United States: FDA Issues Draft Guidance On Bulk Substances For ...

Mondaq News Alerts-12 hours ago

On March 23, 2018, the U.S. Food and Drug Administration (FDA) released draft guidance regarding the process through which it proposes to evaluate bulk drug substances nominated for use in compounding by outsourcing facilities registered under section 503B of the Federal Food, Drug and Cosmetic Act (FD&C Act).