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# Label Safety Considerations Guidance
- URL: https://www.fdaweb.com/label-safety-considerations-guidance/
- Published: 2022-05-18T12:00:00.000Z
- Updated: 2026-09-14T17:45:04.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5151845

FDA has published a guidance, *Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors*, to help human prescription drug and biological product sponsors, application holders, and applicants minimize medication errors associated with their products. The [document](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/safety-considerations-container-labels-and-carton-labeling-design-minimize-medication-errors?utm%5Fmedium=email&utm%5Fsource=govdelivery) provides a set of principles and recommendations for ensuring that critical elements of a product’s container label and carton labeling are designed to promote safe dispensing, administration, and use of the product.

“Although this guidance does not apply to over-the-counter drug products, compounded products, marketed prescription products used in clinical or bioequivalence studies, or investigational products, the principles outlined in this guidance may still be useful for such products,” FDA says.

The contents of the guidance are Introduction, Background, General Considerations, Special Considerations and Recommendations, Other Special Container Label and Carton Labeling Considerations, and Glossary.