FDA Releases Draft Recommendations on Using the Inactive Ingredient Database

The FDA issued draft recommendations for drug developers on how to make the best use of the agency’s online database of inactive ingredients and said it plans to add more information.

The Inactive Ingredient Database lists excipients that have been used in approved NDAs and ANDAs. The agency says it may consult the database when reviewing applications to find out whether the levels of excipients in product formulations are “acceptable or require additional documentation to support the proposed level.”

The FDA plans to add new details by Oct. 1, 2020, including Maximum Daily Intakes and Maximum Daily Exposures. The database currently lists the Maximum Potency, which “reflects the level per unit of the excipient that has been used previously in approved drug products,” but does not indicate the maximum permissible daily intake or acceptable daily intake.