499.025 Drug products in finished, solid, oral dosage form; identification requirements.—(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 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.History.—s. 34, ch. 82-225; s. 1, ch. 83-265; s. 22, ch. 86-256; ss. 28, 52, ch. 92-69; s. 18, ch. 2000-326.
Florida Legal Code