The tariff classification and country of origin of Phytonadione Injectable Emulsion 10 mg/mL in dosage form, from Switzerland

N305364 August 13, 2019 CLA-2-30:OT:RR:NC:N3:138 CATEGORY: Classification; Country of Origin TARIFF NO.: 3004.50.5020 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 Phytonadione Injectable Emulsion 10 mg/mL in dosage form, from Switzerland Dear Mr. Braier: In your letter dated July 18, 2019, on behalf of Dr. Reddy’s Laboratories, Inc., you requested a tariff classification and country of origin ruling. The subject product, Phytonadione Injectable Emulsion 10 mg/mL, is also known as vitamin K1. It is available by prescription only and indicated for the treatment of coagulation disorders, which are due to faulty formation of factors II, VII, IX and X when caused by vitamin K deficiency or interference with vitamin K activity. The applicable subheading for the Phytonadione Injectable Emulsion 10 mg/mL in dosage form will be 3004.50.5020, 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, containing vitamins or other products of heading 2936: Other: Other: Single Vitamins: Other." 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), Phytonadione, is manufactured in Switzerland. In India, the Phytonadione will be mixed with inactive ingredients sourced from various countries to produce the final product, Phytonadione Injectable Emulsion 10 mg/mL in dosage form. You suggest that the country of origin remains Switzerland, 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 mixing of the active ingredient Phytonadione (made in Switzerland) with the inactive ingredients into the final dosage injectable emulsion in India does not result in a substantial transformation and the country of origin will be Switzerland. 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 [email protected]. Sincerely, Steven A. Mack Director National Commodity Specialist Division