FDA In Brief: FDA finalizes guidance on evaluating the clinical need for outsourcing facilities to compound drugs with bulk drug substances; provides final decision on two substances

Today, the U.S. Food and Drug Administration issued a final guidance for industry, Evaluation of Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act. This guidance addresses the FDA’s policies for developing a list of bulk drug substances that can be used in compounding under section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act), also known as the 503B bulks list, including the agency’s interpretation of “bulk drug substance for which there is a clinical need,” which is the statutory standard for compounding from bulk drug substances. The guidance also highlights criteria the agency generally intends to use to ...