The Inactive Ingredient Database (IID) is changing. 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. As stated on page 17 of the GDUFA II Commitment Letter,
- By October 1, 2020, FDA will complete enhancements to the Inactive Ingredient Database so users can perform electronic queries to obtain accurate Maximum Daily Intake and Maximum Daily Exposure information for each route of administration for which data is available.
- FDA will update the Inactive Ingredient Database on an ongoing basis, and post quarterly notice of updates made. Such notices will include each change made and, for each change, the information replaced.
These enhancements are intended to help industry make informed decisions about excipient selection during drug development. For example, excipient maximum daily exposure (MDE) information may help in decisions about whether additional excipient qualification is warranted when an excipient is proposed in a regulatory submission. The change log will inform users of recent IID updates and corrections. This provides greater transparency and informs users about the information displayed on the primary IID webpage when updates occur. Our Question & Answer webpage provides additional information regarding the enhancements.
We are actively working to meet our GDUFA II commitments. This requires making changes to the IID that improve data consistency and accuracy. Planned changes will be implemented in phases. 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.
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 attached mapping table.
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 will be standardized within the database so that numeric potency values can be accurately compared for each excipient-ROA-DF combination to select the highest potency. We expect to roll out the IID with new SPL terminology and consistent units of measure in the near future.
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.
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