2004N-0115 - Prescription Drug Importation; Public Meeting
FDA Comment Number : EC9
Submitter : Dr. Dayton Reardan Date & Time: 03/29/2004 11:03:51
Organization : Orphan Medical Inc
Drug Industry
Category :
Issue Areas/Comments
GENERAL
GENERAL
Canada and European regulations and laws require manufacturers to quarantine, sample, and test any imports (to assure lots of drug product have not been adulterated in transit and still meet release criteria) and to release imported product to those markets. These costs can run $10-20,000 per lot of drug product. The US has no requirement for products manufactured outside the US as long as the importer is the manufacturer or NDA holder and chain of custody, or pedigree papers exist and shipment is validated to ensure potency and stability, for example with refrigerated or frozen products. This is a relatively unknown barrier to free trade which costs US firms and US based manufacturers who export from the US, but not foreign based firms or importers to the US.

Can FDA establish memorandums of understanding with Canada and/or Europe to eliminate such barriers to allow free trade of pharmaceutical drug products at the manufacturer level?