Notice of Issuance of Final Determinations Concerning Certain Pharmaceutical Products, 40786-40793 [2017-18205]

Agencies

• DEPARTMENT OF HOMELAND SECURITY
• U.S. Customs and Border Protection

[Federal Register Volume 82, Number 165 (Monday, August 28, 2017)]
[Notices]
[Pages 40786-40793]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-18205]


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DEPARTMENT OF HOMELAND SECURITY

U.S. Customs and Border Protection


Notice of Issuance of Final Determinations Concerning Certain 
Pharmaceutical Products

AGENCY: U.S. Customs and Border Protection, Department of Homeland 
Security.

ACTION: Notice of final determinations.

-----------------------------------------------------------------------

SUMMARY: This document provides notice that U.S. Customs and Border 
Protection (``CBP'') has issued six final determinations concerning the 
country of origin of certain pharmaceutical products produced by Lupin 
Pharmaceuticals, Inc. Based upon the facts presented, CBP has concluded 
that the country of origin of the meloxicam tablets is Italy for 
purposes of U.S. Government procurement, that the country of origin of 
the bimatoprost ophthalmic solution is Taiwan for purposes of U.S. 
Government procurement, that the country of origin of the niacin ER 
tablets is Belgium or Switzerland for purposes of U.S. Government 
procurement, that the country of origin of the calcium acetate capsules 
is the Netherlands for purposes of U.S. Government procurement, that 
the country of origin of the quinine sulfate capsules is Germany for 
purposes of U.S. Government procurement, and that the country of origin 
of the pravastatin sodium tablets is Taiwan for purposes of U.S. 
Government procurement.

DATES: These final determinations were issued on August 22, 2017. 
Copies of the final determinations are attached. Any party-at-interest, 
as defined in 19 CFR 177.22(d), may seek judicial review of these final 
determinations within September 27, 2017.

FOR FURTHER INFORMATION CONTACT: Ross M. Cunningham, Valuation and 
Special Programs Branch, Regulations and Rulings, Office of Trade, 
(202) 325-0034.

SUPPLEMENTARY INFORMATION: Notice is hereby given that on August 22, 
2017 pursuant to subpart B of Part 177, U.S. Customs and Border 
Protection Regulations (19 CFR part 177, subpart B), CBP issued six 
final determinations concerning the country of origin of certain 
pharmaceutical products, which may be offered to the U.S. Government 
under an undesignated government procurement contract. These final 
determinations (HQ H284690, HQ H284961, HQ H284692, HQ H284694, HQ 
H284695, and HQ H284697), were issued 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 
determinations, CBP concluded that the processing in India does not 
result in a substantial transformation. Therefore, the country of 
origin for purposes of U.S. Government procurement of the 
pharmaceutical products is the country in which the active 
pharmaceutical ingredient was produced.
    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.

    Dated: August 22, 2017.
Alice A. Kipel,
Executive Director, Regulations and Rulings, Office of Trade.

ATTACHMENT A

HQ H284690

August 22, 20917

OT:RR:CTF:VS H284690 RMC

CATEGORY: Origin

Kevin J. Maynard
Wiley Rein LLP
1776 K St. NW
Washington, DC 20006

Re: U.S. Government Procurement; Country of Origin of Meloxicam 
Tablets; Substantial Transformation

Dear Mr. Maynard:

    This is in response to your letter, dated March 20, 2017, 
requesting a final determination on behalf of Lupin Pharmaceuticals, 
Inc. (``Lupin'') pursuant to subpart B of Part 177 of the U.S. 
Customs and Border Protection (``CBP'') Regulations (19 CFR Part 
177). Under these regulations, which implement Title III of the 
Trade Agreements Act of 1979 (``TAA''), as amended (19 U.S.C. Sec.  
2511 et seq.), 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 purposes 
of granting waivers of certain ``Buy American'' restrictions in U.S. 
law or for products offered for sale to the U.S. Government. This 
final determination concerns the country of origin of meloxicam 
tablets. As a U.S. importer, Lupin is a party-at-interest within the 
meaning of 19 CFR 177.22(d)(1) and is entitled to request this final 
determination.
    You have asked that certain information submitted in connection 
with this ruling request be treated as confidential. Inasmuch as 
this request conforms to the requirements of 19 CFR 177.2(b)(7), the 
request for confidentiality is approved. The information contained 
within brackets and all attachments to this ruling request, 
forwarded to our office, will not be released to the public and will 
be withheld from published versions of this ruling.

FACTS:

    Lupin is a subsidiary of Lupin Limited, one of the five largest 
pharmaceutical companies in India. At issue in this case are 
meloxicam tablets, in doses of 7.5 milligrams and 15 milligrams, 
which you describe as ``nonsteroidal anti-inflammator[ies] used for 
the relief of the signs and symptoms of rheumatoid arthritis and 
osteoarthritis.''
    The manufacturing process for Lupin's meloxicam tablets begins 
in Italy, where the active pharmaceutical ingredient (``API'') 
meloxicam (chemical formula C14H13N3O4S2) is produced. You state 
that the Italian meloxicam is the only active ingredient in the 
finished pharmaceutical product. However, the finished product 
contains a number of other inactive ingredients, which you describe 
as excipients. These ingredients are combined with the Italian API 
in India during the manufacturing process. The ingredients include 
the following chemicals, which you note are products of TAA-eligible 
countries:
     [ ]
     [ ]
     [ ]
     [ ]
     [ ]
     [ ]
     [ ]
    The manufacturing process in India involves four steps. First, 
the API and inactive ingredients are sifted and blended. Second, the 
materials are granulated, and the wet granulates are then sieved and 
dried. Third, the product is compressed into tablets. Finally, in 
the fourth step, the finished tablets are packaged into approved 
packaging.
    You state that the processes performed to produce the finished 
meloxicam tablets do not result in any change to the chemical 
characteristics of the Italian API or to any other ingredients. You 
also state that the medicinal use, molecular formula, and solubility 
of the API are unchanged by the manufacturing operations in India. 
In short, you characterize the Indian operations as mere processing 
of bulk API into 7.5 milligram and 15 milligram dosage form.

