The country of origin of Norelgestromin and Ethinyl Estradiol Transdermal System (Patch)

N363448August 14, 2026OT:RR:NC:N3:138
CATEGORY: OriginPradeep ShahZydus Pharmaceuticals USA Inc.73 Route 31 NorthPennington, NJ 08534RE: 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 EthinylEstradiol Transdermal System, (Patch) 150/35 mcg per day.Norelgestromin and Ethinyl Estradiol Transdermal System, imported in 150/35 mcg per day, is acombination 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 bodymass 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 EthinylEstradiol Patches. In your scenarios, the active pharmaceutical ingredients (APIs) Norelgestromin will bemanufactured in Argentina or Italy, and the Ethinyl Estradiol will be manufactured in Italy or India. In allscenarios, the APIs (Norelgestromin and Ethinyl Estradiol) will be mixed with various inactive ingredients toproduce the final transdermal patches in dosage form in India.When determining the country of origin, the substantial transformation analysis is applicble. See, e.g.,aHeadquarters Ruling Letter (“HQ”) H301619, dated November 6, 2018. The test for determining whether asubstantial 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 exas Instruments Inc. v.T, 681 F.2d 778 (C.C.P.A. 1982). This determination is based on the totality of the evidence. See United States, 16 C.I.T. 308 (1992), aff’d, 989 F.2d 1201 (Fed. Cir. 1993).ational Hand Tool Corp. v. United StatesNIn determining whether a substantial transformation occurs in the manufacture of chemical products such aspharmaceuticals, CBP has consistently examined the complexity of the processing and whether the finalarticle retains the essential identity and character of the raw material. To that end, CBP has generally heldthat the processing of pharmaceutical products from bulk form into measured doses does not result in asubstantial transformation of the product. See, e.g., HQ 561975, dated April 3, 2002; HQ 561544, dated May1, 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 bulkform into measured doses involves the combination of two or more APIs, and the resulting combinationoffers additional medicinal benefits compared to taking each API alone, CBP has held that a substantialtransformation occurred. See, e.g., HQ 563207, dated June 1, 2005. I, we note that the two separate APIs are mixed to create a combination drug that offersn these casesadditional medicinal benefits compared to taking each API alone. Therefore, we find the mixing of the activeingredients, Norelgestromin and Ethinyl Estradiol with the inactive ingredients and processed into the finaltransdermal 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 HealthSecurity and Bioterrorism Preparedness and Response Act of 2002 (The Bioterrorism Act), which areadministered by the U.S. Food and Drug Administration (FDA). Information on the Federal Food, Drug, andCosmetic Act, as well as The Bioterrorism Act, can be obtained by calling the FDA at 1-888-463-6332, or byvisiting their website at www.fda.gov.The holding set forth above applies only to the specific factual situation and merchandise description asidentified 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 theinformation furnished in the ruling letter, whether directly, by reference, or by implication, is accurate andcomplete in every material respect. In the event that the facts are modified in any way, or if the goods do notconform to these facts at time of importation, you should bring this to the attention of U.S. Customs andBorder 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 periodicverification by CBP.This ruling is being issued under the provisions of Part 177 of the Customs and Border ProtectionRegulations (19 C.F.R. 177).A copy of the ruling or the control number indicated above should be provided with the entry documentsfiled at the time this merchandise is imported. If you have any questions regarding the ruling, please contactNational Import Specialist Judy Lee at [email protected].
Sincerely,
(for)James P. ForkanDirectorNational Commodity Specialist Division