Florida Senate - 2014 SB 662
By the Committee on Health Policy
588-01081-14 2014662__
1 A bill to be entitled
2 An act relating to nonresident pharmacies; amending s.
3 465.0156, F.S.; conforming provisions to changes made
4 by the act; deleting a requirement that the Board of
5 Pharmacy refer regulatory issues affecting a
6 nonresident pharmacy to the state where the pharmacy
7 is located; creating s. 465.0158, F.S.; requiring
8 registered nonresident pharmacies to obtain a permit
9 in order to ship, mail, deliver, or dispense
10 compounded sterile products into this state; requiring
11 submission of an application and a nonrefundable fee;
12 specifying requirements; requiring the Department of
13 Health to inform permittees of any law or rule
14 changes; authorizing the board to deny, revoke, or
15 suspend a permit for certain actions; providing dates
16 by which certain registered and unregistered
17 nonresident pharmacies must obtain a permit;
18 authorizing the Board of Pharmacy to adopt rules;
19 providing for future repeal; amending s. 465.017,
20 F.S.; authorizing the department to inspect registered
21 nonresident pharmacies; requiring nonresident
22 pharmacies to pay for the costs of such inspections;
23 providing an effective date.
24
25 Be It Enacted by the Legislature of the State of Florida:
26
27 Section 1. Subsections (4) and (5) of section 465.0156,
28 Florida Statutes, are amended to read:
29 465.0156 Registration of nonresident pharmacies.—
30 (4) The board may deny, revoke, or suspend registration of,
31 or fine or reprimand, a nonresident pharmacy for failure to
32 comply with s. 465.025, s. 465.0158, or with any requirement of
33 this section in accordance with the provisions of this chapter.
34 (5) In addition to the prohibitions of subsection (4), the
35 board may deny, revoke, or suspend registration of, or fine or
36 reprimand, a nonresident pharmacy in accordance with the
37 provisions of this chapter for conduct that which causes or
38 could cause serious bodily injury or serious psychological
39 injury to a human or animal in resident of this state if the
40 board has referred the matter to the regulatory or licensing
41 agency in the state in which the pharmacy is located and the
42 regulatory or licensing agency fails to investigate within 180
43 days of the referral.
44 Section 2. Section 465.0158, Florida Statutes, is created
45 to read:
46 465.0158 Nonresident pharmacy compounded sterile products
47 permit.—A nonresident pharmacy registered under s. 465.0156 must
48 also hold a compounded sterile products permit issued under this
49 section in order to ship, mail, deliver, or dispense, in any
50 manner, a compounded sterile product into this state.
51 (1) Application for a permit shall be submitted on a form
52 furnished by the board, together with a nonrefundable permit fee
53 as provided under s. 465.022(14). The board may require such
54 information as it deems reasonably necessary to carry out the
55 purposes of this section, including information pertaining to
56 registration as an outsourcing facility with the Secretary of
57 the United States Department of Health and Human Services.
58 (2) As a condition of initial permitting and permit
59 renewal, the owners, officers, and prescription department
60 manager or pharmacist in charge of the nonresident pharmacy must
61 attest in writing that they have read and understand the laws
62 and rules governing sterile compounding in this state and that
63 any compounded sterile product shipped, mailed, delivered, or
64 dispensed into this state will meet or exceed this state’s
65 standards for sterile compounding.
66 (a) The department shall notify all compounded sterile
67 products permittees when state laws or rules affecting the
68 standards for sterile compounding in this state are adopted or
69 revised, along with the effective date of the law or rule.
70 (b) If the department fails to notify a permittee of a
71 change in state laws or rules, or the permittee does not receive
72 notification of applicable rules, the permittee remains legally
73 obligated to meet or exceed this state’s standards with respect
74 to any compounded sterile product shipped, mailed, delivered, or
75 dispensed into this state. The board may provide an exception to
76 this requirement by rule if the sterile compounding laws and
77 rules of the state in which the nonresident pharmacy is located
78 directly conflict with a board rule for sterile compounding in
79 this state but provide a comparable standard of product safety
80 and integrity.
