Michael J. Glazer, General Counsel on behalf of H.D. Smith Wholesale, filed on July 9, 2014.; H.D. Smith is requesting that the Department of Business and Professional Regulation issue a declaratory statement as to the following. 1. HDS is a ...

 

DEPARTMENT OF BUSINESS AND PROFESSIONAL REGULATION

Drugs, Devices and Cosmetics

NOTICE IS HEREBY GIVEN that Division of Drugs, Devices and Cosmetics has received the petition for declaratory statement from Michael J. Glazer, General Counsel on behalf of H.D. Smith Wholesale, filed on July 9, 2014. The petition seeks the agency’s opinion as to the applicability of paragraph 499.01(2)(s), Sections 499.002, 499.0051, 499.066, 499.0661, and 499.067, Florida Statutes, and related administrative rules as they apply to the petitioner.

H.D. Smith is requesting that the Department of Business and Professional Regulation issue a declaratory statement as to the following. 1. HDS is a prescription drug wholesaler. HDS has historically and continues to comply with the requirements of Florida law that it only engage in transactions with properly licensed parties as it relates to the distribution of prescription drugs. 2. Certain 3PLs shipping products to HDS for distribution in Florida have taken the position that a Florida 3PL license is not required due to the provisions of DQSA. 3. HDS has held to its belief that a 3PL license is required. This disagreement regarding the interaction of state and federal law has made it difficult in certain instances for HDS to obtain products and provide these medications to Florida pharmacies. 4. HDS is substantially affected by these regulations. If HDS obtains and distributes product from an unlicensed 3PL and if DBPR determines that the 3PL should have been licensed, then HDS is subject to sanctions for violating Chapter 499, Florida statutes. HDS is therefore sufficiently and substantially affected and is justified in requesting this declaratory statement to clarify its rights under the referenced statutes and rule. WHEREFORE, HDS respectfully requests that DBPR issue a Final Order determining that if HDS obtains prescription drug products from a 3PL for distribution in Florida, then the 3PL must hold a valid Florida 3PL license.

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

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.