Bulk mixers of prescribed drugs get more scrutiny

November 18, 2013 by Matthew Perrone

Congress has taken a half step toward increasing federal oversight of so-called compounding pharmacies that custom mix medications in bulk, a year after a meningitis outbreak from contaminated pain injections killed at least 64 people and sickened hundreds of others.

The Senate approved the bill Monday by voice vote, sending it to President Barack Obama for his signature. The House passed the bill in September.

Last year's was traced to a now-closed pharmacy in Framingham, Mass., where inspectors found mold and other unsterile conditions.

Jurisdiction over large-volume compounders has been murky. Pharmacies are typically regulated by state boards, but the Food and Drug Administration regulates drug manufacturers. The gives the FDA authority to inspect large-volume compounders, but doesn't require them to register with the federal agency.

Explore further: Senate questions pharmacy boards after outbreak

Related Stories

Senate questions pharmacy boards after outbreak

November 19, 2012

(AP)—A Senate committee investigating a deadly outbreak of meningitis wants to know how regulators in all 50 states oversee specialty pharmacies like the one that triggered the illness.

Consumer watchdog asks FDA to revisit compounders

November 29, 2012

(AP)—A government watchdog group is calling on the Food and Drug Administration to re-inspect more than a dozen specialty pharmacies with prior records of violations, in light of a recent deadly outbreak tied to compounded ...

Congress investigating compounding trade group

December 7, 2012

(AP)—House lawmakers are investigating whether the industry group for compounding pharmacies coached the company responsible for a deadly outbreak of meningitis in dealing with regulators.

FDA chief renews push for specialty pharmacy rules

December 19, 2012

(AP)—The head of the Food and Drug Administration renewed her push for new rules to help police pharmacies like the one that triggered a deadly meningitis outbreak, even as members of Congress expressed little interest ...

House unveils bill to police specialty pharmacies

September 13, 2013

(AP)—House lawmakers have introduced legislation that would bring more federal oversight to large specialty pharmacies like the one that triggered a deadly meningitis outbreak last year.

Recommended for you

Re-framing the placebo effect and informed consent

October 29, 2015

(Medical Xpress)—Imagine that your doctor knows from evidence-based studies that if he tells you about certain, small side-effects to a particular drug, you are significantly more likely to experience that side effect than ...

Can exercise be replaced with a pill?

October 2, 2015

Everyone knows that exercise improves health, and ongoing research continues to uncover increasingly detailed information on its benefits for metabolism, circulation, and improved functioning of organs such as the heart, ...


Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.