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Survey: Veterinary Practices Are Uninformed About and Unprepared to Comply With New FDA Guidance Slated for October 1, 2022 Enforcement

SWEDESBORO, N.J.–(BUSINESS WIRE)–#CompoundingPharmacyA 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.

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.

About Wedgewood Pharmacy

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