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