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# Comments on Inactive Ingredient Database Guidance
- URL: https://www.fdaweb.com/comments-on-inactive-ingredient-database-guidance/
- Published: 2019-10-10T12:00:00.000Z
- Updated: 2026-09-15T01:55:32.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5145222

The U.S. Pharmacopeia commends FDA for its draft guidance to enhance the utility and usability of the inactive ingredient database (IID) and says it has seen marked enhancements in the document. “We believe the information presented in the draft guidance will help reduce discrepancies between the IID and USP-NF monograph names by aligning preferred terms for single substance excipients with the USP-NF excipient monograph official title,” the group’s [comment letter](https://www.regulations.gov/document?D=FDA-2019-D-2397-0005&ref=fdaweb.com) says.

AstraZeneca [says](https://www.regulations.gov/document?D=FDA-2019-D-2397-0007&ref=fdaweb.com) the guidance is welcomed because it is useful to have clear descriptions of the terms used in the IID and to have information on the further improvements planned for it. It particularly says the proposal to use the word “excipient” rather than “inactive ingredient” in the guidance is very useful in helping reinforce the fact that pharmaceutical scientists should not be complacent in assuming excipients have no effect on the efficacy of biologically-active ingredients.

Teva [comments](https://www.regulations.gov/document?D=FDA-2019-D-2397-0008&ref=fdaweb.com) on ways FDA can better communicate with sponsors about the IID and the regulatory science surrounding excipient choice for generic formulations. Topics of Teva concern are: 

- changes to the IID made after an ANDA is submitted should not preclude receipt of the ANDA;
- FDA should be more transparent about intended IID updates;
- FDA should clarify how it intends to meet its GDUFA commitment to enhance the IID; and
- changes to excipients are scientific and not policy issues.

Lonza provided line-by-line [comments](https://www.regulations.gov/document?D=FDA-2019-D-2397-0009&ref=fdaweb.com) only.