9 Bulk Drugs Proposed for Compounding Exclusion

Federal Register notice: FDA is seeking comments on nine bulk drug substances that the agency has considered and is proposing not to include on its list of bulk drug substances (or active pharmaceutical ingredients) that outsourcing facilities may use in drug compounding. The nine bulk drug substances are: dipyridamole, ephedrine sulfate, famotidine, hydralazine hydrochloride, methacholine chloride, sodium bicarbonate, sodium tetradecyl sulfate, trypan blue, and vecuronium bromide. The nominations for these substances did not provide a reason why FDA-approved drug products containing these substances could not be either used or adapted instead of compounding new drug products using bulk drug substances. To date, the agency says it has not found a clinical need for an outsourcing facility to use the bulk drug substances to compound finished products, which is the statutory standard for adding a bulk drug substance to the list. To view the notice, click here.