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

Share this article:
close

Next Article in News

Email Newsletters

More in News

Sanofi tightens PCSK9 race, exceeds Q2 expectations

Sanofi tightens PCSK9 race, exceeds Q2 expectations

Sanofi and partner Regeneron attached a $67.5-million priority review voucher to their experimental cholesterol drug alirocumab, making for a tighter race with Amgen.

HHS shows how diabetes adds up

HHS shows how diabetes adds up

A 2005-to-2010 survey shows diabetics 65-and-up juggle at least four co-morbid conditions and five medications for them.

AstraZeneca beefs up respiratory portfolio

AstraZeneca beefs up respiratory portfolio

AstraZeneca has made an $875-million move to beef up its respiratory pipeline by making Almirall's lineup its own.