FDA Extends Comment Period on Guidance for Industry

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The FDA has granted a 90-day extension to the public comment period on its highly controversial draft guidance for industry (GFI #230) entitled “Compounding Animal Drugs from Bulk Substances” in response to several requests to do so. The comment period will now close on November 16, 2015. Public comments are encouraged at

Drug Quality and Security Act Does Not Apply to Veterinary Compounding

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While the Drug Quality and Security Act (DQSA) provided a new regulatory framework for compounded medications for use in human medicine, it does not apply to veterinary compounded medications. There has been some confusion in the industry, but veterinary compounded medications are still regulated by state pharmacy authorities, while FDA retains enforcement discretion over activities that raise the kind of concerns associated with a drug manufacturer. FDA has stated that it intends to develop new policy guidance with respect to veterinary compounding.