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FDA official outlines the Inactive Ingredient Database and how to use it
Summary
An FDA agency official explained the scope, history and public features of the Inactive Ingredient Database (IID), noting what products and records are included, limitations of the public data and where to find guidance and FAQs.
An agency official from the U.S. Food and Drug Administration gave an overview of the agency's Inactive Ingredient Database (IID), describing its history and what users can expect to find in the public resource. The official said the IID grew from a 1987 printed inactive ingredient guide and has been available online since 2003.
"The IID provides information on excipients present in FDA approved drug products," the agency official said, emphasizing the database's role as a public reference for excipients used in ANDAs and NDAs. The speaker noted that excipients in approved biologics license applications (BLAs) and OTC monograph drug products are not contained in the IID.
