FDA Final Guidance for Industry #256 on Compounding From Bulk Drug Substances in Effect

Jun 1, 2022 | Companion Animal, Equine News, Livestock, News, Practice Management

On April 14, the U.S. Food and Drug Administration released its final guidance on animal drug compounding from bulk drug substances. The FDA has indicated it will focus on education and apply discretion regarding enforcement until October 1, 2022.

Animal drug compounding is the process of combining, mixing or altering ingredients to create a medication tailored to the needs of an individual animal or particular group of animals. Current laws and regulations already allow animal drug compounding using an FDA-approved drug as the starting point. The final guidance addresses the practice of preparing a medication when bulk drug substances are used as the starting point.

As a veterinary professional, what does this complex topic mean for you? Hear the explanation directly from the experts when you view the on-demand webinar in addition to other written resources.

· Breaking Down the FDA Guidance on Animal Drug Compounding

· FDA Q&A on GFI #256

· AVMA Compounding from Bulk Drug Substances Resource Page