Florida Senate - 2018 SB 848
By Senator Grimsley
26-00972-18 2018848__
1 A bill to be entitled
2 An act relating to remote dispensing site pharmacies;
3 amending s. 465.003, F.S.; redefining the term
4 “pharmacy” to include remote dispensing site
5 pharmacies; providing that an offsite pharmacist who
6 supervises a registered pharmacy technician at a
7 remote dispensing site is not considered to be not
8 present or off duty; amending s. 465.014, F.S.;
9 authorizing registered pharmacy technicians to
10 compound and dispense medicinal drugs when operating
11 under the electronic supervision of an offsite
12 pharmacist; amending s. 465.015, F.S.; conforming
13 provisions to changes made by the act; creating s.
14 465.0198, F.S.; providing permit requirements for
15 remote dispensing site pharmacies; providing a
16 permitting process for such pharmacies; providing
17 requirements for such pharmacies; providing that such
18 pharmacies are not considered pharmacy locations for
19 certain purposes; authorizing such pharmacies to
20 store, hold, and dispense medicinal drugs; prohibiting
21 such pharmacies from performing centralized
22 prescription filling; requiring such pharmacies to
23 maintain a policy and procedures manual that includes
24 specified information; amending s. 465.022, F.S.;
25 authorizing a registered pharmacist to serve as the
26 prescription department manager at up to a specified
27 number of remote dispensing site pharmacies under
28 certain conditions; amending s. 465.0265, F.S.;
29 conforming a provision to changes made by the act;
30 providing an effective date.
31
32 Be It Enacted by the Legislature of the State of Florida:
33
34 Section 1. Subsection (11) of section 465.003, Florida
35 Statutes, is amended to read:
36 465.003 Definitions.—As used in this chapter, the term:
37 (11)(a) “Pharmacy” includes a community pharmacy, an
38 institutional pharmacy, a nuclear pharmacy, a special pharmacy,
39 and an Internet pharmacy, and a remote dispensing site pharmacy.
40 1. The term “community pharmacy” includes every location
41 where medicinal drugs are compounded, dispensed, stored, or sold
42 or where prescriptions are filled or dispensed on an outpatient
43 basis.
44 2. The term “institutional pharmacy” includes every
45 location in a hospital, clinic, nursing home, dispensary,
46 sanitarium, extended care facility, or other facility,
47 hereinafter referred to as “health care institutions,” where
48 medicinal drugs are compounded, dispensed, stored, or sold.
49 3. The term “nuclear pharmacy” includes every location
50 where radioactive drugs and chemicals within the classification
51 of medicinal drugs are compounded, dispensed, stored, or sold.
52 The term “nuclear pharmacy” does not include hospitals licensed
53 under chapter 395 or the nuclear medicine facilities of such
54 hospitals.
55 4. The term “special pharmacy” includes every location
56 where medicinal drugs are compounded, dispensed, stored, or sold
57 if such locations are not otherwise defined in this subsection.
58 5. The term “Internet pharmacy” includes locations not
59 otherwise licensed or issued a permit under this chapter, within
60 or outside this state, which use the Internet to communicate
61 with or obtain information from consumers in this state and use
62 such communication or information to fill or refill
63 prescriptions or to dispense, distribute, or otherwise engage in
64 the practice of pharmacy in this state. Any act described in
65 this definition constitutes the practice of pharmacy as defined
66 in subsection (13).
67 6. The term “remote dispensing site pharmacy” includes
68 every location where medicinal drugs are compounded or dispensed
69 by a registered pharmacy technician who is electronically
70 supervised by an offsite pharmacist and which is overseen by a
71 prescription department manager.
72 (b) The pharmacy department of any permittee is shall be
73 considered closed whenever a Florida licensed pharmacist is not
74 present and on duty. The term “not present and on duty” may
75 shall not be construed to prevent:
76 1. A pharmacist from exiting the prescription department
77 for the purposes of:
78 a. Consulting or responding to inquiries or providing
79 assistance to patients or customers;,
80 b. Attending to personal hygiene needs;, or
81 c. Performing any other function for which the pharmacist
82 is responsible, provided that such activities are conducted in a
83 manner consistent with the pharmacist’s responsibility to
84 provide pharmacy services.
