The base credit percentage is 35 percent in the 
case of the final production of— 
‘‘(i) a drug substance, 
‘‘(ii) a drug product, or 
‘‘(iii) a biological product. 
‘‘(C) DOMESTIC
CONTENT
BONUS
CRED-
IT.— 
‘‘(i) IN GENERAL.—In the case of an 
eligible component which contains domestic 
content, the base credit percentage deter-
mined under this paragraph (determined 
without regard to this subparagraph) shall 
be increased by an amount equal to— 
‘‘(I) the domestic content per-
centage, multiplied by 
‘‘(II) 0.20. 
‘‘(ii) DOMESTIC
CONTENT
PERCENT-
AGE.—For purposes of this subparagraph, 
the term ‘domestic content percentage’ 
means the percentage of the total cost of 
the eligible components taken into account 
for purposes of paragraph (2) which is at-
tributable to materials and components 
that were produced in the United States. 
‘‘(iii) DOCUMENTATION RULES.— 
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‘‘(I) RECORD KEEPING.—No do-
mestic content bonus credit shall be 
determined under this subparagraph 
unless the taxpayer provides docu-
mentation supporting the domestic 
content percentage (in such form and 
manner as the Secretary shall pre-
scribe). 
‘‘(II) CERTIFICATION BY UNRE-
LATED PARTY.—In the case of mate-
rials or components provided to the 
taxpayer by an unrelated party, the 
Secretary shall accept certification (in 
such form and manner as the Sec-
retary shall prescribe) by such unre-
lated party that the materials or com-
ponents were produced in the United 
States. 
‘‘(4) PHASE OUT.— 
‘‘(A) IN GENERAL.—In the case of any eli-
gible component sold after December 31, 2030, 
the amount determined under this subsection 
with respect to such component shall be equal 
to the product of— 
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‘‘(i) the amount determined under 
paragraph (1) with respect to such compo-
nent (determined without regard to this 
paragraph and after the application of 
paragraphs (2) and (3)), and 
‘‘(ii) the phase out percentage. 
‘‘(B) PHASE OUT PERCENTAGE.—For pur-
poses of subparagraph (A), the phase out per-
centage is— 
‘‘(i) in the case of an eligible compo-
nent sold during calendar year 2031, 75 
percent, 
‘‘(ii) in the case of an eligible compo-
nent sold during calendar year 2032, 50 
percent, 
‘‘(iii) in the case of an eligible compo-
nent sold during calendar year 2033, 25 
percent, and 
‘‘(iv) in the case of an eligible compo-
nent sold after December 31, 2033, 0 per-
cent. 
‘‘(c) DEFINITIONS.—For purposes of this section— 
‘‘(1) ELIGIBLE COMPONENT.— 
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‘‘(A) IN GENERAL.—Except as provided in 
subparagraphs (B) and (C), the term ‘eligible 
component’ means— 
‘‘(i) an approved generic drug, 
‘‘(ii) a licensed biosimilar, and 
‘‘(iii) any drug substance, inter-
mediate raw material, starting material, 
reagent, component, in-process material, 
inactive ingredient, container closure sys-
tem, packaging, quality testing, or other 
material or service used, or sold with in-
tention for use, in the production of an ap-
proved generic drug or a licensed bio-
similar. 
‘‘(B) EXCLUSION
OF
CERTAIN
COMPO-
NENTS.—The term ‘eligible component’ shall 
not include a component any portion of the pro-
duction of which occurred at a facility which is 
the subject of a warning letter— 
‘‘(i) which was issued by the Food 
and Drug Administration on or after Sep-
tember 1, 2009, and 
‘‘(ii) with respect to which the Food 
and Drug Administration has not issued a 
close-out letter. 
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‘‘(C) APPLICATION
WITH
OTHER
CRED-
ITS.—The term ‘eligible component’ shall not 
include any property which is produced at a fa-
cility if the basis of any property which is part 
of such facility is taken into account for pur-
poses of the credit allowed under section 48F 
after the date of the enactment of this section. 
‘‘(2) APPROVED
GENERIC
DRUG.—The term 
‘approved generic drug’ means— 
‘‘(A) a drug for which an approval of an 
application filed under section 505(j) of the 
Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355(j)) is in effect, or 
‘‘(B) an authorized generic drug (as de-
fined in section 314.3 of title 21, Code of Fed-
eral Regulations (or any successor regulation)). 
‘‘(3) LICENSED BIOSIMILAR.— 
‘‘(A) IN
GENERAL.—The term ‘licensed 
biosimilar’ means a biological product for which 
a biologics license has been issued under section 
351(k) of the Public Health Service Act (42 
U.S.C. 262(k)). 
‘‘(B) BIOLOGICAL
PRODUCT.—The term 
‘biological product’ has the meaning given such 
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