The Florida Senate

499.051  Inspections and investigations.--

(1)  The agents of the ¹Department of Health and Rehabilitative Services and of the Department of Law Enforcement, after they present proper identification, may inspect, monitor, and investigate any establishment permitted pursuant to ss. 499.001-499.081 during business hours for the purpose of enforcing ss. 499.001-499.081, 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 ss. 499.001-499.081 and rules adopted under those sections regarding any drug, device, or cosmetic product. The authority to enter and inspect does not extend to the practice of the profession of pharmacy, as defined in chapter 465 and the rules adopted under that chapter, in a pharmacy permitted under chapter 465. The Department of Business and Professional Regulation shall conduct routine inspections of retail pharmacy wholesalers at the time of the regular pharmacy permit inspection and shall send the inspection report regarding drug wholesale activity to the ¹Department of Health and Rehabilitative Services.

(3)  Any application for a permit or product registration or for renewal of such permit or registration made pursuant to ss. 499.001-499.081 and rules adopted under those sections constitutes permission for any entry or inspection of the premises in order to verify compliance with those sections and rules; to discover, investigate, and determine the existence of compliance; or to elicit, receive, respond to, and resolve complaints and violations.

(4)  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 ss. 499.001-499.081 and the rules adopted under those sections.

(5)  The complaint and all information obtained pursuant to the investigation by the department are confidential and exempt from the provisions of 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. 499.0121(6)(d), and the pedigree papers required in that subsection 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.

¹Note.--The Department of Health and Rehabilitative Services was redesignated as the Department of Children and Family Services by s. 5, ch. 96-403, and the Department of Health was created by s. 8, ch. 96-403.