FDA issues Draft Guidance on Container and Carton Labeling Design to Minimize Medication Errors

“Medication errors are a significant public health concern that account for an estimated 7,000 deaths annually in the United States.In July 2006, the Institute of Medicine (IOM) published a report titled Preventing Medication Errors. The report cited labeling and packaging issues as  the cause of 33 percent of all medication errors and 30 percent of fatalities from medication errors.”

The purpose of the guidance document is to help Rx and biologic manufacturers minimize medication errors associated with their products.  The guidance document 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.  There are a list of topics to consider for labels and labeling.

Download the guidance here.