Bill Giving FDA New Power Over Compounders Unveiled

Law360, New York (April 26, 2013, 2:42 PM EDT) -- Senate health committee leaders on Friday announced legislation that would give the U.S. Food and Drug Administration new authority to directly regulate certain compounding pharmacies, which would be defined as “compounding manufacturers” and no longer licensed as pharmacies.

The draft bill is a response to last year's deadly, widespread fungal meningitis outbreak, which was traced to contaminated drugs made by New England Compounding Center in Massachusetts. More than 700 people were affected and 53 people killed.

Compounding pharmacies traditionally make custom-order drugs for patients with special...
To view the full article, register now.
Law360 Pro Say Podcast
Check out Law360's new podcast, Pro Say, which offers a weekly recap of both the biggest stories and hidden gems from the world of law.