Terms Used In Florida Statutes 499.04

  • 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
  • Device: means any instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including its components, parts, or accessories, which is:
    (a) Recognized in the current edition of the United States Pharmacopoeia and National Formulary, or any supplement thereof,
    (b) Intended for use in the diagnosis, cure, mitigation, treatment, therapy, or prevention of disease in humans or other animals, or
    (c) Intended to affect the structure or any function of the body of humans or other animals,

    and that does not achieve any of its principal intended purposes through chemical action within or on the body of humans or other animals and which is not dependent upon being metabolized for the achievement of any of its principal intended purposes. 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
The department may collect fees for all drug, device, and cosmetic applications, permits, product registrations, and free-sale certificates. The total amount of fees collected from all permits, applications, product registrations, and free-sale certificates must be adequate to fund the expenses incurred by the department in carrying out this part. The department shall, by rule, establish a schedule of fees that are within the ranges provided in this section and shall adjust those fees from time to time based on the costs associated with administering this part. The fees are payable to the department to be deposited into the Professional Regulation Trust Fund for the sole purpose of carrying out this part.
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