61N-2.014. Application for Prescription Drug Manufacturer Permit  


Effective on Thursday, June 9, 2016
  • 1A 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. 89This form is available upon request from the 97Department of Business and Professional Regulation, Division of Drugs, Devices and Cosmetics, 2601 Blair Stone Road, Tallahassee, Florida 32399-1047, 116(850)717-1800, 117or at 119http://www.flrules.org/Gateway/reference.asp?No=Ref-06913121.

    122Rulemaking Authority 124499.012125(1263), 449.041(1)(a) FS. Law Implemented 131499.01, 132499.012, 133499.0121, 134499.015, 135499.04, 136499.041, 137499.005(6), 138499.0051(13), 139499.051(1), 140559.79 141FS. History‒New 6-9-16.

     

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