81 (3) A nonresident pharmacy may not ship, mail, deliver, or
82 dispense any compounded sterile product into this state which:
83 (a) Was compounded in violation of the laws and rules of
84 the state in which the nonresident pharmacy is located; or
85 (b) Does not meet or exceed this state’s sterile
86 compounding standards as provided in subsection (2).
87 (4) To the extent feasible, biennial permit renewal shall
88 be timed to coincide with nonresident pharmacies’ registration
89 renewal under s. 465.0156.
90 (5) In accordance with this chapter, the board may deny,
91 revoke, or suspend the permit of, or fine or reprimand, a
92 nonresident pharmacy for:
93 (a) Failure to comply with the requirements of this
94 section; or
95 (b) Conduct that causes or could cause serious bodily
96 injury or serious psychological injury to a human or animal in
97 this state.
98 (6) A registered nonresident pharmacy that is currently
99 shipping, mailing, delivering, or dispensing compounded sterile
100 products into this state may continue to do so if such products
101 meet or exceed the standards for sterile compounding in this
102 state and the pharmacy is issued a nonresident pharmacy
103 compounded sterile products permit on or before January 31,
104 2015.
105 (7) A nonresident pharmacy seeking registration in this
106 state under s. 465.0156 on or after July 1, 2014, may not ship,
107 mail, deliver, or dispense a compounded sterile product into
108 this state until it has received the sterile compounded products
109 permit required under this section.
110 (8) The board shall adopt rules necessary to administer
111 this section.
112 (9) This section is repealed October 1, 2018, unless
113 reenacted by the Legislature.
114 Section 3. Section 465.017, Florida Statutes, is amended to
115 read:
116 465.017 Authority to inspect; disposal.—
117 (1) Duly authorized agents and employees of the department
118 may shall have the power to inspect in a lawful manner at all
119 reasonable hours any pharmacy, including a nonresident pharmacy
120 registered under s. 465.0156, and any, hospital, clinic,
121 wholesale establishment, manufacturer, physician’s office, or
122 any other place in the state in which drugs and medical supplies
123 are manufactured, packed, packaged, made, stored, sold, offered
124 for sale, exposed for sale, or kept for sale for the purpose of:
125 (a) Determining if any provision of the provisions of this
126 chapter or any rule adopted promulgated under its authority is
127 being violated;
128 (b) Securing samples or specimens of any drug or medical
129 supply after paying or offering to pay for such sample or
130 specimen; or
131 (c) Securing such other evidence as may be needed for
132 prosecution under this chapter.
133 (2) The cost for inspecting a nonresident pharmacy shall be
134 reimbursed by the pharmacy. The cost to the pharmacy is limited
135 to the actual costs incurred by the department.
136 (3)(2)(a) Except as permitted by this chapter, and chapters
137 406, 409, 456, 499, and 893 or upon the written authorization of
138 the patient, records maintained in a pharmacy relating to the
139 filling of prescriptions and the dispensing of medicinal drugs
140 may shall not be furnished only to any person other than to the
141 patient for whom the drugs were dispensed, or her or his legal
142 representative, or to the department pursuant to existing law,
143 or if, in the event that the patient is incapacitated or unable
144 to request such said records, her or his spouse except upon the
145 written authorization of such patient.
146 (a) Such records may be furnished in any civil or criminal
147 proceeding, upon the issuance of a subpoena from a court of
148 competent jurisdiction and proper notice to the patient or her
149 or his legal representative by the party seeking such records.
150 (b) The board shall adopt rules establishing to establish
151 practice guidelines for pharmacies to dispose of records
152 maintained in a pharmacy relating to the filling of
153 prescriptions and the dispensing of medicinal drugs. Such rules
154 must shall be consistent with the duty to preserve the
155 confidentiality of such records in accordance with applicable
156 state and federal law.
157 Section 4. This act shall take effect July 1, 2014.