security 206 |
|---|
| 316 | + | adequate to protect the confidentiality and integrity of patient 207 |
|---|
| 317 | + | information. 208 |
|---|
| 318 | + | 5. The written plan for recovery from an event that 209 |
|---|
| 319 | + | interrupts or prevents the prescription department manager from 210 |
|---|
| 320 | + | supervising the remote -site pharmacy's operation. 211 |
|---|
| 321 | + | 6. The procedures for use of the state prescription drug 212 |
|---|
| 322 | + | monitoring program by the prescription department manager before 213 |
|---|
| 323 | + | he or she may authorize the dispensing of an y controlled 214 |
|---|
| 324 | + | substance. 215 |
|---|
| 325 | + | 7. The procedures for maintaining a perpetual inventory of 216 |
|---|
| 326 | + | the controlled substances listed in Schedule II of s. 893.03. 217 |
|---|
| 327 | + | 8. The specific duties, tasks, and functions that 218 |
|---|
| 328 | + | registered pharmacy technicians are authorized to perform at the 219 |
|---|
| 329 | + | remote-site pharmacy. 220 |
|---|
| 330 | + | (4) A remote-site pharmacy may store, hold, or dispense 221 |
|---|
| 331 | + | any medicinal drug, including proprietary drugs and controlled 222 |
|---|
| 332 | + | substances. However, a remote -site pharmacy may not dispense 223 |
|---|
| 333 | + | Schedule II controlled substances listed in s. 893.03 unless a 224 |
|---|
| 334 | + | pharmacist is present at the remote -site pharmacy. 225 |
|---|
| 335 | + | |
|---|
| 336 | + | HB 493 2024 |
|---|
| 337 | + | |
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| 338 | + | |
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| 339 | + | |
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| 340 | + | CODING: Words stricken are deletions; words underlined are additions. |
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| 341 | + | hb0493-00 |
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| 342 | + | Page 10 of 11 |
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| 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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| 344 | + | |
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| 345 | + | |
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| 346 | + | |
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| 347 | + | (5) The prescription department manager must visit the 226 |
|---|
| 348 | + | remote-site pharmacy, based on a schedule determined by the 227 |
|---|
| 349 | + | board, to inspect the pharmacy, address personnel matters, and 228 |
|---|
| 350 | + | provide clinical services for patients. 229 |
|---|
| 351 | + | (6) A remote-site pharmacy may not be open when the 230 |
|---|
| 352 | + | supervising pharmacy is closed, unless a pharmacist employed by 231 |
|---|
| 353 | + | or under contract with the supervising pharmacy, or a pharmacy 232 |
|---|
| 354 | + | under contract with the supervising pharm acy, is present at the 233 |
|---|
| 355 | + | remote-site pharmacy or is providing remote supervision as 234 |
|---|
| 356 | + | required under this section. 235 |
|---|
| 357 | + | (7) A registered pharmacist may not serve as the 236 |
|---|
| 358 | + | prescription department manager for more than three remote -site 237 |
|---|
| 359 | + | pharmacies that are under comm on control of the same supervising 238 |
|---|
| 360 | + | pharmacy, at a ratio of one pharmacist to up to six registered 239 |
|---|
| 361 | + | pharmacy technicians at each remote -site pharmacy. 240 |
|---|
| 362 | + | (8) The board may adopt rules as necessary to specify 241 |
|---|
| 363 | + | additional criteria for a remote -site pharmacy. Any additional 242 |
|---|
| 364 | + | criteria adopted by the board must be limited to rules 243 |
|---|
| 365 | + | concerning one or more of the following: 244 |
|---|
| 366 | + | (a) Application requirements. 245 |
|---|
| 367 | + | (b) Structural and equipment requirements. 246 |
|---|
| 368 | + | (c) Training requirements. 247 |
|---|
| 369 | + | (d) Inventory recordkeeping and storage requirements. 248 |
|---|
| 370 | + | Section 5. Paragraph (c) of subsection (11) of section 249 |
|---|
| 371 | + | 465.022, Florida Statutes, is amended to read: 250 |
|---|
| 372 | + | |
|---|
| 373 | + | HB 493 2024 |
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| 374 | + | |
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| 375 | + | |
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| 376 | + | |
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| 377 | + | CODING: Words stricken are deletions; words underlined are additions. |
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| 378 | + | hb0493-00 |
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| 379 | + | Page 11 of 11 |
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| 380 | + | 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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| 381 | + | |
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| 382 | + | |
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| 383 | + | |
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| 384 | + | 465.022 Pharmacies; general requirements; fees. — 251 |
|---|
| 385 | + | (11) A permittee must notify the department of the 252 |
|---|
| 386 | + | identity of the prescription dep artment manager within 10 days 253 |
|---|
| 387 | + | after employment. The prescription department manager must 254 |
|---|
| 388 | + | comply with the following requirements: 255 |
|---|
| 389 | + | (c) A registered pharmacist may not serve as the 256 |
|---|
| 390 | + | prescription department manager in more than one location , 257 |
|---|
| 391 | + | except as authorized under s. 465.0198, unless approved by the 258 |
|---|
| 392 | + | board. 259 |
|---|
| 393 | + | Section 6. This act shall take effect July 1, 2024. 260 |
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