Wm. J. Hartig, on behalf of PreScript Pharmaceuticals, Inc., (Petitioners), on April 13, 2016.; The Petition seeks a formal opinion from the Department as to whether the Petitioners, a non-resident prescription drug repackager is required to be ...

 

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 Wm. J. Hartig, on behalf of PreScript Pharmaceuticals, Inc., (Petitioners), on April 13, 2016. The petition seeks the agency’s opinion as to the applicability of Chapter 499, Florida Statutes, and Rule 61N-1, Florida Administrative Code, as it applies to the petitioner.

The Petition seeks a formal opinion from the Department as to whether the Petitioners, a non-resident prescription drug repackager is required to be permitted by the Department, where the Petitioner is not a wholesale distributor as that term is defined under the Federal Act as amended by the Drug Supply Chain Security Act.

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

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, [e-mail], website: http://interredesignalpha/dbpr/ddc/ddc_division_notices.html.

Except for good cause shown, motions for leave to intervene must be filed within 21 days after the publication of this notice.