[[Page 40787]]

ISSUE:

    What is the country of origin of the meloxicam tablets for 
purposes of U.S. Government procurement?

LAW AND ANALYSIS:

    Pursuant to subpart B of Part 177, 19 CFR 177.21 et seq., which 
implements Title III of the Trade Agreements Act of 1979, as amended 
(19 U.S.C. 2511 et seq.), 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 purposes of granting waivers of certain ``Buy American'' 
restrictions in U.S. law or practice for products offered for sale 
to the U.S. Government.
    Under the rule of origin set forth under 19 U.S.C. 2518(4)(B):
    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).
    A substantial transformation occurs when an article emerges from 
a process with a new name, character, and use different from that 
possessed by the article prior to processing. A substantial 
transformation will not result from a minor manufacturing or 
combining process that leaves the identity of the article intact. 
See United States v. Gibson-Thomsen Co., 27 C.C.P.A. 267 (1940); and 
National Juice Products Ass'n v. United States, 628 F.Supp. 978 (Ct. 
Int'l Trade 1986).
    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.
    For example, in HQ H267177, CBP held that Indian- and Chinese-
origin Acyclovir was not substantially transformed in the United 
States when it was combined with excipients and processed into 
tablets. In that case, the Indian or Chinese Acyclovir was the only 
active pharmaceutical ingredient in the final product. Accordingly, 
we found that the processing performed in the United States did not 
result in a change in the medicinal use of the finished product. 
Furthermore, the Acyclovir maintained its chemical and physical 
characteristics and did not undergo a change in name, character, or 
use. Consistent with our previous rulings, we held that processing 
the Acyclovir into dosage form and packaging it for sale in the 
United States did not constitute a substantial transformation. 
Accordingly, the country of origin of the final product for purposes 
of U.S. Government procurement was either China or India, where the 
active ingredient was produced.
    Similarly, in HQ H233356, CBP held that the processing and 
packaging of imported mefenamic acid into dosage form in the United 
States did not constitute substantial transformation. Based on 
previous CBP rulings, we found that the specific U.S. processing--
which involved blending the active ingredients with inactive 
ingredients in a tumbler and then encapsulating and packaging the 
product--did not substantially transform the mefenamic acid because 
its chemical character remained the same. Accordingly, we held that 
the country of origin of the final product was India, where the 
mefanamic acid was produced.
    In HQ 561975, we also held that the processing of imported bulk 
Japanese-origin anesthetic drugs into dosage form in the United 
States did not constitute substantial transformation. Although the 
bulk form of the drug underwent testing operations, filtering, and 
packaging in the United States, these processes did not change the 
chemical or physical properties of the drug. Furthermore, there was 
no change in the product's name, which was referred to as 
sevoflurane in both its bulk and processed form. Additionally, 
because the imported bulk drug had a predetermined medicinal use as 
an anesthetic drug, the processing in the United States did not 
result in a change in the product's use. The country of origin of 
the finished product was therefore Japan.
    Here, as in the cases cited above, the processing of bulk 
imported pharmaceuticals into dosage form will not result in a 
substantial transformation. In this case, the processing begins with 
Italian-origin bulk meloxicam and, after this product is combined 
with inactive ingredients from TAA-eligible countries in India, 
results in meloxicam tablets in individual doses of either 7.5 
milligrams or 15 milligrams. Because the product is referred to as 
``meloxicam'' both before and after the Indian processing, no change 
in name occurs in India. Furthermore, no change in character occurs 
in India because the meloxicam maintains the same chemical and 
physical properties both before and after the Indian processing. 
Finally, because the imported, bulk-form meloxicam had a 
predetermined medicinal use as a nonsteroidal anti-inflammatory, no 
change in use occurs after processing in India. Under these 
circumstances, and consistent with previous CBP rulings, we find 
that the country of origin of the final product is Italy, where the 
active ingredient was produced.

HOLDING:

    The country of origin of the meloxicam 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.

ATTACHMENT B

HQ H284691

August 22, 2017

OT:RR:CTF:VS H284691 RMC

CATEGORY: Origin

Kevin J. Maynard
Wiley Rein LLP
1776 K St. NW
Washington, DC 20006

Re: U.S. Government Procurement; Country of Origin of Bimatoprost 
Ophthalmic Solution; Substantial Transformation

Dear Mr. Maynard:

    This is in response to your letter, dated March 20, 2017, 
requesting a final determination on behalf of Lupin Pharmaceuticals, 
Inc. (``Lupin'') pursuant to subpart B of Part 177 of the U.S. 
Customs and Border Protection (``CBP'') Regulations (19 CFR Part 
177). Under these regulations, which implement Title III of the 
Trade Agreements Act of 1979 (``TAA''), as amended (19 U.S.C. 2511 
et seq.), 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 purposes of granting 
waivers of certain ``Buy American'' restrictions in U.S. law or for 
products offered for sale to the U.S. Government. This final 
determination concerns the country of origin of bimatoprost 
ophthalmic solution. As a U.S. importer, Lupin is a party-at-
interest within the meaning of 19 CFR 177.22(d)(1) and is entitled 
to request this final determination.
    You have asked that certain information submitted in connection 
with this ruling request be treated as confidential. Inasmuch as 
this request conforms to the requirements of 19 CFR 177.2(b)(7), the 
request for confidentiality is approved. The information contained 
within brackets and all attachments to this ruling request, 
forwarded to our office, will not be released to the public and will 
be withheld from published versions of this ruling.

