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Capitol Health Call
September 11, 2013

FDA Remains Hampered in Inspecting Compounding Facilities

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Copyright 2013 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.

JAMA. 2013;310(10):1015. doi:10.1001/jama.2013.277678

The Food and Drug Administration (FDA) lacks clear authority and the necessary data to oversee large-scale drug compounding facilities such as those whose tainted products were associated with 63 patient deaths and 749 patient illnesses due to a fungal meningitis outbreak that started in 2012, reported the Government Accountability Office (GAO).

The GAO, in a report released August 7 to leadership of the Senate Health, Education, Labor, and Pensions Committee, said 2 federal court decisions have resulted in varying FDA authority in different parts of the country and that the agency’s inspection database cannot identify all of its inspections of compounding pharmacies or the final classification of inspection results. The GAO suggested that Congress should clarify FDA authority to oversee drug compounding and that the agency should ensure its databases collect reliable and timely data on compounding drug facility inspections (

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