Florida Senate - 2014 COMMITTEE AMENDMENT
Bill No. CS for SB 662
Ì298952JÎ298952
LEGISLATIVE ACTION
Senate . House
Comm: RCS .
04/24/2014 .
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The Committee on Appropriations (Bean) recommended the
following:
1 Senate Amendment (with title amendment)
2
3 Delete lines 28 - 151
4 and insert:
5 Section 1. Subsections (18), (19) and (20) are added to
6 section 465.003, Florida Statutes, to read:
7 465.003 Definitions.—As used in this chapter, the term:
8 (18) “Compounding” means combining, mixing, or altering the
9 ingredients of one or more drugs or products to create another
10 drug or product.
11 (19) “Outsourcing facility” means a single physical
12 location registered as an outsourcing facility under the federal
13 Drug Quality and Security Act, Pub. L. No. 113-54, at which
14 sterile compounding of a drug or product is conducted.
15 (20) “Compounded sterile product” means a drug that is
16 intended for parenteral administration, an ophthalmic or oral
17 inhalation drug in aqueous format, or a drug or product that is
18 required to be sterile under federal or state law or rule, which
19 is produced through compounding but is not approved by the
20 federal Food and Drug Administration.
21 Section 2. Subsections (4) and (5) of section 465.0156,
22 Florida Statutes, are amended, present subsections (6) through
23 (8) of that section are redesignated as subsections (7) through
24 (9), respectively, and a new subsection (6) is added to that
25 section, to read:
26 465.0156 Registration of nonresident pharmacies.—
27 (4) The board may deny, revoke, or suspend registration of,
28 or fine or reprimand, a nonresident pharmacy for failure to
29 comply with s. 465.0158, s. 465.017(2), or s. 465.025, or with
30 any requirement of this section in accordance with the
31 provisions of this chapter.
32 (5) In addition to the prohibitions of subsection (4) the
33 board may deny, revoke, or suspend registration of, or fine or
34 reprimand, a nonresident pharmacy in accordance with the
35 provisions of this chapter for conduct which causes or could
36 cause serious bodily injury or serious psychological injury to a
37 human or serious bodily injury to a nonhuman animal in resident
38 of this state if the board has referred the matter to the
39 regulatory or licensing agency in the state in which the
40 pharmacy is located and the regulatory or licensing agency fails
41 to investigate within 180 days of the referral.
42 (6) A nonresident pharmacy is subject to s. 456.0635.
43 Section 3. Section 465.0158, Florida Statutes, is created
44 to read:
45 465.0158 Nonresident sterile compounding permit.—
46 (1) In order to ship, mail, deliver, or dispense, in any
47 manner, a compounded sterile product into this state, a
48 nonresident pharmacy registered under s. 465.0156, or an
49 outsourcing facility, must hold a nonresident sterile
50 compounding permit.
51 (2) An application for a nonresident sterile compounding
52 permit shall be submitted on a form furnished by the board. The
53 board may require such information as it deems reasonably
54 necessary to carry out the purposes of this section. The fee for
55 an initial permit and biennial renewal of the permit shall be
56 set by the board pursuant to s. 465.022(14).
57 (3) An applicant must submit the following to the board to
58 obtain an initial permit, or to the department to renew a
59 permit:
60 (a) Proof of registration as an outsourcing facility with
61 the Secretary of the United States Department of Health and
62 Human Services if the applicant is eligible for such
63 registration pursuant to the federal Drug Quality and Security
64 Act, Pub. L. No. 113-54.
65 (b) Proof of registration as a nonresident pharmacy,
66 pursuant to s. 465.0156, unless the applicant is an outsourcing
67 facility and not a pharmacy, in which case the application must
68 include proof of an active and unencumbered license, permit, or
69 registration issued by the state, territory, or district in
70 which the outsourcing facility is physically located which
71 allows the outsourcing facility to engage in compounding and to
72 ship, mail, deliver, or dispense a compounded sterile product
73 into this state if required by the state, territory, or district
74 in which the outsourcing facility is physically located.
