New FDA Draft Guidance: Practices to Prevent Unsafe Contamination of Animal Feed From Drug Carryover
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The U.S. Food and Drug Administration (FDA) has released a new Draft Guidance for Industry document, GFI #272 Practices to Prevent Unsafe Contamination of Animal Feed from Drug Carryover, to replace Compliance Policy Guides 680.500, Unsafe Contamination Compliance Policy Guides of Animal Feed from Drug Carryover, and 680.600, Sequencing as a Means to Prevent Unsafe Drug Contamination in the Production, Storage, and Distribution of Feeds.
The new draft document is open for comments from industry through August 8, 2022.
Draft GFI: Practices to Prevent Unsafe Contamination of Animal Feed from Drug Carryover
The new guidance highlights acceptable practices that can be utilized in feed mills to minimize cross contamination of products when medications are being used. These techniques are useful to meet the regulatory standards for Medicated Feed Current Good Manufacturing Practice (CGMP), as well as the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals regulation.
The three strategies proposed by the FDA are:
- Physical Cleanout,
- Flushing,
- Sequencing, and
- Other Equally Effective Practices.
For each of the strategies, the FDA provides relevant information for when to use each strategy and how to perform the procedure.
How can I use this information throughout my facility?
Although this new guidance document provides information on how to minimize medication carryover, the principles discussed can be applied to other scenarios as well. For example, flushing or sequencing procedures might be useful to avoid nutrient or other ingredient carryover that could lead to toxicities.
If you have any comments or suggestions for other equally effective practices for preventing drug carryover, please contact the FDA at AskCVM@fda.hhs.gov.
If you have questions about animal food safety, contact Marissa Cohen.