Florida Senate - 2018 SENATOR AMENDMENT
Bill No. CS for SB 848
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LEGISLATIVE ACTION
Senate . House
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Floor: 1/AD/2R .
03/08/2018 03:38 PM .
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Senator Grimsley moved the following:
1 Senate Amendment (with title amendment)
2
3 Delete lines 63 - 226
4 and insert:
5 certified pharmacy technician who is electronically supervised
6 by an offsite pharmacist and dispensed pursuant to s. 465.014(1)
7 to the patient after verification, certification, and counseling
8 by the pharmacist.
9 (b) The pharmacy department of any permittee shall be
10 considered closed whenever a Florida licensed pharmacist is not
11 present and on duty. The term “not present and on duty” may
12 shall not be construed to prevent:
13 1. A pharmacist from exiting the prescription department
14 for the purposes of consulting or responding to inquiries or
15 providing assistance to patients or customers;,
16 2. A pharmacist attending to personal hygiene needs;, or
17 3. A pharmacist performing any other function for which the
18 pharmacist is responsible, provided that such activities are
19 conducted in a manner consistent with the pharmacist’s
20 responsibility to provide pharmacy services; or
21 4. An offsite pharmacist from remotely supervising a
22 certified pharmacy technician at a remote dispensing site
23 pharmacy.
24 Section 2. Subsection (1) of section 465.014, Florida
25 Statutes, is amended to read:
26 465.014 Pharmacy technician.—
27 (1) A person other than a licensed pharmacist or pharmacy
28 intern may not engage in the practice of the profession of
29 pharmacy, except that a licensed pharmacist may delegate to
30 pharmacy technicians who are certified registered pursuant to
31 this section those duties, tasks, and functions that do not fall
32 within the purview of s. 465.003(13). However, a certified
33 pharmacy technician may dispense medicinal drugs when operating
34 under the electronic supervision of an offsite Florida licensed
35 pharmacist pursuant to s. 465.0198. All such delegated acts must
36 be performed under the direct supervision of a licensed
37 pharmacist who is responsible for all such acts performed by
38 persons under his or her supervision. A certified registered
39 pharmacy technician, under the supervision of a pharmacist, may
40 initiate or receive communications with a practitioner or his or
41 her agent, on behalf of a patient, regarding refill
42 authorization requests. A licensed pharmacist may not supervise
43 more than one certified registered pharmacy technician unless
44 otherwise permitted by the guidelines adopted by the board. The
45 board shall establish guidelines to be followed by licensees or
46 permittees in determining the circumstances under which a
47 licensed pharmacist may supervise more than one pharmacy
48 technician.
49 Section 3. Subsections (1) and (2) of section 465.015,
50 Florida Statutes, are amended to read:
51 465.015 Violations and penalties.—
52 (1) It is unlawful for any person to own, operate,
53 maintain, open, establish, conduct, or have charge of, either
54 alone or with another person or persons, a pharmacy:
55 (a) Which is not registered under the provisions of this
56 chapter.
57 (b) In which a person not licensed as a pharmacist in this
58 state or not registered as an intern in this state or in which
59 an intern who is not acting under the direct and immediate
60 personal supervision of a licensed pharmacist fills, compounds,
61 or dispenses any prescription or dispenses medicinal drugs. This
62 paragraph does not apply to any person who owns, operates,
63 maintains, opens, establishes, conducts, or has charge of a
64 remote dispensing site pharmacy pursuant to s. 465.0198.
65 (2) It is unlawful for any person:
66 (a) To make a false or fraudulent statement, either for
67 herself or himself or for another person, in any application,
68 affidavit, or statement presented to the board or in any
69 proceeding before the board.
70 (b) To fill, compound, or dispense prescriptions or to
71 dispense medicinal drugs if such person does not hold an active
72 license as a pharmacist in this state, is not registered as an
73 intern in this state, or is an intern not acting under the
74 direct and immediate personal supervision of a licensed
75 pharmacist. This paragraph does not apply to a certified
76 pharmacy technician dispensing medicinal drugs pursuant to s.
77 465.0198.
78 (c) To sell or dispense drugs as defined in s. 465.003(8)
79 without first being furnished with a prescription.
80 (d) To sell samples or complimentary packages of drug
81 products.
82 Section 4. Section 465.0198, Florida Statutes, is created
83 to read:
84 465.0198 Remote dispensing site pharmacy permits.—
85 (1) Any person desiring a permit to operate a remote
86 dispensing site pharmacy must apply to the department for a
87 remote dispensing site pharmacy permit. If the board certifies
88 that the application complies with the laws and board rules
89 governing the practice of the profession of pharmacy, the
90 department must issue the permit. A permit may not be issued
91 unless a licensed pharmacist or consultant pharmacist is
92 designated as the prescription department manager responsible
93 for the oversight of the remote dispensing site pharmacy. The
94 permittee must notify the department within 10 days after any
95 change of the prescription department manager.