FACTS:

    Lupin is a subsidiary of Lupin Limited, one of the five largest 
pharmaceutical companies in India. At issue in this case are 
bimatoprost ophthalmic solution (0.03%), which you describe as ``a 
`prostaglandin analog' used to reduce elevated intraocular 
pressure.''
    The manufacturing process for Lupin's bimatoprost ophthalmic 
solution begins in Taiwan, where the active pharmaceutical 
ingredient (``API'') bimatoprost (chemical

[[Page 40788]]

formula C25H37NO4) is produced. You state that the Taiwanese 
bimatoprost is the only active ingredient in the finished 
pharmaceutical product. However, the finished product contains a 
number of other inactive ingredients, which you describe as 
excipients. These ingredients are combined with the Taiwanese API in 
India during the manufacturing process. The ingredients include the 
following:
     [ ]
     [ ]
     [ ]
     [ ]
     [ ]
     [ ]
    The manufacturing processes performed in India include the 
following four steps: First, the weights of the API and inactive 
ingredients are verified. Second, the active and inactive 
ingredients are dissolved in water. Third, the inactive and active 
ingredient solutions are combined and the pH level is adjusted if 
necessary. Finally, in the fourth step, the solution is filtered and 
placed into approved packaging.
    You state that the processes performed to produce the finished 
bimatoprost ophthalmic solution do not result in any change to the 
chemical characteristics of the Taiwanese API or to any other 
ingredients. You also state that the medicinal use, molecular 
formula, and solubility of the API are unchanged by the 
manufacturing operations in India. In short, you characterize the 
Indian operations as mere processing of bulk API into 0.03%-strength 
dosage form.

ISSUE:

    What is the country of origin of the bimatoprost ophthalmic 
solution for purposes of U.S. Government procurement?

LAW AND ANALYSIS:

    Pursuant to subpart B of Part 177, 19 CFR 177.21 et seq., which 
implements Title III of the Trade Agreements Act of 1979, as amended 
(19 U.S.C. Sec.  2511 et seq.), 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 purposes of granting waivers of certain ``Buy American'' 
restrictions in U.S. law or practice for products offered for sale 
to the U.S. Government.
    Under the rule of origin set forth under 19 U.S.C. Sec.  
2518(4)(B):
    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).
    A substantial transformation occurs when an article emerges from 
a process with a new name, character, and use different from that 
possessed by the article prior to processing. A substantial 
transformation will not result from a minor manufacturing or 
combining process that leaves the identity of the article intact. 
See United States v. Gibson-Thomsen Co., 27 C.C.P.A. 267 (1940); and 
National Juice Products Ass'n v. United States, 628 F.Supp. 978 (Ct. 
Int'l Trade 1986).
    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.
    For example, in HQ H267177, CBP held that Indian- and Chinese-
origin Acyclovir was not substantially transformed in the United 
States when it was combined with excipients and processed into 
tablets. In that case, the Indian or Chinese Acyclovir was the only 
active pharmaceutical ingredient in the final product. Accordingly, 
we found that the processing performed in the United States did not 
result in a change in the medicinal use of the finished product. 
Furthermore, the Acyclovir maintained its chemical and physical 
characteristics and did not undergo a change in name, character, or 
use. Consistent with our previous rulings, we held that processing 
the Acyclovir into dosage form and packaging it for sale in the 
United States did not constitute a substantial transformation. 
Accordingly, the country of origin of the final product for purposes 
of U.S. Government procurement was either China or India, where the 
active ingredient was produced.
    Similarly, in HQ H233356, CBP held that the processing and 
packaging of imported mefenamic acid into dosage form in the United 
States did not constitute substantial transformation. Based on 
previous CBP rulings, we found that the specific U.S. processing--
which involved blending the active ingredients with inactive 
ingredients in a tumbler and then encapsulating and packaging the 
product--did not substantially transform the mefenamic acid because 
its chemical character remained the same. Accordingly, we held that 
the country of origin of the final product was India, where the 
mefanamic acid was produced.
    In HQ 561975, we also held that the processing of imported bulk 
Japanese-origin anesthetic drugs into dosage form in the United 
States did not constitute substantial transformation. Although the 
bulk form of the drug underwent testing operations, filtering, and 
packaging in the United States, these processes did not change the 
chemical or physical properties of the drug. Furthermore, there was 
no change in the product's name, which was referred to as 
sevoflurane in both its bulk and processed form. Additionally, 
because the imported bulk drug had a predetermined medicinal use as 
an anesthetic drug, the processing in the United States did not 
result in a change in the product's use. The country of origin of 
the finished product was therefore Japan.
    Here, as in the cases cited above, the processing of bulk 
imported pharmaceuticals into dosage form will not result in a 
substantial transformation. In this case, the processing begins with 
Taiwanese-origin bulk bimatoprost and, after this product is 
combined with inactive ingredients in India, results in bimatoprost 
ophthalmic solution in 0.03%-strength form. Because the product is 
referred to as ``bimatoprost'' both before and after the Indian 
processing, no change in name occurs in India. Furthermore, no 
change in character occurs in India because the bimatoprost 
maintains the same chemical and physical properties both before and 
after the Indian processing. Finally, because the imported, bulk-
form bimatoprost had a predetermined medicinal use as a 
``prostaglandin analog'' used to reduce elevated intraocular 
pressure, no change in use occurs after processing in India. Under 
these circumstances, and consistent with previous CBP rulings, we 
find that the country of origin of the final product is Taiwan, 
where the active ingredient was produced.

HOLDING:

    The country of origin of the bimatoprost ophthalmic solution for 
purposes of U.S. Government procurement is Taiwan.
    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.

