FDA is issuing this guidance to help sponsors of human drugs, including those that are biological products, develop proprietary names that do not cause or contribute to medication errors or otherwise contribute to the misbranding of the drug. This guidance describes design practices to help avoid such errors with proprietary names and provides a qualitative systematic framework for evaluating proposed proprietary names before submitting them for FDA review. This guidance does not address the selection of established names or proper names.
This guidance applies to all human prescription and nonprescription drug products, including those that are biological products. In this guidance, all such products are jointly referred to as products, and persons responsible for developing the products are referred to as sponsors.
This is the last in a series of three guidance documents that FDA is issuing to help sponsors minimize the potential for medication errors when designing and developing products. The first guidance focuses on minimizing risks associated with the design of the drug product and its container closure system. The second guidance focuses on safety aspects of the container label and carton labeling design. This third guidance presents FDA’s current thinking on best practices for developing and selecting proposed proprietary names.