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.
Fla. Stat. § 499.023
New drugs; sale, manufacture, repackaging, distribution
Known as the Florida Drug and Cosmetic Act
The act spans §§ 499–499 (82 sections).
Applied in 1 court decision — leading case Zyla Life Sciences v. Wells Pharma (2025)
Most recently applied in Zyla Life Sciences v. Wells Pharma (April 2025)
History.--s. 34, ch. 82-225; s. 1, ch. 83-265; ss. 26, 52, ch. 92-69.
Official source: Online Sunshine (Florida Legislature). Reproduced from public-domain Florida statutes; confirm against the official source for the current text. Not legal advice.