Mary Ellen Kleiman, of National Association of Chain Drug Stores (NACDS). (Petitioner), on October 17, 2016; The Petition seeks a formal opinion from the Department as to whether NACDS members operating in Florida: (a) are subject to felony ...

 

DEPARTMENT OF BUSINESS AND PROFESSIONAL REGULATION

Drugs, Devices and Cosmetics

NOTICE IS HEREBY GIVEN that The Division of Drugs, Devices and Cosmetics, has received the petition for declaratory statement from Mary Ellen Kleiman, of National Association of Chain Drug Stores (NACDS). (Petitioner), on October 17, 2016. The petition seeks the agency’s opinion as to the applicability of 499.0121, 499.0051, F.S., as it applies to the petitioner.

The Petition seeks a formal opinion from the Department as to whether NACDS members operating in Florida: (a) are subject to felony criminal liability and penalties in instances when the transaction history, transaction information, or transaction statement (3Ts) they may receive and maintain from manufacturer and wholesalers does not completely nor accurately reflect what is actually received by the pharmacy but is otherwise in compliance with federal law and (b) are required to maintain records beyond those mandated by federal law for the purpose of product tracking and tracing.

A copy of the Petition for Declaratory Statement may be obtained by contacting: Dinah Greene, Division of Drugs, Devices and Cosmetics, 2601 Blair Stone Road, Tallahassee, FL 32399-1047, [e-mail], [phone].

Please refer all comments to: Reggie Dixon, Director, Division of Drugs, Devices and Cosmetics, 2601 Blair Stone Road, Tallahassee, FL 32399-1047, [e-mail]; website: http://interredesignalpha/dbpr/ddc/ddc_division_notices.html.

Except for good cause shown, motions for leave to intervene or petitions for administrative hearing by persons whose substantial interests may be affected must be filed within 21 days after the publication of this notice.