GUIDANCE DOCUMENT
Best Practices in Developing Proprietary Names for Human Nonprescription Drug Products; Draft Guidance for Industry Draft Guidance for Industry December 2020
Not for implementation. Contains non-binding recommendations.
- Docket Number:
- FDA-2020-D-0770
- Issued by:
-
Guidance Issuing OfficeCenter for Biologics Evaluation and ResearchCenter for Drug Evaluation and Research
FDA is issuing this guidance to help sponsors of human nonprescription drug products develop proprietary names2 16 for those products. This guidance describes best practices to help minimize proprietary name-related medication errors and otherwise avoid adoption of proprietary names that contribute to violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and its implementing regulations. It also describes the framework FDA uses in evaluating proposed proprietary names that is available to sponsors to use for nonprescription drug products before a product bearing that proprietary name is marketed. This guidance does not address the designation of established names or proper names.
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All written comments should be identified with this document's docket number: FDA-2020-D-0770.