CVM GFI #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.

FDA extends comment period on GFI #256 to June 17, 2020.

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UPDATE: February 14, 2020

 
In response to requests to extend the comment period for the revised draft guidance, “Compounding Animal Drugs from Bulk Drug Substances,” the FDA plans to provide an additional 120 days for the public to submit comments. The initial comment period is scheduled to end on February 18, 2020, but FDA will be reopening the comment period using the same docket number. Otherwise, the submission process remains unchanged.
 
The new deadline to receive comments will be June 17, 2020.
 

Facts About FDA's Guidance for Industry #256

Background

FDA’s Center for Veterinary Medicine (CVM) recently issued draft guidance (GFI #256) that, if finalized, threatens to have serious and damaging ramifications for your practice and your patients. You may recall in 2015, FDA introduced guidance (GFI #230) that was substantially similar on the compounding of animal drugs from bulk drug substances. Following significant pushback from the veterinary and pharmacy community and intervention from members of Congress, FDA formally withdrew that Guidance in 2017.

Two Veterinarian Members of Congress Ask FDA to Extend Comment Period for GFI #256

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On February 4, 2020, Kurt Schrader, DVM and Ted. S. Yoho, DVM sent this letter to the FDA:

 
February 4, 2020
 
Commissioner Stephen M. Hahn, M.D.
Food & Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993
 
Dear Commissioner Hahn,
 
We write today regarding FDA's draft Guidance for Industry (GFI) #256, "Compounding Animal Drugs 
from Bulk Drug Substances" ("OFT #256"), which was published in the Federal Register on November 

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