September 2, 2022

Surveys say: Vets and Compounders aren’t ready for GFI 256

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In an APC member survey conducted last month, 59 percent of compounders said they were not aware that FDA’s Guidance for Industry #256, Compounding Animal Drugs from Bulk Drug Substances, is slated to be enforced beginning October 1, 2022.

Only 54 percent of respondents said they knew the guidance had been finalized back in April.

Not only that, but a new nationwide poll of veterinary practices conducted by Wedgewood Pharmacy shows that 69% of veterinary practices are not confident they are prepared to comply with provisions of that guidance document.

“These survey results give credence to our request that FDA’s Center for Veterinary Medicine delay enforcement of the GFI until October 2024,” said APC CEO Scott Brunner, CAE. “Not only is awareness of the GFI low among those to whom it applies, but we don’t even have clarity from the agency yet on what compliance looks like. To begin enforcement under these conditions makes no sense. CVM needs to slow down and work with stakeholders to get this right.”

In the APC member survey, 83 percent of respondents said they had not developed policies and procedures for documenting a veterinarian’s clinical rationale for a compounded medication and 82 percent said they had not developed policies and procedures for reporting adverse events. Both are required under the GFI. Only nine percent of respondents indicated high confidence that their compounding practice would be prepared to comply with the provisions of the GFI by the stated October 1 enforcement date.