Florida Statutes 499.02851 – Federal arrangement to operate a pilot program for importing prescription drugs
Current as of: 2023 | Check for updates
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Terms Used In Florida Statutes 499.02851
- Cosmetic: means an article, with the exception of soap, that is:(a) Intended to be rubbed, poured, sprinkled, or sprayed on; introduced into; or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance; or(b) Intended for use as a component of any such article. See Florida Statutes 499.003
- Department: means the Department of Business and Professional Regulation. See Florida Statutes 499.003
- distribution: means to sell, purchase, trade, deliver, handle, store, or receive. See Florida Statutes 499.003
- Drug: means an article that is:
(a) Recognized in the current edition of the United States Pharmacopoeia and National Formulary, official Homeopathic Pharmacopoeia of the United States, or any supplement to any of those publications;(b) Intended for use in the diagnosis, cure, mitigation, treatment, therapy, or prevention of disease in humans or other animals;(c) Intended to affect the structure or any function of the body of humans or other animals; or(d) Intended for use as a component of any article specified in paragraph (a), paragraph (b), or paragraph (c), and includes active pharmaceutical ingredients, but does not include devices or their nondrug components, parts, or accessories. See Florida Statutes 499.003- Manufacture: means the preparation, deriving, compounding, propagation, processing, producing, or fabrication of any drug, device, or cosmetic. See Florida Statutes 499.003
Notwithstanding the Federal Food, Drug, and Cosmetic Act, the Department of Business and Professional Regulation, in collaboration with the Department of Health, shall negotiate a federal arrangement to operate a pilot program for importing prescription drugs into this state. The proposal to operate such a pilot program shall demonstrate that the program sets safety standards consistent with the current federal requirements for the manufacturing and distribution of prescription drugs; limits the importation of prescription drugs under the program to entities licensed or permitted by the state to manufacture, distribute, or dispense prescription drugs; and includes inspection and enforcement authority. Implementation of sections 2 through 10 of this act is contingent upon authorization granted under federal law, rule, or approval. The department shall notify the President of the Senate, the Speaker of the House of Representatives, and the relevant committees of the Senate and the House of Representatives before implementation of the pilot program. The department shall submit to all parties a proposal for program implementation and program funding.