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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comment period for its draft guidance #256, “Compounding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.
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
comments to FDA:
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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This content is intended for counseling purposes only. This content is informational/educational and is not intended to treat or diagnose any disease or patient. No claims are made as to the safety or efficacy of mentioned preparations. The compounded medications featured in this content have been prescribed and/or administered by prescribers who work with Wedgewood Pharmacy. You are encouraged to speak with your prescriber as to the appropriate use of any medication. Wedgewood Pharmacy’s compounded veterinary preparations are not intended for use in food and food-producing animals. All product and company names are trademarks™ or registered® trademarks of their respective holders. Use of them does not imply any affiliation with or endorsement by them.