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Congress should consider clarifying FDA’s authority over compounding, GAO says
Modern Healthcare

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.