ATTACHMENT C

HQ H284692

August 22, 2017

OT:RR:CTF:VS H284692 RMC

CATEGORY: Origin

Kevin J. Maynard
Wiley Rein LLP
1776 K St. NW
Washington, DC 20006

Re: U.S. Government Procurement; Country of Origin of Niacin ER 
Tablets; Substantial Transformation

Dear Mr. Maynard:

    This is in response to your letter, dated March 20, 2017, 
requesting a final determination on behalf of Lupin Pharmaceuticals, 
Inc. (``Lupin'') pursuant to subpart B of Part 177 of the U.S. 
Customs and Border Protection (``CBP'') Regulations (19 CFR part 
177). Under these regulations, which implement Title III of the 
Trade

[[Page 40789]]

Agreements Act of 1979 (``TAA''), as amended (19 U.S.C. 2511 et 
seq.), 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 purposes of granting 
waivers of certain ``Buy American'' restrictions in U.S. law or for 
products offered for sale to the U.S. Government. This final 
determination concerns the country of origin of niacin ER tablets. 
As a U.S. importer, Lupin is a party-at-interest within the meaning 
of 19 CFR 177.22(d)(1) and is entitled to request this final 
determination.
    You have asked that certain information submitted in connection 
with this ruling request be treated as confidential. Inasmuch as 
this request conforms to the requirements of 19 CFR 177.2(b)(7), the 
request for confidentiality is approved. The information contained 
within brackets and all attachments to this ruling request, 
forwarded to our office, will not be released to the public and will 
be withheld from published versions of this ruling.

FACTS:

    Lupin is a subsidiary of Lupin Limited, one of the five largest 
pharmaceutical companies in India. At issue in this case are niacin 
ER tablets, in doses of 500 milligrams, 750 milligrams, and 1000 
milligrams, which you describe as ``an antihyperlipidemic agent . . 
. used in patients with primary hyperlipidemia and mixed 
dyslipidemia.''
    The manufacturing process for Lupin's niacin ER tablets begins 
in either Belgium or Switzerland, where the active pharmaceutical 
ingredient (``API'') nicotinic acid (chemical formula C6H5NO2) is 
produced. You state that the Belgian or Swiss nicotinic acid is the 
only active ingredient in the finished pharmaceutical product. 
However, the finished product contains a number of other inactive 
ingredients, which you describe as excipients. These ingredients are 
combined with the Belgian or Swiss API in India during the 
manufacturing process. The ingredients include the following:
     [ ]
     [ ]
     [ ]
     [ ]
     [ ]
     [ ]
     [ ]
     [ ]
     [ ]
     [ ]
    The manufacturing processes performed in India include the 
following four steps: First, the API and inactive ingredients are 
sifted and blended. Second, the materials are granulated, and then 
sieved. Third, the blend is compressed into tablets and the tablets 
are coated. Finally, in the fourth step, the finished tablets are 
packaged into approved packaging.
    You state that the processes performed to produce the finished 
niacin ER tablets do not result in any change to the chemical 
characteristics of the Belgian or Swiss API or to any other 
ingredients. You also state that the medicinal use, molecular 
formula, and solubility of the API are unchanged by the 
manufacturing operations in India. In short, you characterize the 
Indian operations as mere processing of bulk API into 500-milligram, 
750-milligram, and 1000-milligram dosage form.

ISSUE:

    What is the country of origin of the niacin ER tablets for 
purposes of U.S. Government procurement?

LAW AND ANALYSIS:

    Pursuant to subpart B of Part 177, 19 CFR 177.21 et seq., which 
implements Title III of the Trade Agreements Act of 1979, as amended 
(19 U.S.C. 2511 et seq.), 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 purposes of granting waivers of certain ``Buy American'' 
restrictions in U.S. law or practice for products offered for sale 
to the U.S. Government.
    Under the rule of origin set forth under 19 U.S.C. 2518(4)(B):
    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).
    A substantial transformation occurs when an article emerges from 
a process with a new name, character, and use different from that 
possessed by the article prior to processing. A substantial 
transformation will not result from a minor manufacturing or 
combining process that leaves the identity of the article intact. 
See United States v. Gibson-Thomsen Co., 27 C.C.P.A. 267 (1940); and 
National Juice Products Ass'n v. United States, 628 F.Supp. 978 (Ct. 
Int'l Trade 1986).
    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.
    For example, in HQ H267177, CBP held that Indian- and Chinese-
origin Acyclovir was not substantially transformed in the United 
States when it was combined with excipients and processed into 
tablets. In that case, the Indian or Chinese Acyclovir was the only 
active pharmaceutical ingredient in the final product. Accordingly, 
we found that the processing performed in the United States did not 
result in a change in the medicinal use of the finished product. 
Furthermore, the Acyclovir maintained its chemical and physical 
characteristics and did not undergo a change in name, character, or 
use. Consistent with our previous rulings, we held that processing 
the Acyclovir into dosage form and packaging it for sale in the 
United States did not constitute a substantial transformation. 
Accordingly, the country of origin of the final product for purposes 
of U.S. Government procurement was either China or India, where the 
active ingredient was produced.
    Similarly, in HQ H233356, CBP held that the processing and 
packaging of imported mefenamic acid into dosage form in the United 
States did not constitute substantial transformation. Based on 
previous CBP rulings, we found that the specific U.S. processing--
which involved blending the active ingredients with inactive 
ingredients in a tumbler and then encapsulating and packaging the 
product--did not substantially transform the mefenamic acid because 
its chemical character remained the same. Accordingly, we held that 
the country of origin of the final product was India, where the 
mefanamic acid was produced.
    In HQ 561975, we also held that the processing of imported bulk 
Japanese-origin anesthetic drugs into dosage form in the United 
States did not constitute substantial transformation. Although the 
bulk form of the drug underwent testing operations, filtering, and 
packaging in the United States, these processes did not change the 
chemical or physical properties of the drug. Furthermore, there was 
no change in the product's name, which was referred to as 
sevoflurane in both its bulk and processed form. Additionally, 
because the imported bulk drug had a predetermined medicinal use as 
an anesthetic drug, the processing in the United States did not 
result in a change in the product's use. The country of origin of 
the finished product was therefore Japan.
    Here, as in the cases cited above, the processing of bulk 
imported pharmaceuticals into dosage form will not result in a 
substantial transformation. In this case, the processing begins with 
Belgian- or Swiss-origin bulk nicotinic acid and, after this product 
is combined with inactive ingredients in India, results in niacin ER 
tablets in individual doses of 500 milligrams, 750 milligrams, or 
1000 milligrams. Although Lupin refers to the final product as 
niacin, it is also commonly known as nicotinic acid. See WebMD, 
Niacin ER, https://webmd.com/drugs/2/drug-3745-9126/niacin-oral/niacin-extended-release-oral/details (last visited June 22, 2017). 
Because the product is referred to as nicotinic acid both before and 
after the Indian processing, no change in name occurs in India. 
Furthermore, no change in character occurs in India because the 
nicotinic acid maintains the same chemical and physical properties 
both before and after the Indian processing. Finally, because the 
imported, bulk-form nicotinic acid had a predetermined medicinal use 
as an antihyperlipidemic agent, no change in use occurs after 
processing in India. Under these circumstances, and consistent with 
previous CBP rulings, we find that the country of origin of the 
final product is

