This guidance for industry is intended to help you, the sponsor, understand how products with active ingredients that are salts may be affected by CDER’s implementation of the United States Pharmacopeia (USP) policy entitled, Monograph Naming Policy for Salt Drug Substances in Drug Products and Compounded Preparations (the USP Salt Policy). Your involvement with the implementation of this policy helps to ensure drug product naming that is consistent with the USP Salt Policy, which became effective on May 1, 2013.

 

This guidance addresses prescription drug products approved under the Federal Food, Drug, and Cosmetic Act (FD&C Act). This guidance does not address implementation of the USP Salt Policy for nonprescription drug products or biological products licensed under the Public Health Service Act (PHS Act).

 

 

Posted on the FDA website on 16 June 2015