Safecor Health, LLC; Petitioner is seeking a declaratory statement regarding the applicability of Sections 499.003(54)(b)7., 499.005(21), 499.0051(12)(a), 499.006(10) and 499.01212, Florida Statutes (2013), to Petitioner’s facts. Petitioner also ...

 

DEPARTMENT OF BUSINESS AND PROFESSIONAL REGULATION

Drugs, Devices and Cosmetics

NOTICE IS HEREBY GIVEN that the Department of Business and Professional Regulation, Division of Drugs, Devices and Cosmetics has issued an order disposing of the petition for declaratory statement filed by Safecor Health, LLC on March 12, 2014. The following is a summary of the agency’s disposition of the petition:

Petitioner is seeking a declaratory statement regarding the applicability of subparagraph 499.003(54)(b)7., subsection 499.005(21), paragraph 499.0051(12)(a), subsection 499.006(10) and Section 499.01212, Florida Statutes (2013), to Petitioner’s facts. Petitioner also seeks a statement as to the Department’s enforcement authority as set forth in Sections 499.002, 499.051, 499.06, 499.061, and 499.067, Florida Statutes, as applied to Petitioner’s facts. Accordingly, applying the foregoing to Petitioner’s facts, Petitioner’s requests are answered as follows: 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, the Department will not prohibit Safecor from transferring 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, so long as ownership of the drug remains with the hospital or other health care entity at all times. B. The transfers as described in paragraph A above would require Safecor to comply with minimum recordkeeping requirements, including tracking requirements as set forth in the PDMA. However, for transfers described in paragraph A, the Department will not require Safecor to receive or provide a Florida-compliant pedigree paper.

A copy of the Order Disposing of the Petition for Declaratory Statement may be obtained by contacting: Division of Drugs, Devices and Cosmetics, Dinah Greene, 1940 N. Monroe Street, Suite 26A, Tallahassee, FL 32399-1047.

Please refer all comments to: Reginald Dixon, Division Director Division of Drugs, Devices and Cosmetics, 1940 N. Monroe Street, Suite 26A Tallahassee, FL 32399-1047.