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

N319435 June 10, 2021 CLA-2-30:OT:RR:NC:N3:138 CATEGORY: Classification; Country of Origin TARIFF NO.: 3004.20.0060 Mr. Pradeep Shah Zydus Pharmaceuticals USA Inc. 73 Route 31 North Pennington, NJ 08534 RE: The tariff classification and country of origin of Micafungin for Injection in dosage form Dear Mr. Shah: In your letter dated May 13, 2021, you requested a tariff classification and country of origin ruling. Micafungin for Injection, imported in 50 mg and 100 mg vials, is an antifungal medication containing Micafungin Sodium, as the active ingredient. It is indicated for the treatment of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses in adult and pediatric patients four months of age and older. The applicable subheading for the Micafungin for Injection in dosage form will be 3004.20.0060, 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 antibiotics: Other: 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. You also requested a country of origin ruling. You stated that the active pharmaceutical ingredient (API), Micafungin Sodium, is manufactured in Malta and that the finished Micafungin for Injection in dosage form is made in India. In India, the Micafungin Sodium will be mixed with various inactive ingredients to produce the final Micafungin for 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 mixing of the active ingredient Micafungin Sodium (made in Malta) with the inactive ingredients into the Micafungin injection in dosage form in India does not result in a substantial transformation and the country of origin will be Malta. 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