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.