Fla. Admin. Code R. 61N-2.014
A prescription drug manufacturer permit is required for any person that is a manufacturer of a prescription drug and that manufactures or distributes such prescription drugs in this state. A person located in this state engaging in activity for which a prescription drug manufacturer permit is required, must file an application on form number DBPR-DDC-201, Application for Permit as a Prescription 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, (850)717-1800, or at http://www.flrules.org/Gateway/reference.asp?No=Ref-06913.
Fla. Admin. Code Ann. R. 61N-2.014
Rulemaking Authority 499.012(3), 449.041(1)(a) 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.
New 6-9-16.