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FDA Signals Tougher Approach To Animal Drug Compounding

Law360, New York (June 1, 2015, 5:12 PM EDT) -- On May 18, 2015, the U.S. Food and Drug Administration withdrew its 2003 Compliance Policy Guide — Section 608.400, Compounding of Drugs for Use in Animals and signaled new plans to constrain animal drug compounding in its Draft Guidance for Industry (GFI) #230, Compounding Animal Drugs from Bulk Drug Substances.[1] The draft guidance suggests that a dramatic shift in the FDA's enforcement approach may be underway and provides insight into the FDA's enforcement priorities and its interpretation of the applicable regulatory regime. Stakeholders have until Aug. 17, 2015, to submit comments that could influence the final guidance and policies adopted by the agency....

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