Florida Senate - 2021 (PROPOSED BILL) SPB 7034
FOR CONSIDERATION By the Committee on Regulated Industries
580-01136-21 20217034pb
1 A bill to be entitled
2 An act relating to a review under the Open Government
3 Sunset Review Act; amending s. 499.051, F.S., which
4 relates to an exemption from public records
5 requirements for trade secrets contained within
6 complaints or pursuant to an investigation of such
7 complaints obtained by the Department of Business and
8 Professional Regulation, which are submitted by
9 permittees relating to the manufacture, repackaging,
10 or distribution of a drug or for a permit or product
11 registration or for the renewal of such permit or
12 product registration; removing the scheduled repeal of
13 the exemption; providing an effective date.
14
15 Be It Enacted by the Legislature of the State of Florida:
16
17 Section 1. Section 499.051, Florida Statutes, is amended to
18 read:
19 499.051 Inspections and investigations.—
20 (1) The agents of the department and of the Department of
21 Law Enforcement, after they present proper identification, may
22 inspect, monitor, and investigate any establishment permitted
23 pursuant to this chapter during business hours for the purpose
24 of enforcing this chapter, chapters 465, 501, and 893, and the
25 rules of the department that protect the public health, safety,
26 and welfare.
27 (2) In addition to the authority set forth in subsection
28 (1), the department and any duly designated officer or employee
29 of the department may enter and inspect any other establishment
30 for the purpose of determining compliance with this chapter and
31 rules adopted under this chapter regarding any drug, device, or
32 cosmetic.
33 (3) Any application for a permit or product registration or
34 for renewal of such permit or registration made pursuant to this
35 chapter and rules adopted under this chapter constitutes
36 permission for any entry or inspection of the premises in order
37 to verify compliance with this chapter and rules; to discover,
38 investigate, and determine the existence of compliance; or to
39 elicit, receive, respond to, and resolve complaints and
40 violations.
41 (4) Any application for a permit made pursuant to s.
42 499.012 or s. 499.831 and rules adopted under those sections
43 constitutes permission for agents of the department and the
44 Department of Law Enforcement, after presenting proper
45 identification, to inspect, review, and copy any financial
46 document or record related to the manufacture, repackaging, or
47 distribution of a drug as is necessary to verify compliance with
48 this chapter and the rules adopted by the department to
49 administer this chapter, in order to discover, investigate, and
50 determine the existence of compliance, or to elicit, receive,
51 respond to, and resolve complaints and violations.
52 (5) The authority to inspect under this section includes
53 the authority to access, review, and copy any and all financial
54 documents related to the activity of manufacturing, repackaging,
55 or distributing prescription drugs.
56 (6) The authority to inspect under this section includes
57 the authority to secure:
58 (a) Samples or specimens of any drug, device, or cosmetic;
59 or
60 (b) Such other evidence as is needed for any action to
61 enforce this part and the rules adopted under this part.
62 (7)(a) The complaint and all information obtained pursuant
63 to the investigation by the department are confidential and
64 exempt from s. 119.07(1) and s. 24(a), Art. I of the State
65 Constitution until the investigation and the enforcement action
66 are completed.
67 (b) Information that constitutes a trade secret, as defined
68 in s. 812.081, contained in the complaint or obtained by the
69 department pursuant to the investigation must remain
70 confidential and exempt from s. 119.07(1) and s. 24(a), Art. I
71 of the State Constitution as long as the information is held by
72 the department. This paragraph is subject to the Open Government
73 Sunset Review Act in accordance with s. 119.15 and shall stand
74 repealed on October 2, 2021, unless reviewed and saved from
75 repeal through reenactment by the Legislature.
76 (c) This subsection does not prohibit the department from
77 using such information for regulatory or enforcement proceedings
78 under this chapter or from providing such information to any law
79 enforcement agency or any other regulatory agency. However, the
80 receiving agency shall keep such records confidential and exempt
81 as provided in this subsection.
82 Section 2. This act shall take effect October 1, 2021.