[[Page 40790]]

Belgium or Switzerland, where the active ingredient was produced.

HOLDING:

    The country of origin of the niacin ER tablets for purposes of 
U.S. Government procurement is Belgium or Switzerland.

ATTACHMENT D

HQ H284694

August 22, 2017

OT:RR:CTF:VS H284694 RMC

CATEGORY: Origin

Kevin J. Maynard
Wiley Rein LLP
1776 K St. NW
Washington, DC 20006

Re: U.S. Government Procurement; Country of Origin of Calcium 
Acetate Capsules; Substantial Transformation

Dear Mr. Maynard:

    This is in response to your letter, dated March 20, 2017, 
requesting a final determination on behalf of Lupin Pharmaceuticals, 
Inc. (``Lupin'') pursuant to subpart B of Part 177 of the U.S. 
Customs and Border Protection (``CBP'') Regulations (19 CFR Part 
177). Under these regulations, which implement Title III of the 
Trade Agreements Act of 1979 (``TAA''), as amended (19 U.S.C. 2511 
et seq.), 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 purposes of granting 
waivers of certain ``Buy American'' restrictions in U.S. law or for 
products offered for sale to the U.S. Government. This final 
determination concerns the country of origin of calcium acetate 
capsules. As a U.S. importer, Lupin is a party-at-interest within 
the meaning of 19 CFR 177.22(d)(1) and is entitled to request this 
final determination.
    You have asked that certain information submitted in connection 
with this ruling request be treated as confidential. Inasmuch as 
this request conforms to the requirements of 19 CFR 177.2(b)(7), the 
request for confidentiality is approved. The information contained 
within brackets and all attachments to this ruling request, 
forwarded to our office, will not be released to the public and will 
be withheld from published versions of this ruling.

FACTS:

    Lupin is a subsidiary of Lupin Limited, one of the five largest 
pharmaceutical companies in India. At issue in this case are calcium 
acetate capsules, in doses of 667 milligrams, which you describe as 
a `` `antihyperphosphatemic' or `phosphate binder' that is used to 
reduce the levels of phosphate in the blood.''
    The manufacturing process for Lupin's calcium acetate capsules 
begins in the Netherlands, where the active pharmaceutical 
ingredient (``API'') calcium acetate (chemical formula C4H6CaO4) is 
produced. You state that the Dutch calcium acetate is the only 
active ingredient in the finished pharmaceutical product. However, 
the finished product contains a number of other inactive 
ingredients. These ingredients are combined with the Dutch API in 
India during the manufacturing process. The ingredients include the 
following:
     [ ]
     [ ]
     [ ]
    The manufacturing processes performed in India include the 
following three steps: First, the API and inactive ingredients are 
sifted and blended. Second, the blend is filled in gelatin capsules. 
Finally, in the third step, the finished capsules are packaged into 
approved packaging.
    You state that the processes performed to produce the finished 
calcium acetate capsules do not result in any change to the chemical 
characteristics of the Dutch API or to any other ingredients. You 
also state that the medicinal use, molecular formula, and solubility 
of the API are unchanged by the manufacturing operations in India. 
In short, you characterize the Indian operations as mere processing 
of bulk API into 667 milligram dosage form.

ISSUE:

    What is the country of origin of the calcium acetate capsules 
for purposes of U.S. Government procurement?

