Zdrowie i gospodarka · 04/03/2019

FDA Releases Final Guidance on Bulk Drug Substances for Compounding Under Section 503B of the FD&C Act

The FDA has released a final guidance for industry outlining policies for evaluating bulk drug substances nominated for use in compounding under section 503B of the Federal Food, Drug, and Cosmetic Act, which will help determine the list of approved substances for compounding.