40786 Federal Register / Vol. 82, No. 165 / Monday, August 28, 2017 / Notices 

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 and Rulings, 

Office of Trade. 

[FR Doc. 2017–18202 Filed 8–25–17; 8:45 am] 

BILLING CODE 9111–14–P 

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. § 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 partyat-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. 


asabaliauskas on DSKBBXCHB2PROD with NOTICES
Federal Register / Vol. 82, No. 165 / Monday, August 28, 2017 / Notices 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 antiinflammatory, 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-atinterest 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-atinterest 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 


asabaliauskas on DSKBBXCHB2PROD with NOTICES
40788 Federal Register / Vol. 82, No. 165 / Monday, August 28, 2017 / Notices 

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. § 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 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-atinterest 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 


asabaliauskas on DSKBBXCHB2PROD with NOTICES
Federal Register / Vol. 82, No. 165 / Monday, August 28, 2017 / Notices 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 Swissorigin 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, http://webmd.com/ 

drugs/2/drug-3745–9126/niacin-oral/niacinextended-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 


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40790 Federal Register / Vol. 82, No. 165 / Monday, August 28, 2017 / Notices 

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 


asabaliauskas on DSKBBXCHB2PROD with NOTICES
Federal Register / Vol. 82, No. 165 / Monday, August 28, 2017 / Notices 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-atinterest 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-atinterest 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 


asabaliauskas on DSKBBXCHB2PROD with NOTICES
40792 Federal Register / Vol. 82, No. 165 / Monday, August 28, 2017 / Notices 

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-atinterest 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 


asabaliauskas on DSKBBXCHB2PROD with NOTICES
Federal Register / Vol. 82, No. 165 / Monday, August 28, 2017 / Notices 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-atinterest 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 

INTER-AMERICAN FOUNDATION 

Sunshine Act Meetings 

TIME AND DATE: September 6, 2017, 

11:00 a.m.–12:00 p.m. 

PLACE: Via tele-conference hosted at 

Inter-American Foundation, 1331 

Pennsylvania Ave. Suite 1200, NW., 

Washington, DC 20004. 

STATUS: Meeting of the Board of 

Directors, Open to the public. 

MATTERS TO BE CONSIDERED: Next steps 

for updating advisory council 

membership. 

The role of the Board in funding 

decisions. 

FOR DIAL-IN INFORMATION CONTACT: Karen 

Vargas, Executive Assistant, (202) 524– 

8869. 

CONTACT PERSON FOR MORE INFORMATION: 

Paul Zimmerman, General Counsel, 

(202) 683–7118. 

Paul Zimmerman, 

General Counsel. 

[FR Doc. 2017–18263 Filed 8–24–17; 4:15 pm] 

BILLING CODE 7025–01–P 

DEPARTMENT OF THE INTERIOR 

Fish and Wildlife Service 

[FWS–R8–ES–2017–N084; FF08EVEN00– 

FXFR1337088SSO0] 

Marine Mammal Protection Act; Stock 

Assessment Report for the Southern 

Sea Otter in California 

AGENCY: Fish and Wildlife Service, 

Interior. 

ACTION: Notice of availability; response 

to comments. 

SUMMARY: In accordance with the 

Marine Mammal Protection Act of 1972, 

as amended (MMPA), and its 

implementing regulations, we, the U.S. 

Fish and Wildlife Service (Service), 

announce that we have revised our 

stock assessment report (SAR) for the 

southern sea otter stock in the State of 

California, including incorporation of 

public comments. We now make our 

final revised SAR available to the 

public. 

ADDRESSES: Document Availability: You 

may obtain a copy of the SAR from our 

Web site at https://www.fws.gov/ 

ventura/endangered/species/info/ 

sso.html. Alternatively, you may contact 

the Ventura Fish and Wildlife Office, 

U.S. Fish and Wildlife Service, 2493 

Portola Road, Suite B, Ventura, CA 

93003; telephone: 805–644–1766. 

FOR FURTHER INFORMATION CONTACT: For 

information on the methods, data, and 

results of the stock assessment, contact 

Lilian Carswell by telephone (805–677– 

3325) or by email (Lilian_Carswell@

fws.gov). Persons who use a 

telecommunications device for the deaf 

(TDD) may call the Federal Relay 

Service at 800–877–8339. 

SUPPLEMENTARY INFORMATION: We are 

announcing the availability of the final 

revised SAR for the southern sea otter 

(Enhydra lutris nereis) stock in the State 

of California. 

Background 

Under the MMPA (16 U.S.C. 1361 et 

seq.) and its implementing regulations 


asabaliauskas on DSKBBXCHB2PROD with NOTICES