The country of origin of Arsenic Trioxide Injection in dosage form

N308198 January 7, 2020 OT:RR:NC:N3:138 CATEGORY: Country of Origin Mr. Pradeep Shah Zydus Pharmaceuticals USA, Inc. 73 Route 31 North Pennington, NJ 08534 RE: The country of origin of Arsenic Trioxide Injection in dosage form Dear Mr. Shah: In your letter dated December 9, 2019, you requested a country of origin ruling determination on Arsenic Trioxide Injection. Arsenic Trioxide Injection, imported in 1 mg/mL and 2 mg/mL, is in a class of medications called antineoplastics. It is indicated for induction of remission and consolidation in patients with acute promyelocytic leukemia (APL) who are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy, and whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression. You stated that the active pharmaceutical ingredient (API), Arsenic Trioxide, is manufactured in Germany and that the finished injection in dosage form is made in India. In India, Arsenic Trioxide will be mixed with inactive ingredients and processed into the final injection in dosage form. 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 processing of the active ingredient Arsenic Trioxide (German origin) into the final injection form in India does not result in a substantial transformation and the country of origin will be Germany. 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 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, contact National Import Specialist Judy Lee at judy.h.lee@cbp.dhs.gov. Sincerely, Steven A. Mack Director National Commodity Specialist Division