(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
(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.
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; s. 8, ch. 2014-89; s. 11, ch. 2016-6; s. 13, ch. 2016-212; s. 4, ch. 2017-51; s. 22, ch. 2022-5.
Structure Florida Statutes
Title XXXIII - Regulation of Trade, Commerce, Investments, and Solicitations
Chapter 499 - Florida Drug and Cosmetic Act
Part I - Drugs; Devices; Cosmetics; Household Products (Ss. 499.001-499.067)
499.001 - Florida Drug and Cosmetic Act; short title.
499.002 - Purpose, administration, and enforcement of and exemption from this part.
499.003 - Definitions of terms used in this part.
499.0054 - Advertising and labeling of drugs, devices, and cosmetics; exemptions.
499.006 - Adulterated drug or device.
499.007 - Misbranded drug or device.
499.008 - Adulterated cosmetics.
499.009 - Misbranded cosmetics.
499.012 - Permit application requirements.
499.0121 - Storage and handling of prescription drugs; recordkeeping.
499.01211 - Drug Wholesale Distributor Advisory Council.
499.015 - Registration of drugs and devices; issuance of certificates of free sale.
499.023 - New drugs; sale, manufacture, repackaging, distribution.
499.024 - Drug product classification.
499.025 - Drug products in finished, solid, oral dosage form; identification requirements.
499.028 - Drug samples or complimentary drugs; starter packs; permits to distribute.
499.0285 - International Prescription Drug Importation Program.
499.02851 - Federal arrangement to operate a pilot program for importing prescription drugs.
499.029 - Cancer Drug Donation Program.
499.0295 - Experimental treatments for terminal conditions.
499.03 - Possession of certain drugs without prescriptions unlawful; exemptions and exceptions.
499.032 - Phenylalanine; prescription required.
499.033 - Ephedrine; prescription required.
499.035 - Dimethyl sulfoxide (DMSO); labeling and advertising.
499.036 - Restrictions on sale of dextromethorphan.
499.051 - Inspections and investigations.
499.052 - Records of interstate shipment.
499.055 - Reports and dissemination of information by department.
499.057 - Expenses and salaries.
499.062 - Seizure and condemnation of drugs, devices, or cosmetics.
499.065 - Inspections; imminent danger.
499.066 - Penalties; remedies.
499.0661 - Cease and desist orders; removal of certain persons.
499.067 - Denial, suspension, or revocation of permit, certification, or registration.