85 2. An offsite pharmacist from electronically supervising a
86 registered pharmacy technician at a remote dispensing site
87 pharmacy.
88 Section 2. Subsection (1) of section 465.014, Florida
89 Statutes, is amended to read:
90 465.014 Pharmacy technician.—
91 (1) A person other than a licensed pharmacist or pharmacy
92 intern may not engage in the practice of the profession of
93 pharmacy, however:
94 (a) except that A licensed pharmacist may delegate to
95 pharmacy technicians who are registered pursuant to this section
96 those duties, tasks, and functions that do not fall within the
97 purview of s. 465.003(13). All such delegated acts must be
98 performed under the direct supervision of a licensed pharmacist
99 who is responsible for all such acts performed by persons under
100 his or her supervision.
101 (b) A registered pharmacy technician who is registered
102 pursuant to this section may compound and dispense medicinal
103 drugs when operating under the electronic supervision of an
104 offsite pharmacist pursuant to s. 465.0198.
105
106 A registered pharmacy technician, under the supervision of a
107 pharmacist, may initiate or receive communications with a
108 practitioner or his or her agent, on behalf of a patient,
109 regarding refill authorization requests. A licensed pharmacist
110 may not supervise more than one registered pharmacy technician
111 unless otherwise permitted by the guidelines adopted by the
112 board. The board shall establish guidelines to be followed by
113 licensees or permittees in determining the circumstances under
114 which a licensed pharmacist may supervise more than one pharmacy
115 technician.
116 Section 3. Subsections (1) and (2) of section 465.015,
117 Florida Statutes, are amended to read:
118 465.015 Violations and penalties.—
119 (1) It is unlawful for any person to own, operate,
120 maintain, open, establish, conduct, or have charge of, either
121 alone or with another person or persons, a pharmacy:
122 (a) Which is not registered under the provisions of this
123 chapter.
124 (b) In which a person not licensed as a pharmacist in this
125 state or not registered as an intern in this state or in which
126 an intern who is not acting under the direct and immediate
127 personal supervision of a licensed pharmacist fills, compounds,
128 or dispenses any prescription or dispenses medicinal drugs. This
129 paragraph does not apply to any person who owns, operates,
130 maintains, opens, establishes, conducts, or has charge of a
131 remote dispensing site pharmacy pursuant to s. 465.0198.
132 (2) It is unlawful for any person:
133 (a) To make a false or fraudulent statement, either for
134 herself or himself or for another person, in any application,
135 affidavit, or statement presented to the board or in any
136 proceeding before the board.
137 (b) To fill, compound, or dispense prescriptions or to
138 dispense medicinal drugs if such person does not hold an active
139 license as a pharmacist in this state, is not registered as an
140 intern in this state, or is an intern not acting under the
141 direct and immediate personal supervision of a licensed
142 pharmacist. This paragraph does not apply to a registered
143 pharmacy technician preparing or dispensing medicinal drugs
144 pursuant to s. 465.0198.
145 (c) To sell or dispense drugs as defined in s. 465.003(8)
146 without first being furnished with a prescription.
147 (d) To sell samples or complimentary packages of drug
148 products.
149 Section 4. Section 465.0198, Florida Statutes, is created
150 to read:
151 465.0198 Remote dispensing site pharmacy permits.—
152 (1) Any person desiring a permit to operate a remote
153 dispensing site pharmacy shall apply to the department for a
154 remote dispensing site pharmacy permit. If the board certifies
155 that the application complies with the laws and rules of the
156 board governing the practice of the profession of pharmacy, the
157 department must issue the permit. A permit may not be issued
158 unless a pharmacist is designated as the prescription department
159 manager responsible for the oversight of the remote dispensing
160 site pharmacy.
