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GUIDANCE DOCUMENT

Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors April 2013

Download the Draft Guidance Document
Draft

Not for implementation. Contains non-binding recommendations.

Issued by:
Guidance Issuing Office
Office of Medical Products and Tobacco, Center for Drug Evaluation and Research

The purpose of this guidance is to help prescription drug and biologic product manufacturers minimize medication errors 2associated with their products. This guidance focuses on safety aspects of the container label3 and carton labeling design, and provides a set of principles and recommendations for ensuring that critical elements of a product’s container labels and carton labeling are designed to promote safe dispensing, administration, and use of the product.

Submit Comments

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.