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 
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