Zdrowie i gospodarka · 26/03/2018

FDA Releases Draft Guidance for Evaluating Bulk Drug Substances for Compounding Under Section 503B of the FD&C Act

The FDA has announced the availability of a draft guidance document outlining policies for evaluating bulk drug substances nominated for use in compounding under section 503B of the Federal Food, Drug, and Cosmetic Act, which aims to ensure the safe use of these substances in compounding pharmacies.