Florida Statutes 499.024 – Drug product classification
Current as of: 2023 | Check for updates
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Terms Used In Florida Statutes 499.024
- 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
- Labeling: means all labels and other written, printed, or graphic matters:
(a) Upon a drug, device, or cosmetic, or any of its containers or wrappers; or(b) Accompanying or related to such 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
The department shall adopt rules to classify drug products intended for use by humans which the United States Food and Drug Administration has not classified in the federal act or the Code of Federal Regulations.(1) Drug products must be classified as proprietary, prescription, or investigational drugs.(2) If a product is distributed without required labeling, it is misbranded while held for sale.(3) Any product that falls under the definition of drug in s. 499.003 may be classified under the authority of this section. This section does not subject portable emergency oxygen inhalators to classification; however, this section does not exempt any person from ss. 499.01 and 499.015.(4) Any product classified under the authority of this section reverts to the federal classification, if different, upon the federal regulation or act becoming effective.(5) The department may by rule reclassify drugs subject to this part when such classification action is necessary to protect the public health.(6) The department may adopt rules that exempt from any labeling or packaging requirements of this part drugs classified under this section if those requirements are not necessary to protect the public health.