Florida Senate - 2021 COMMITTEE AMENDMENT
Bill No. CS for SB 700
Ì607286DÎ607286
LEGISLATIVE ACTION
Senate . House
Comm: RCS .
04/08/2021 .
.
.
.
—————————————————————————————————————————————————————————————————
—————————————————————————————————————————————————————————————————
Appropriations Subcommittee on Health and Human Services
(Rodriguez) recommended the following:
1 Senate Amendment to Amendment (645592) (with title
2 amendment)
3
4 Between lines 134 and 135
5 insert:
6 Section 5. Paragraph (a) of subsection (11) of section
7 465.003, Florida Statutes, is amended to read
8 465.003 Definitions.—As used in this chapter, the term:
9 (11)(a) “Pharmacy” includes a community pharmacy, an
10 institutional pharmacy, a nuclear pharmacy, a special pharmacy,
11 and an Internet pharmacy, and a remote-site pharmacy.
12 1. The term “community pharmacy” includes every location
13 where medicinal drugs are compounded, dispensed, stored, or sold
14 or where prescriptions are filled or dispensed on an outpatient
15 basis.
16 2. The term “institutional pharmacy” includes every
17 location in a hospital, clinic, nursing home, dispensary,
18 sanitarium, extended care facility, or other facility,
19 hereinafter referred to as “health care institutions,” where
20 medicinal drugs are compounded, dispensed, stored, or sold.
21 3. The term “nuclear pharmacy” includes every location
22 where radioactive drugs and chemicals within the classification
23 of medicinal drugs are compounded, dispensed, stored, or sold.
24 The term “nuclear pharmacy” does not include hospitals licensed
25 under chapter 395 or the nuclear medicine facilities of such
26 hospitals.
27 4. The term “special pharmacy” includes every location
28 where medicinal drugs are compounded, dispensed, stored, or sold
29 if such locations are not otherwise defined in this subsection.
30 5. The term “Internet pharmacy” includes locations not
31 otherwise licensed or issued a permit under this chapter, within
32 or outside this state, which use the Internet to communicate
33 with or obtain information from consumers in this state and use
34 such communication or information to fill or refill
35 prescriptions or to dispense, distribute, or otherwise engage in
36 the practice of pharmacy in this state. Any act described in
37 this definition constitutes the practice of pharmacy as defined
38 in subsection (13).
39 6. The term “remote-site pharmacy” or “remote site”
40 includes every location within a community mental health center
41 or clinic as defined in s. 394.455 in which medicinal drugs are
42 compounded or dispensed by a registered pharmacy technician who
43 is remotely supervised by an off-site pharmacist acting in the
44 capacity of a prescription department manager.
45 Section 6. Section 465.0198, Florida Statutes, is created
46 to read:
47 465.0198 Remote-site pharmacy permits.—
48 (1) As used in this section, the term “supervising
49 pharmacy” means a pharmacy licensed in this state which employs
50 a licensed pharmacist who remotely supervises a registered
51 pharmacy technician at a remote-site pharmacy.
52 (2) Any person desiring a permit to operate a remote-site
53 pharmacy must apply to the department. If the board certifies
54 that the application complies with the laws and rules of the
55 board, the department must issue the permit. A permit may not be
56 issued unless a licensed pharmacist or consultant pharmacist is
57 designated as the prescription department manager responsible
58 for the oversight of the remote site. The permittee must notify
59 the department within 10 days after any change of the
60 prescription department manager.
61 (3) A remote-site pharmacy must comply with all of the
62 following:
63 (a) Be jointly owned by or operated under a contract with a
64 supervising pharmacy.
65 (b) Maintain a video surveillance system that records
66 continuously 24 hours per day and retain video surveillance
67 recordings for at least 45 days.
68 (c) Display a sign visible to the public indicating that
69 the location is a remote-site pharmacy and that the facility is
70 under 24-hour video surveillance.
71 (d) Maintain a policies and procedures manual, which must
72 be made available to the board or its agent upon request, and
73 must include, but need not be limited to, all of the following:
74 1. A description of how the pharmacy will comply with
75 federal and state laws and rules.
76 2. The procedures for supervising the remote site and
77 counseling its patients.
78 3. The procedures for reviewing the prescription drug
79 inventory and drug records maintained by the remote site.
80 4. The policies and procedures for providing security
81 adequate to protect the confidentiality and integrity of patient
82 information.
83 5. The written plan for recovery from an event that
84 interrupts or prevents the prescription department manager from
85 supervising the remote site’s operation.
86 6. The procedures for use of the state prescription drug
87 monitoring program by the prescription department manager before
88 he or she may authorize the dispensing of any controlled
89 substance.
90 7. The procedures for maintaining a perpetual inventory of
91 the controlled substances listed in s. 893.03(2).
92 8. The specific duties, tasks, and functions that
93 registered pharmacy technicians are authorized to perform at the
94 remote site.
95 (4) A remote-site pharmacy is not considered a pharmacy
96 location for purposes of network access in managed care
97 programs.
98 (5) A remote-site pharmacy may store, hold, or dispense any
99 medicinal drug.
100 (6) A remote-site pharmacy may not perform centralized
101 prescription filling as defined in s. 465.003(16).
102 (7) The prescription department manager must visit the
103 remote site, based on a schedule determined by the board, to
104 inspect the pharmacy, address personnel matters, and provide
105 clinical services for patients.
106 (8) A registered pharmacist may serve as the prescription
107 department manager for up to three remote-site pharmacies that
108 are under common control of the same supervising pharmacy.
109
110 ================= T I T L E A M E N D M E N T ================
111 And the title is amended as follows:
112 Between lines 207 and 208
113 insert:
114 amending s. 465.003, F.S.; revising the definition of
115 the term “pharmacy”; creating s. 465.0198, F.S.;
116 defining the term “supervising pharmacy”; providing
117 for the permitting of remote-site pharmacies;
118 requiring a licensed or consultant pharmacist to serve
119 as the prescription department manager of a remote
120 site; requiring remote-site pharmacies to notify the
121 Department of Health of a change in the pharmacy’s
122 prescription department manager within a specified
123 timeframe; providing requirements for remote-site
124 pharmacies; providing that remote-site pharmacies are
125 not considered pharmacy locations for purposes of
126 network access in managed care programs; authorizing
127 remote-site pharmacies to store, hold, and dispense
128 medicinal drugs; prohibiting remote-site pharmacies
129 from performing centralized prescription filling;
130 requiring prescription department managers to visit
131 remote sites, based on a certain schedule, to perform
132 specified tasks; authorizing registered pharmacists to
133 serve as prescription department managers for up to
134 three remote-site pharmacies under certain
135 circumstances;