The tariff classification and country of origin of Thiotepa for Injection USP in dosage form

N325787 May 26, 2022 CLA-2-30:OT:RR:NC:N3:138 CATEGORY: Classification; Country of Origin TARIFF NO.: 3004.90.9215 William Gerard Braier Radix Group International Dba DHL Global Forwarding 6120 Ace Industrial Drive Cudahy, WI 53110 RE: The tariff classification and country of origin of Thiotepa for Injection USP in dosage form Dear Mr. Braier: In your letter dated April 29, 2022, on behalf of Dr. Reddy’s Laboratories, Inc., you requested a tariff classification and country of origin ruling. Thiotepa for Injection USP, imported in 15 mg vials, is an anti-cancer (“antineoplastic” or “cytotoxic”) chemotherapy drug. It is indicated for the treatment of breast and ovarian cancer, Hodgkin's and non-Hodgkin's lymphomas, superficial tumors of the bladder, and to help control the accumulation of fluid in body cavities that may result from certain cancers. The applicable subheading for the Thiotepa for Injection USP in dosage form will be 3004.90.9215, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Medicaments … consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses … or in forms or packings for retail sale: Other: Other: Other: Antineoplastic and immunosuppressive medicaments.” The rate of duty will be free. Duty rates are provided for your convenience and are subject to change. The text of the most recent HTSUS and the accompanying duty rates are provided on the World Wide Web at https://hts.usitc.gov/current. 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. You also requested a country of origin determination. You stated that the active pharmaceutical ingredient (API), Thiotepa, is manufactured in Germany and that the finished Thiotepa for Injection in dosage is made in India. You suggest that the country of origin remains Germany, the country in which the API was manufactured. 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 Thiotepa (made in Germany) into the final Thiotepa for Injection in dosage form does not result in a substantial transformation and the country of origin will be Germany. 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