Agency Updates Bulk Substances for Compounding List

Federal Register notice: FDA is identifying two bulk drug substances that it has considered and proposes to include on its list of bulk drug substances (active pharmaceutical ingredients) for which there is a clinical need (the 503B Bulks List). Drug products that outsourcing facilities compound using bulk drug substances on the 503B Bulks List can qualify for certain exemptions from FDA regulations provided certain conditions are met. The two substances are listed for compounding three categories of compounded drug products — arginine hydrochloride (HCl) for oral use, lysine HCl for oral use, and lysine HCl for intravenous use in combination with FDA- approved, single-ingredient arginine HCl for intravenous use. The agency is also proposing not to include on the 503B Bulks List three drug substances: etomidate, furosemide, and rocuronium bromide. To view the notice, click here.