subsection for a drug that is required by regulation to con-
tain one or more of the same inactive ingredients in the 
same concentrations as the listed drug referred to, or for 
which the Secretary determines there is a scientific jus-
tification for an approach that is in vitro in whole or in 
part to be used to demonstrate bioequivalence for a drug 
if such a drug contains one or more of the same inactive 
ingredients in the same concentrations as the listed drug, 
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 sub-
section for such drug. 
‘‘(ii) Notwithstanding section 301(j), if the Secretary 
determines that such drug is not qualitatively or quan-
titatively the same as the listed drug, the Secretary shall 
identify and disclose to the person— 
‘‘(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. 
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‘‘(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 deter-
mination after the submission of an abbreviated applica-
tion 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prior listed drug formulation was withdrawn for rea-
sons of safety or effectiveness; or 
‘‘(II) the Secretary makes a written determina-
tion that the prior determination must be changed 
because an error has been identified. 
‘‘(iv) If the Secretary makes a written determination 
described in clause (iii)(II), the Secretary shall provide no-
tice and a copy of the written determination to the person 
making the request under clause (i). 
‘‘(v) The disclosures required by this subparagraph 
are disclosures authorized by law, including for purposes 
of section 1905 of title 18, United States Code.’’. 
(b) GUIDANCE.— 
(1) IN
GENERAL.—Not later than one year 
after the date of enactment of this Act, the Sec-
retary of Health and Human Services shall issue 
draft guidance, or update guidance, describing how 
the Secretary will determine whether a drug is quali-
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tatively and quantitatively the same as the listed 
drug 
(as 
such 
terms 
are 
used 
in 
section 
505(j)(3)(H) of the Federal Food, Drug, and Cos-
metic Act, as added by subsection (a)), including 
with respect to assessing pH adjusters. 
(2) PROCESS.—In issuing guidance under this 
subsection, the Secretary of Health and Human 
Services shall— 
(A) publish draft guidance; 
(B) provide a period of at least 60 days for 
comment on the draft guidance; and 
(C) after considering any comments re-
ceived and not later than one year after the 
close of the comment period on the draft guid-
ance, publish final guidance. 
(c) APPLICABILITY.—Section 505(j)(3)(H) of the 
Federal Food, Drug, and Cosmetic Act, as added by sub-
section (a), applies beginning on the date of enactment 
of this Act, irrespective of the date on which the guidance 
required by subsection (b) is finalized. 
Æ 
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