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:
You must be a registered member of MMM to post a comment.
close

Next Article in Channel

Email Newsletters

MM&M EBOOK: PATIENT ACCESS

Patient access to pharmaceuticals is a tale of two worlds—affordability has improved for the majority, while the minority is hampered by cost, distribution and red tape. To provide marketers with a well-rounded perspective, MM&M presents this e-book chock full of key insights. Click here to access it.

More in Channel

Five things for pharma marketers to know: Monday, September 15

Five things for pharma marketers to know: ...

Pharma has sought 76 meetings with FDA over biosimilars; Gilead licenses Sovaldi to India generic drugmakers; Pfizer and Ranbaxy Lipitor lawsuit dismissed.

Liraglutide, aiming for new indication, gets new name

Liraglutide, aiming for new indication, gets new name

Why Novo Nordisk is choosing not to leverage Victoza's brand equity as it seeks a weight-loss indication for liraglutide.

Five things for pharma marketers to know: Friday, September 12

Five things for pharma marketers to know: Friday, ...

An FDA panel voted in favor of liraglutide for weight loss; Allergan investors backing an attempted takeover of the firm crossed a critical threshold; and 100 million health wearables are ...