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GUIDANCE DOCUMENT

Naming of Drug Products Containing Salt Drug Substances June 2015

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2013-D-1566
Issued by:
Guidance Issuing Office
Center 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.

Submit Comments

Submit Comments Online

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:

Dockets Management
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.

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