FDA Issues Draft Guidance on Bulk Substances for Compounding by ...

https://www.jdsupra.com/legalnews/fda-issues-draft-guidance-on-bulk-72392/

19 hours ago - On March 23, 2018, the U.S. Food and Drug Administration (FDA) released draft guidance regarding the process through which it proposes to evaluate bulk drug substances nominated for use incompounding by outsourcing facilities registered under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