Bill Text: FL S0662 | 2014 | Regular Session | Comm Sub
Bill Title: Nonresident Sterile Compounding Permits
Spectrum: Committee Bill
Status: (Introduced - Dead) 2014-04-29 - Laid on Table, companion bill(s) passed, see CS/HB 7077 (Ch. 2014-148) [S0662 Detail]
Download: Florida-2014-S0662-Comm_Sub.html
Florida Senate - 2014 CS for CS for SB 662
By the Committees on Appropriations; Regulated Industries; and
Health Policy
576-04577-14 2014662c2
1 A bill to be entitled
2 An act relating to nonresident sterile compounding
3 permits; amending s. 465.003, F.S.; defining the terms
4 “compounding,” “outsourcing facility,” and “compounded
5 sterile product”; amending s. 465.0156, F.S.;
6 conforming provisions to changes made by the act;
7 expanding penalties to apply to injury to a nonhuman
8 animal; deleting a requirement that the Board of
9 Pharmacy refer regulatory issues affecting a
10 nonresident pharmacy to the state where the pharmacy
11 is located; providing that a nonresident pharmacy is
12 subject to certain health care fraud provisions;
13 creating s. 465.0158, F.S.; requiring registered
14 nonresident pharmacies and outsourcing facilities to
15 obtain a permit in order to ship, mail, deliver, or
16 dispense compounded sterile products into this state;
17 requiring submission of an application and a
18 nonrefundable fee; providing application requirements;
19 authorizing the board to deny, revoke, or suspend a
20 permit, or impose a fine or reprimand for certain
21 actions; providing dates by which certain nonresident
22 pharmacies must obtain a permit; authorizing the board
23 to adopt rules; amending s. 465.017, F.S.; authorizing
24 the department to inspect nonresident pharmacies and
25 nonresident sterile compounding permittees; requiring
26 such pharmacies and permittees to pay for the costs of
27 such inspections; providing an effective date.
28
29 Be It Enacted by the Legislature of the State of Florida:
30
31
32 Section 1. Subsections (18), (19) and (20) are added to
33 section 465.003, Florida Statutes, to read:
34 465.003 Definitions.—As used in this chapter, the term:
35 (18) “Compounding” means combining, mixing, or altering the
36 ingredients of one or more drugs or products to create another
37 drug or product.
38 (19) “Outsourcing facility” means a single physical
39 location registered as an outsourcing facility under the federal
40 Drug Quality and Security Act, Pub. L. No. 113-54, at which
41 sterile compounding of a drug or product is conducted.
42 (20) “Compounded sterile product” means a drug intended
43 for parenteral administration, an ophthalmic or oral inhalation
44 drug in aqueous format, or a drug or product required to be
45 sterile under federal or state law or rule, which is produced
46 through compounding but is not approved by the federal Food and
47 Drug Administration.
48 Section 2. Subsections (4) and (5) of section 465.0156,
49 Florida Statutes, are amended, present subsections (6) through
50 (8) of that section are redesignated as subsections (7) through
51 (9), respectively, and a new subsection (6) is added to that
52 section, to read:
53 465.0156 Registration of nonresident pharmacies.—
54 (4) The board may deny, revoke, or suspend registration of,
55 or fine or reprimand, a nonresident pharmacy for failure to
56 comply with s. 465.0158, s. 465.017(2), or s. 465.025, or with
57 any requirement of this section in accordance with the
58 provisions of this chapter.
59 (5) In addition to the prohibitions of subsection (4) the
60 board may deny, revoke, or suspend registration of, or fine or
61 reprimand, a nonresident pharmacy in accordance with the
62 provisions of this chapter for conduct which causes or could
63 cause serious bodily injury or serious psychological injury to a
64 human or serious bodily injury to a nonhuman animal in resident
65 of this state if the board has referred the matter to the
66 regulatory or licensing agency in the state in which the
67 pharmacy is located and the regulatory or licensing agency fails
68 to investigate within 180 days of the referral.
