USA – FDA Finalizes Guidance on 503B Bulks List

Today, the US Food and Drug Administration (FDA) issued a final guidance for the drug compounding industry on the 503B Bulks List, which is a list of bulk drug substances for which there is a clinical need.

Drug products compounded using bulk drug substances on the 503B list qualify for certain exemptions from the Food, Drug, and Cosmetic Act (FD&C Act), provided certain conditions in section 503B are met.

This guidance addresses FDA policies for developing the 503B Bulks List, including the agency’s interpretation of what exactly bulk drug substances for which there is a clinical need means, and as it is used in section 503B…