U.S. FDA Issues Revised MAPP on Naming of Drug Products Containing Salt Drug Substances
The Manual of Policies and Procedures (MAPP) (effective December 7, 2017) describes how the Center for Drug Evaluation and Research (CDER) will consistently apply the U.S. Pharmacopeia (USP) policy entitled, Monograph Naming Policy for Salt Drug Substances in Drug Products and Compounded Preparations (the USP Salt Policy) to prescription drug products. The USP Salt Policy became effective May 1, 2013 in accordance with CDER’s guidance for industry (Salt Guidance). The MAPP provides information to help reviewers determine when the USP Salt Policy’s exceptions should be granted and outlines a process to be followed when reviewing the nonproprietary name of a prescription drug product that contains an active ingredient that is a salt. The revision to this MAPP incorporates internal procedures to be consistent with the published Salt Guidance dated June 2015.