The country of origin of Estradiol Transdermal Systems, USP

N333205 June 23, 2023 OT:RR:NC:N3:138 CATEGORY: Origin Pradeep Shah Zydus Pharmaceuticals USA Inc. 73 Route 31 NPennington, NJ 08534 RE:  The country of origin of Estradiol Transdermal Systems, USP Dear Mr. Shah: In your letter dated May 30, 2023, you requested a country of origin ruling on Estradiol Transdermal Systems, USP.   Estradiol Transdermal System is a prescription medicine that contains estradiol, an estrogen hormone, as the active ingredient. It is indicated for the treatment of moderate to severe vasomotor symptoms due to menopause. The Estradiol Transdermal System (twice weekly) will be imported in 0.025 mg, 0.0375 mg, 0.05 mg, 0.075 mg and 0.1 mg/day patches, administered as continuous delivery for twice-weekly application. The Estradiol Transdermal System (once weekly) will also be imported in 0.025 mg, 0.0375 mg, 0.05 mg, 0.06 mg, 0.075 mg and 0.1 mg/day patches administered as continuous delivery for once-weekly application. Except for the dosage amounts and schedule, these two system are essentially the same and the same rules for the country of origin apply to both of them. You stated that the active pharmaceutical ingredient (API), Estradiol, is manufactured in the Netherlands and that the finished Estradiol Transdermal System is made in India.  In India, the Estradiol will be mixed with various inactive ingredients to produce the final Estradiol Transdermal System.   Section 134.1(b), Customs Regulations (19 CFR 134.1(b)), defines "country of origin" as: The country of manufacture, production or growth of any article of foreign origin entering the United States. Further work or material added to an article in another country must effect a substantial transformation in order to render such other country the "country of origin" within the meaning of this part; …. A substantial transformation occurs when an article emerges from a process with a new name, character or 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 Association v. United States, 628 F. Supp. 978 (Ct. Int’l Trade 1986). In this case, we find the mixing of the active ingredient Estradiol (made in the Netherlands) with the inactive ingredients into the final Estradiol Transdermal System does not result in a substantial transformation and the country of origin will be the Netherlands. 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. 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 judy.h.lee@cbp.dhs.gov. Sincerely, Steven A. Mack Director National Commodity Specialist Division