Florida Statutes 499.025 – Drug products in finished, solid, oral dosage form; identification requirements
Current as of: 2023 | Check for updates
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Terms Used In Florida Statutes 499.025
- 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
- Manufacturer: means :
(a) A person who holds a New Drug Application, an Abbreviated New Drug Application, a Biologics License Application, or a New Animal Drug Application approved under the federal act or a license issued under…. See Florida Statutes 499.003- Pharmacist: means a person licensed under chapter 465. See Florida Statutes 499.003
- Pharmacy: means an entity licensed under chapter 465. See Florida Statutes 499.003
(1) A drug product in finished, solid, oral dosage form for which a prescription is required by federal or state law may not be manufactured or distributed within this state unless it is clearly and prominently marked or imprinted with an individual symbol, number, company name, words, letters, marking, or national drug code, or any combination thereof, that identifies the drug product and the manufacturer or distributor of the drug product which has the ability to respond to requests for information regarding the drug product.(2) A manufacturer or distributor must make available to the department on request descriptive material that identifies each current imprint used by the manufacturer.(3) The department, upon application by a manufacturer, may exempt a particular drug product from the requirements of subsection (1) on the ground that imprinting is not feasible because of the size, texture, or other unique characteristic of the drug product.(4) This section does not apply to drug products compounded by a pharmacist licensed under chapter 465 in a pharmacy operating under a permit issued by the Board of Pharmacy.(5) The department shall adopt rules for implementing this section.