FDA Releases Draft Guidance on Labeling Safety

Apr 23, 2013
By PharmTech Editors

FDA has released the second in a series of three guidance documents written to minimize medication errors. The draft guidance offers guidelines to help prescription drug and biologic product manufacturers minimize medication errors and focuses on safety aspects of the container label and carton labeling design. The guidance also provides recommendations for ensuring that crucial elements of a product’s container labels and carton labeling are designed to promote safe dispensing, administration, and use. 

The guidance applies to prescription drug products marketed under an approved new drug application (NDA) or abbreviated new drug application (ANDA); prescription drugs marketed without an approved NDA or ANDA; and biological products marketed under an approved biologics licensing application (BLA). This guidance does not apply to over-the-counter (OTC) drug products.

The first guidance in the series focuses on minimizing risks associated with drug product design and container closure systems. The third planned guidance will focus on best practices for the development and testing of proposed proprietary names to minimize risks associated with drug product nomenclature, such as proprietary names that look or sound like the name of another product (e.g., look-alike or sound-alike names).