Bill Text: FL S0848 | 2018 | Regular Session | Engrossed
Bill Title: Telepharmacy
Spectrum: Slight Partisan Bill (Republican 2-1)
Status: (Failed) 2018-03-10 - Died in Messages [S0848 Detail]
Download: Florida-2018-S0848-Engrossed.html
CS for SB 848 First Engrossed 2018848e1 1 A bill to be entitled 2 An act relating to telepharmacy; amending s. 465.003, 3 F.S.; revising and providing definitions; amending s. 4 465.014, F.S.; authorizing a certified pharmacy 5 technician to dispense medicinal drugs under certain 6 conditions; amending s. 465.015, F.S.; conforming 7 provisions to changes made by the act; creating s. 8 465.0198, F.S.; providing permit requirements for 9 remote dispensing site pharmacies; providing operating 10 requirements and prohibitions for a remote dispensing 11 site pharmacy; requiring the prescription department 12 manager or other pharmacist employed by the 13 supervising pharmacy to visit the remote dispensing 14 site pharmacy; providing certification and experience 15 requirements for a certified pharmacy technician 16 working at a remote site pharmacy; prohibiting a 17 certified pharmacy technician from performing sterile 18 or nonsterile compounding; providing an exception; 19 providing construction; amending s. 465.022, F.S.; 20 authorizing a Florida licensed pharmacist to serve as 21 the prescription drug manager at more than one remote 22 dispensing site pharmacy under certain conditions; 23 amending s. 465.0265, F.S.; conforming provisions to 24 changes made by the act; providing an effective date. 25 26 Be It Enacted by the Legislature of the State of Florida: 27 28 Section 1. Subsection (11) of section 465.003, Florida 29 Statutes, is amended to read: 30 465.003 Definitions.—As used in this chapter, the term: 31 (11)(a) “Pharmacy” includes a community pharmacy, an 32 institutional pharmacy, a nuclear pharmacy, a special pharmacy, 33andan Internet pharmacy, and a remote dispensing site pharmacy. 34 1. The term “community pharmacy” includes every location 35 where medicinal drugs are compounded, dispensed, stored, or sold 36 or where prescriptions are filled or dispensed on an outpatient 37 basis. 38 2. The term “institutional pharmacy” includes every 39 location in a hospital, clinic, nursing home, dispensary, 40 sanitarium, extended care facility, or other facility, 41 hereinafter referred to as “health care institutions,” where 42 medicinal drugs are compounded, dispensed, stored, or sold. 43 3. The term “nuclear pharmacy” includes every location 44 where radioactive drugs and chemicals within the classification 45 of medicinal drugs are compounded, dispensed, stored, or sold. 46 The term “nuclear pharmacy” does not include hospitals licensed 47 under chapter 395 or the nuclear medicine facilities of such 48 hospitals. 49 4. The term “special pharmacy” includes every location 50 where medicinal drugs are compounded, dispensed, stored, or sold 51 if such locations are not otherwise defined in this subsection. 52 5. The term “Internet pharmacy” includes locations not 53 otherwise licensed or issued a permit under this chapter, within 54 or outside this state, which use the Internet to communicate 55 with or obtain information from consumers in this state and use 56 such communication or information to fill or refill 57 prescriptions or to dispense, distribute, or otherwise engage in 58 the practice of pharmacy in this state. Any act described in 59 this definition constitutes the practice of pharmacy as defined 60 in subsection (13). 61 6. The term “remote dispensing site pharmacy” includes 62 every location where medicinal drugs are prepared by a certified 63 pharmacy technician who is electronically supervised by an 64 offsite pharmacist and dispensed pursuant to s. 465.014(1) to 65 the patient after verification, certification, and counseling by 66 the pharmacist. 67 (b) The pharmacy department of any permittee shall be 68 considered closed whenever a Florida licensed pharmacist is not 69 present and on duty. The term “not present and on duty” may 70shallnot be construed to prevent: 71 1. A pharmacist from exiting the prescription department 72 for the purposes of consulting or responding to inquiries or 73 providing assistance to patients or customers;,74 2. A pharmacist attending to personal hygiene needs;, or75 3. A pharmacist performing any other function for which the 76 pharmacist is responsible, provided that such activities are 77 conducted in a manner consistent with the pharmacist’s 78 responsibility to provide pharmacy services; or 79 4. An offsite pharmacist from remotely supervising a 80 certified pharmacy technician at a remote dispensing site 81 pharmacy. 82 Section 2. Subsection (1) of section 465.014, Florida 83 Statutes, is amended to read: 84 465.014 Pharmacy technician.