161 (2) A remote dispensing site pharmacy must:
162 (a) Be jointly owned by a supervising pharmacy or operated
163 under a contract with a supervising pharmacy. For purposes of
164 this subsection, “supervising pharmacy” means a pharmacy
165 licensed under this chapter which employs a pharmacist who
166 remotely supervises a registered pharmacy technician at a remote
167 dispensing site pharmacy.
168 (b) Display a sign visible to the public indicating that
169 the location is a remote dispensing site pharmacy and that the
170 facility is under 24-hour video surveillance. The remote
171 dispensing site pharmacy must retain the video surveillance
172 recordings for at least 45 days after the date they are
173 recorded.
174 (c) Be located at least 10 miles from an existing community
175 pharmacy, unless:
176 1. The applicant for the proposed remote dispensing site
177 pharmacy demonstrates to the board that the proposed remote
178 dispensing site pharmacy will promote public health without
179 unduly harming an existing community pharmacy located within the
180 10-mile radius;
181 2. The community pharmacy that is located within the 10
182 mile radius from the remote dispensing site pharmacy is an
183 institutional pharmacy; or
184 3. A community pharmacy opens within 10 miles of an
185 existing remote dispensing site pharmacy.
186 (d) Ensure that the prescription department manager visits
187 the remote dispensing site pharmacy on a schedule determined by
188 the board to inspect the pharmacy and address personnel matters.
189 (e) Provide clinical services for patients and must notify
190 the department within 10 days after any change in the employment
191 of the prescription department manager.
192 (3) A remote dispensing site pharmacy is not considered a
193 pharmacy location for purposes of network access in managed care
194 programs.
195 (4) A remote dispensing site pharmacy may store, hold, and
196 dispense all medicinal drugs including those listed in s.
197 893.03.
198 (5) A remote dispensing site pharmacy may not perform
199 centralized prescription filling, as defined in s. 465.003(16).
200 (6) A remote dispensing site pharmacy must maintain a
201 policy and procedures manual, which shall be made available to
202 the board or its agent upon request. The policy and procedures
203 manual must include:
204 (a) A description of how the remote dispensing site
205 pharmacy will comply with federal and state laws, rules, and
206 regulations.
207 (b) The procedure for supervising the remote dispensing
208 site pharmacy and counseling its patients.
209 (c) The procedure for reviewing the prescription drug
210 inventory and drug records maintained by the remote dispensing
211 site pharmacy.
212 (d) The policy and procedure for providing appropriate
213 security to protect the confidentiality and integrity of patient
214 information.
215 (e) The written plan for recovery from an event that
216 interrupts or prevents the prescription department manager from
217 supervising the remote dispensing site pharmacy’s operation.
218 (f) The procedure by which the prescription department
219 manager uses the state prescription drug monitoring program
220 before authorizing any controlled substance for dispensing.
221 (g) The procedure for maintaining a perpetual inventory of
222 the controlled substances listed in s. 893.03(2).
223 (h) The specific duties, tasks, and functions that a
224 registered pharmacy technician is authorized to perform at the
225 remote dispensing site pharmacy.
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 registered pharmacist may not serve as the
234 prescription department manager in more than one location unless
235 approved by the board. However, a registered pharmacist may
236 serve as a prescription department manager for up to two remote
237 dispensing site pharmacies that are under common control.
238 Section 6. Subsection (1) of section 465.0265, Florida
239 Statutes, is amended to read:
240 465.0265 Centralized prescription filling.—
241 (1) A pharmacy licensed under this chapter, other than a
242 remote dispensing site pharmacy permitted under s. 465.0198, may
243 perform centralized prescription filling for another pharmacy,
244 provided that the pharmacies have the same owner or have a
245 written contract specifying the services to be provided by each
246 pharmacy, the responsibilities of each pharmacy, and the manner
247 in which the pharmacies will comply with federal and state laws,
248 rules, and regulations.
249 Section 7. This act shall take effect July 1, 2018.