Florida Statutes
Fla. Stat. § 499.023 (2025)
New drugs; sale, manufacture, repackaging, distribution.
✓ 2025 Florida Statutes — current through the 2025 Regular Session
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499.023 New drugs; sale, manufacture, repackaging, distribution.—A person may not sell, offer for sale, hold for sale, manufacture, repackage, distribute, or give away any new drug unless an approved application has become effective under s. 505 of the federal act or unless otherwise permitted by the Secretary of the United States Department of Health and Human Services for shipment in interstate commerce.
Notes of Decisions
Cited in 7
cases (6 in the last 5 years), 1991–2025 · leading case: Zyla Life Sciences v. Wells Pharma, 134 F.4th 326 (5th Cir. 2025).
Zyla Life Sciences v. Wells Pharma, 134 F.4th 326 (5th Cir. 2025). “If anyone sells drugs in violation of these state laws, competitors may bring suit under traditional state unfair-competition law. B This dispute arises between two such competitors: Zyla Life Sciences, LLC (“Zyla”) and Wells Pharma of Houston, LLC (“Wells Pharma”).”
Novo Nordisk Inc. v. Brooksville Pharm. Inc. (M.D. Fla. 2023). “Plaintiff points to the Florida Drug and Cosmetic Act, Fla. Stat. § 499.023 , as one such law proscribing unconscionable acts or practices.”
Novo Nordisk Inc. v. Brooksville Pharm. Inc. (M.D. Fla. 2025). “The Court dismissed Plaintiff’s Complaint without prejudice since its FDUTPA claim based on a predicate violation of Fla. Stat. § 499.023 was impliedly preempted by the FDCA.”
Eli Lilly & Co. v. Rxcompoundstore.com, LLC (S.D. Fla. 2024). “§ 499.023). FDUTPA, on the other hand, creates a private right of action for violations of “[a]ny law, statute, rule, regulation, or ordinance which proscribes unfair methods of competition, or 3 Eli Lilly has “regulatory approval” from the FDA to market and sell Mounjaro® as a…”
Zyla Life Sciences v. Wells Pharma. (5th Cir. 2025). “If anyone sells drugs in violation of these state laws, competitors may bring suit under traditional state unfair-competition law. B This dispute arises between two such competitors: Zyla Life Sciences, LLC (“Zyla”) and Wells Pharma of Houston, LLC (“Wells Pharma”).”
Bubak v. Golo, LLC (9th Cir. 2025). “There is yet another clue that Congress permitted States to enact parallel food labeling requirements while not permitting private citizens to enforce those requirements.”
Parke-Davis & Co. v. Ricci, 587 So. 2d 589 (Fla. 4th DCA 1991). “…herein, was repealed subsequent to this case by Laws 1982, c. 82-225, § 38, effective Oct. 1, 1982. But see § 499.023.”
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