The tariff classification of Micafungin Sodium for Injection in dosage form, from Malta

N328951 November 16, 2022 CLA-2-30:OT:RR:NC:N3:138 CATEGORY: Classification TARIFF NO.: 3004.20.0060 Mrs. Rhona M. Keeler NorthStar Healthcare 3300 Cork Airport Business Park Kinsale Road, Cork T12 XN72 Ireland RE: The tariff classification of Micafungin Sodium for Injection in dosage form, from Malta Dear Mrs. Keeler: In your letter dated October 25, 2022, you requested a tariff classification ruling. Micafungin Sodium 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. It is also used for the prophylaxis of Candida infections during stem cell transplantation. The applicable subheading for Micafungin Sodium 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. 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