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
From the July 01, 2006 Issue of MM+M - Medical Marketing and Media
