Product Registration

 

DEPARTMENT OF BUSINESS AND PROFESSIONAL REGULATION

Drugs, Devices and Cosmetics

RULE NO.:RULE TITLE:

61N-1.016Product Registration

NOTICE OF CHANGE

Notice is hereby given that the following changes have been made to the proposed rule in accordance with subparagraph 120.54(3)(d)1., F.S., published in Vol. 43 No. 160, August 17, 2017 issue of the Florida Administrative Register.

61N-1.016 Product Registration.

(1)(a) Each drug product shall be registered with the department division, but shall not have duplicate registrations. Products that are both a cosmetic and a drug must be registered as a drug.

(b) A formula marketed under different brand names, sizes, quantities, or distributors is not considered a separate and distinct product for registration purposes. Furthermore, the adding of color, flavor, or scents to a formula does not make a separate and distinct product for registration purposes, even for fragrance preparations where the scent is the primary product. However, the different variations must be listed with the department division.

(c) through (d) No change.

(2) through (3) No change.

Rulemaking Authority 499.05 FS. Law Implemented 499.01, 499.015, 499.04, 499.05, 559.79(2) FS. History–New 7-1-96, Formerly 10D-45.0542, Amended 1-26-99, 4-17-01, 1-1-04, Formerly 64F-12.016, Amended 8-2-15,                   .

 

THE PERSON TO BE CONTACTED REGARDING THE NOTICE OF CHAGNE IS: Dinah Greene, Division of Drugs, Devices and Cosmetics, Department of Business and Professional Regulation, 2601 Blair Stone Road, Tallahassee, FL 32399-1047, [e-mail], [phone].