The Florida Senate

499.015  Registration of drugs, devices, and cosmetics; issuance of certificates of free sale.--

(1)  Except for those persons exempted from the definition in s. 499.003(21), any person who manufactures, packages, repackages, labels, or relabels a drug, device, or cosmetic in this state must register such drug, device, or cosmetic biennially with the department; pay a fee in accordance with the fee schedule provided by s. 499.041; and comply with this section. The registrant must list each separate and distinct drug, device, or cosmetic at the time of registration.

(2)  The department may require the submission of a catalog and specimens of labels at the time of application for registration of drugs, devices, and cosmetics packaged and prepared in compliance with the federal act, which submission constitutes a satisfactory compliance for registration of the products. With respect to all other drugs, devices, and cosmetics, the department may require the submission of a catalog and specimens of labels at the time of application for registration, but the registration will not become effective until the department has examined and approved the label of the drug, device, or cosmetic product. This approval or denial must include written notification to the manufacturer.

(3)  Except for those persons exempted from the definition in s. 499.003(21), a person may not sell any product that he or she has failed to register in conformity with this section. Such failure to register subjects such drug, device, or cosmetic product to seizure and condemnation as provided in ss. 499.062-499.064, and subjects such person to the penalties and remedies provided in ss. 499.001-499.081.

(4)  Unless a registration is renewed, it expires 2 years after the last day of the month in which it was issued. The department may issue a stop-sale notice or order against a person that is subject to the requirements of this section and that fails to comply with this section within 31 days after the date the registration expires. The notice or order shall prohibit such person from selling or causing to be sold any drugs, devices, or cosmetics covered by ss. 499.001-499.081 until he or she complies with the requirements of this section.

(5)  A product regulated under this section which is not included in the biennial registration may not be sold until it is registered and complies with this section.

(6)  The department may issue a certificate of free sale for any product that is required to be registered under ss. 499.001-499.081.

History.--s. 34, ch. 82-225; s. 110, ch. 83-218; s. 1, ch. 83-265; s. 3, ch. 84-115; ss. 20, 52, ch. 92-69; s. 587, ch. 97-103.