FDA Releases Draft Guidance on Labeling Safety

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 The draft guidance offers guidelines to help prescription drug and biologic product manufacturers minimize medication errors and focuses on safety aspects of the container label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.