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May 19, 2022 Agency Alerts

FDA Issues Final Guidance on Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors


FDA has issued the final guidance titled “Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors.” The recommendations for prescription drug and biological products in this guidance are intended to provide 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 use of the product. The guidance also provides examples of container label and carton labeling designs that resulted in postmarketing medication errors. This guidance applies to human prescription drug and biological products, including prescription drugs marketed under an approved new drug application or abbreviated new drug application, prescription drugs marketed without an approved application, and biological products marketed under an approved biologics license application. This document finalizes the draft guidance FDA issued in April 2013. The agency made changes from the draft guidance based on comments and information learned through evaluating postmarketing medication errors.  These changes include clarifying language that some commenters considered unnecessarily restrictive and emphasizing that labeling statements should be considered within a risk framework.  The final guidance has also been updated to reflect regulations and policy that have been established since the draft guidance was published.

Download the Final Guidance Document

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