Compounder Oversight Bill Needs Tweaks, FDA Official Says

Law360, New York (May 9, 2013, 3:53 PM EDT) -- A proposed bill allowing the U.S. Food and Drug Administration to directly regulate certain compounding pharmacies would give the agency most of the authority it requires to help prevent future disease outbreaks, but some loopholes still need closing, a senior FDA official told lawmakers Thursday.

According to Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, the draft Senate bill had been appropriately framed to give the agency more oversight over many of the largest compounders — those which prepare drugs in bulk...
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