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US appeals court affirms hold on pedigree requirements

This article was originally published in Scrip

Executive Summary

A US federal appeals court has affirmed a preliminary injunction blocking implementation of federal drug pedigree requirements. The injunction was granted in late 2006 at the request of secondary wholesalers, who challenged theFDA's decision to begin enforcing pedigree requirements for wholesalers who are not "authorised distributors". The provisions, which are aimed at stemming counterfeiting, would have required non-authorised distributors to provide written documentation of the chain of custody of products. The secondary wholesalers asserted they could not comply because authorised distributors were not required to turn over the necessary documentation to them. The appeals court agreed with the trial judge's ruling that the plaintiffs had demonstrated a likelihood of success on the merits of their claim that the FDA's actions were arbitrary and capricious.

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