NOTICE IS HEREBY GIVEN that Division of Drugs, Devices and Cosmetics has received the petition for declaratory statement from Jack Jerrett, General Counsel on behalf of OraSure Technologies, Inc., filed on September 13, 2012.The petition seeks the agency's opinion as to the applicability of Section 499.005 (13), Florida Statutes, to the Petitioner’s sale, delivery, holding, or offering for sale of Petitioner’s FDA-approved HIV test kit, the OraQuick In-Home HIV Test. as it applies to the petitioner.
A copy of the Petition for Declaratory Statement may be obtained by contacting: The Division of Drugs, Devices and Cosmetics, 1940 N. Monroe Street, Suite 26A, Tallahassee, Florida 32399-1047
Please refer all comments to: Reggie Dixon, Executive Director, Division of Drugs, Devices and Cosmetics, 1940 N. Monroe Street, Suite 26A, Tallahassee, Florida 32399-1047