Latest on Compounding: FDA Proposes to Strike Three Bulk Drug Substances from List
08/26/2018
The FDA has issued a Federal Register notice proposing not to include three bulk drug substances, bumetanide, nicardipine hydrochloride, and vasopressin, on the list of bulk drug substances (or active pharmaceutical ingredients) that outsourcing facilities may use in compounding under section 503B of the Federal Food, Drug & Cosmetic Act (503B bulks list).