Shannon Salimone, General Counsel on behalf of Safecor Health, LLC; The petition seeks a formal opinion from the Department regarding the following questions: A. If Safecor receives, for purposes of repackaging, finished pharmaceutical products ...

 

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 Shannon Salimone, General Counsel on behalf of Safecor Health, LLC. The petition seeks the agency's opinion as to the applicability of Sections 499.051, 499.002, 499.06, 499.066, 499.061 and 499.067, F.S., as they apply to the petitioner.

The petition seeks a formal opinion from the Department regarding the following questions: A. If Safecor receives, for purposes of repackaging, finished pharmaceutical products that have been purchased by a public or private hospital or other health care entity and distributed to Safecor by or at the direction of the health care entity, whether Safecor may transfer those repackaged drugs to the public or private hospitals’ or health care entities’ locations in Florida which are under common control with the hospital or other health care entity that originally purchased the products, if ownership of the drug remains with the hospital or other health care entity at all times. B. Whether any of the transfers of drugs, as described in subsection (a) above, would require Safecor to receive or provide a Florida-compliant pedigree paper.

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, [phone].

Please refer all comments to: 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.