96 (2) As a prerequisite to issuance of an initial permit or a
97 permit for a change of location, the remote dispensing site
98 pharmacy must pass an onsite inspection. The department must
99 make the inspection within 90 days before issuance of the
100 permit.
101 (3) The remote dispensing site pharmacy must:
102 (a) Be jointly owned by a supervising pharmacy or operated
103 under a contract with a supervising pharmacy. For purposes of
104 this subsection, “supervising pharmacy” means a licensed
105 pharmacy in this state which employs a Florida licensed
106 pharmacist who remotely supervises a certified pharmacy
107 technician at a remote dispensing site pharmacy.
108 (b) Display a sign visible to the public indicating that
109 the location is a remote dispensing site pharmacy and that the
110 facility is under 24-hour video surveillance. The remote
111 dispensing site pharmacy must retain the video surveillance
112 recordings for at least 45 days.
113 (c) Be located in a rural hospital as defined in s.
114 395.602.
115 (4) A remote dispensing site pharmacy may not lose its
116 permit based on the subsequent opening of a community pharmacy
117 within 10 miles of the remote dispensing site pharmacy.
118 (5) A remote dispensing site pharmacy may store, hold, and
119 dispense all medicinal drugs including those listed in s.
120 893.03(3)-(5). A remote dispensing pharmacy may not store, hold,
121 or dispense controlled substances listed in s. 893.03(2).
122 (6) A remote dispensing site pharmacy may not perform
123 centralized prescription filling, as defined in s. 465.003(16).
124 (7) A remote dispensing site pharmacy must maintain a
125 policy and procedures manual, which shall be made available to
126 the board or its agent upon request. The policy and procedures
127 manual shall include:
128 (a) A description of how the pharmacy will comply with
129 federal and state laws, rules, and regulations.
130 (b) The procedure for supervising the remote dispensing
131 site pharmacy and counseling its patients before the dispensing
132 of any medicinal drug pursuant to this section.
133 (c) The procedure for reviewing the prescription drug
134 inventory and drug records maintained by the remote dispensing
135 site pharmacy.
136 (d) The policy and procedure for providing appropriate
137 security to protect the confidentiality and integrity of patient
138 information.
139 (e) The written plan for recovery from an event that
140 interrupts or prevents the pharmacist from supervising the
141 remote dispensing site pharmacy’s operation.
142 (f) The procedure by which a supervising pharmacist
143 consults the state prescription drug monitoring program before
144 authorizing any controlled substance for dispensing and reports
145 the dispensing of a controlled substance as required under s.
146 893.055.
147 (g) The specific duties, tasks, and functions that a
148 certified pharmacy technician is authorized to perform at the
149 remote dispensing site pharmacy.
150 (8) The prescription department manager or other pharmacist
151 employed by the supervising pharmacy must visit the remote
152 dispensing site pharmacy, based on a schedule designated by the
153 board, to inspect the pharmacy, address personnel matters, and
154 provide clinical services for patients.
155 (9) A certified pharmacy technician must be certified by a
156 pharmacy technician certification program that is accredited by
157 the National Commission of Certifying Agencies and have
158 completed at least 2,080 hours of experience at a pharmacy
159 within the 2 years immediately preceding the date on which the
160 certified pharmacy technician begins employment at the remote
161 dispensing site pharmacy.
162 (10) A certified pharmacy technician working at a remote
163 dispensing site pharmacy may not perform sterile or nonsterile
164 compounding, except that a certified pharmacy technician may
165 reconstitute orally administered powder antibiotics.
166
167 ================= T I T L E A M E N D M E N T ================
168 And the title is amended as follows:
169 Delete lines 4 - 18
170 and insert:
171 465.014, F.S.; authorizing a certified pharmacy
172 technician to dispense medicinal drugs under certain
173 conditions; amending s. 465.015, F.S.; conforming
174 provisions to changes made by the act; creating s.
175 465.0198, F.S.; providing permit requirements for
176 remote dispensing site pharmacies; providing operating
177 requirements and prohibitions for a remote dispensing
178 site pharmacy; requiring the prescription department
179 manager or other pharmacist employed by the
180 supervising pharmacy to visit the remote dispensing
181 site pharmacy; providing certification and experience
182 requirements for a certified pharmacy technician
183 working at a remote site pharmacy; prohibiting a
184 certified pharmacy technician from performing sterile
185 or nonsterile compounding; providing an exception;