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SWEDESBORO, N.J.--(BUSINESS WIRE)—A
new nationwide poll of veterinary practices shows that 69% of veterinary
practices are not confident they are prepared to comply with provisions of the
Food & Drug Administration (FDA) Guidance for Industry #256, Compounding Animal
Drugs from Bulk Drug Substances, which was finalized on April 13, 2022. The
Guidance is slated to be “enforced” beginning October 1, 2022. [Extended by FDA to April 2023.]
The survey, sponsored by Wedgewood Pharmacy, was fielded August 15 – 17,
2022. The survey reports on the responses of 1,574 veterinary professionals in
the U.S, all of whom work in practices that prescribe compounded medications for
animal health. The company conducted the research to learn how knowledgeable its
professional customers are about the FDA’s Guidance and the changes it
will require to ordering and prescribing procedures.
Marcy A. Bliss, CEO of Wedgewood Pharmacy, said: "We are working in a very
focused way across our organization and industry not only to comply with the
letter and spirit of this Guidance but to help our more than 60,000 veterinary
prescribers to interact with us so that they, too, are in compliance when they
order compounded medications, which are specially formulated for animal
patients. FDA's new Guidance will change the way medication is obtained by
veterinary practices for difficult-to-treat patients, those whose needs cannot
be met by FDA-approved alternatives.”
The Guidance details significant changes to the practices of pharmacy
compounding and veterinary medicine. Yet 83% of those surveyed, just weeks
before the Guidance is slated to be enforced, say they are not aware that the
Guidance had been finalized; 90% said they were not aware that it will be
enforced beginning October 1.
The survey tested how knowledgeable the respondents are with four key
provisions of the Guidance:
Meghann Abbott, assistant product manager for Wedgewood Pharmacy, noted,
“Wedgewood Pharmacy is taking an aggressive lead in nominating Bulk Drug
Substances to FDA for approval for office-use compounding. So far, we have
nominated more than 50 families of medication. We have devoted significant
resources to this nomination process because we strongly believe that
veterinarians should be able to stock the medications they believe are critical
to immediate patient care.”
The most current FDA lists of nominated, under review, approved, and “not
listed” bulk pharmaceutical ingredients are
published by FDA.
With a majority of practices not aware that the Guidance has been finalized
and soon will be enforced, the survey also showed that most practices have not
taken steps necessary to understand or comply with its provisions:
The survey sample was not randomized and therefore the results cannot not be
projected statistically to any other group. The results represent the opinions
of the 1,574 veterinary professionals who responded to the survey.
David Kirk, APR, Fellow PRSA
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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.