Florida Senate - 2021                                    SB 7034
       By the Committee on Regulated Industries
       580-02164-21                                          20217034__
    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.
   15  Be It Enacted by the Legislature of the State of Florida:
   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.