— 85 (1) A person other than a licensed pharmacist or pharmacy 86 intern may not engage in the practice of the profession of 87 pharmacy, except that a licensed pharmacist may delegate to 88 pharmacy technicians who are certifiedregisteredpursuant to 89 this section those duties, tasks, and functions that do not fall 90 within the purview of s. 465.003(13). However, a certified 91 pharmacy technician may dispense medicinal drugs when operating 92 under the electronic supervision of an offsite Florida licensed 93 pharmacist pursuant to s. 465.0198. All such delegated acts must 94 be performed under the direct supervision of a licensed 95 pharmacist who is responsible for all such acts performed by 96 persons under his or her supervision. A certifiedregistered97 pharmacy technician, under the supervision of a pharmacist, may 98 initiate or receive communications with a practitioner or his or 99 her agent, on behalf of a patient, regarding refill 100 authorization requests. A licensed pharmacist may not supervise 101 more than one certifiedregisteredpharmacy technician unless 102 otherwise permitted by the guidelines adopted by the board. The 103 board shall establish guidelines to be followed by licensees or 104 permittees in determining the circumstances under which a 105 licensed pharmacist may supervise more than one pharmacy 106 technician. 107 Section 3. Subsections (1) and (2) of section 465.015, 108 Florida Statutes, are amended to read: 109 465.015 Violations and penalties.— 110 (1) It is unlawful for any person to own, operate, 111 maintain, open, establish, conduct, or have charge of, either 112 alone or with another person or persons, a pharmacy: 113 (a) Which is not registered underthe provisions ofthis 114 chapter. 115 (b) In which a person not licensed as a pharmacist in this 116 state or not registered as an intern in this state or in which 117 an intern who is not acting under the direct and immediate 118 personal supervision of a licensed pharmacist fills, compounds, 119 or dispenses any prescription or dispenses medicinal drugs. This 120 paragraph does not apply to any person who owns, operates, 121 maintains, opens, establishes, conducts, or has charge of a 122 remote dispensing site pharmacy pursuant to s. 465.0198. 123 (2) It is unlawful for any person: 124 (a) To make a false or fraudulent statement, either for 125 herself or himself or for another person, in any application, 126 affidavit, or statement presented to the board or in any 127 proceeding before the board. 128 (b) To fill, compound, or dispense prescriptions or to 129 dispense medicinal drugs if such person does not hold an active 130 license as a pharmacist in this state, is not registered as an 131 intern in this state, or is an intern not acting under the 132 direct and immediate personal supervision of a licensed 133 pharmacist. This paragraph does not apply to a certified 134 pharmacy technician dispensing medicinal drugs pursuant to s. 135 465.0198. 136 (c) To sell or dispense drugs as defined in s. 465.003(8) 137 without first being furnished with a prescription. 138 (d) To sell samples or complimentary packages of drug 139 products. 140 Section 4. Section 465.0198, Florida Statutes, is created 141 to read: 142 465.0198 Remote dispensing site pharmacy permits.— 143 (1) Any person desiring a permit to operate a remote 144 dispensing site pharmacy must apply to the department for a 145 remote dispensing site pharmacy permit. If the board certifies 146 that the application complies with the laws and board rules 147 governing the practice of the profession of pharmacy, the 148 department must issue the permit. A permit may not be issued 149 unless a licensed pharmacist or consultant pharmacist is 150 designated as the prescription department manager responsible 151 for the oversight of the remote dispensing site pharmacy. The 152 permittee must notify the department within 10 days after any 153 change of the prescription department manager. 154 (2) As a prerequisite to issuance of an initial permit or a 155 permit for a change of location, the remote dispensing site 156 pharmacy must pass an onsite inspection. The department must 157 make the inspection within 90 days before issuance of the 158 permit. 159 (3) The remote dispensing site pharmacy must: 160 (a) Be jointly owned by a supervising pharmacy or operated 161 under a contract with a supervising pharmacy. For purposes of 162 this subsection, “supervising pharmacy” means a licensed 163 pharmacy in this state which employs a Florida licensed 164 pharmacist who remotely supervises a certified pharmacy 165 technician at a remote dispensing site pharmacy. 