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Congress Scrutinizing FDA’s Regulation of Drug Compounding

Oct 12, 2018

STAT Plus reports that lawmakers have been “pulling the FDA in different directions” in the five years since the agency was granted “sweeping authority to regulate compounding.” The article states, “Congress left it up to the FDA to interpret a number of key provisions of the 2013 compounding law” and “few regulations have been more challenging to write than those dealing with bulk compounding.” Julie Dohm, the FDA’s senior science adviser for compounding, is quoted throughout the piece, and she concludes, “Obviously, FDA will interpret the statute and implement it the way that it has to irrespective of outside factors.”

From the news release of the American Association for Justice.

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