Michael J. Glazer, Ausley McMullen, Post Office Box 391, 123 South Calhoun Street, Tallahassee, FL 32301, on behalf of H.D. Smith Wholesale Drug Company; Currently, Section 499.01(2)(p), Florida Statutes (2014), which requires 3PLs to comply with ...

 

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 issued an order disposing of the petition for declaratory statement filed by Michael J. Glazer, Ausley McMullen, Post Office Box 391, 123 South Calhoun Street, Tallahassee, FL 32301, on behalf of H.D. Smith Wholesale Drug Company on September 29, 2014. The following is a summary of the agency’s disposition of the petition:

Currently, Section 499.01(2)(p), Florida Statutes (2014), which requires 3PLs to comply with the wholesale distributor requirements and with pedigree requirements (unless the 3PL is performing a wholesale distribution of a prescription drug for a manufacturer), is inconsistent with the new federal standards. It is not clear from a reading of the other relevant provisions of the DQSA regarding 3PL licensure whether the Department is pre-empted from permitting 3PLs in this interim period prior to the effective date of the regulations referenced in section 584 of the DQSA, or whether the Department is authorized to continue its current permitting program for 3PLs. However, it is clear that Section 585(c) of the DQSA allows state licensure that is not inconsistent with the federal standards. Therefore, so long as the department does not require 3PLs to meet the distributor and pedigree requirements, the Department can continue to license 3PLs. In a declaratory statement, the Department is limited to providing a statement of how statutes over which the agency has regulatory authority, agency rules or agency orders affect the Petitioner. Accordingly, the Department cannot interpret the provisions of the DQSA regarding 3PL licensure as it applies to Petitioner’s facts. However, there is no prohibition against the Department determining in a declaratory statement whether its statutes (or portions thereof) are pre-empted by a federal statute, and how that statute, whether pre-empted or not, affects a Petitioner. The Department determines that the requirements of the Department’s 3PL licensing program that relate to 3PLs being treated as wholesale distributors and the requirements for pedigrees will not be administratively enforced by the Department. Section 499.002(1), Florida Statutes, states that Chapter 499, Part I, is intended to safeguard the public health and promote the public welfare by protecting the public from injury by product use and by merchandising deceit involving drugs, devices, and cosmetics. The Department is charged with promoting uniformity of state and federal laws and their administration and enforcement throughout the United States. In addition, the Department is charged with administering and enforcing Part I, Chapter 499, Florida Statutes, to prevent fraud, adulteration, misbranding, or false advertising in the preparation, manufacture, repackaging or distribution of drugs, devices, and cosmetics. In keeping with its legislative mandates set forth in Section 499.002, Florida Statutes, and notwithstanding the DQSA’s various provisions regarding 3PL licensure, the Department will continue its present 3PL permitting program and will continue to require permits for 3PLs distributing prescription drugs from or into this state. Accordingly, the Department declares that if HDS obtains prescription drug product from a 3PL for distribution in Florida, then the 3PL must hold a valid Florida 3PL license.

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

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.