The Secretary must say whether the drug is the same as the listed drug
What the document says“the Secretary shall inform the person whether such drug is qualitatively and quantitatively the same as the listed drug. The Secretary may also provide such information to such a person on the Secretary's own initiative during the review of an abbreviated application under this subsection for such drug.”
Section 6703 adds a new subparagraph (H) to section 505(j)(3) of the Federal Food, Drug, and Cosmetic Act. On request by a person who has submitted or intends to submit an abbreviated application for a drug required to have the same inactive ingredients in the same concentrations as the listed drug, or where the Secretary finds scientific justification for an in vitro approach to bioequivalence for such a drug, the Secretary must say whether the drug is qualitatively and quantitatively the same as the listed drug. The Secretary may also volunteer that during review.
What the document actually says“the Secretary shall inform the person whether such drug is qualitatively and quantitatively the same as the listed drug. The Secretary may also provide such information to such a person on the Secretary's own initiative during the review of an abbreviated application under this subsection for such drug.”
The health chief must tell the maker whether its drug is the same as the brand drug. Same means the same parts in the same amounts.
A generic must match the brand drug in its inactive parts. Those are the parts that carry the drug but do not treat. A maker cannot see the brand's recipe.
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