LAW AND ANALYSIS:

    Pursuant to subpart B of Part 177, 19 CFR 177.21 et seq., which 
implements Title III of the Trade Agreements Act of 1979, as amended 
(19 U.S.C. 2511 et seq.), 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 purposes of granting waivers of certain ``Buy American'' 
restrictions in U.S. law or practice for products offered for sale 
to the U.S. Government.
    Under the rule of origin set forth under 19 U.S.C. 2518(4)(B):
    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).
    A substantial transformation occurs when an article emerges from 
a process with a new name, character, and use different from that 
possessed by the article prior to processing. A substantial 
transformation will not result from a minor manufacturing or 
combining process that leaves the identity of the article intact. 
See United States v. Gibson-Thomsen Co., 27 C.C.P.A. 267 (1940); and 
National Juice Products Ass'n v. United States, 628 F.Supp. 978 (Ct. 
Int'l Trade 1986).
    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.
    For example, in HQ H267177, CBP held that Indian- and Chinese-
origin Acyclovir was not substantially transformed in the United 
States when it was combined with excipients and processed into 
tablets. In that case, the Indian or Chinese Acyclovir was the only 
active pharmaceutical ingredient in the final product. Accordingly, 
we found that the processing performed in the United States did not 
result in a change in the medicinal use of the finished product. 
Furthermore, the Acyclovir maintained its chemical and physical 
characteristics and did not undergo a change in name, character, or 
use. Consistent with our previous rulings, we held that processing 
the Acyclovir into dosage form and packaging it for sale in the 
United States did not constitute a substantial transformation. 
Accordingly, the country of origin of the final product for purposes 
of U.S. Government procurement was either China or India, where the 
active ingredient was produced.
    Similarly, in HQ H233356, CBP held that the processing and 
packaging of imported mefenamic acid into dosage form in the United 
States did not constitute substantial transformation. Based on 
previous CBP rulings, we found that the specific U.S. processing--
which involved blending the active ingredients with inactive 
ingredients in a tumbler and then encapsulating and packaging the 
product--did not substantially transform the mefenamic acid because 
its chemical character remained the same. Accordingly, we held that 
the country of origin of the final product was India, where the 
mefanamic acid was produced.
    In HQ 561975, we also held that the processing of imported bulk 
Japanese-origin anesthetic drugs into dosage form in the United 
States did not constitute substantial transformation. Although the 
bulk form of the drug underwent testing operations, filtering, and 
packaging in the United States, these processes did not change the 
chemical or physical properties of the drug. Furthermore, there was 
no change in the product's name, which was referred to as 
sevoflurane in both its bulk and processed form. Additionally, 
because the imported bulk drug had a predetermined medicinal use as 
an anesthetic drug, the processing in the United States did not 
result in a change in the product's use. The country of origin of 
the finished product was therefore Japan.
    Here, as in the cases cited above, the processing of bulk 
imported pharmaceuticals into dosage form will not result in a 
substantial transformation. In this case, the processing begins with 
Dutch-origin bulk calcium acetate and, after this product is 
combined with inactive ingredients in India, results in calcium 
acetate capsules in individual doses of 667 milligrams. Because the 
product is referred to as ``calcium

[[Page 40791]]

acetate'' both before and after the Indian processing, no change in 
name occurs in India. Furthermore, no change in character occurs in 
India because the calcium acetate maintains the same chemical and 
physical properties both before and after the Indian processing. 
Finally, because the imported, bulk-form calcium acetate had a 
predetermined medicinal use as an antihyperphosphatemic or phosphate 
binder, no change in use occurs after processing in India. Under 
these circumstances, and consistent with previous CBP rulings, we 
find that the country of origin of the final product is the 
Netherlands, where the active ingredient was produced.

HOLDING:

    The country of origin of the calcium acetate capsules for 
purposes of U.S. Government procurement is the Netherlands.
    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.

    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.

ATTACHMENT E

HQ H284695

August 22, 2017

OT:RR:CTF:VS H284695 RMC

CATEGORY: Origin

Kevin J. Maynard
Wiley Rein LLP
1776 K St. NW
Washington, DC 20006

Re: U.S. Government Procurement; Country of Origin of Quinine 
Sulfate Capsules; Substantial Transformation

Dear Mr. Maynard:

    This is in response to your letter, dated March 20, 2017, 
requesting a final determination on behalf of Lupin Pharmaceuticals, 
Inc. (``Lupin'') pursuant to subpart B of Part 177 of the U.S. 
Customs and Border Protection (``CBP'') Regulations (19 CFR Part 
177). Under these regulations, which implement Title III of the 
Trade Agreements Act of 1979 (``TAA''), as amended (19 U.S.C. 2511 
et seq.), 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 purposes of granting 
waivers of certain ``Buy American'' restrictions in U.S. law or for 
products offered for sale to the U.S. Government. This final 
determination concerns the country of origin of quinine sulfate 
capsules. As a U.S. importer, Lupin is a party-at-interest within 
the meaning of 19 CFR 177.22(d)(1) and is entitled to request this 
final determination.
    You have asked that certain information submitted in connection 
with this ruling request be treated as confidential. Inasmuch as 
this request conforms to the requirements of 19 CFR 177.2(b)(7), the 
request for confidentiality is approved. The information contained 
within brackets and all attachments to this ruling request, 
forwarded to our office, will not be released to the public and will 
be withheld from published versions of this ruling.

FACTS:

    Lupin is a subsidiary of Lupin Limited, one of the five largest 
pharmaceutical companies in India. At issue in this case are quinine 
sulfate capsules, in doses of 324 milligrams, which you describe as 
`` `cinchona alkaloid[s]' that [are] used for the treatment of 
malaria.''
    The manufacturing process for Lupin's quinine sulfate capsules 
begins in Germany, where the active pharmaceutical ingredient 
(``API'') quinine sulfate (chemical formula ((C20H24N2O2)2H2SO42H2O) 
is produced. You state that the German quinine sulfate is the only 
active ingredient in the finished pharmaceutical product. However, 
the finished product contains a number of other inactive 
ingredients, which you describe as excipients. These ingredients are 
combined with the German API in India during the manufacturing 
process. The ingredients include the following:
     [ ]
     [ ]
     [ ]
     [ ]
    The manufacturing processes performed in India include the 
following four steps: First, the API and inactive ingredients are 
sifted and blended. Second, the materials are granulated, and then 
sieved. Third, the blend is filled in gelatin capsules. Finally, in 
the fourth step, the finished capsules are packaged into approved 
packaging.
    You state that the processes performed to produce the finished 
quinine sulfate capsules do not result in any change to the chemical 
characteristics of the German API or to any other ingredients. You 
also state that the medicinal use, molecular formula, and solubility 
of the API are unchanged by the manufacturing operations in India. 
In short, you characterize the Indian operations as mere processing 
of bulk API into 324 milligram dosage form.

