Lucy Ketner, Payer Relations Coordinator, Prism Medical Products, LLC. (“Prism”).; Petitioner states: I am seeking to determine if our entity requires any form of medical distributor license from your organization to dispense wound care, ostomy, or ...

 

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 Lucy Ketner, Payer Relations Coordinator, Prism Medical Products, LLC., (“Prism”), on March 1, 2016. The following is a summary of the agency's disposition of the petition:

Petitioner states: I am seeking to determine if our entity requires any form of medical distributor license from your organization to dispense wound care, ostomy, or urological supplies, more specifically the product Vashe Wound Cleanser. The Department declares that no permit under Chapter 499, Florida Statutes, is required for the delivery of Vashe Wound Cleanser, a medical device which Prism does not manufacture or assemble, to patients pursuant to a practitioner’s order.

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.