499.015 Registration of drugs and devices; issuance of certificates of free sale.—
1(1)(a) Except for those persons exempted from the definition of manufacturer in s. 499.003, any person who manufactures, packages, repackages, labels, or relabels a drug or device in this state must register such drug or device 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 or device at the time of registration.
(b) The department may not register any product that does not comply with the Federal Food, Drug, and Cosmetic Act, as amended, or Title 21 C.F.R. Registration of a product by the department does not mean that the product does in fact comply with all provisions of the Federal Food, Drug, and Cosmetic Act, as amended.
(2) The department may require the submission of a catalog and specimens of labels at the time of application for registration of drugs or devices 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 and devices, 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 or device. This approval or denial must include written notification to the manufacturer.
(3) Except for those persons exempted from the definition of manufacturer in s. 499.003, 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 or device to seizure and condemnation as provided in s. 499.062, and subjects such person to the penalties and remedies provided in this part.
(4) Unless a registration is renewed, it expires 2 years after the last day of the month in which it was issued. Any product registration issued or renewed on or after July 1, 2016, shall expire on the same date as the manufacturer or repackager permit of the person seeking to register the product. If the first product registration issued to a person on or after July 1, 2016, expires less than 366 days after issuance, the fee for product registration shall be $15. If the first product registration issued to a person on or after July 1, 2016, expires more than 365 days after issuance, the fee for product registration shall be $30. 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 or devices covered by this part 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 this part.
(7) A product registration is valid only for the company named on the registration and located at the address on the registration. A person whose product is registered by the department under this section must notify the department before any change in the name or address of the establishment to which the product is registered. If a person whose product is registered ceases conducting business, the person must notify the department before closing the business.
(8) Notwithstanding any requirements set forth in this part, a manufacturer of medical devices that is registered with the federal Food and Drug Administration is exempt from this section and s. 499.041(6) if:
(a) The manufacturer’s medical devices are approved for marketing by, or listed with the federal Food and Drug Administration in accordance with federal law for commercial distribution; or
(b) The manufacturer subcontracts with a manufacturer of medical devices to manufacture components of such devices.
(9) However, the manufacturer must submit evidence of such registration, listing, or approval with its initial application for a permit to do business in this state, as required in s. 499.01, and any changes to such information previously submitted at the time of renewal of the permit. Evidence of approval, listing, and registration by the federal Food and Drug Administration must include:
(a) For Class II devices, a copy of the premarket notification letter (510K);
(b) For Class III devices, a federal Food and Drug Administration premarket approval number;
(c) For a manufacturer who subcontracts with a manufacturer of medical devices to manufacture components of such devices, a federal Food and Drug Administration registration number; or
(d) For a manufacturer of medical devices whose devices are exempt from premarket approval by the federal Food and Drug Administration, a federal Food and Drug Administration registration number.
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; s. 36, ch. 98-151; s. 1, ch. 99-165; s. 41, ch. 2000-242; s. 12, ch. 2000-326; s. 18, ch. 2001-63; s. 33, ch. 2001-89; s. 88, ch. 2004-5; s. 18, ch. 2008-207; s. 63, ch. 2009-21; s. 36, ch. 2014-89; s. 10, ch. 2016-212; s. 33, ch. 2017-3; s. 1, ch. 2017-51; s. 8, ch. 2019-99.
1Note.—Section 11, ch. 2019-99, which was codified as s. 499.02851, provides in part that “[i]mplementation of sections 2 through 10 of this act is contingent upon authorization granted under federal law, rule, or approval.” If the contingency occurs, subsection (1), as amended by s. 8, ch. 2019-99, will read:
(1)(a) Except for those persons exempted from the definition of manufacturer in s. 499.003, any person who manufactures, packages, repackages, labels, or relabels a drug or device in this state must register such drug or device 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 or device at the time of registration.
(b) The department may not register any product that does not comply with the Federal Food, Drug, and Cosmetic Act, as amended, or Title 21 C.F.R. Registration of a product by the department does not mean that the product does in fact comply with all provisions of the Federal Food, Drug, and Cosmetic Act, as amended.
(c) Registration under this section is not required for prescription drugs imported under the International Prescription Drug Importation Program established in s. 499.0285.
