Inactive Ingredient Database: A Draft Guidance by FDA

The US Food and Drug Administration (FDA) issued a draft guidance for public consultation providing recommendations for drug makers on using the agency’s inactive ingredient database (IID) during drug development.

This guidance describes the FDA’s Inactive Ingredient Database (IID) and provides recommendations for how to use the IID in the development of drug products. The guidance also describes how the IID can be used in evaluating excipient safety, which can affect application filing and scientific review. In addition, this guidance discusses how the IID is structured; the data regarding excipients in the IID; and how nomenclature, maximum potency levels, and units of measure are presented in the IID. Lastly, the guidance is intended to give IID users a clearer understanding of the database’s benefits and limitations.

Within the database, FDA provides information including the various routes of administration, dosage form and maximum potency per unit dose for each inactive ingredient, as well as the chemical abstracts service (CAS) number and unique ingredient identifier (UNII) for each listing.

According to FDA, drug makers can reference inactive ingredients listed in the database in marketing applications as any excipient used in an approved drug product for a specific route of administration “generally is not considered new and may warrant less extensive assessment the next time it is included in a new drug product for the same route of administration.”

Additionally, the guidance provides specific recommendations for referencing the IID in different application types, including investigational new drug (IND) applications, new drug applications (NDAs) and abbreviated new drug applications (ANDAs).


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