FDA Issues Labeling Guidance

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The final guidance addresses safety aspects of container and carton labeling design.

FDA published final guidance on May 18, 2022 to help drug companies minimize medication errors. The guidance, Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors, focuses on safety aspects of container labels and carton labeling design by providing principles and recommendations to ensure a product’s label and carton promote safe dispensing, administration, and use.

The document details the impact poor label design can have on safety and the importance of risk assessments. Label size, text size, and abbreviations are among the specific label qualities addressed. The guidance also discusses name, lettering, product strength, route of administration, warnings, expiration dates, and other packaging information.

A variety of packaging is addressed, including blister packs, transdermal and topical systems, large-volume injections, oral liquid drug products, unit dose cups, bulk packages, ferrules, and color closures.


Source: FDA