FDA announces upcoming changes to the Inactive Ingredient Database (IID)

FDA announces upcoming changes to the Inactive Ingredient Database (IID)

The Food and Drug Administration (FDA) posted an announcement of upcoming changes in the Inactive Ingredient Database (IID) on the Inactive Ingredient Database web page. The IID provides information on inactive ingredients present in FDA-approved drugs. This information can be used by industry as an aid in developing new drugs. Once an inactive ingredient is used in approved drugs for a particular route of administration, it is not considered novel and may require a less extensive review the next time it is included in a new drug.

Under the reauthorization of the Generic Drug User Fee Act (GDUFA) for fiscal years 2018-2022, FDA made a commitment to amend the IID in significant ways by October 2020. Under GDUFA II, FDA committed to updating the IID by October 1, 2020, to facilitate queries for accurate maximum daily intake and maximum daily exposure information.  FDA also committed to posting quarterly notices of updates made to the database.

FDA will use a phased approach to make additional changes to the IID that improve data consistency and accuracy. In phase I, new data standards will be applied for route of administration (ROA), dosage form (DF) and units of measure (UOM). Standardizing terminology for ROA and DF and implementing consistent UOM allows us to compare apples to apples, a necessary first step in improving the accuracy of the IID.

Information about FDA’s plans for upcoming changes to the IID can be found on the IID web page at: https://www.fda.gov/drugs/drug-approvals-and-databases/most-recent-changes-iid-database. The web page will be continually updated as FDA makes changes to the IID over the coming year.