Florida Statutes

Fla. Stat. § 499.002 (2025)

Purpose, administration, and enforcement of and exemption from this part.

✓ 2025 Florida Statutes — current through the 2025 Regular Session
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499.002 Purpose, administration, and enforcement of and exemption from this part.
(1) This part is intended to:
(a) Safeguard the public health and promote the public welfare by protecting the public from injury by product use and by merchandising deceit involving drugs, devices, and cosmetics.
(b) Provide uniform legislation to be administered so far as practicable in conformity with the provisions of, and regulations issued under the authority of, the Federal Food, Drug, and Cosmetic Act and that portion of the Federal Trade Commission Act which expressly prohibits the false advertisement of drugs, devices, and cosmetics.
(c) Promote thereby uniformity of such state and federal laws, and their administration and enforcement, throughout the United States.
(2) The department shall administer and enforce this part to prevent fraud, adulteration, misbranding, or false advertising in the preparation, manufacture, repackaging, or distribution of drugs, devices, and cosmetics.
(3) For the purpose of any investigation or proceeding conducted by the department under this part, the department may administer oaths, take depositions, issue and serve subpoenas, and compel the attendance of witnesses and the production of books, papers, documents, or other evidence. The department shall exercise this power on its own initiative. Challenges to, and enforcement of, the subpoenas and orders shall be handled as provided in s. 120.569.
(4) Each state attorney, county attorney, or municipal attorney to whom the department or its designated agent reports any violation of this part shall cause appropriate proceedings to be instituted in the proper courts without delay and to be prosecuted in the manner required by law.
(5) This part does not require the department to report, for the institution of proceedings under this part, minor violations of this part when it believes that the public interest will be adequately served in the circumstances by a suitable written notice or warning.
(6) Common carriers engaged in interstate commerce are not subject to this part if they are engaged in the usual course of business as common carriers.
(7) Notwithstanding any other law or local ordinance or regulation to the contrary, the regulation of over-the-counter proprietary drugs and cosmetics is expressly preempted to the state.
History.s. 34, ch. 82-225; s. 1, ch. 83-265; ss. 2, 3, ch. 86-133; s. 2, ch. 87-50; ss. 2, 4, 6, 48, 49, 50, 52, ch. 92-69; s. 240, ch. 96-410; s. 236, ch. 99-8; s. 1, ch. 2008-207; s. 1, ch. 2020-118.
Note.Subsection (2) former s. 499.004; subsection (3) former s. 499.0053; subsection (4) former s. 499.07; subsection (5) former s. 499.071; subsection (6) former s. 499.081.
Notes of Decisions
Cited in 5 cases (1 in the last 5 years), 1995–2025 · leading case: Fields v. Mylan Pharm., Inc., 751 F. Supp. 2d 1257 (N.D. Fla. 2009).
Fields v. Mylan Pharm., Inc., 751 F. Supp. 2d 1257 (N.D. Fla. 2009). · cites it 5× “” Fla. Stat. § 499.002 (1)(a)(2008). Section 499.”
T.W.M. v. Am. Med. Sys., Inc., 886 F. Supp. 842 (N.D. Fla. 1995). “” § 499.002(1), Fla.Stat. (1993). Section 499.”
United States v. Franck's Lab, Inc., 816 F. Supp. 2d 1209 (M.D. Fla. 2011). “§ 499.002(b) (emphasis added), defines “manufacture” as “the preparation, deriving, compounding, propagation, producing, or fabrication of any drug, device, or cosmetic,” id.”
Novo Nordisk Inc. v. Brooksville Pharm. Inc. (M.D. Fla. 2025). · cites it 5× “” Fla. Stat. § 499.002 (4). Finally, the penalties and remedies section authorizes the imposition of injunctions, administrative fines, and emergency orders suspending permits for violations of the Florida DCA.”
Ronald Brown, Jr. v. Sheriff Mike Williams, 270 So. 3d 447 (Fla. 1st DCA 2019). · cites it 4× “” § 499.002, Fla. Stat. Because we agree with the trial court that probable cause existed to support the seizure, the order is affirmed.”
— 499.002(1) — 1 case
T.W.M. v. Am. Med. Sys., Inc., 886 F. Supp. 842 (N.D. Fla. 1995). “” § 499.002(1), Fla.Stat. (1993). Section 499.”
— 499.002(1)(a) — 1 case
Ronald Brown, Jr. v. Sheriff Mike Williams, 270 So. 3d 447 (Fla. 1st DCA 2019). “” § 499.002, Fla. Stat. Because we agree with the trial court that probable cause existed to support the seizure, the order is affirmed.”
— 499.002(2) — 1 case
Novo Nordisk Inc. v. Brooksville Pharm. Inc. (M.D. Fla. 2025). “” Fla. Stat. § 499.002 (4). Finally, the penalties and remedies section authorizes the imposition of injunctions, administrative fines, and emergency orders suspending permits for violations of the Florida DCA.”
— 499.002(b) — 1 case
United States v. Franck's Lab, Inc., 816 F. Supp. 2d 1209 (M.D. Fla. 2011). “§ 499.002(b) (emphasis added), defines “manufacture” as “the preparation, deriving, compounding, propagation, producing, or fabrication of any drug, device, or cosmetic,” id.”
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