69 (6) A nonresident pharmacy is subject to s. 456.0635.
70 Section 3. Section 465.0158, Florida Statutes, is created
71 to read:
72 465.0158 Nonresident sterile compounding permit.—
73 (1) In order to ship, mail, deliver, or dispense, in any
74 manner, a compounded sterile product into this state, a
75 nonresident pharmacy registered under s. 465.0156, or an
76 outsourcing facility, must hold a nonresident sterile
77 compounding permit.
78 (2) An application for a nonresident sterile compounding
79 permit shall be submitted on a form furnished by the board. The
80 board may require such information as it deems reasonably
81 necessary to carry out the purposes of this section. The fee for
82 an initial permit and biennial renewal of the permit shall be
83 set by the board pursuant to s. 465.022(14).
84 (3) An applicant must submit the following to the board to
85 obtain an initial permit, or to the department to renew a
86 permit:
87 (a) Proof of registration as an outsourcing facility with
88 the Secretary of the United States Department of Health and
89 Human Services if the applicant is eligible for such
90 registration pursuant to the federal Drug Quality and Security
91 Act, Pub. L. No. 113-54.
92 (b) Proof of registration as a nonresident pharmacy,
93 pursuant to s. 465.0156, unless the applicant is an outsourcing
94 facility and not a pharmacy, in which case the application must
95 include proof of an active and unencumbered license, permit, or
96 registration issued by the state, territory, or district in
97 which the outsourcing facility is physically located which
98 allows the outsourcing facility to engage in compounding and to
99 ship, mail, deliver, or dispense a compounded sterile product
100 into this state if required by the state, territory, or district
101 in which the outsourcing facility is physically located.
102 (c) Written attestation by an owner or officer of the
103 applicant, and by the applicant’s prescription department
104 manager or pharmacist in charge, that:
105 1. The attestor has read and understands the laws and rules
106 governing sterile compounding in this state.
107 2. A compounded sterile product shipped, mailed, delivered,
108 or dispensed into this state meets or exceeds this state’s
109 standards for sterile compounding.
110 3. A compounded sterile product shipped, mailed, delivered,
111 or dispensed into this state must not have been, and may not be,
112 compounded in violation of the laws and rules of the state,
113 territory or district in which the applicant is located.
114 (d) The applicant’s existing policies and procedures for
115 sterile compounding, which must comply with pharmaceutical
116 standards in chapter 797 of the United States Pharmacopoeia and
117 any standards for sterile compounding required by board rule or
118 current good manufacturing practices for an outsourcing
119 facility.
120 (e) A current inspection report from an inspection
121 conducted by the regulatory or licensing agency of the state,
122 territory, or district in which the applicant is located. The
123 inspection report must reflect compliance with this section. An
124 inspection report is current if the inspection was conducted
125 within 6 months before the date of submitting the application
126 for the initial permit or within 1 year before the date of
127 submitting an application for permit renewal. If the applicant
128 is unable to submit a current inspection report conducted by the
129 regulatory or licensing agency of the state, territory, or
130 district in which the applicant is located due to acceptable
131 circumstances, as established by rule, or if an inspection has
132 not been performed, the department shall:
133 1. Conduct, or contract with an entity to conduct, an
134 onsite inspection for which all costs shall be borne by the
135 applicant;
136 2. Accept a current and satisfactory inspection report, as
137 determined by rule, from an entity approved by the board; or
138 3. Accept a current inspection report from the United
139 States Food and Drug Administration conducted pursuant to the
140 federal Drug Quality and Security Act, Pub. L. No. 113-54.
141 (4) A permittee may not ship, mail, deliver, or dispense a
142 compounded sterile product into this state if the product was
143 compounded in violation of the laws or rules of the state,
144 territory, or district in which the permittee is located or does
145 not meet or exceed this state’s sterile compounding standards.
