Glossary
Also written nominat
A nomination is a request that the FDA place a bulk drug substance on the section 503A list so that pharmacies may compound with it. Nominations come from parties with an interest in the substance, and the agency sorts each one while it reviews.
A nomination has more than two endings. It may result in listing, in placement among the substances with identified safety concerns, in removal without listing, or in withdrawal by the nominators themselves — which is what happened to CJC-1295 and ipamorelin in September 2024. A withdrawn nomination leaves the process rather than moving within it, and this index files it as its own disposition for that reason.