OT:RR:NC:N3:138
Pradeep Shah
Zydus Pharmaceuticals USA Inc.
73 Route 31 North
Pennington, NJ 08534
RE: The country of origin of Norelgestromin and Ethinyl Estradiol Transdermal System (Patch)
Dear Mr. Shah:
In your letter dated July 20, 2026, you requested a country of origin ruling on Norelgestromin and Ethinyl
Estradiol Transdermal System, (Patch) 150/35 mcg per day.
Norelgestromin and Ethinyl Estradiol Transdermal System, imported in 150/35 mcg per day, is a
combination transdermal contraceptive system containing Norelgestromin (a progestin) and Ethinyl Estradiol
(an estrogen), as the active ingredients. It is indicated for the prevention of pregnancy in women with a body
mass index BMI < 30 kg/m2 for whom a combined hormonal contraceptive is appropriate.
In your letter, you are requesting three different manufacturing scenarios for the Norelgestromin and Ethinyl
Estradiol Patches. In your scenarios, the active pharmaceutical ingredients (APIs) Norelgestromin will be
manufactured in Argentina or Italy, and the Ethinyl Estradiol will be manufactured in Italy or India. In all
scenarios, the APIs (Norelgestromin and Ethinyl Estradiol) will be mixed with various inactive ingredients to
produce the final transdermal patches in dosage form in India.
When determining the country of origin, the substantial transformation analysis is applicable. See, e.g.,
Headquarters Ruling Letter (“HQ”) H301619, dated November 6, 2018. The test for determining whether a
substantial transformation will occur is whether an article emerges from a process with a new name,
character, or use different from that possessed by the article prior to processing. See Texas Instruments Inc. v.
United States, 681 F.2d 778 (C.C.P.A. 1982). This determination is based on the totality of the evidence. See
National Hand Tool Corp. v. United States, 16 C.I.T. 308 (1992), aff’d, 989 F.2d 1201 (Fed. Cir. 1993).
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., 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. However, where the processing from bulk
form into measured doses involves the combination of two or more APIs, and the resulting combination
offers additional medicinal benefits compared to taking each API alone, CBP has held that a substantial
transformation occurred. See, e.g., HQ 563207, dated June 1, 2005.
In these cases, we note that the two separate APIs are mixed to create a combination drug that offers
additional medicinal benefits compared to taking each API alone. Therefore, we find the mixing of the active
ingredients, Norelgestromin and Ethinyl Estradiol with the inactive ingredients and processed into the final
transdermal patches in India results in a substantial transformation and the country of origin will be India.
This merchandise may be subject to the Federal Food, Drug, and Cosmetic Act and/or The Public Health
Security and Bioterrorism Preparedness and Response Act of 2002 (The Bioterrorism Act), which are
administered by the U.S. Food and Drug Administration (FDA). Information on the Federal Food, Drug, and
Cosmetic Act, as well as The Bioterrorism Act, can be obtained by calling the FDA at 1-888-463-6332, or by
visiting their website at www.fda.gov.
The holding set forth above applies only to the specific factual situation and merchandise description as
identified in the ruling request. This position is clearly set forth in Title 19, Code of Federal Regulations
(CFR), Section 177.9(b)(1). This section states that a ruling letter is issued on the assumption that all of the
information furnished in the ruling letter, whether directly, by reference, or by implication, is accurate and
complete in every material respect. In the event that the facts are modified in any way, or if the goods do not
conform to these facts at time of importation, you should bring this to the attention of U.S. Customs and
Border Protection (CBP) and submit a request for a new ruling in accordance with 19 CFR 177.2.
Additionally, we note that the material facts described in the foregoing ruling may be subject to periodic
verification by CBP.
This ruling is being issued under the provisions of Part 177 of the Customs and Border Protection
Regulations (19 C.F.R. 177).
A copy of the ruling or the control number indicated above should be provided with the entry documents
filed at the time this merchandise is imported. If you have any questions regarding the ruling, please contact
National Import Specialist Judy Lee at [email protected].
Sincerely,
(for)
James P. Forkan
Director
National Commodity Specialist Division