History of sterile compounding in U.S. hospitals: Learning from the tragic lessons of the past

History of sterile compounding in U.S. hospitals: Learning from the tragic lessons of the past

Senate should act efficiently on drug compounding bill

07/31/2013 | Washington Post (tiered subscription model), The

A Senate vote for legislation that would put some compounding pharmacies under the FDA's regulatory oversight would be a crucial step even if it's not yet clear how the House will act, according to this editorial. The bill's approval would show Congress is ready to help prevent events similar to last year's fungalmeningitis outbreak tied to the New England Compounding Center.

View Full Article in: Washington Post (tiered subscription model), The

Rep. Cummings and Tierney Release GAO Report on Drug Compounding

 

FOR IMMEDIATE RELEASE

Members Urge Action on Legislation to Protect Nation’s Drug Supply
 
Washington, DC (July 31, 2013)—Today, Rep. Elijah E. Cummings, the top Democrat on the House Committee on Oversight and Government Reform, and Rep. John Tierney, Ranking Member of the Subcommittee on National Security, Homeland Defense and Foreign Operations, released a report from the Government Accountability Office (GAO) on the oversight of pharmaceutical drug compounding.
 
Cumming and Tierney requested the report last year after a fungal meningitis outbreak from a contaminated compound drug led to more than 50 deaths and hundreds of illnesses.

You may read the full report on the Oversight Committee website by clicking here.

Congress should consider clarifying FDA's authority over compounding, GAO says--FDA officials said they had to obtain 11 warrants to gain access to drug compounders' facilities that had challenged FDA's inspection authority.”

By Jessica Zigmond 

Posted: July 31, 2013 - 7:15 pm ET

Tags: Government Accountability Office (GAO), Pharmaceuticals, Regulation, Supply Chain, U.S. Food and Drug Administration (FDA)

Congress should think about clarifying the Food and Drug Administration's authority to oversee drug compounding, the Government Accountability Office concluded in a report released on Wednesday.

A deadly outbreak of fungal meningitis linked to contaminated compounded drugs in 2012 led to a series of federal hearings on Capitol Hill last fall. In those heated discussions, FDA Commissioner Dr. Margaret Hamburg implored lawmakers for more clarity on her agency's authority over compounding, a process in which a pharmacist combines, mixes or changes ingredients to create a drug that is tailored to an individual's needs.

Read more: Congress should consider clarifying FDA's authority over compounding, GAO says | Modern Healthcare http://www.modernhealthcare.com/article/20130731/NEWS/307319946#ixzz2agWCkXAQ 
?trk=tynt