75 (c) Written attestation by an owner or officer of the
76 applicant, and by the applicant’s prescription department
77 manager or pharmacist in charge, that:
78 1. The attestor has read and understands the laws and rules
79 governing sterile compounding in this state.
80 2. A compounded sterile product shipped, mailed, delivered,
81 or dispensed into this state meets or exceeds this state’s
82 standards for sterile compounding.
83 3. A compounded sterile product shipped, mailed, delivered,
84 or dispensed into this state must not have been, and may not be,
85 compounded in violation of the laws and rules of the state,
86 territory or district in which the applicant is located.
87 (d) The applicant’s existing policies and procedures for
88 sterile compounding, which must comply with pharmaceutical
89 standards in chapter 797 of the United States Pharmacopoeia and
90 any standards for sterile compounding required by board rule or
91 current good manufacturing practices for an outsourcing
92 facility.
93 (e) A current inspection report from an inspection
94 conducted by the regulatory or licensing agency of the state,
95 territory, or district in which the applicant is located. The
96 inspection report must reflect compliance with this section. An
97 inspection report is current if the inspection was conducted
98 within 6 months before the date of submitting the application
99 for the initial permit or within 1 year before the date of
100 submitting an application for permit renewal. If the applicant
101 is unable to submit a current inspection report conducted by the
102 regulatory or licensing agency of the state, territory, or
103 district in which the applicant is located due to acceptable
104 circumstances, as established by rule, or if an inspection has
105 not been performed, the department shall:
106 1. Conduct, or contract with an entity to conduct, an
107 onsite inspection for which all costs shall be borne by the
108 applicant;
109 2. Accept a current and satisfactory inspection report, as
110 determined by rule, from an entity approved by the board; or
111 3. Accept a current inspection report from the United
112 States Food and Drug Administration conducted pursuant to the
113 federal Drug Quality and Security Act, Pub. L. No. 113-54.
114 (4) A permittee may not ship, mail, deliver, or dispense a
115 compounded sterile product into this state if the product was
116 compounded in violation of the laws or rules of the state,
117 territory, or district, in which the permittee is located or
118 does not meet or exceed this state’s sterile compounding
119 standards.
120 (5) In accordance with this chapter, the board may deny,
121 revoke, or suspend the permit of, fine, or reprimand a permittee
122 for:
123 (a) Failure to comply with this section;
124 (b) A violation listed under s. 456.0635, s. 456.065, or s.
125 456.072, except s. 456.072(1)(s) or (1)(u);
126 (c) A violation under s. 465.0156(5); or
127 (d) A violation listed under s. 465.016.
128 (6) A nonresident pharmacy registered under s. 465.0156
129 which ships, mails, delivers, or dispenses a compounded sterile
130 product into this state may continue to do so if the product
131 meets or exceeds the standards for sterile compounding in this
132 state, the product is not compounded in violation of any law or
133 rule of the state, territory, or district, where the pharmacy is
134 located, and the pharmacy is issued a permit under this section
135
136 ================= T I T L E A M E N D M E N T ================
137 And the title is amended as follows:
138 Delete lines 4 - 15
139 and insert:
140 “compounding”, “outsourcing facility”, and “compounded
141 sterile product”; amending s. 465.0156, F.S.;
142 conforming provisions to changes made by the act;
143 expanding penalties to apply to injury to a nonhuman
144 animal; deleting a requirement that the Board of
145 Pharmacy refer regulatory issues affecting a
146 nonresident pharmacy to the state where the pharmacy
147 is located; providing that a nonresident pharmacy is
148 subject to certain health care fraud provisions;
149 creating s. 465.0158, F.S.; requiring registered
150 nonresident pharmacies and outsourcing facilities to
151 obtain a permit in order to ship, mail, deliver, or
152 dispense compounded sterile products into this state;
153 requiring submission of an application and a
154 nonrefundable fee; providing application requirements;
155