Glossary
Also written nominated without adequate support
Category 3 of the interim 503A bulks list holds substances that were nominated for use in compounding and whose nominations the FDA found inadequately supported. It is the least understood of the three categories, and it is routinely reported as though it were one of the other two.
It is not a safety finding: that is Category 2, where the agency publishes an identified risk substance by substance. It is not a permission to compound during review: that is Category 1. Category 3 records a fact about a submission rather than about a molecule, and it confers nothing. A substance can hold a large published literature and a Category 3 file at the same time, because the category is not measuring the literature.