Mary Ellen Kleiman, Esquire of the National Association of Chain Drug Stores (“NACDS” or “Petitioner”).; The Petitioner makes the conclusion that the Department’s statutes and rules are preempted by federal law, based on Petitioner’s interpretation ...

 

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 declined to rule on the petition for declaratory statement filed by Mary Ellen Kleiman, Esquire of the National Association of Chain Drug Stores (“NACDS” or “Petitioner”) on October 17, 2016. The following is a summary of the agency's declination of the petition:

The Petitioner makes the conclusion that the Department’s statutes and rules are preempted by federal law, based on Petitioner’s interpretation of the Drug Supply Chain Security Act. The Petitioner cites to a declaratory statement issued by the Department in In Re Petition for Declaratory Statement, Publix Super Markets, Inc., Petitioner (DS 2014-007 April 15, 2014), in which the Department interpreted its pedigree laws in light of changes to the federal law and concluded that the Department’s pedigree laws were preempted by the enactment of the federal law. Since enactment of the Drug Supply Chain Security Act, the Florida Legislature enacted changes to Sections 499.0121(6)(a), 499.0121)(6)(b), 499.0121(6)(f), and 499.0051(1)(c), Florida Statutes, making it clear the requirements for business records that are required to be kept to ensure that persons distributing, packaging, shipping and receiving prescription drugs are permitted to do so. Further, the Department engaged in rulemaking to add new rules 61N-1.028, and 61N-1.031, Florida Administrative Code. Petitioner is not asking how these statutes and rules affect petitioner in its circumstances. Rather, the Petitioner is attempting to challenge both the statutes and the rules referenced above. The Petitioner asks the Department to declare that the DSCSA pre-empts the Department’s statutes and rules cited in the Petition, in accordance with the Petitioner’s interpretation of the DSCSA. This the Department cannot do in a proceeding on a Petition for Declaratory Statement. Based on the foregoing, the Department declines to issue a declaratory statement, and the Petition is DENIED. The Denial was filed on December 29, 2016.

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

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, [e-mail], website http://interredesignalpha/dbpr/ddc/ddc_division_notices.html.