Notice2025-12965
Notice of Issuance of Final Determination Concerning Pirfenidone Tablets
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
July 11, 2025
Issuing agencies
Homeland Security DepartmentU.S. Customs and Border Protection
Abstract
This document provides notice that U.S. Customs and Border Protection (CBP) has issued a final determination concerning the country of origin of pirfenidone tablets. Based upon the facts presented, CBP has concluded that the pirfenidone tablets would be the product of a foreign country or instrumentality designated pursuant to 19 U.S.C. 2511(b).
Full Text
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<title>Federal Register, Volume 90 Issue 131 (Friday, July 11, 2025)</title>
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[Federal Register Volume 90, Number 131 (Friday, July 11, 2025)]
[Notices]
[Pages 30947-30948]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-12965]
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DEPARTMENT OF HOMELAND SECURITY
U.S. Customs and Border Protection
Notice of Issuance of Final Determination Concerning Pirfenidone
Tablets
AGENCY: U.S. Customs and Border Protection, Department of Homeland
Security.
ACTION: Notice of final determination.
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SUMMARY: This document provides notice that U.S. Customs and Border
Protection (CBP) has issued a final determination concerning the
country of origin of pirfenidone tablets. Based upon the facts
presented, CBP has concluded that the pirfenidone tablets would be the
product of a foreign country or instrumentality designated pursuant to
19 U.S.C. 2511(b).
DATES: The final determination was issued on June 24, 2025. A copy of
the final determination is attached. Any party-at-interest, as defined
in 19 CFR 177.22(d), may seek judicial review of this final
determination no later than August 11, 2025.
FOR FURTHER INFORMATION CONTACT: Jordan Higgins, Valuation and Special
Programs Branch, Regulations and Rulings, Office of Trade, at (202)
325-1134.
SUPPLEMENTARY INFORMATION: Notice is hereby given that on June 24,
2025, U.S. Customs and Border Protection (CBP) issued a final
determination concerning the country of origin of pirfenidone tablets
for purposes of Title III of the Trade Agreements Act of 1979. This
final determination, Headquarters Ruling Letter (HQ) H342828, was
issued at the request of Alembic Pharmaceuticals, Inc. under procedures
set forth at 19 CFR part 177, subpart B, which implements Title III of
the Trade Agreements Act of 1979, as amended (19 U.S.C. 2511-18). In
the final determination, CBP has concluded that, based upon the facts
presented, the country of origin of the pirfenidone tablets is the
country of origin of the active pharmaceutical ingredient (API), which
is Italy.
Section 177.29, CBP Regulations (19 CFR 177.29), provides that a
notice of final determination shall be published in the Federal
Register within 60 days of the date the final determination is issued.
Section 177.30, CBP Regulations (19 CFR 177.30), provides that any
party-at-interest, as defined in 19 CFR 177.22(d), may seek judicial
review of a final determination within 30 days of publication of such
determination in the Federal Register.
Alice A. Kipel,
Executive Director, Regulations and Rulings, Office of Trade.
[GRAPHIC] [TIFF OMITTED] TN11JY25.004
HQ H342828
June 24, 2025
OT:RR:CTF:VS H342828 JH
CATEGORY: Origin
Gregory S. McCue, Steptoe, 1330 Connecticut Ave. NW, Washington, DC
20036-1795
Re: U.S. Government Procurement; Country of Origin of Pirfenidone
Tablets
Dear Mr. McCue:
This is in response to your request, dated October 8, 2024, on
behalf of Alembic Pharmaceuticals, Inc. (``Alembic''), for a final
determination concerning the country of origin of pirfenidone tablets
pursuant to Title III of the Trade Agreements Act of 1979 (``TAA''), as
amended (19 U.S.C. 2511 et seq.), and subpart B of Part 177, U.S.
Customs and Border Protection (``CBP'') Regulations (19 CFR 177.21, et
seq.). Alembic is a party-at-interest within the meaning of 19 CFR
177.22(d)(1) and 177.23(a) and is therefore entitled to request this
final determination.
Facts
The articles under consideration are pirfenidone tablets. The
tablets are used for the treatment of idiopathic pulmonary fibrosis
(scarring of the lungs with an unknown cause). The tablets have one
active pharmaceutical ingredient (``API'') that is manufactured in
Italy and shipped to India for final processing which includes mixing
with inactive materials, forming tablets, and packaging. Specifically,
the tablets are manufactured in a seven-step process in India:
(1) The API pirfenidone is sifted along with three inactive
ingredients: microcrystalline cellulose, croscarmellose sodium, and
povidone.
(2) Wet granulation is employed. This process includes rapid mixer
granulator
[[Page 30948]]
dry mixing, adding a binder (purified water), and kneading.
(3) The mixture is screened and dried in a fluid bed dryer.
(4) The mixture undergoes sifting through a vibratory sifter and
milling of retain granules through a multimill machine. Afterwards, the
mixture undergoes sifting of extra granular material with lubricants
including microcrystalline cellulose, colloidal silicon dioxide, and
magnesium stearate.
(5) The dry mixture is pre-lubricated and lubricated in a conta
blender.
(6) The final mixture is compressed into tablets, which is then
sprayed with a coating of ``Opadry'' and purified water.
(7) The final tablets are packaged and imported into the United
States.
Issue
What is the country of origin of the pirfenidone tablets for
purposes of U.S. Government procurement?