166 (b) Display a sign visible to the public indicating that 167 the location is a remote dispensing site pharmacy and that the 168 facility is under 24-hour video surveillance. The remote 169 dispensing site pharmacy must retain the video surveillance 170 recordings for at least 45 days. 171 (c) Be located in a rural hospital as defined in s. 172 395.602. 173 (4) A remote dispensing site pharmacy may not lose its 174 permit based on the subsequent opening of a community pharmacy 175 within 10 miles of the remote dispensing site pharmacy. 176 (5) A remote dispensing site pharmacy may store, hold, and 177 dispense all medicinal drugs including those listed in s. 178 893.03(3)-(5). A remote dispensing pharmacy may not store, hold, 179 or dispense controlled substances listed in s. 893.03(2). 180 (6) A remote dispensing site pharmacy may not perform 181 centralized prescription filling, as defined in s. 465.003(16). 182 (7) A remote dispensing site pharmacy must maintain a 183 policy and procedures manual, which shall be made available to 184 the board or its agent upon request. The policy and procedures 185 manual shall include: 186 (a) A description of how the pharmacy will comply with 187 federal and state laws, rules, and regulations. 188 (b) The procedure for supervising the remote dispensing 189 site pharmacy and counseling its patients before the dispensing 190 of any medicinal drug pursuant to this section. 191 (c) The procedure for reviewing the prescription drug 192 inventory and drug records maintained by the remote dispensing 193 site pharmacy. 194 (d) The policy and procedure for providing appropriate 195 security to protect the confidentiality and integrity of patient 196 information. 197 (e) The written plan for recovery from an event that 198 interrupts or prevents the pharmacist from supervising the 199 remote dispensing site pharmacy’s operation. 200 (f) The procedure by which a supervising pharmacist 201 consults the state prescription drug monitoring program before 202 authorizing any controlled substance for dispensing and reports 203 the dispensing of a controlled substance as required under s. 204 893.055. 205 (g) The specific duties, tasks, and functions that a 206 certified pharmacy technician is authorized to perform at the 207 remote dispensing site pharmacy. 208 (8) The prescription department manager or other pharmacist 209 employed by the supervising pharmacy must visit the remote 210 dispensing site pharmacy, based on a schedule designated by the 211 board, to inspect the pharmacy, address personnel matters, and 212 provide clinical services for patients. 213 (9) A certified pharmacy technician must be certified by a 214 pharmacy technician certification program that is accredited by 215 the National Commission of Certifying Agencies and have 216 completed at least 2,080 hours of experience at a pharmacy 217 within the 2 years immediately preceding the date on which the 218 certified pharmacy technician begins employment at the remote 219 dispensing site pharmacy. 220 (10) A certified pharmacy technician working at a remote 221 dispensing site pharmacy may not perform sterile or nonsterile 222 compounding, except that a certified pharmacy technician may 223 reconstitute orally administered powder antibiotics. 224 (11) This section does not alter the supervision 225 requirements established in s. 465.014. 226 Section 5. Paragraph (c) of subsection (11) of section 227 465.022, Florida Statutes, is amended to read: 228 465.022 Pharmacies; general requirements; fees.— 229 (11) A permittee must notify the department of the identity 230 of the prescription department manager within 10 days after 231 employment. The prescription department manager must comply with 232 the following requirements: 233 (c) A Florida licensedregisteredpharmacist may not serve 234 as the prescription department manager in more than one location 235 unless approved by the board. However, a Florida licensed 236 pharmacist may serve as a prescription department manager for no 237 more than two remote dispensing site pharmacies, if such 238 pharmacies are under common control. 239 Section 6. Subsection (1) of section 465.0265, Florida 240 Statutes, is amended to read: 241 465.0265 Centralized prescription filling.— 242 (1) Except as otherwise provided in this chapter, a 243 pharmacy licensed under this chapter may perform centralized 244 prescription filling for another pharmacy, provided that the 245 pharmacies have the same owner or have a written contract 246 specifying the services to be provided by each pharmacy, the 247 responsibilities of each pharmacy, and the manner in which the 248 pharmacies will comply with federal and state laws, rules, and 249 regulations. 250 Section 7. This act shall take effect July 1, 2018.