Karen Asher-Cohen, Attorney on behalf of Exegi Pharma, LLC, on March 11, 2016.; The Petition seeks a formal opinion from the Department as to whether the Petitioner is required to obtain a permit as a Nonresident Prescription Drug Manufacturer under ...

 

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 Karen Asher-Cohen, Attorney on behalf of Exegi Pharma, LLC, on March 11, 2016.The petition seeks the agency's opinion as to the applicability of Sections 499.01(2) (c), 499.003, Florida Statutes as it applies to the petitioner.

The Petition seeks a formal opinion from the Department as to whether the Petitioner is required to obtain a permit as a Nonresident Prescription Drug Manufacturer under Chapter 499, Florida Statutes to sell Visbiome ™ Extra Strength a medical food.

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

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 to intervene or petitions for administrative hearings by persons whose substantial interests may be affected must be filed within 21 days after publication of (or such later time as is specified in) the notice in the Florida Administrative Register.