FDA Compounding Authority Unclear

Published Online: Tuesday, September 10, 2013
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The Government Accountability Office (GAO) concluded in a new report that the authority of the FDA to oversee drug compounding is unclear. The agency suggests that Congress should consider clarifying the agency’s authority to eliminate gaps in compounding inspections and regulations.

After reviewing relevant statutes and FDA data, the GAO found that 2 federal circuit court decisions have led to differing FDA authority in different regions of the country. In interviews conducted by the GAO, FDA officials claimed that these conflicting decisions make it more difficult for the agency to inspect compounding pharmacies. In fact, officials said they had to sometimes obtain search warrants in order to inspect facilities.

In additional interviews with pharmacy organization leaders, the GAO also found that organizations and the FDA do not agree on whether compounding large amounts of drugs and selling them across state lines should be considered a type of drug manufacturing and, therefore, should be overseen by the FDA.

The report also notes that the FDA has limited access to timely and reliable information as its inspection database cannot identify every compounding pharmacy or the final classification of inspection results for all of its inspections. The GAO recommends that the FDA improve the information in its database and that it differentiate drug manufacturers from drug compounders.


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