Michael J. Glazer, General Counsel on behalf of H.D. Smith Wholesale, filed on June 24, 2014.; The petition seeks a formal opinion from the Department that the purchase and sale of certain prescription drugs by H.D. Smith (HDS) can be made without ...

 

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 June 24, 2014.The petition seeks the agency's opinion as to the applicability of Sections 499.002, 499.003, 499.0051, 499.066, 499.0661, 499.01212 and 499.067 Florida Statutes and Rule 61N-1.012(3) as it applies to the petitioner.

The petition seeks a formal opinion from the Department that the purchase and sale of certain prescription drugs by H.D. Smith (HDS) can be made without meeting the pedigree, authentication and return requirements of Florida law to the extent they impose requirements that are inconsistent with, more stringent than, or in addition to, any requirements of the new Drug Quality and Security Act. H.D. Smith is requesting that the Department of Business and Professional Regulation issue a determination on the following. 1. H.D. Smith does not have to comply with the pedigree requirements of section 499.1212, Florida Statutes and related administrative rules to the extent they impose requirements that are inconsistent with, more stringent than, or in addition to, any requirements of DQSA. 2. H.D. Smith does not have to comply with the authentication requirements of Florida law to the extent they impose requirements that are inconsistent with, more stringent than, or in addition to, any requirements of DQSA. 3. H.D. Smith does not have to comply with the return requirements of Florida Administrative Code Rule 61N-1.012 to the extent they impose requirements that are inconsistent with, more stringent than, or in addition to, any requirements of DQSA.

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 [phone]

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.