FDA to Add Two APIs to 503B Bulks List

The FDA is proposing to add arginine hydrochloride (HCl) and lysine HCl to its 503B Bulks List of active pharmaceutical ingredients (API) approved for compounding.

The two substances could be used to compound three categories of drug products: arginine HCl for oral use, lysine HCl for oral use, and lysine HCl for intravenous use in combination with single-ingredient arginine HCl.

The agency also considered three other bulk drug substances that did not pass muster for inclusion on the list — etomidate, furosemide and rocuronium bromide.