Florida Senate - 2014 COMMITTEE AMENDMENT
Bill No. SB 662
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LEGISLATIVE ACTION
Senate . House
Comm: RCS .
03/17/2014 .
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following:
1 Senate Amendment (with title amendment)
2
3 Delete everything after the enacting clause
4 and insert:
5 Section 1. Subsections (18) and (19) are added to section
6 465.003, Florida Statutes, to read:
7 465.003 Definitions.—As used in this chapter, the term:
8 (18) “Compounding” means a practice in which a licensed
9 pharmacist or, in the case of an outsourcing facility, a person
10 acting under the supervision of a licensed pharmacist, combines,
11 mixes, or alters ingredients of a drug or product to create
12 another drug or product.
13 (19) “Outsourcing facility” means a single physical
14 location registered as an outsourcing facility under the federal
15 Drug Quality and Security Act, Pub. L. No. 113-54, at which
16 sterile compounding of a product is conducted.
17 Section 2. Subsections (4) and (5) of section 465.0156,
18 Florida Statutes, are amended, present subsections (6) through
19 (8) of that section are redesignated as subsections (7) through
20 (9), respectively, and a new subsection (6) is added to that
21 section, to read:
22 465.0156 Registration of nonresident pharmacies.—
23 (4) The board may deny, revoke, or suspend registration of,
24 or fine or reprimand, a nonresident pharmacy for failure to
25 comply with s. 465.0158, s. 465.017(2), or s. 465.025, or with
26 any requirement of this section in accordance with the
27 provisions of this chapter.
28 (5) In addition to the prohibitions of subsection (4) the
29 board may deny, revoke, or suspend registration of, or fine or
30 reprimand, a nonresident pharmacy in accordance with the
31 provisions of this chapter for conduct which causes or could
32 cause serious bodily injury or serious psychological injury to a
33 human or serious bodily injury to a nonhuman animal in resident
34 of this state if the board has referred the matter to the
35 regulatory or licensing agency in the state in which the
36 pharmacy is located and the regulatory or licensing agency fails
37 to investigate within 180 days of the referral.
38 (6) A nonresident pharmacy is subject to s. 456.0635.
39 Section 3. Section 465.0158, Florida Statutes, is created
40 to read:
41 465.0158 Nonresident sterile compounding permit.—
42 (1) In order to ship, mail, deliver, or dispense, in any
43 manner, a compounded sterile product into this state, a
44 nonresident pharmacy registered under s. 465.0156, or an
45 outsourcing facility, must hold a nonresident sterile
46 compounding permit.
47 (2) An application for a nonresident sterile compounding
48 permit shall be submitted on a form furnished by the board. The
49 board may require such information as it deems reasonably
50 necessary to carry out the purposes of this section. The fee for
51 an initial permit and biennial renewal of the permit shall be
52 set by the board pursuant to s. 465.022(14).
53 (3) An applicant must submit the following to the board to
54 obtain an initial permit, or to the department to renew a
55 permit:
56 (a) Proof of registration as an outsourcing facility with
57 the Secretary of the United States Department of Health and
58 Human Services if the applicant is eligible for such
59 registration pursuant to the federal Drug Quality and Security
60 Act, Pub. L. No. 113-54.
61 (b) Proof of registration as a nonresident pharmacy,
62 pursuant to s. 465.0156, unless the applicant is an outsourcing
63 facility and not a pharmacy, in which case the application must
64 include proof of an active and unencumbered license, permit, or
65 registration issued by the state, territory, or district in
66 which the outsourcing facility is physically located which
67 allows the outsourcing facility to engage in compounding and to
68 ship, mail, deliver, or dispense a compounded sterile product
69 into this state if required by the state, territory, or district
70 in which the outsourcing facility is physically located.
71 (c) Written attestation by an owner or officer of the
72 applicant, and by the applicant’s prescription department
73 manager or pharmacist in charge, that:
74 1. The applicant has read and understands the laws and
75 rules governing sterile compounding in this state.
76 2. A compounded sterile product shipped, mailed, delivered,
77 or dispensed into this state meets or exceeds this state’s
78 standards for sterile compounding.
79 3. A compounded sterile product shipped, mailed, delivered,
80 or dispensed into this state must not have been, and may not be,
81 compounded in violation of the laws and rules of the state in
82 which the applicant is located.
83 (d) The applicant’s existing policies and procedures for
84 sterile compounding, which must comply with pharmaceutical
85 standards in chapter 797 of the United States Pharmacopoeia and
86 any standards for sterile compounding required by board rule or
87 current good manufacturing practices for an outsourcing
88 facility.
89 (e) A current inspection report from an inspection
90 conducted by the regulatory or licensing agency of the state,
91 territory, or district in which the applicant is located. The
92 inspection report must reflect compliance with this section. An
93 inspection report is current if the inspection was conducted
94 within 6 months before the date of submitting the application
95 for the initial permit or within 1 year before the date of
96 submitting an application for permit renewal. If the applicant
97 is unable to submit a current inspection report conducted by the
98 regulatory or licensing agency of the state, territory, or
99 district in which the applicant is located due to acceptable
100 circumstances, as established by rule, the department shall:
101 1. Conduct, or contract with an entity approved by the
102 board to conduct, an onsite inspection for which all costs shall
103 be borne by the applicant;
104 2. Accept a current and satisfactory inspection report, as
105 determined by rule, from an entity approved by the board; or
106 3. Accept a current inspection report from the United
107 States Food and Drug Administration conducted pursuant to the
108 federal Drug Quality and Security Act, Pub. L. No. 113-54.
