Florida Senate - 2018 COMMITTEE AMENDMENT
Bill No. SB 848
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LEGISLATIVE ACTION
Senate . House
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The Committee on Health Policy (Grimsley) recommended the
following:
1 Senate Amendment (with title amendment)
2
3 Delete everything after the enacting clause
4 and insert:
5 Section 1. Subsection (11) of section 465.003, Florida
6 Statutes, is amended to read:
7 465.003 Definitions.—As used in this chapter, the term:
8 (11)(a) “Pharmacy” includes a community pharmacy, an
9 institutional pharmacy, a nuclear pharmacy, a special pharmacy,
10 and an Internet pharmacy, and a remote dispensing site pharmacy.
11 1. The term “community pharmacy” includes every location
12 where medicinal drugs are compounded, dispensed, stored, or sold
13 or where prescriptions are filled or dispensed on an outpatient
14 basis.
15 2. The term “institutional pharmacy” includes every
16 location in a hospital, clinic, nursing home, dispensary,
17 sanitarium, extended care facility, or other facility,
18 hereinafter referred to as “health care institutions,” where
19 medicinal drugs are compounded, dispensed, stored, or sold.
20 3. The term “nuclear pharmacy” includes every location
21 where radioactive drugs and chemicals within the classification
22 of medicinal drugs are compounded, dispensed, stored, or sold.
23 The term “nuclear pharmacy” does not include hospitals licensed
24 under chapter 395 or the nuclear medicine facilities of such
25 hospitals.
26 4. The term “special pharmacy” includes every location
27 where medicinal drugs are compounded, dispensed, stored, or sold
28 if such locations are not otherwise defined in this subsection.
29 5. The term “Internet pharmacy” includes locations not
30 otherwise licensed or issued a permit under this chapter, within
31 or outside this state, which use the Internet to communicate
32 with or obtain information from consumers in this state and use
33 such communication or information to fill or refill
34 prescriptions or to dispense, distribute, or otherwise engage in
35 the practice of pharmacy in this state. Any act described in
36 this definition constitutes the practice of pharmacy as defined
37 in subsection (13).
38 6. The term “remote dispensing site pharmacy” includes
39 every location where medicinal drugs are prepared by a
40 registered pharmacy technician who is electronically supervised
41 by an offsite pharmacist and dispensed pursuant to s. 465.014(1)
42 to the patient after verification, certification, and counseling
43 by the pharmacist.
44 (b) The pharmacy department of any permittee shall be
45 considered closed whenever a Florida licensed pharmacist is not
46 present and on duty. The term “not present and on duty” may
47 shall not be construed to prevent:
48 1. A pharmacist from exiting the prescription department
49 for the purposes of consulting or responding to inquiries or
50 providing assistance to patients or customers;,
51 2. A pharmacist attending to personal hygiene needs;, or
52 3. A pharmacist performing any other function for which the
53 pharmacist is responsible, provided that such activities are
54 conducted in a manner consistent with the pharmacist’s
55 responsibility to provide pharmacy services; or
56 4. An offsite pharmacist from remotely supervising a
57 registered pharmacy technician at a remote dispensing site
58 pharmacy.
59 Section 2. Subsection (1) of section 465.014, Florida
60 Statutes, is amended to read:
61 465.014 Pharmacy technician.—
62 (1) A person other than a licensed pharmacist or pharmacy
63 intern may not engage in the practice of the profession of
64 pharmacy, except that a licensed pharmacist may delegate to
65 pharmacy technicians who are registered pursuant to this section
66 those duties, tasks, and functions that do not fall within the
67 purview of s. 465.003(13). However, a registered pharmacy
68 technician may dispense medicinal drugs when operating under the
69 electronic supervision of an offsite Florida licensed pharmacist
70 pursuant to s. 465.0198. All such delegated acts must be
71 performed under the direct supervision of a licensed pharmacist
72 who is responsible for all such acts performed by persons under
73 his or her supervision. A registered pharmacy technician, under
74 the supervision of a pharmacist, may initiate or receive
75 communications with a practitioner or his or her agent, on
76 behalf of a patient, regarding refill authorization requests. A
77 licensed pharmacist may not supervise more than one registered
78 pharmacy technician unless otherwise permitted by the guidelines
79 adopted by the board. The board shall establish guidelines to be
80 followed by licensees or permittees in determining the
81 circumstances under which a licensed pharmacist may supervise
82 more than one pharmacy technician.
