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# Guide on Animal Drug In-use Stability Studies
- URL: https://www.fdaweb.com/guide-on-animal-drug-in-use-stability-studies/
- Published: 2020-11-30T12:00:00.000Z
- Updated: 2026-09-14T16:38:16.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5148180

*Federal Register* notice: FDA has made available a final guidance for industry #242 entitled *In-Use Stability Studies and Associated Labeling Statements for Multiple-Dose Injectable Animal Drug Products*. In-use stability testing is intended to establish a period of time during which a multiple-dose drug product may be used while retaining acceptable quality specifications once the container is opened (e.g., after a container has been needle-punctured). The document discusses how to formulate in-use statements, as well as how to design and carry out in-use stability studies to support these in-use statements, for multiple-dose injectable drug products intended for use in animals. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2020-11-27/pdf/2020-26183.pdf?ref=fdaweb.com).