Florida Senate - 2018 CS for SB 848
By the Committee on Health Policy; and Senator Grimsley
588-02911-18 2018848c1
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 registered 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; defining the term “clinic”; requiring
12 the prescription department manager or other
13 pharmacist employed by the supervising pharmacy to
14 visit the remote dispensing site pharmacy; providing
15 an experience requirement for a registered pharmacy
16 technician working at a remote site pharmacy;
17 prohibiting a registered pharmacy technician from
18 performing sterile or nonsterile compounding;
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,
33 and an 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
63 registered pharmacy technician who is electronically supervised
64 by an offsite pharmacist and dispensed pursuant to s. 465.014(1)
65 to the patient after verification, certification, and counseling
66 by 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
70 shall not 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;, or
75 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 registered 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 registered pursuant to this section
89 those duties, tasks, and functions that do not fall within the
90 purview of s. 465.003(13). However, a registered pharmacy
91 technician may dispense medicinal drugs when operating under the
92 electronic supervision of an offsite Florida licensed pharmacist
93 pursuant to s. 465.0198. All such delegated acts must be
94 performed under the direct supervision of a licensed pharmacist
95 who is responsible for all such acts performed by persons under
96 his or her supervision. A registered pharmacy technician, under
97 the supervision of a pharmacist, may initiate or receive
98 communications with a practitioner or his or her agent, on
99 behalf of a patient, regarding refill authorization requests. A
100 licensed pharmacist may not supervise more than one registered
101 pharmacy technician unless otherwise permitted by the guidelines
102 adopted by the board. The board shall establish guidelines to be
103 followed by licensees or permittees in determining the
104 circumstances under which a licensed pharmacist may supervise
105 more than one pharmacy technician.
106 Section 3. Subsections (1) and (2) of section 465.015,
107 Florida Statutes, are amended to read:
108 465.015 Violations and penalties.—
109 (1) It is unlawful for any person to own, operate,
110 maintain, open, establish, conduct, or have charge of, either
111 alone or with another person or persons, a pharmacy:
112 (a) Which is not registered under the provisions of this
113 chapter.
114 (b) In which a person not licensed as a pharmacist in this
115 state or not registered as an intern in this state or in which
116 an intern who is not acting under the direct and immediate
117 personal supervision of a licensed pharmacist fills, compounds,
118 or dispenses any prescription or dispenses medicinal drugs. This
119 paragraph does not apply to any person who owns, operates,
120 maintains, opens, establishes, conducts, or has charge of a
121 remote dispensing site pharmacy pursuant to s. 465.0198.
122 (2) It is unlawful for any person:
123 (a) To make a false or fraudulent statement, either for
124 herself or himself or for another person, in any application,
125 affidavit, or statement presented to the board or in any
126 proceeding before the board.
127 (b) To fill, compound, or dispense prescriptions or to
128 dispense medicinal drugs if such person does not hold an active
129 license as a pharmacist in this state, is not registered as an
130 intern in this state, or is an intern not acting under the
131 direct and immediate personal supervision of a licensed
132 pharmacist. This paragraph does not apply to a registered
133 pharmacy technician dispensing medicinal drugs pursuant to s.
134 465.0198.
135 (c) To sell or dispense drugs as defined in s. 465.003(8)
136 without first being furnished with a prescription.
137 (d) To sell samples or complimentary packages of drug
138 products.
139 Section 4. Section 465.0198, Florida Statutes, is created
140 to read:
141 465.0198 Remote dispensing site pharmacy permits.—
142 (1) Any person desiring a permit to operate a remote
143 dispensing site pharmacy must apply to the department for a
144 remote dispensing site pharmacy permit. If the board certifies
145 that the application complies with the laws and board rules
146 governing the practice of the profession of pharmacy, the
147 department must issue the permit. A permit may not be issued
148 unless a licensed pharmacist or consultant pharmacist is
149 designated as the prescription department manager responsible
150 for the oversight of the remote dispensing site pharmacy. The
151 permittee must notify the department within 10 days after any
152 change of the prescription department manager.
153 (2) As a prerequisite to issuance of an initial permit or a
154 permit for a change of location, the remote dispensing site
155 pharmacy must pass an onsite inspection. The department must
156 make the inspection within 90 days before issuance of the
157 permit.
158 (3) The remote dispensing site pharmacy must:
159 (a) Be jointly owned by a supervising pharmacy or operated
160 under a contract with a supervising pharmacy. For purposes of
161 this subsection, “supervising pharmacy” means a licensed
162 pharmacy in this state which employs a Florida licensed
163 pharmacist who remotely supervises a registered pharmacy
164 technician at a remote dispensing site pharmacy.