83 Section 3. Subsections (1) and (2) of section 465.015,
84 Florida Statutes, are amended to read:
85 465.015 Violations and penalties.—
86 (1) It is unlawful for any person to own, operate,
87 maintain, open, establish, conduct, or have charge of, either
88 alone or with another person or persons, a pharmacy:
89 (a) Which is not registered under the provisions of this
90 chapter.
91 (b) In which a person not licensed as a pharmacist in this
92 state or not registered as an intern in this state or in which
93 an intern who is not acting under the direct and immediate
94 personal supervision of a licensed pharmacist fills, compounds,
95 or dispenses any prescription or dispenses medicinal drugs. This
96 paragraph does not apply to any person who owns, operates,
97 maintains, opens, establishes, conducts, or has charge of a
98 remote dispensing site pharmacy pursuant to s. 465.0198.
99 (2) It is unlawful for any person:
100 (a) To make a false or fraudulent statement, either for
101 herself or himself or for another person, in any application,
102 affidavit, or statement presented to the board or in any
103 proceeding before the board.
104 (b) To fill, compound, or dispense prescriptions or to
105 dispense medicinal drugs if such person does not hold an active
106 license as a pharmacist in this state, is not registered as an
107 intern in this state, or is an intern not acting under the
108 direct and immediate personal supervision of a licensed
109 pharmacist. This paragraph does not apply to a registered
110 pharmacy technician dispensing medicinal drugs pursuant to s.
111 465.0198.
112 (c) To sell or dispense drugs as defined in s. 465.003(8)
113 without first being furnished with a prescription.
114 (d) To sell samples or complimentary packages of drug
115 products.
116 Section 4. Section 465.0198, Florida Statutes, is created
117 to read:
118 465.0198 Remote dispensing site pharmacy permits.—
119 (1) Any person desiring a permit to operate a remote
120 dispensing site pharmacy must apply to the department for a
121 remote dispensing site pharmacy permit. If the board certifies
122 that the application complies with the laws and board rules
123 governing the practice of the profession of pharmacy, the
124 department must issue the permit. A permit may not be issued
125 unless a licensed pharmacist or consultant pharmacist is
126 designated as the prescription department manager responsible
127 for the oversight of the remote dispensing site pharmacy. The
128 permittee must notify the department within 10 days after any
129 change of the prescription department manager.
130 (2) As a prerequisite to issuance of an initial permit or a
131 permit for a change of location, the remote dispensing site
132 pharmacy must pass an onsite inspection. The department must
133 make the inspection within 90 days before issuance of the
134 permit.
135 (3) The remote dispensing site pharmacy must:
136 (a) Be jointly owned by a supervising pharmacy or operated
137 under a contract with a supervising pharmacy. For purposes of
138 this subsection, “supervising pharmacy” means a licensed
139 pharmacy in this state which employs a Florida licensed
140 pharmacist who remotely supervises a registered pharmacy
141 technician at a remote dispensing site pharmacy.
142 (b) Display a sign visible to the public indicating that
143 the location is a remote dispensing site pharmacy and that the
144 facility is under 24-hour video surveillance. The remote
145 dispensing site pharmacy must retain the video surveillance
146 recordings for at least 45 days.
147 (c) Be located in an area defined as rural pursuant to s.
148 381.0406 and be at least 10 miles from an existing community
149 pharmacy, unless the remote dispensing site pharmacy is located
150 in a hospital licensed under chapter 395 or in a clinic. For
151 purposes of this paragraph, the term “clinic” means an entity
152 where health care services are provided to individuals and which
153 tenders charges for reimbursement for such services, excluding a
154 mobile clinic and a portable equipment provider.
155 (4) A remote dispensing site pharmacy may not lose its
156 permit based on the subsequent opening of a community pharmacy
157 within 10 miles of the remote dispensing site pharmacy.
158 (5) A remote dispensing site pharmacy may store, hold, and
159 dispense all medicinal drugs including those listed in s.
160 893.03(3)-(5). A remote dispensing pharmacy may not store, hold,
161 or dispense narcotic controlled substances listed in s.
162 893.03(2).
163 (6) A remote dispensing site pharmacy may not perform
164 centralized prescription filling, as defined in s. 465.003(16).
