> , Training > FDA Guidance for Industry: Evaluation of Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act

FDA Guidance for Industry: Evaluation of Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act

The Food and Drug Administration (FDA or the Agency) is announcing the availability of a final guidance for industry entitled “Evaluation of Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act.” This guidance describes policies that FDA intends to use in evaluating bulk drug substances nominated for use in compounding under section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act) for inclusion on the list of bulk drug substances that can be used in compounding under section 503B.

 

Posted on the FDA website on 13 June 2019

2019-06-18T20:20:08+00:0018.06.2019|Regulatory Affairs, Training|