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News & Press: Breaking News

FDA Grants Comment Extension on Veterinary Compounding Draft Guidance for Industry

Friday, August 14, 2015   (0 Comments)
Posted by: Dagmar Anderson
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The International Academy of Compounding Pharmacists (IACP) is pleased to announce that the Food & Drug Administration (FDA) has granted an extension for comments on Compounding Animal Drugs From Bulk Drug Substances; Draft Guidance for Industry. FDA has extended the comment period by 90 days to November 16, 2015. Please click here to read FDA's announcement and instructions for submitting comments.


Official notice of FDA's comment extension will appear on Monday, August, 17th in the Federal Register. Click here to view the Federal Register's page.




On July 27th, the International Academy of Compounding Pharmacists (IACP) requested a formal 90-day extension of the comment period for the Food & Drug Administration's (FDA) Guidance for Industry (GFI): Compounding Animal Drugs from Bulk Drug Substances from August 17, 2015 to November 2015.


In a letter sent to the FDA, David G. Miller, RPh, IACP Executive Vice President/CEO says, "IACP is gravely concerned with many issues within this GFI that create distinct conflicts with existing State-regulated pharmacy practice laws and regulations, that authorizes the preparation and distribution of veterinary medications by 503B outsourcing facilities without the necessary enabling statutory authority from Congress, and will have a detrimental impact on the availability of medications for use by veterinarians in the care and treatment of animals within their practices."


Please click here to read the entire IACP letter.


Please email IACP at with any questions. Thank you for being an IACP Member!









































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