FDA 发布含盐原料药药品命名最终指南 FDA-2013-D-1566
Naming of Drug Products Containing Salt Drug Substances
FDA 发布最终指南 FDA-2013-D-1566，说明 CDER 实施 USP 盐类原料药专论命名政策后，含盐活性成分药品的命名可能受到影响。该指南所对应的 USP 盐政策于 2013 年 5 月 1 日生效。公众可随时就该指南提交评论，书面评论需注明案卷号 FDA-2013-D-1566。
GUIDANCE DOCUMENT
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
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.
来源：FDA Pharmaceutical Quality Documents · fda.gov