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,
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 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
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 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 certified registered pursuant 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 certified registered
97 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 certified registered pharmacy 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 under the provisions of this
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 licensed registered pharmacist 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.