FDA can't regulate compounded Rxs

Share this article:
In a bench decision, Texas Western District federal judge Robert Junell ruled in May that pharmacy-compounded drugs are not new drugs subject to FDA regulation, as the agency has unsuccessfully asserted in various courts for over a decade. In 2002, the FDA lost in an advertising-related compounding case in the Supreme Court.

Junell granted summary judgment in part to the plaintiffs Medical Center Pharmacy, et al. against the government, leaving two issues to be decided: the scope of the FDA's authority to inspect pharmacies' records, and pharmacies' ability to compound using bulk active ingredients for non-food-animal drugs

This material may not be published, broadcast, rewritten or redistributed in any form without prior authorization. Your use of this website constitutes acceptance of Haymarket Media's Privacy Policy and Terms & Conditions