ISSUE:

    What is the country of origin of the quinine sulfate capsules 
for purposes of U.S. Government procurement?

LAW AND ANALYSIS:

    Pursuant to subpart B of Part 177, 19 CFR 177.21 et seq., which 
implements Title III of the Trade Agreements Act of 1979, as amended 
(19 U.S.C. 2511 et seq.), 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 purposes of granting waivers of certain ``Buy American'' 
restrictions in U.S. law or practice for products offered for sale 
to the U.S. Government.
    Under the rule of origin set forth under 19 U.S.C. 2518(4)(B):
    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).
    A substantial transformation occurs when an article emerges from 
a process with a new name, character, and use different from that 
possessed by the article prior to processing. A substantial 
transformation will not result from a minor manufacturing or 
combining process that leaves the identity of the article intact. 
See United States v. Gibson-Thomsen Co., 27 C.C.P.A. 267 (1940); and 
National Juice Products Ass'n v. United States, 628 F.Supp. 978 (Ct. 
Int'l Trade 1986).
    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.
    For example, in HQ H267177, CBP held that Indian- and Chinese-
origin Acyclovir was not substantially transformed in the United 
States when it was combined with excipients and processed into 
tablets. In that case, the Indian or Chinese Acyclovir was the only 
active pharmaceutical ingredient in the final product. Accordingly, 
we found that the processing performed in the United States did not 
result in a change in the medicinal use of the finished product. 
Furthermore, the Acyclovir maintained its chemical and physical 
characteristics and did not undergo a change in name, character, or 
use. Consistent with our previous rulings, we

[[Page 40792]]

held that processing the Acyclovir into dosage form and packaging it 
for sale in the United States did not constitute a substantial 
transformation. Accordingly, the country of origin of the final 
product for purposes of U.S. Government procurement was either China 
or India, where the active ingredient was produced.
    Similarly, in HQ H233356, CBP held that the processing and 
packaging of imported mefenamic acid into dosage form in the United 
States did not constitute substantial transformation. Based on 
previous CBP rulings, we found that the specific U.S. processing--
which involved blending the active ingredients with inactive 
ingredients in a tumbler and then encapsulating and packaging the 
product--did not substantially transform the mefenamic acid because 
its chemical character remained the same. Accordingly, we held that 
the country of origin of the final product was India, where the 
mefanamic acid was produced.
    In HQ 561975, we also held that the processing of imported bulk 
Japanese-origin anesthetic drugs into dosage form in the United 
States did not constitute substantial transformation. Although the 
bulk form of the drug underwent testing operations, filtering, and 
packaging in the United States, these processes did not change the 
chemical or physical properties of the drug. Furthermore, there was 
no change in the product's name, which was referred to as 
sevoflurane in both its bulk and processed form. Additionally, 
because the imported bulk drug had a predetermined medicinal use as 
an anesthetic drug, the processing in the United States did not 
result in a change in the product's use. The country of origin of 
the finished product was therefore Japan.
    Here, as in the cases cited above, the processing of bulk 
imported pharmaceuticals into dosage form will not result in a 
substantial transformation. In this case, the processing begins with 
German-origin bulk quinine sulfate and, after this product is 
combined with inactive ingredients in India, results in quinine 
sulfate capsules in 324 milligram doses. Because the product is 
referred to as ``quinine sulfate'' both before and after the Indian 
processing, no change in name occurs in India. Furthermore, no 
change in character occurs in India because the quinine sulfate 
maintains the same chemical and physical properties both before and 
after the Indian processing. Finally, because the imported, bulk-
form quinine sulfate had a predetermined medicinal use as an 
antimalarial drug, no change in use occurs after processing in 
India. Under these circumstances, and consistent with previous CBP 
rulings, we find that the country of origin of the final product is 
Germany, where the active ingredient was produced.

HOLDING:

    The country of origin of the quinine sulfate capsules for 
purposes of U.S. Government procurement is Germany.
    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.

ATTACHMENT F

HQ H284697

August 22, 2017

OT:RR:CTF:VS H284697 RMC

CATEGORY: Origin

Kevin J. Maynard
Wiley Rein LLP
1776 K St. NW
Washington, DC 20006

Re: U.S. Government Procurement; Country of Origin of Pravastatin 
Sodium Tablets; Substantial Transformation

    Dear Mr. Maynard:

    This is in response to your letter, dated March 20, 2017, 
requesting a final determination on behalf of Lupin Pharmaceuticals, 
Inc. (``Lupin'') pursuant to subpart B of Part 177 of the U.S. 
Customs and Border Protection (``CBP'') Regulations (19 CFR Part 
177). Under these regulations, which implement Title III of the 
Trade Agreements Act of 1979 (``TAA''), as amended (19 U.S.C. 2511 
et seq.), 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 purposes of granting 
waivers of certain ``Buy American'' restrictions in U.S. law or for 
products offered for sale to the U.S. Government. This final 
determination concerns the country of origin of pravastatin sodium 
tablets. As a U.S. importer, Lupin is a party-at-interest within the 
meaning of 19 CFR 177.22(d)(1) and is entitled to request this final 
determination.
    You have asked that certain information submitted in connection 
with this ruling request be treated as confidential. Inasmuch as 
this request conforms to the requirements of 19 CFR 177.2(b)(7), the 
request for confidentiality is approved. The information contained 
within brackets and all attachments to this ruling request, 
forwarded to our office, will not be released to the public and will 
be withheld from published versions of this ruling.

