Martin R. Dix, of Akerman LLP on behalf of Publix Super Markets, Inc.; The petitioner is seeking a declaratory statement regarding the applicability of Sections 499.003(54), 499.003(17), 499.005(14), and 499.01, Florida Statutes, and Rule 61N-1.012, ...

 

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 Martin R. Dix, of Akerman LLP on behalf of Publix Super Markets, Inc. on January 14, 2014. The following is a summary of the agency's disposition of the petition:

The petitioner is seeking a declaratory statement regarding the applicability of Sections 499.003(54), 499.003(17), 499.005(14), and 499.01, Florida Statutes, and Rule 61N-1.012, Florida Administrative Code, to the 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, 499.066 and 499.067, as applied to Petitioner’s facts. The following is a summary of the agency’s disposition of the petition: Publix owns and operates 596 community pharmacies within the state of Florida. The pharmacies are licensed by the Florida Department of Health. These pharmacies do not possess Florida prescription drug wholesale distributor permits. Publix also owns and operates a chain pharmacy warehouse that is licensed by the Department as a wholesale distributor, holding permit number 22-1471. This Publix chain pharmacy warehouse purchases prescription drugs from authorized suppliers and distributes these drugs to Publix pharmacies. Publix controls all of its pharmacies and controls its chain pharmacy warehouse. Publix asserts that its pharmacies need to be able to do the following: Publix requests a statement from the Department declaring the following: Accordingly, applying the foregoing to Petitioner’s facts, Petitioner’s requests for declarations are answered as follows: A. Publix pharmacies’ sale of prescription drugs from one Publix pharmacy to other Publix Pharmacies is not the wholesale distribution of prescription drugs. B. Publix pharmacies’ transfers of prescription drugs from one Publix pharmacy to other Publix pharmacies are not the wholesale distribution of prescription drugs, so long as such transfers are intracompany sales. C. Publix pharmacies’ sale of prescription drugs from one Publix pharmacy to other Publix pharmacies does not require any type of Florida prescription drug wholesale distributor’s permit. D. Publix pharmacies’ transfers of prescription drugs from one Publix pharmacy to other Publix pharmacies do not require a prescription drug pedigree to be provided at this time, so long as such transfers are intracompany sales. In the future, federal tracking and tracing requirements may apply. E. Publix pharmacies’ sales of prescription drugs to the Publix chain pharmacy warehouse are not the “wholesale distribution” of prescription drugs. F. Publix pharmacies’ transfer of prescription drugs to the Publix chain pharmacy warehouse is not the “wholesale distribution” of prescription drugs, so long as transfers are intracompany sales. G. Publix pharmacies’ sales of prescription drugs to the Publix chain pharmacy warehouse do not require a Florida prescription drug wholesale distributor permit and does not require Publix to provide pedigree papers for these returns. H. Publix pharmacies’ transfers of prescription drugs to the Publix chain pharmacy warehouse do not require a Florida prescription drug wholesale distributor’s permit, so long as such transfers are intracompany sales, and does not require Publix to provide pedigree papers for these returns.

A copy of the Order Disposing of the Petition for Declaratory Statement may be obtained by contacting: Dinah Greene, Division of Drugs, Devices and Cosmetics 1940 N.Monroe Street, Suite 26A, Tallahassee, FL 32399, [phone] or via email at [e-mail].

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