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FDA extends comment period on GFI #256 to October 15, 2020.


The Food & Drug Administration announced today that it has extended the comment period for its draft guidance #256, “Compounding Animal Drugs from Bulk Drug Substances," by 120 days, to October 15, 2020. In its announcement, FDA said that it did so “in response to requests to extend the comment period.” These included letters from the Alliance for Pharmacy Compounding, Congressional Veterinarians, and the American Veterinary Medical Association.

Wedgewood Pharmacy and the MyMedsMatter coalition of compounding pharmacies worked closely with APC and members of Congress in making their requests to FDA. The coalition submitted comments to FDA on February 26, 2020 outlining how FDA is overreaching and exceeding its statutory authority. It also published “Facts About FDA’s Guidance for Industry #256,” explaining how the guidance would restrict access to compounded medications, reduce the quality and safety of compounded medications, increase the cost by an average 300%, and burden veterinarians with additional FDA regulatory oversight. Veterinarians, pet owners, compounding pharmacy representatives and any person or organization that would be impacted negatively by FDA’s guidance if enacted, may now submit comments directly to FDA until the extended deadline of October 15, 2020.

To have the greatest impact, follow these best practices for submitting comments to FDA:

  • Make your comments personal. Be sure to include your name, company name, and contact information.
  • Draw from your past experiences and clearly state how GFI #256 would have an impact on your practice and patients, or your pet.
  • Know the facts. Read more about the impacts of GFI #256 at MyMedsMatter.com

Remember: comments are not votes. One well-written, well-supported comment is often considered more influential than hundreds of copied letters. Submit a comment to FDA before October 15, 2020.

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