FDA Plans to Exclude Three Substances From 503B List

The FDA is proposing to exclude three substances from its 503B Bulks List of substances for outsourcing facilities to use in compounding drugs — including one that’s the subject of an Endo lawsuit against the agency.

The agency said the three substances — vasopressin (an antidiuretic), bumetanide (a diuretic) and nicardipine hydrochloride (an antihypertension drug) — are available through existing products and the nominators failed to justify why they should be included on the 503B list.

“At this point, we don’t see a clinical need for outsourcing facilities to compound from these bulk substances,” said FDA Commissioner Scott Gottlieb.