US FDA Guidance Explains Upcoming Enhancements To Inactive Ingredients Database

11 Jul 2019

• By Joanne S. Eglovitch

Next year, generic drug manufacturers will finally get some of the improvements they have been asking for in the US FDA’s Inactive Ingredient Database, such as being able to access the maximum daily intake (MDI) for each excipient. This information is helpful to industry in formulating products.

assortment of pills and capsules of colors in plastic jars isolated in white - Image

The US Food and Drug Administration has issued draft guidance explaining some of the improvements soon to be made to the agency's Inactive Ingredients Database, including allowing manufacturers to obtain maximum daily intake limits for each excipient and more frequent updates to the database. These changes will take effect 1 October 2020 and were sought by the generic drug industry under the Generic Drug User Fee Act II.

The guidance also addresses how to reference the use of excipients in new drug applications, investigational new drug applications and...