Glossary
FDA compounding Category 2
FDA's interim-policy category for bulk drug substances nominated for use in compounding that the agency states may present significant safety risks.
FDA publishes a table of substances currently in Category 2, each marked as 503A, 503B or both with the date added, and a separate table of substances whose nominations were withdrawn after placement. Neither table is an approval, and a withdrawn nomination is not a finding that a substance is safe.