Shayna Desai, Director of Account Services, Licenselogix, 140 Grand Street, Suite 300, White Plains, NY 10601, on behalf of ALK-Albello, Inc., filed on November 17, 2014.; ALK-Albello, Inc., is a veterinary reference laboratory located in the State ...

 

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 Shayna Desai, Director of Account Services, Licenselogix, 140 Grand Street, Suite 300, White Plains, NY 10601, on behalf of ALK-Albello, Inc., filed on November 17, 2014. The petition seeks the agency’s opinion as to the applicability of Sections 499.003(30) and 499.003(54), Florida Statutes, as it applies to the petitioner.

ALK-Albello, Inc., is a veterinary reference laboratory located in the State of Texas. ALK-Abello, Inc., specializes in allergy testing and treatment for dogs, cats and horses. They proffer services to only licensed veterinarians, not actual pet owners. They formulate allergy treatment in the form of immunotherapy which, under federal law, is defined as a veterinary biological product. These are distinct from vaccines. The product is shipped to the state-licensed veterinarian, who then distributes the product to the patient pursuant to a written prescription. ALK-Albello, Inc., is requesting that the Department of Business and Professional Regulation issue a declaratory statement determining whether: ALK-Abello, Inc., would be required to obtain any of the following permits: a. 499.01(1)(c): Nonresident prescription drug manufacturer; b. 499.01(1)(e): Out-of state prescription drug wholesale distributor: c. 499.01(1)(k): Veterinary prescription drug wholesale distributor; d. 499.01(1)(l): Limited prescription drug veterinary wholesale distributor.

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, 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.