CVM GFI #256 Compounding Animal Drugs from Bulk Drug Substances

Wedgewood Pharmacy Leads More Action to Advocate for Access to Compounded Medication

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Wedgewood Pharmacy again took the lead in an industry-wide effort to make FDA’s Draft Guidance #256, Compounding Animal Drugs from Bulk Drug Substances, workable for veterinarians, pet owners, and compounding pharmacies that prepare medications for animal health.

34 members of Congress ask FDA to cite statutory authority for GFI #256

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Ted Yoho (R-FL), Mark Pocan (D-WI), and Donald Norcross (D-NJ), members of the U.S. House of Representatives, are the lead sponsors of a letter sent to Food and Drug Administration Commissioner, Stephen Hahn, M.D., expressing their concerns about the FDA’s draft Guidance for Industry #256 - Compounding Animal Drugs from Bulk Drug Substances.
 

Report Language for FDA Appropriations Bill Includes Directions About Compounding

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The report language for the bill that funds the Food and Drug Administration (FDA) has been released by the U.S. House of Representatives Committee on Appropriations. While this language does not have the force of law, it instructs federal agencies on actions to take as part of accepting new funding from Congress.

Here are excerpts that relate to compounding pharmacy: 

Alliance for Pharmacy Compounding Asks FDA To Extend GFI #256 Comment Period Again.

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On May 5, 2020, Scott Brunner, CEO of the Alliance for Pharmacy Compounding (formerly the International Academy of Compounding Pharmacists) wrote to Dr. Steven Solomon, DVM, Director of the Center for Veterinary Medicine of the Food and Drug Administration, and requested a further 180-day extension of the comment period for FDA’s draft GI #256, Compounding Animal Drugs from Bulk Drug Substances.

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