FDA announces publication of the first Quarterly Inactive Ingredient Database Change Log

The Food and Drug Administration (FDA) recently posted its first Quarterly Inactive Ingredient Database (IID) Change Log. The IID provides information on inactive ingredients used in FDA-approved products. Publication of the Quarterly Inactive Ingredient Database (IID) Change Log fulfills a commitment made under the reauthorization of the Generic Drug User Fee Amendments (GDUFA) for fiscal years 2018-2022, known as GDUFA II. The Quarterly IID Change Log identifies certain changes that have been made since the previous IID publication, giving IID users a clear picture of any differences between the current and previous IID publication. The Quarterly IID Change Log is reserved for changes resulting from corrections and shows quarterly corrected records and quarterly deleted records. New records, such as new ingredients and higher potencies, are displayed on the primary IID web page and are identified in the IID with a “Y” in the Updated Record column. Additional information about FDA’s plans for changes to the IID can be found on the IID web page. The web page will be continually updated as FDA makes changes to the IID over the coming year.