Guidance for Industry: Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors

The purpose of this guidance is to help prescription drug and biologic product manufacturers minimize medication errors associated with their products. This guidance focuses on safety aspects of the container label and carton labeling design, and 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. This guidance applies to prescription drug and CDER-regulated biological products, including the following: • 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). In this guidance, all such products are jointly referred to as products, and persons responsible for designing product container labels and carton labeling are referred to as sponsors. References to end user(s) include, but are not limited to, the patient, patient’s caregiver, the prescribing physician, nurse, pharmacist, pharmacy technician, and other individuals who are involved in 36 routine procurement, stocking, storage, and administration of medications (e.g., medication technicians).