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Panel: UNII codes can help link excipients to IID entries
Summary
FDA IID staff said sponsors may use UNII codes to help match excipient names and grades to IID entries and that the IID team searches internally using that identifier.
Attendees asked whether the Unique Ingredient Identifier (UNII) can be used to connect sponsor excipient names to IID entries. An IID team representative confirmed UNII is the practical identifier the group uses when searching internally and encouraged sponsors to include it when available.
"Because we actually search for our excipients internally like that," Diana said when asked whether UNII can be used to link excipient entries. She added that different grades and forms of an excipient can be searched and that providing a UNII code can help the IID team find the correct entry.
Panelists reiterated that UNII is a useful tool for matching entries but that application‑specific questions about how an excipient is used in a product still warrant controlled correspondence for formal review.
