William Chelak, Director, Sales US on behalf of Hetero USA, Inc., 1035 Centennial Avenue, Piscataway, NJ 00854, filed on August 27, 2014.; Hetero USA, Inc., is requesting that the Department of Business and Professional Regulation issue a ...

 

DEPARTMENT OF BUSINESS AND PROFESSIONAL REGULATION

Drugs, Devices and Cosmetics

NOTICE IS HEREBY GIVEN that Division of Drugs, Devices and Cosmetics has received the petition for declaratory statement from William Chelak, Director, Sales US on behalf of Hetero USA, Inc., 1035 Centennial Avenue, Piscataway, NJ 00854, filed on August 27, 2014.The petition seeks the agency’s opinion as to the applicability of Sections 499.01 and 499.01(4) (a), Florida Statutes, and related administrative rules as they apply to the petitioner.

Hetero USA, Inc., is requesting that the Department of Business and Professional Regulation issue a declaratory statement as to the following. 1. Hetero USA, Inc. (“Hetero USA”) is requesting a waiver from the licensing requirements for a nonresident manufacturer. Hetero is the U.S. affiliate of Hetero Drugs Limited (“HDL”) and Hetero Labs Limited (“HLL”), manufacturers of prescription active pharmaceutical ingredients (“API”) in Andhra Pradesh, India. Hetero USA, as the U.S.-based affiliate, performs sales and arrangements of distribution as the importer of record of API from HDL and HLL to Florida resident prescription drug manufacturers for commercial manufacturing. Hetero USA is properly licensed in its resident state with the New Jersey Department of Health, Registration No. 5004050 with an expiration of January 1, 2015. 2. HDL and HLL maintain a current and valid FDA Establishment Registration. WHEREFORE, Hetero USA, Inc., respectfully requests that DBPR issue a Final Order determining that: the sale and distribution of API as exempt from the Florida nonresident manufacturer licensing requirements.

A copy of the Petition for Declaratory Statement may be obtained by contacting: The Division of Drugs, Devices and Cosmetics, Dinah Greene, 1940 N. Monroe Street, Suite 26A, Tallahassee, FL 32399-1047.

Please refer all comments to: Reggie Dixon, Division Director, Division of Drugs, Devices and Cosmetics, 1940 N. Monroe Street, Suite 26A, Tallahassee, FL 32399-1047, website: http://interredesignalpha/dbpr/ddc/ddc_division_notices.html.