This is a draft guidance – not for immediate implementation. 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 routine procurement, stocking, storage, and administration of medications (e.g., medication technicians).
The purpose of this guidance is to help prescription drug and biologic product manufacturers minimize medication errors associated with their products. This guidance does not apply to over-the-counter (OTC) drug products.
This is the second in a series of three guidance documents that the FDA is issuing to help minimize medication errors. The first guidance focuses on minimizing risks associated with the design of the drug product and its container closure system. 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).