Wednesday, December 5, 2012

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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FDA Fights Web Pharmacies Selling Unapproved Drugs

posted: Oct 05, 2012 3:55 PM CDTUpdated: Oct 05, 2012 3:55 PM CDT
WASHINGTON (AP) -- The Food and Drug Administration is stepping up its fight against counterfeit and other potentially harmful medicine sold over the Internet.
The agency is ordering operators of about 4,100 websites to immediately stop selling unapproved medications to U.S. consumers.
The FDA has sent warning letters to three companies behind most of the websites. It's also seized some illegal medicines, filed civil and criminal charges against companies and people, and contacted Internet registrars and service providers, asking them to suspend the 4,100 websites.
Those efforts are part of a global crackdown on online sellers of counterfeit and illegal medical products. Interpol, the international police agency, says about $10.5 million worth of medicines were seized worldwide last week and more than 18,000 illegal pharmacy websites were shuttered.
Source found here