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GUIDANCE DOCUMENT

Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors May 2022

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2013-D-0401
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

The purpose of this guidance is to help human prescription drug and biological product sponsors, application holders, and applicants minimize medication errors associated with their products. This guidance focuses on safety aspects of the application holder’s container label and carton labeling design. It 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.

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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

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

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5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2013-D-0401.

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