61N-2.013. Application for Over-The-Counter Drug Manufacturer Permit

An over-the-counter drug manufacturer permit is required for any person that engages in the manufacture or repackaging of an over-the-counter drug. A person located in this state, other than a pharmacy operating in compliance with pharmacy practice standards set forth in Chapter 465, F.S., and the rules promulgated thereunder, engaging in activity for which an over-the-counter drug manufacturer permit is required, must file an application on form number DBPR-DDC-205, Application for Permit as an Over-The-Counter Drug Manufacturer, effective April 2016, adopted and incorporated herein by reference and comply with all the requirements for permitting in Chapter 499, F.S., and Title 61N, F.A.C. This form is available upon request from the Department of Business and Professional Regulation, Division of Drugs, Devices and Cosmetics, 2601 Blair Stone Road, Tallahassee, Florida 32399-1047, [phone], or at http://www.flrules.org/Gateway/reference.asp?No=Ref-06912.

Rulemaking Authority 499.012(3), 499.041(1)(d) FS. Law Implemented 499.01, 499.012, 499.0121, 499.015, 499.04, 499.041, 499.005(6), 499.0051(13), 499.051(1), 559.79 FS. History‒New 6-9-16.