Scrip is part of the Business Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

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.

Advertisement
Advertisement
UsernamePublicRestriction

Register

SC006873

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel