Wednesday, July 22, 2009

Foreign-Trade Zone 7 Scope Clarification Request; IPR Pharmaceuticals, Inc.

Foreign-Trade Zone 7--Mayaguez, PR; Scope Clarification Request; IPR Pharmaceuticals, Inc. (Pharmaceuticals)


A request for clarification of scope has been submitted to the Foreign-Trade Zones Board (the Board) by IPR Pharmaceuticals, Inc. (IPR), operator of IPR's pharmaceuticals manufacturing operations within FTZ 7, in Canovanas, Puerto Rico.

Manufacturing authority for pharmaceuticals and intermediates at IPR's FTZ 7 manufacturing facilities was issued on December 14, 2001 (Board Order 1203, 67 FR 71934, 12/03/2002). IPR listed in the original application specific component/product manufacturing which would be performed at the outset and also listed categories of components and products which might be sourced from abroad in the future. IPR has now informed the Board that future production will involve the use of an imported ingredient that was not specifically listed as a foreign-sourced component in the original manufacturing request. The company intends to use a foreign-sourced active ingredient, AZD0530 difumarate (HTSUS 2934.99.3000--6.5%), in production of difumarate tablets (HTSUS 3004.90.9115--duty-free).

The FTZ staff invites the comments of interested parties for consideration in its review. Submissions shall be addressed to the Board's Executive Secretary at the address listed below. The closing period for their receipt is August 21, 2009.

A copy of the request will be available for public inspection at the Office of the Executive Secretary, Foreign-Trade Zones Board, Room 2111, U.S. Department of Commerce, 1401 Constitution Avenue, NW., Washington, DC 20230-0002.