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The new guidance document is intended to minimize medication errors and avoid violations of the FD&C Act.
On Dec. 8, 2020, FDA announced the publication of guidance to help sponsors develop proprietary names for prescription medicines. The best practices included in the guidance will help to 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,” the agency stated in a press release. The guidance also describes how FDA evaluates proposed proprietary names, but it does not address designation of established names or proper names. A separate guidance was published for proprietary names for nonprescription drugs.
“This guidance is intended to provide clarity and transparency to sponsors on the factors and systematic framework FDA uses to evaluate proposed proprietary names for prescription drugs and to recommend best practices for sponsors considering such names. Using the best practice recommendations and other assessment tools addressed in this guidance is not mandatory, and applying them does not dictate specific outcomes. Assessments of a proprietary name are necessarily fact-specific, and therefore, FDA’s determinations are made on a case-by-case basis, considering the totality of the information,” the guidance states.