109 (4) A permittee may not ship, mail, deliver, or dispense a
110 compounded sterile product into this state if the product was
111 compounded in violation of the laws or rules of the state in
112 which the permittee is located or does not meet or exceed this
113 state’s sterile compounding standards.
114 (5) In accordance with this chapter, the board may deny,
115 revoke, or suspend the permit of, fine, or reprimand a permittee
116 for:
117 (a) Failure to comply with this section;
118 (b) A violation listed under s. 456.0635, s. 456.065, or s.
119 456.072, except s. 456.072(1)(s) or (1)(u);
120 (c) A violation under s. 465.0156(5); or
121 (d) A violation listed under s. 465.016.
122 (6) A nonresident pharmacy registered under s. 465.0156
123 which ships, mails, delivers, or dispenses a compounded sterile
124 product into this state may continue to do so if the product
125 meets or exceeds the standards for sterile compounding in this
126 state, the product is not compounded in violation of any law or
127 rule of the state where the pharmacy is located, and the
128 pharmacy applies for and is issued a permit under this section
129 on or before February 28, 2015.
130 (7) An applicant registering on or after October 1, 2014,
131 as a nonresident pharmacy under s. 465.0156 may not ship, mail,
132 deliver, or dispense a compounded sterile product into this
133 state until the applicant is registered as a nonresident
134 pharmacy and is issued a permit under this section.
135 (8) The board shall adopt rules as necessary to administer
136 this section, including rules for:
137 (a) Submitting an application for the permit required by
138 this section.
139 (b) Determining how, when, and under what circumstances an
140 inspection of a nonresident sterile compounding permittee must
141 be conducted.
142 (c) Evaluating and approving entities from which a
143 satisfactory inspection report will be accepted in lieu of an
144 onsite inspection by the department or an inspection by the
145 licensing or regulatory agency of the state, territory, or
146 district where the applicant is located.
147 Section 4. Section 465.017, Florida Statutes, is amended to
148 read:
149 465.017 Authority to inspect; disposal.—
150 (1) Duly authorized agents and employees of the department
151 may shall have the power to inspect in a lawful manner at all
152 reasonable hours any pharmacy, hospital, clinic, wholesale
153 establishment, manufacturer, physician’s office, or any other
154 place in the state in which drugs and medical supplies are
155 compounded, manufactured, packed, packaged, made, stored, sold,
156 offered for sale, exposed for sale, or kept for sale for the
157 purpose of:
158 (a) Determining if any provision of the provisions of this
159 chapter or any rule adopted promulgated under its authority is
160 being violated;
161 (b) Securing samples or specimens of any drug or medical
162 supply after paying or offering to pay for such sample or
163 specimen; or
164 (c) Securing such other evidence as may be needed for
165 prosecution under this chapter.
166 (2) Duly authorized agents and employees of the department
167 may inspect a nonresident pharmacy registered under s. 465.0156
168 or a nonresident sterile compounding permittee under s. 465.0158
169 pursuant to this section. The costs of such inspections shall be
170 borne by such pharmacy or permittee.
171 (3)(2)(a) Except as permitted by this chapter, and chapters
172 406, 409, 456, 499, and 893, records maintained in a pharmacy
173 relating to the filling of prescriptions and the dispensing of
174 medicinal drugs may shall not be furnished only to any person
175 other than to the patient for whom the drugs were dispensed, or
176 her or his legal representative, or to the department pursuant
177 to existing law, or, if in the event that the patient is
178 incapacitated or unable to request such said records, her or his
179 spouse except upon the written authorization of such patient.
180 (a) Such records may be furnished in any civil or criminal
181 proceeding, upon the issuance of a subpoena from a court of
182 competent jurisdiction and proper notice to the patient or her
183 or his legal representative by the party seeking such records.
184 (b) The board shall adopt rules establishing to establish
185 practice guidelines for pharmacies to dispose of records
186 maintained in a pharmacy relating to the filling of
187 prescriptions and the dispensing of medicinal drugs. Such rules
188 must shall be consistent with the duty to preserve the
189 confidentiality of such records in accordance with applicable
190 state and federal law.
191 Section 5. This act shall take effect October 1, 2014.
192
193 ================= T I T L E A M E N D M E N T ================
194 And the title is amended as follows:
195 Delete everything before the enacting clause
196 and insert:
197 A bill to be entitled
198 An act relating to nonresident sterile compounding
199 permits; amending s. 465.003, F.S.; defining the terms
200 “compounding” and “outsourcing facility”; amending s.
201 465.0156, F.S.; conforming provisions to changes made
202 by the act; expanding penalties to apply to injury to
203 a nonhuman animal; deleting a requirement that the
204 Board of Pharmacy refer regulatory issues affecting a
205 nonresident pharmacy to the state where the pharmacy
206 is located; creating s. 465.0158, F.S.; requiring
207 registered nonresident pharmacies and outsourcing
208 facilities to obtain a permit in order to ship, mail,
209 deliver, or dispense compounded sterile products into
210 this state; requiring submission of an application and
211 a nonrefundable fee; specifying requirements;
212 authorizing the board to deny, revoke, or suspend a
213 permit, or impose a fine or reprimand for certain
214 actions; providing dates by which certain nonresident
215 pharmacies must obtain a permit; authorizing the board
216 to adopt rules; amending s. 465.017, F.S.; authorizing
217 the department to inspect nonresident pharmacies and
218 nonresident sterile compounding permittees; requiring
219 such pharmacies and permittees to pay for the costs of
220 such inspections; providing an effective date.