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2011 Florida Statutes
Inspections and investigations.
Inspections and investigations.
499.051 Inspections and investigations.—
(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 part during business hours for the purpose of enforcing this part, 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 part and rules adopted under this part regarding any drug, device, or cosmetic product.
(3) Any application for a permit or product registration or for renewal of such permit or registration made pursuant to this part and rules adopted under this part constitutes permission for any entry or inspection of the premises in order to verify compliance with this part 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 and rules adopted under that section 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 part and the rules adopted by the department to administer this part, 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
(b) Such other evidence as is needed for any action to enforce this part and the rules adopted under this part.
(7) 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. However, trade secret information contained therein as defined by s. 812.081(1)(c) shall remain confidential and exempt from the provisions of s. 119.07(1) and s. 24(a), Art. I of the State Constitution, as long as the information is retained by the department. 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. In addition, this subsection is not intended to prevent compliance with the provisions of s. 499.01212, and the pedigree papers required in that section shall not be deemed a trade secret.
History.—s. 34, ch. 82-225; s. 26, ch. 82-402; s. 1, ch. 83-265; s. 5, ch. 86-133; s. 11, ch. 88-159; ss. 37, 52, ch. 92-69; s. 199, ch. 94-218; ss. 3, 5, 8, ch. 94-309; s. 7, ch. 95-366; s. 332, ch. 96-406; s. 240, ch. 99-8; s. 62, ch. 2003-1; s. 21, ch. 2003-155; s. 26, ch. 2007-6; s. 29, ch. 2008-207.