FDA In Brief > FDA In Brief: FDA seeks comment on its preliminary finding that there is no clinical need for outsourcing facilities to compound from three bulk drug substances that are ingredients in FDA-approved drugs

FDA In Brief > FDA In Brief: FDA seeks comment on its preliminary finding that there is no clinical need for outsourcing facilities to compound from three bulk drug substances that are ingredients in FDA-approved drugs

FDA seeks comment on its preliminary finding that there is no clinical need for outsourcing facilities to compound from three bulk drug substances that are ingredients in FDA-approved drugs

Today, the FDA 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). Continue reading...