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Terms Used In Florida Statutes 499.023

  • Department: means the Department of Business and Professional Regulation. 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
  • Federal act: means the Federal Food, Drug, and Cosmetic Act, 21 U. 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
  • Person: means any individual, child, joint venture, syndicate, fiduciary, partnership, corporation, division of a corporation, firm, trust, business trust, company, estate, public or private institution, association, organization, group, city, county, city and county, political subdivision of this state, other governmental agency within this state, and any representative, agent, or agency of any of the foregoing, or any other group or combination of the foregoing. See Florida Statutes 499.003
  • Repackage: includes repacking or otherwise changing the container, wrapper, or labeling to further the distribution of the drug, device, or cosmetic. See Florida Statutes 499.003
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.