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Quarterly Inactive Ingredient Database (IID) Change Log







Understanding the Change Log

Welcome to the Quarterly IID Change Log. FDA publishes the IID on a quarterly basis. The Quarterly IID Change Log displays changes made since the previous quarterly IID publication.

The Quarterly IID Change Log shows three types of changes: quarterly corrected records, quarterly deleted records and MDE replacements. Note that new records are displayed on the primary IID webpage, not in the Quarterly IID Change Log. New records include the first appearance of an excipient in the IID, higher potencies for excipients, new routes of administration and dosage forms.  MDE records that are higher than the previous quarter are also displayed on the primary IID webpage. New records are identified in the IID with a “Y” in Updated Record column.

What are quarterly corrected records?

The list of corrected records displays the current “changed” record above the previous record as it appeared in the last quarterly IID publication. The type of change made is evident in this display format which gives a before and after view of each changed record.  Corrected records are those for which the ingredient name, unit of measure or potency were corrected in the current quarterly IID publication. Note that potency corrections that resulted in a decreased potency value are displayed in the Change Log because these are corrections of erroneous data. Increases in potency are displayed on the IID primary webpage and are designated as new entries.

What are quarterly deleted records?

The list of deleted records displays records that appeared in the previous IID publication but have been deleted from the current publication. Excipients are seldom completely removed from the IID. Most “deletions” reflect corrections of the route of administration or dosage form associated with the excipient record. These types of corrections create a new record for the excipient, thus deleting the old record.  For example, the record for BETADEX SULFOBUTYL ETHER SODIUM, route of administration INTRAVENOUS, dosage form POWDER with maximum potency 270.00 mg/ml appeared on the deleted records list in October 2019. The reason for deletion of this record was a correction of the dosage form from POWDER to INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION. The new record for this excipient appeared in the October 2019 IID with the correct dosage form. Along with the correction of dosage form, the units of measure were also update for this record to percentage weight per volume (27 %w/v).

What are quarterly MDE replacements?

The list of MDE replacements shows IID records from the previous IID publication that have been replaced with MDEs. A replacement will only appear when an MDE is found in the FDA’s master database that is higher than the existing maximum potency. Both maximum potency and MDE come from multiple approved applications, but the sources for maximum potency and MDE are not the same. Therefore, MDE should not be assumed to be a multiple of the replaced maximum potency. MDE will be populated in the IID in a phased approach. As we collect information, we expect MDEs to increase until MDE replaces maximum potency for most IID records.   

Go to Most Recent Changes to the IID Database

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