1. Short title This Act may be cited as the Increasing Transparency in Generic Drug Applications Act . 2. Increasing transparency in generic drug applications (a) In general Section 505(j)(3) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(j)(3) ) is amended by adding at the end the following: (H) (i) Upon request (in controlled correspondence or otherwise) by a person that has submitted or intends to submit an abbreviated application under this subsection for a drug that is generally required by regulation or recommended in guidance to contain the same inactive ingredients in the same concentration as the listed drug referred to or for which there is a scientific justification that an in vitro approach can be used to demonstrate bioequivalence based on certain qualitative or quantitative criteria with respect to an inactive ingredient, or on the Secretary’s own initiative during the review of an application under this subsection for such a drug, the Secretary shall inform the person whether such drug is qualitatively and quantitatively the same as the listed drug. (ii) If the Secretary determines that such drug is not qualitatively or quantitatively the same as the listed drug, the Secretary shall identify and disclose to the person— (I) the ingredient or ingredients that cause the drug not to be qualitatively or quantitatively the same as the listed drug; and (II) for any ingredient for which there is an identified quantitative deviation, the amount of such deviation. (iii) If the Secretary determines that such drug is qualitatively and quantitatively the same as the listed drug, the Secretary shall not change or rescind such determination after the submission of an abbreviated application for such drug under this subsection unless— (I) the formulation of the listed drug has been changed and the Secretary has determined that the prior listed drug formulation was withdrawn for reasons of safety or effectiveness