To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications.

This bill makes the FDA more open with generic drug makers. When asked, or during review, the FDA must tell a generic applicant if their product uses the same inactive ingredients, in the same amounts, as the brand-name drug. If it doesn’t match, the FDA must say which ingredients are different and by how much. Once the FDA says a product matches, it generally cannot take that back after the application is filed—unless the brand drug’s formula changed for safety reasons or an error is found, and the applicant is told in writing.

The bill also requires HHS to publish guidance explaining how these matching decisions are made (including how pH adjusters are handled). Draft guidance must come within a year, with at least 60 days for public comments, and final guidance within a year after comments close. These transparency rules start on the day the bill becomes law, even before the guidance is finalized.

• Who is affected: Generic drug applicants; indirectly, patients and providers who rely on generics.
• What changes: FDA must clearly confirm ingredient matching or explain differences, and stick to its matching decision unless there’s a safety-related change or an error.
• When: Requirements take effect on enactment; guidance timeline begins within one year.