FDA Proposes 4 Additions to Outsourcing Bulk Drug List

FDA says it is proposing to include four bulk drug substances on the list of bulk drug substances that outsourcing facilities may use in drug compounding consistent with Section 503B of the Federal Food, Drug, and Cosmetic Act. An agency notice says the four substances are diphenylcyclopropenone, glycolic acid, squaric acid dibutyl ester, and trichloroacetic acid. The substances are not components of FDA-approved drug products, the notice says.

FDA says it also identified 19 bulk drug substances that it has considered and proposed not to include on the bulks list because the agency did not find a clinical need for an outsourcing facility to compound drug products starting from these bulk drug substances, and therefore the statutory standard for adding the substances to the bulks list has not been met.

The notice says FDA is seeking public comment on the proposal before finalizing a decision.