Where it is not the same, the Secretary must name the ingredient and the amount
What the document says“``(I) the ingredient or ingredients that cause such 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.”
Where the Secretary determines the drug is not qualitatively or quantitatively the same, the Secretary must identify and disclose to the person the ingredient or ingredients that make it different and, for any ingredient with a quantitative deviation, the amount of that deviation. This applies notwithstanding section 301(j) of that Act.
What the document actually says“``(I) the ingredient or ingredients that cause such 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.”
Say which part or parts make the drug different. For any part off by an amount, say how far off it is.
A plain no leaves the maker guessing. Naming the part and the gap lets it fix the recipe. It is told only what it needs.
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