165 (b) Display a sign visible to the public indicating that
166 the location is a remote dispensing site pharmacy and that the
167 facility is under 24-hour video surveillance. The remote
168 dispensing site pharmacy must retain the video surveillance
169 recordings for at least 45 days.
170 (c) Be located in an area defined as rural pursuant to s.
171 381.0406 and be at least 10 miles from an existing community
172 pharmacy, unless the remote dispensing site pharmacy is located
173 in a hospital licensed under chapter 395 or in a clinic. For
174 purposes of this paragraph, the term “clinic” means an entity
175 where health care services are provided to individuals and which
176 tenders charges for reimbursement for such services, excluding a
177 mobile clinic and a portable equipment provider.
178 (4) A remote dispensing site pharmacy may not lose its
179 permit based on the subsequent opening of a community pharmacy
180 within 10 miles of the remote dispensing site pharmacy.
181 (5) A remote dispensing site pharmacy may store, hold, and
182 dispense all medicinal drugs including those listed in s.
183 893.03(3)-(5). A remote dispensing pharmacy may not store, hold,
184 or dispense narcotic controlled substances listed in s.
185 893.03(2).
186 (6) A remote dispensing site pharmacy may not perform
187 centralized prescription filling, as defined in s. 465.003(16).
188 (7) A remote dispensing site pharmacy must maintain a
189 policy and procedures manual, which shall be made available to
190 the board or its agent upon request. The policy and procedures
191 manual shall include:
192 (a) A description of how the pharmacy will comply with
193 federal and state laws, rules, and regulations.
194 (b) The procedure for supervising the remote dispensing
195 site pharmacy and counseling its patients before the dispensing
196 of any medicinal drug pursuant to this section.
197 (c) The procedure for reviewing the prescription drug
198 inventory and drug records maintained by the remote dispensing
199 site pharmacy.
200 (d) The policy and procedure for providing appropriate
201 security to protect the confidentiality and integrity of patient
202 information.
203 (e) The written plan for recovery from an event that
204 interrupts or prevents the pharmacist from supervising the
205 remote dispensing site pharmacy’s operation.
206 (f) The procedure by which a supervising pharmacist
207 consults the state prescription drug monitoring program before
208 authorizing any controlled substance for dispensing and reports
209 the dispensing of a controlled substance as required under s.
210 893.055.
211 (g) The specific duties, tasks, and functions that a
212 registered pharmacy technician is authorized to perform at the
213 remote dispensing site pharmacy.
214 (8) The prescription department manager or other pharmacist
215 employed by the supervising pharmacy must visit the remote
216 dispensing site pharmacy, based on a schedule designated by the
217 board, to inspect the pharmacy, address personnel matters, and
218 provide clinical services for patients.
219 (9) A registered pharmacy technician must have completed at
220 least 2,080 hours of experience at a pharmacy within the 2 years
221 immediately preceding the date on which the registered pharmacy
222 technician begins employment at the remote dispensing site
223 pharmacy.
224 (10) A registered pharmacy technician working at a remote
225 dispensing site pharmacy may not perform sterile or complex
226 nonsterile compounding.
227 (11) This section does not alter the supervision
228 requirements established in s. 465.014.
229 Section 5. Paragraph (c) of subsection (11) of section
230 465.022, Florida Statutes, is amended to read:
231 465.022 Pharmacies; general requirements; fees.—
232 (11) A permittee must notify the department of the identity
233 of the prescription department manager within 10 days after
234 employment. The prescription department manager must comply with
235 the following requirements:
236 (c) A Florida licensed registered pharmacist may not serve
237 as the prescription department manager in more than one location
238 unless approved by the board. However, a Florida licensed
239 pharmacist may serve as a prescription department manager for no
240 more than two remote dispensing site pharmacies, if such
241 pharmacies are under common control.
242 Section 6. Subsection (1) of section 465.0265, Florida
243 Statutes, is amended to read:
244 465.0265 Centralized prescription filling.—
245 (1) Except as otherwise provided in this chapter, a
246 pharmacy licensed under this chapter may perform centralized
247 prescription filling for another pharmacy, provided that the
248 pharmacies have the same owner or have a written contract
249 specifying the services to be provided by each pharmacy, the
250 responsibilities of each pharmacy, and the manner in which the
251 pharmacies will comply with federal and state laws, rules, and
252 regulations.
253 Section 7. This act shall take effect July 1, 2018.