Karen Asher-Cohen, Esquire, on behalf of Exegi Pharma, LLC located at 312 Main Street, #200, Gaithersburg, MD 20878.; “Should Petitioner be permitted to sell Visbiome Extra Strength in Florida without obtaining a permit from DBPR as a nonresident ...

 

DEPARTMENT OF BUSINESS AND PROFESSIONAL REGULATION

Drugs, Devices and Cosmetics

NOTICE IS HEREBY GIVEN that The Department of Business & Professional Regulation, Division of Drugs, Devices, and Cosmetics has issued an order disposing of the petition for declaratory statement filed by Karen Asher-Cohen, Esquire, on behalf of Exegi Pharma, LLC located at 312 Main Street, #200, Gaithersburg, MD 20878. on March 11, 2016. The following is a summary of the agency's disposition of the petition:

“Should Petitioner be permitted to sell Visbiome Extra Strength in Florida without obtaining a permit from DBPR as a nonresident prescription drug manufacturer per the requirements of Part I of Chapter 499, Florida Statutes, because Visbiome Extra Strength is a medical food which is not included in the definition of “prescription drug” or “drug” and which meets the act’s definition and criteria for a medical food? Based on the foregoing, the Department answers the Petitioner’s question and declares: Petitioner is not required to be permitted as a non-resident prescription drug manufacturer to engage in the sale of Visbiome ES, a medical food, into Florida.

A copy of the Order Disposing of the Petition for Declaratory Statement may be obtained by contacting: The Division of Drugs, Devices and Cosmetics, 2601 Blair Stone Road, Tallahassee, FL 32399-1047.

Please refer all comments to Reginald D. Dixon, Division Director, The Division of Drugs, Devices and Cosmetics, 2601 Blair Stone Road, Tallahassee, FL 32399-1047.