Edwin A. Bayo, Counsel on behalf of Owens and Minor Distribution, Inc., filed on October 9, 2014.; Owens and Minor Distribution, Inc., a duly permitted prescription drug wholesale distributor is requesting that the Department of Business and ...

 

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 Edwin A. Bayo, Counsel on behalf of Owens and Minor Distribution, Inc., filed on October 9, 2014. The petition seeks the agency’s opinion as to the applicability of Sections 499.01, and 499.01212, Florida Statutes ,and Rule 61N-1, Florida Administrative Code, as they apply to the petitioner.

Owens and Minor Distribution, Inc., a duly permitted prescription drug wholesale distributor is requesting that the Department of Business and Professional Regulation issue a declaratory statement determining whether: (A) Resident and non-resident prescription drug wholesale distributors, third party logistics providers, re-packers and manufacturers doing business with the State of Florida must maintain a license with the State of Florida, DBPR if conducting distributions of DQSA exempted drug products, or whether entities conducting distributions of drug products exempted under the DQSA are no longer required to maintain State DBPR licensure as resident and non-resident prescription drug wholesale distributors, third party logistics providers, re-packers or manufacturers since distributions of these products are not by definition a “transaction” under Federal Law. (B) Resident and non-resident prescription drug wholesale distributors, third party logistics providers, re-packers and manufacturers doing business with the State of Florida must continue to comply with the recordkeeping requirements of Section 499.0121(6)(a)-1-5, Florida Statutes and paragraphs 61N-1.012(1)(a) and (2), Florida Administrative Code, with regard to the sale or transfer of DQSA exempted prescription drug containing kits and IV solutions into or within Florida, or whether entities so engaged need not comply with recordkeeping laws since distributions of these products are not by definition a “transaction” under Federal Law. (C) Resident and non-resident prescription drug wholesale distributors, third party logistics providers, re-packers and manufacturers doing business with the State of Florida must, starting January 1, 2015, provide prior to or at the time of each transaction, transaction history (TH), transaction information (TI) and a transaction statement (TS), defined by Section 581 of the DQSA paragraphs (25), (26) and (27) and further implemented into tracing requirements under Section 582 of the DQSA paragraph (b)(1)(A)(i) et.al., and paragraph (c)(1)(A)(i) et. al., for the sale and transfer (distribution) of “exempt” prescription drug containing kits and IV products into or within the State of Florida or whether entities so engaged need not comply with recordkeeping laws since distributions of these products are not by definition a “transaction” under Federal Law.

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.

Please refer all comments to: 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.