Naming of Drug Products Containing Salt Drug Substances: Guidance for Industry.

摘要

The USP Salt Policy became effective on May 1, 2013, and USP is now applying it to all new drug product monographs for products that contain an active ingredient that is a salt. It affects the development of new drug products, because a USP monograph title for a new drug product, in most instances, serves as the nonproprietary or “established” name of the related drug product. A drug product with a label or labeling that contains a name that is inconsistent with the applicable monograph title risks being misbranded.