Law and Analysis
CBP issues country of origin advisory rulings and final
determinations as to whether an article is or would be a product of a
designated country or instrumentality for the purpose of granting
waivers of certain ``Buy American'' restrictions in U.S. law or
practice for products offered for sale to the U.S. Government, pursuant
to subpart B of Part 177, 19 CFR 177.21 et seq., which implements Title
III, Trade Agreements Act of 1979, as amended (19 U.S.C. 2511-2518).
CBP's authority to issue advisory rulings and final determinations
stems from 19 U.S.C. 2515(b)(1), which states:
For the purposes of this subchapter, the Secretary of the
Treasury shall provide for the prompt issuance of advisory rulings
and final determinations on whether, under section 2518(4)(B) of
this title, an article is or would be a product of a foreign country
or instrumentality designated pursuant to section 2511(b) of this
title.
Emphasis added.
The Secretary of the Treasury's authority mentioned above, along
with other customs revenue functions, are delegated to the Secretary of
Homeland Security via Treasury Department Order (TO) 100-20
``Delegation of Customs revenue functions to Homeland Security,'' dated
October 30, 2024, and are subject to further delegations to CBP (see
also 19 CFR part 177, subpart B).
The rule of origin set forth in 19 U.S.C. 2518(4)(B) states:
An article is a product of a country or instrumentality only if
(i) it is wholly the growth, product, or manufacture of that country
or instrumentality, or (ii) in the case of an article which consists
in whole or in part of materials from another country or
instrumentality, it has been substantially transformed into a new
and different article of commerce with a name, character, or use
distinct from that of the article or articles from which it was so
transformed.
See also 19 CFR 177.22(a).
In rendering advisory rulings and final determinations for purposes
of U.S. Government procurement, CBP applies the provisions of subpart B
of Part 177 consistent with the Federal Acquisition Regulation
(``FAR''). See 19 CFR 177.21. In this regard, CBP recognizes that the
FAR restricts the U.S. Government's purchase of products to U.S.-made
or designated country end products for acquisitions subject to the TAA.
See 48 CFR 25.403(c)(1).
The FAR, 48 CFR 25.003, defines ``designated country end product''
as:
a WTO GPA [World Trade Organization Government Procurement
Agreement] country end product, an FTA [Free Trade Agreement]
country end product, a least developed country end product, or a
Caribbean Basin country end product.
Section 25.003 defines ``WTO GPA country end product'' as an
article that:
(1) Is wholly the growth, product, or manufacture of a WTO GPA
country; or
(2) In the case of an article that consists in whole or in part
of materials from another country, has been substantially
transformed in a WTO GPA country into a new and different article of
commerce with a name, character, or use distinct from that of the
article or articles from which it was transformed. The term refers
to a product offered for purchase under a supply contract, but for
purposes of calculating the value of the end product includes
services (except transportation services) incidental to the article,
provided that the value of those incidental services does not exceed
that of the article itself.
We note that the API is produced in Italy and the tablet
formulation occurs in India. Italy is a TAA-designated country, and
India is not.
In determining whether a substantial transformation occurs in the
manufacture of chemical products such as pharmaceuticals, CBP has
consistently examined the complexity of the processing and whether the
final article retains the essential identity and character of the raw
material. To that end, CBP has generally held that the processing of
pharmaceutical products from bulk form into measured doses does not
result in a substantial transformation of the product. See, e.g.,
Headquarters Ruling (``HQ'') 561975, dated April 3, 2002; HQ 561544,
dated May 1, 2000; HQ 735146, dated November 15, 1993; HQ H267177,
dated November 5, 2016; HQ H233356, dated December 26, 2012; and, HQ
561975, dated April 3, 2002.
In HQ 289702, dated January 30, 2018, concerning the country of
origin of Levetiracetam tablets, the API underwent coating, mixing with
inactive ingredients, blending, and compression. CBP determined that
the API retained its physical and chemical properties through the
processing that was performed. Therefore, the API did not undergo a
substantial transformation. Additionally, in HQ 243567, dated July 26,
2013, concerning the country of origin of Dificid tablets, the API was
mixed with various other ingredients via a wet granulation process and
was then compressed into tablets that were then coated. CBP did not
find that the API underwent a substantial transformation and determined
that the country of origin was where the API originated from as the API
imparts the essential character of the goods.
Consistent with the cases above, the processing in India does not
result in a change in the medicinal use of the finished tablets, the
API retains its chemical and physical properties, and it is merely put
into a tablet form and packaged. Accordingly, we find that no
substantial transformation occurs in India, and the imported tablets
would be of the same country of origin as the API, which is Italy.
Holding
The country of origin of the pirfenidone tablets for purposes of
U.S. Government procurement is Italy.
Notice of this final determination will be given in the Federal
Register, as required by 19 CFR 177.29. Any party-at-interest other
than the party which requested this final determination may request,
pursuant to 19 CFR 177.31, that CBP reexamine the matter anew and issue
a new final determination. Pursuant to 19 CFR 177.30, any party-at-
interest may, within 30 days of publication of the Federal Register
Notice referenced above, seek judicial review of this final
determination before the Court of International Trade.
Sincerely,
Alice A. Kipel,
Executive Director, Regulations & Rulings, Office of Trade.
[FR Doc. 2025-12965 Filed 7-10-25; 8:45 am]
BILLING CODE 9111-14-P
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</html>Indexed from Federal Register on July 11, 2025.
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