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USFDA's Guidance on Safety Considerations for Container Labels and Carton Labeling


In July 2006, the Institute of Medicine (IOM) published a report titled Preventing Medication Errors, which cited labeling and packaging issues as the cause of 33 percent of medication errors and 30 percent of fatalities from medication errors.


As part of the Prescription Drug User Fee Act reauthorization, FDA committed to certain performance goals, including measures to reduce medication errors related to look-alike and sound-alike proprietary names; unclear label abbreviations, acronyms, and dose designations; and error-prone labeling and packaging designs.

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.


This guidance 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.


Click on the LINK to know more about this guidance on Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors.



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