Naming of Drug Products Containing Salt Drug Substances June 2015
- Docket Number:
- Issued by:
Guidance Issuing OfficeCenter for Drug Evaluation and Research
This guidance for industry is intended to help you, the sponsor, understand how products with 16 active ingredients that are salts may be affected by CDER’s implementation of the United States 17 Pharmacopeia (USP) policy entitled, Monograph Naming Policy for Salt Drug Substances in 18 Drug Products and Compounded Preparations2 (the USP Salt Policy). Your involvement with 19 the implementation of this policy helps to ensure drug product naming that is consistent with the 20 USP Salt Policy, which became effective on May 1, 2013.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2013-D-1566.