FDA Announces Six-Month Delay in GFI #256 Enforcement Until April 2023

On September 9, 2022, the Food & Drug Administration (FDA) shared with Wedgewood Pharmacy in a phone call that the Agency will delay enforcing its Guidance for Industry #256, Compounding Animal Drugs from Bulk Drug Substances, which was slated to be begin on October 1, 2022, until April 2023.

FDA confirmed the details in a letter that day to the Alliance for Pharmacy Compounding, American College of Veterinary Pharmacists, American Pharmacists Association, National Community Pharmacists Association, and Society of Veterinary Hospital Pharmacists, all of which had requested the delay.

In the letter, Steven M. Solomon, DVM, MPH director, FDA’s Center for Veterinary Medicine, wrote “Since publication of the final guidance on animal drug compounding FDA has engaged with a variety of stakeholders. We recognize that some pharmacies may need additional time to review the recommendations described in the guidance or make suggested changes to their processes, as well as to submit nominations for bulk drug substances for compounding office stock. Therefore, we are extending the ongoing outreach and education period that we previously announced. At this time, we do not intend to shift our resources toward routine inspectional activities until April 2023.”

Marcy A. Bliss, CEO of Wedgewood Pharmacy, said: "We’re encouraged  by FDA’s decision to delay enforcing this Guidance, which will change the way medication is obtained by veterinary practices for difficult-to-treat patients. In a recent survey that we conducted among our veterinary clients, we were alarmed to learn that 90% of veterinarians are unaware that the Guidance has been finalized. We appreciate FDA’s willingness to engage with stakeholders, including a review of our survey data, and to adapt to the practical realities that we’re seeing in every day veterinary practice.”

Wedgewood Pharmacy's nationwide poll of veterinary practices shows that only 10% of veterinary practice respondents say they any level of confidence that they are prepared to comply with provisions of the FDA’s Guidance.

Bliss added, “This delay gives us much-needed time to inform veterinarians about the practical implications of the Guidance, to continue in our aggressive efforts to nominate bulk drug substances for FDA review, and to modify our own systems, procedures, and training to comply with the letter and spirit of FDA’s current thinking.”

For more information visit the Wedgewood Pharmacy GFI resource center.