146 (5) In accordance with this chapter, the board may deny,
147 revoke, or suspend the permit of, fine, or reprimand a permittee
148 for:
149 (a) Failure to comply with this section;
150 (b) A violation listed under s. 456.0635, s. 456.065, or s.
151 456.072, except s. 456.072(1)(s) or (1)(u);
152 (c) A violation under s. 465.0156(5); or
153 (d) A violation listed under s. 465.016.
154 (6) A nonresident pharmacy registered under s. 465.0156
155 which ships, mails, delivers, or dispenses a compounded sterile
156 product into this state may continue to do so if the product
157 meets or exceeds the standards for sterile compounding in this
158 state, the product is not compounded in violation of any law or
159 rule of the state, territory, or district where the pharmacy is
160 located, and the pharmacy is issued a permit under this section
161 on or before February 28, 2015.
162 (7) An applicant registering on or after October 1, 2014,
163 as a nonresident pharmacy under s. 465.0156 may not ship, mail,
164 deliver, or dispense a compounded sterile product into this
165 state until the applicant is registered as a nonresident
166 pharmacy and is issued a permit under this section.
167 (8) The board shall adopt rules as necessary to administer
168 this section, including rules for:
169 (a) Submitting an application for the permit required by
170 this section.
171 (b) Determining how, when, and under what circumstances an
172 inspection of a nonresident sterile compounding permittee must
173 be conducted.
174 (c) Evaluating and approving entities from which a
175 satisfactory inspection report will be accepted in lieu of an
176 onsite inspection by the department or an inspection by the
177 licensing or regulatory agency of the state, territory, or
178 district where the applicant is located.
179 Section 4. Section 465.017, Florida Statutes, is amended to
180 read:
181 465.017 Authority to inspect; disposal.—
182 (1) Duly authorized agents and employees of the department
183 may shall have the power to inspect in a lawful manner at all
184 reasonable hours any pharmacy, hospital, clinic, wholesale
185 establishment, manufacturer, physician’s office, or any other
186 place in the state in which drugs and medical supplies are
187 compounded, manufactured, packed, packaged, made, stored, sold,
188 offered for sale, exposed for sale, or kept for sale for the
189 purpose of:
190 (a) Determining if any provision of the provisions of this
191 chapter or any rule adopted promulgated under its authority is
192 being violated;
193 (b) Securing samples or specimens of any drug or medical
194 supply after paying or offering to pay for such sample or
195 specimen; or
196 (c) Securing such other evidence as may be needed for
197 prosecution under this chapter.
198 (2) Duly authorized agents and employees of the department
199 may inspect a nonresident pharmacy registered under s. 465.0156
200 or a nonresident sterile compounding permittee under s. 465.0158
201 pursuant to this section. The costs of such inspections shall be
202 borne by such pharmacy or permittee.
203 (3)(2)(a) Except as permitted by this chapter, and chapters
204 406, 409, 456, 499, and 893, records maintained in a pharmacy
205 relating to the filling of prescriptions and the dispensing of
206 medicinal drugs may shall not be furnished only to any person
207 other than to the patient for whom the drugs were dispensed, or
208 her or his legal representative, or to the department pursuant
209 to existing law, or, if in the event that the patient is
210 incapacitated or unable to request such said records, her or his
211 spouse except upon the written authorization of such patient.
212 (a) Such records may be furnished in any civil or criminal
213 proceeding, upon the issuance of a subpoena from a court of
214 competent jurisdiction and proper notice to the patient or her
215 or his legal representative by the party seeking such records.
216 (b) The board shall adopt rules establishing to establish
217 practice guidelines for pharmacies to dispose of records
218 maintained in a pharmacy relating to the filling of
219 prescriptions and the dispensing of medicinal drugs. Such rules
220 must shall be consistent with the duty to preserve the
221 confidentiality of such records in accordance with applicable
222 state and federal law.
223 Section 5. This act shall take effect October 1, 2014.
