Compounding: New webinar outlines FDA final guidance #256

Understand the policies that impact veterinarians and our teams

Veterinarians rely on many different types of medications to effectively treat our patients. When there isn’t an FDA-approved or indexed drug available, we may turn to compounded drugs as an alternative. In April 2022, the FDA released Guidance for Industry #256 (GFI #256), Compounding Animal Drugs from Bulk Drug Substances, explaining the parameters within which veterinarians may use compounded drugs that are prepared from bulk drug substances.

A new webinar on AVMA Axon® provides an overview of this guidance, which the FDA plans to begin enforcing through routine inspections in April 2023. In Compounding: Understanding FDA final guidance #256, FDA veterinarian Dr. Amber McCoig examines the policies included in the guidance and what they mean for veterinarians and our teams. She also discusses how the agency’s final guidance tries to balance the risks of compounding animal drugs from bulk substances when there is no FDA-approved drug available, and why the FDA can’t assure the safety, effectiveness, or quality of bulk drug substances.

As compounding is such a critical tool for veterinarians and our patients, the course is available to all veterinary team members free of charge. It offers 0.5 hours of continuing education (CE) credit.

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More compounding resources

Complementing the new webinar, AVMA’s webpage Compounding from Bulk Substances summarizes what’s included in GFI #256 and what it means for veterinarians. The AVMA is continuing to develop materials to help the veterinary community understand and comply with the guidance.

Importantly, in September, the FDA announced that it was extending the educational period for GFI #256 and will not begin enforcing the guidance until April 2023.

Advocating for the profession

AVMA actively works with the FDA to ensure that veterinarians have medically appropriate access to compounded drugs prepared from bulk drug substances and that such access is not unduly burdensome. We will continue to advocate for changes if implementation of the guidance does not meet veterinarians’ needs.