FACTS:

    Lupin is a subsidiary of Lupin Limited, one of the five largest 
pharmaceutical companies in India. At issue in this case are 
pravastatin sodium tablets in doses of 10, 20, 40, and 80 
milligrams, which you describe as a pharmaceutical product that is 
``an antilipimic agent that is used to reduce the risk of myocardial 
infarction.''
    The manufacturing process for Lupin's pravastatin sodium tablets 
begins in Taiwan, where the active pharmaceutical ingredient 
(``API'') pravastatin sodium (chemical formula C23H35NaO7) is 
produced. You state that the Taiwanese pravastatin sodium is the 
only active ingredient in the finished pharmaceutical product. 
However, the finished product contains a number of other inactive 
ingredients, which you describe as excipients. These ingredients are 
combined with the Taiwanese API in India during the manufacturing 
process. The ingredients include the following:
     [ ]
     [ ]
     [ ]
     [ ]
     [ ]
     [ ]
     [ ]
    The manufacturing processes performed in India include the 
following three steps: First, the API and inactive ingredients are 
sifted and blended. Second, the blend is compressed into tablets and 
the tablets are coated. Finally, in the third step, the finished 
tablets are packaged into approved packaging.
    You state that the processes performed to produce the finished 
pravastatin sodium tablets do not result in any change to the 
chemical characteristics of the Taiwanese API or to any other 
ingredients. You also state that the medicinal use, molecular 
formula, and solubility of the API are unchanged by the 
manufacturing operations in India. In short, you characterize the 
Indian operations as mere processing of bulk API into 10-, 20-, 40-, 
and 80-milligram dosage form.

ISSUE:

    What is the country of origin of the pravastatin sodium tablets 
for purposes of U.S. Government procurement?

LAW AND ANALYSIS:

    Pursuant to subpart B of Part 177, 19 CFR 177.21 et seq., which 
implements Title III of the Trade Agreements Act of 1979, as amended 
(19 U.S.C. 2511 et seq.), 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 purposes of granting waivers of certain ``Buy American'' 
restrictions in U.S. law or practice for products offered for sale 
to the U.S. Government.
    Under the rule of origin set forth under 19 U.S.C. 2518(4)(B):
    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).
    A substantial transformation occurs when an article emerges from 
a process with a new name, character, and use different from that 
possessed by the article prior to processing. A substantial 
transformation will not result from a minor manufacturing or 
combining

[[Page 40793]]

process that leaves the identity of the article intact. See United 
States v. Gibson-Thomsen Co., 27 C.C.P.A. 267 (1940); and National 
Juice Products Ass'n v. United States, 628 F.Supp. 978 (Ct. Int'l 
Trade 1986).
    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.
    For example, in HQ H267177, CBP held that Indian- and Chinese-
origin Acyclovir was not substantially transformed in the United 
States when it was combined with excipients and processed into 
tablets. In that case, the Indian or Chinese Acyclovir was the only 
active pharmaceutical ingredient in the final product. Accordingly, 
we found that the processing performed in the United States did not 
result in a change in the medicinal use of the finished product. 
Furthermore, the Acyclovir maintained its chemical and physical 
characteristics and did not undergo a change in name, character, or 
use. Consistent with our previous rulings, we held that processing 
the Acyclovir into dosage form and packaging it for sale in the 
United States did not constitute a substantial transformation. 
Accordingly, the country of origin of the final product for purposes 
of U.S. Government procurement was either China or India, where the 
active ingredient was produced.
    Similarly, in HQ H233356, CBP held that the processing and 
packaging of imported mefenamic acid into dosage form in the United 
States did not constitute substantial transformation. Based on 
previous CBP rulings, we found that the specific U.S. processing--
which involved blending the active ingredients with inactive 
ingredients in a tumbler and then encapsulating and packaging the 
product--did not substantially transform the mefenamic acid because 
its chemical character remained the same. Accordingly, we held that 
the country of origin of the final product was India, where the 
mefanamic acid was produced.
    In HQ 561975, we also held that the processing of imported bulk 
Japanese-origin anesthetic drugs into dosage form in the United 
States did not constitute substantial transformation. Although the 
bulk form of the drug underwent testing operations, filtering, and 
packaging in the United States, these processes did not change the 
chemical or physical properties of the drug. Furthermore, there was 
no change in the product's name, which was referred to as 
sevoflurane in both its bulk and processed form. Additionally, 
because the imported bulk drug had a predetermined medicinal use as 
an anesthetic drug, the processing in the United States did not 
result in a change in the product's use. The country of origin of 
the finished product was therefore Japan.
    Here, as in the cases cited above, the processing of bulk 
imported pharmaceuticals into dosage form will not result in a 
substantial transformation. In this case, the processing begins with 
Taiwanese-origin bulk pravastatin sodium and, after this product is 
combined with inactive ingredients in India, results in pravastatin 
sodium tablets in individual doses of 10, 20, 40, or 80 milligrams. 
Because the product is referred to as ``pravastatin sodium'' both 
before and after the Indian processing, no change in name occurs in 
India. Furthermore, no change in character occurs in India because 
the pravastatin sodium maintains the same chemical and physical 
properties both before and after the Indian processing. Finally, 
because the imported, bulk-form pravastatin sodium had a 
predetermined medicinal use as an antilipimic agent that is used to 
reduce the risk of myocardial infarction, no change in use occurs 
after processing in India. Under these circumstances, and consistent 
with previous CBP rulings, we find that the country of origin of the 
final product is Taiwan, where the active ingredient was produced.

HOLDING:

    The country of origin of the pravastatin sodium tablets for 
purposes of U.S. Government procurement is Taiwan.
    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. 2017-18205 Filed 8-25-17; 8:45 am]
 BILLING CODE 9111-14-P