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
• 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
BeMedWise Program at NeedyMeds encourages healthcare professionals and community groups to foster patient–professional communication about medicines. However, BeMedWise does not supervise or endorse the activities of any group or professional. Discussion and action concerning medicines are solely the responsibility of the patient and their healthcare professionals, and not BeMedWise.
Please consult a licensed health care professional with questions or concerns about your medication and/or condition.