Quarterly Inactive Ingredient Database (IID) Change Log
Notice of changes to the IID since the previous quarterly IID publication
The Inactive Ingredient Database (IID) has changed. Under the reauthorization of the Generic Drug User Fee Amendments (GDUFA) for fiscal years 2018-2022, FDA made a commitment to amend the IID in significant ways by October 2020. As stated on page 17 of the GDUFA II Commitment Letter, FDA committed to complete enhancements to the Inactive Ingredient Database so users can perform electronic queries to obtain accurate Maximum Daily Exposure (MDE) information for excipients, also referred to as Maximum Daily Intake, for each route of administration for which data is available.
FDA also committed to update the Inactive Ingredient Database on an ongoing basis, and post quarterly notices of updates including each change made and, for each change, the information replaced.
On July 28, 2020, FDA began to populate the IID with MDE information for the first time. More excipient MDEs will be populated in future IID publications as FDA obtains more MDE information. We also expect many MDE levels to increase as additional information is gathered. Fulfillment of the commitment to provide MDE information to our stakeholders follows fulfillment of another IID-related GDUFA II commitment, the posting of the Quarterly Inactive Ingredient Change Log. The Change Log first posted in October 2019 as a static document and was updated in June 2020 to an improved searchable interactive format.
FDA adopted new data standards in July 2019 for route of administration (ROA), dosage form (DF) and units of measure (UOM) to improve data consistency and accuracy.
We’ve chosen to use the terminology that industry is familiar with from Structured Product Labeling (SPL) for routes of administration and dosage forms. One advantage of converting to SPL terminology is that there are fewer terms for ROA and DF. This collapses categories of ROA and DF in the IID resulting in fewer entries. The mapping we used to convert non-SPL ROAs and DFs in IID to SPL terms can be found in the linked mapping tables.
The IID algorithm searches our large master database for the highest level of each excipient. This search can only be accurately performed when units of measure are standardized. Therefore, units of measure were standardized within the database so that numeric potency values can be accurately compared for each excipient-ROA-DF combination to select the highest potency or MDE.
If you have questions or concerns about removal of specific ingredients from the Inactive Ingredient Database or would like us to make corrections, you can contact the IID staff at IIDUpdate@fda.hhs.gov.