165 (7) A remote dispensing site pharmacy must maintain a
166 policy and procedures manual, which shall be made available to
167 the board or its agent upon request. The policy and procedures
168 manual shall include:
169 (a) A description of how the pharmacy will comply with
170 federal and state laws, rules, and regulations.
171 (b) The procedure for supervising the remote dispensing
172 site pharmacy and counseling its patients before the dispensing
173 of any medicinal drug pursuant to this section.
174 (c) The procedure for reviewing the prescription drug
175 inventory and drug records maintained by the remote dispensing
176 site pharmacy.
177 (d) The policy and procedure for providing appropriate
178 security to protect the confidentiality and integrity of patient
179 information.
180 (e) The written plan for recovery from an event that
181 interrupts or prevents the pharmacist from supervising the
182 remote dispensing site pharmacy’s operation.
183 (f) The procedure by which a supervising pharmacist
184 consults the state prescription drug monitoring program before
185 authorizing any controlled substance for dispensing and reports
186 the dispensing of a controlled substance as required under s.
187 893.055.
188 (g) The specific duties, tasks, and functions that a
189 registered pharmacy technician is authorized to perform at the
190 remote dispensing site pharmacy.
191 (8) The prescription department manager or other pharmacist
192 employed by the supervising pharmacy must visit the remote
193 dispensing site pharmacy, based on a schedule designated by the
194 board, to inspect the pharmacy, address personnel matters, and
195 provide clinical services for patients.
196 (9) A registered pharmacy technician must have completed at
197 least 2,080 hours of experience at a pharmacy within the 2 years
198 immediately preceding the date on which the registered pharmacy
199 technician begins employment at the remote dispensing site
200 pharmacy.
201 (10) A registered pharmacy technician working at a remote
202 dispensing site pharmacy may not perform sterile or complex
203 nonsterile compounding.
204 (11) This section does not alter the supervision
205 requirements established in s. 465.014.
206 Section 5. Paragraph (c) of subsection (11) of section
207 465.022, Florida Statutes, is amended to read:
208 465.022 Pharmacies; general requirements; fees.—
209 (11) A permittee must notify the department of the identity
210 of the prescription department manager within 10 days after
211 employment. The prescription department manager must comply with
212 the following requirements:
213 (c) A Florida licensed registered pharmacist may not serve
214 as the prescription department manager in more than one location
215 unless approved by the board. However, a Florida licensed
216 pharmacist may serve as a prescription department manager for no
217 more than two remote dispensing site pharmacies, if such
218 pharmacies are under common control.
219 Section 6. Subsection (1) of section 465.0265, Florida
220 Statutes, is amended to read:
221 465.0265 Centralized prescription filling.—
222 (1) Except as otherwise provided in this chapter, a
223 pharmacy licensed under this chapter may perform centralized
224 prescription filling for another pharmacy, provided that the
225 pharmacies have the same owner or have a written contract
226 specifying the services to be provided by each pharmacy, the
227 responsibilities of each pharmacy, and the manner in which the
228 pharmacies will comply with federal and state laws, rules, and
229 regulations.
230 Section 7. This act shall take effect July 1, 2018.
231
232 ================= T I T L E A M E N D M E N T ================
233 And the title is amended as follows:
234 Delete everything before the enacting clause
235 and insert:
236 A bill to be entitled
237 An act relating to telepharmacy; amending s. 465.003,
238 F.S.; revising and providing definitions; amending s.
239 465.014, F.S.; authorizing a registered pharmacy
240 technician to dispense medicinal drugs under certain
241 conditions; amending s. 465.015, F.S.; conforming
242 provisions to changes made by the act; creating s.
243 465.0198, F.S.; providing permit requirements for
244 remote dispensing site pharmacies; providing operating
245 requirements and prohibitions for a remote dispensing
246 site pharmacy; defining the term “clinic”; requiring
247 the prescription department manager or other
248 pharmacist employed by the supervising pharmacy to
249 visit the remote dispensing site pharmacy; providing
250 an experience requirement for a registered pharmacy
251 technician working at a remote site pharmacy;
252 prohibiting a registered pharmacy technician from
253 performing sterile or nonsterile compounding;
254 providing construction; amending s. 465.022, F.S.;
255 authorizing a Florida licensed pharmacist to serve as
256 the prescription drug manager at more than one remote
257 dispensing site pharmacy under certain conditions;
258 amending s. 465.0265, F.S.; conforming provisions to
259 changes made by the act; providing an effective date.