Florida Senate - 2014 (PROPOSED COMMITTEE BILL) SPB 7008
FOR CONSIDERATION By the Committee on Health Policy
588-00653A-14 20147008__
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 amending s. 465.017, F.S.; authorizing the department
20 to inspect registered nonresident pharmacies;
21 requiring nonresident pharmacies to pay for the costs
22 of such inspections; providing an effective date.
23
24 Be It Enacted by the Legislature of the State of Florida:
25
26 Section 1. Subsections (4) and (5) of section 465.0156,
27 Florida Statutes, are amended to read:
28 465.0156 Registration of nonresident pharmacies.—
29 (4) The board may deny, revoke, or suspend registration of,
30 or fine or reprimand, a nonresident pharmacy for failure to
31 comply with s. 465.025, s. 465.0158, or with any requirement of
32 this section in accordance with the provisions of this chapter.
33 (5) In addition to the prohibitions of subsection (4), the
34 board may deny, revoke, or suspend registration of, or fine or
35 reprimand, a nonresident pharmacy in accordance with the
36 provisions of this chapter for conduct that which causes or
37 could cause serious bodily injury or serious psychological
38 injury to a human or animal in resident of this state if the
39 board has referred the matter to the regulatory or licensing
40 agency in the state in which the pharmacy is located and the
41 regulatory or licensing agency fails to investigate within 180
42 days of the referral.
43 Section 2. Section 465.0158, Florida Statutes, is created
44 to read:
45 465.0158 Nonresident pharmacy compounded sterile products
46 permit.—A nonresident pharmacy registered under s. 465.0156 must
47 also hold a compounded sterile products permit issued under this
48 section in order to ship, mail, deliver, or dispense, in any
49 manner, a compounded sterile product into this state.
50 (1) Application for a permit shall be submitted on a form
51 furnished by the board, together with a nonrefundable permit fee
52 as provided under s. 465.022(14). The board may require such
53 information as it deems reasonably necessary to carry out the
54 purposes of this section, including information pertaining to
55 registration as an outsourcing facility with the Secretary of
56 the United States Department of Health and Human Services.
57 (2) As a condition of initial permitting and permit
58 renewal, the owners, officers, and prescription department
59 manager or pharmacist in charge of the nonresident pharmacy must
60 attest in writing that they have read and understand the laws
61 and rules governing sterile compounding in this state and that
62 any compounded sterile product shipped, mailed, delivered, or
63 dispensed into this state will meet or exceed this state’s
64 standards for sterile compounding.
65 (a) The department shall notify all compounded sterile
66 products permittees when state laws or rules affecting the
67 standards for sterile compounding in this state are adopted or
68 revised, along with the effective date of the law or rule.
69 (b) If the department fails to notify a permittee of a
70 change in state laws or rules, or the permittee does not receive
71 notification of applicable rules, the permittee remains legally
72 obligated to meet or exceed this state’s standards with respect
73 to any compounded sterile product shipped, mailed, delivered, or
74 dispensed into this state. The board may provide an exception to
75 this requirement by rule if the sterile compounding laws and
76 rules of the state in which the nonresident pharmacy is located
77 directly conflict with a board rule for sterile compounding in
78 this state but provide a comparable standard of product safety
79 and integrity.
80 (3) A nonresident pharmacy may not ship, mail, deliver, or
81 dispense any compounded sterile product into this state which:
82 (a) Was compounded in violation of the laws and rules of
83 the state in which the nonresident pharmacy is located; and
84 (b) Does not meet or exceed this state’s sterile
85 compounding standards as provided in subsection (2).
86 (4) To the extent feasible, biennial permit renewal shall
87 be timed to coincide with nonresident pharmacies’ registration
88 renewal under s. 465.0156.
89 (5) In accordance with this chapter, the board may deny,
90 revoke, or suspend the permit of, or fine or reprimand, a
91 nonresident pharmacy for:
92 (a) Failure to comply with the requirements of this
93 section; or
94 (b) Conduct that causes or could cause serious bodily
95 injury or serious psychological injury to a human or animal in
96 this state.
97 (6) A registered nonresident pharmacy that is currently
98 shipping, mailing, delivering, or dispensing compounded sterile
99 products into this state may continue to do so if such products
100 meet or exceed the standards for sterile compounding in this
101 state and the pharmacy is issued a nonresident pharmacy
102 compounded sterile products permit on or before January 31,
103 2015.
104 (7) A nonresident pharmacy seeking registration in this
105 state under s. 465.0156 on or after July 1, 2014, may not ship,
106 mail, deliver, or dispense a compounded sterile product into
107 this state until it has received the sterile compounded products
108 permit required under this section.
109 (8) The board shall adopt rules necessary to administer
110 this section.
111 Section 3. Section 465.017, Florida Statutes, is amended to
112 read:
113 465.017 Authority to inspect; disposal.—
114 (1) Duly authorized agents and employees of the department
115 may shall have the power to inspect in a lawful manner at all
116 reasonable hours any pharmacy, including a nonresident pharmacy
117 registered under s. 465.0156, and any, hospital, clinic,
118 wholesale establishment, manufacturer, physician’s office, or
119 any other place in the state in which drugs and medical supplies
120 are manufactured, packed, packaged, made, stored, sold, offered
121 for sale, exposed for sale, or kept for sale for the purpose of:
122 (a) Determining if any provision of the provisions of this
123 chapter or any rule adopted promulgated under its authority is
124 being violated;
125 (b) Securing samples or specimens of any drug or medical
126 supply after paying or offering to pay for such sample or
127 specimen; or
128 (c) Securing such other evidence as may be needed for
129 prosecution under this chapter.
130 (2) The cost for inspecting a nonresident pharmacy shall be
131 reimbursed by the pharmacy. The cost to the pharmacy is limited
132 to the actual costs incurred by the department.
133 (3)(2)(a) Except as permitted by this chapter, and chapters
134 406, 409, 456, 499, and 893 or upon the written authorization of
135 the patient, records maintained in a pharmacy relating to the
136 filling of prescriptions and the dispensing of medicinal drugs
137 may shall not be furnished only to any person other than to the
138 patient for whom the drugs were dispensed, or her or his legal
139 representative, or to the department pursuant to existing law,
140 or if, in the event that the patient is incapacitated or unable
141 to request such said records, her or his spouse except upon the
142 written authorization of such patient.
143 (a) Such records may be furnished in any civil or criminal
144 proceeding, upon the issuance of a subpoena from a court of
145 competent jurisdiction and proper notice to the patient or her
146 or his legal representative by the party seeking such records.
147 (b) The board shall adopt rules establishing to establish
148 practice guidelines for pharmacies to dispose of records
149 maintained in a pharmacy relating to the filling of
150 prescriptions and the dispensing of medicinal drugs. Such rules
151 must shall be consistent with the duty to preserve the
152 confidentiality of such records in accordance with applicable
153 state and federal law.
154 Section 4. This act shall take effect July 1, 2014.