(1) The agents of the department and of the Department of Law Enforcement, after they present proper identification, may inspect, monitor, and investigate any establishment permitted pursuant to this chapter during business hours for the purpose of enforcing this chapter, chapters 465, 501, and 893, and the rules of the department that protect the public health, safety, and welfare.
(2) In addition to the authority set forth in subsection (1), the department and any duly designated officer or employee of the department may enter and inspect any other establishment for the purpose of determining compliance with this chapter and rules adopted under this chapter regarding any drug, device, or cosmetic.
(3) Any application for a permit or product registration or for renewal of such permit or registration made pursuant to this chapter and rules adopted under this chapter constitutes permission for any entry or inspection of the premises in order to verify compliance with this chapter and rules; to discover, investigate, and determine the existence of compliance; or to elicit, receive, respond to, and resolve complaints and violations.
(4) Any application for a permit made pursuant to s. 499.012 or s. 499.831 and rules adopted under those sections constitutes permission for agents of the department and the Department of Law Enforcement, after presenting proper identification, to inspect, review, and copy any financial document or record related to the manufacture, repackaging, or distribution of a drug as is necessary to verify compliance with this chapter and the rules adopted by the department to administer this chapter, in order to discover, investigate, and determine the existence of compliance, or to elicit, receive, respond to, and resolve complaints and violations.
(5) The authority to inspect under this section includes the authority to access, review, and copy any and all financial documents related to the activity of manufacturing, repackaging, or distributing prescription drugs.
(6) The authority to inspect under this section includes the authority to secure:

(a) Samples or specimens of any drug, device, or cosmetic; or

Terms Used In Florida Statutes 499.051

  • Complaint: A written statement by the plaintiff stating the wrongs allegedly committed by the defendant.
  • Cosmetic: means an article, with the exception of soap, that is:
    (a) Intended to be rubbed, poured, sprinkled, or sprayed on; introduced into; or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance; or
    (b) Intended for use as a component of any such article. See Florida Statutes 499.003
  • Department: means the Department of Business and Professional Regulation. See Florida Statutes 499.003
  • Device: means any instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including its components, parts, or accessories, which is:
    (a) Recognized in the current edition of the United States Pharmacopoeia and National Formulary, or any supplement thereof,
    (b) Intended for use in the diagnosis, cure, mitigation, treatment, therapy, or prevention of disease in humans or other animals, or
    (c) Intended to affect the structure or any function of the body of humans or other animals,

    and that does not achieve any of its principal intended purposes through chemical action within or on the body of humans or other animals and which is not dependent upon being metabolized for the achievement of any of its principal intended purposes. See Florida Statutes 499.003

  • distribution: means to sell, purchase, trade, deliver, handle, store, or receive. See Florida Statutes 499.003
  • Drug: means an article that is:
    (a) Recognized in the current edition of the United States Pharmacopoeia and National Formulary, official Homeopathic Pharmacopoeia of the United States, or any supplement to any of those publications;
    (b) Intended for use in the diagnosis, cure, mitigation, treatment, therapy, or prevention of disease in humans or other animals;
    (c) Intended to affect the structure or any function of the body of humans or other animals; or
    (d) Intended for use as a component of any article specified in paragraph (a), paragraph (b), or paragraph (c), and includes active pharmaceutical ingredients, but does not include devices or their nondrug components, parts, or accessories. See Florida Statutes 499.003
  • Establishment: means a place of business which is at one general physical location and may extend to one or more contiguous suites, units, floors, or buildings operated and controlled exclusively by entities under common operation and control. See Florida Statutes 499.003
  • Evidence: Information presented in testimony or in documents that is used to persuade the fact finder (judge or jury) to decide the case for one side or the other.
  • Manufacture: means the preparation, deriving, compounding, propagation, processing, producing, or fabrication of any drug, device, or cosmetic. See Florida Statutes 499.003
(b) Such other evidence as is needed for any action to enforce this part and the rules adopted under this part.
(7)(a) The complaint and all information obtained pursuant to the investigation by the department are confidential and exempt from s. 119.07(1) and s. 24(a), Art. I of the State Constitution until the investigation and the enforcement action are completed.
(b) This subsection does not prohibit the department from using such information for regulatory or enforcement proceedings under this chapter or from providing such information to any law enforcement agency or any other regulatory agency. However, the receiving agency shall keep such records confidential and exempt as provided in this subsection.
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