Bill would make drug compounders register with FDA:Supporting Access to Formulated and Effective Compounded Drugs Act, or SAFE Compounded Drugs Act

By Paul Barr

Posted: December 5, 2012 - 5:15 pm ET

A bill that would require compounding pharmacies to register with the Food and Drug Administration was introduced in the House, according to a news release from the two sponsors of the bill, Reps. Rosa DeLauro (D-Conn.) and Nita Lowey (D-N.Y.).

The bill, called the Supporting Access to Formulated and Effective Compounded Drugs Act, or SAFE Compounded Drugs Act, would establish an FDA database on the pharmacies for use by the FDA and states in oversight of drug compounders, according to the news release. In addition, it would require the FDA to set minimum production standards and direct the FDA to offer training to state regulators. 

A compounding pharmacy in Massachusetts is blamed for a meningitis outbreak that sickened more than 500 people and caused at least 36 deaths.

Read more: Bill would make mixing pharmacies register with FDA | Modern Healthcare http://www.modernhealthcare.com/article/20121205/NEWS/312059954#ixzz2EFMwRWEs 
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