The tariff classification of Levoleucovorin Calcium Injection in dosage form, from Switzerland

N302553 February 27, 2019 CLA-2-30:OT:RR:NC:N3:138 CATEGORY: Classification TARIFF NO.: 3004.50.4000 Ms. Rhona M. Keeler NorthStar Healthcare 3300 Cork Airport Business Park Kinsale Road, Cork T12 XN72 Ireland RE: The tariff classification of Levoleucovorin Calcium Injection in dosage form, from Switzerland Dear Ms. Keeler: In your letter dated January 10, 2019, you requested a tariff classification ruling. Levoleucovorin Calcium Injection, imported in 175 mg/17.5 ml and 250 mg/25 ml vials, is a derivative of folic acid that is useful as an antidote to the inhibition of dihydrofolate reductase by methotrexate. Levoleucovorin Calcium injection rescue is indicated after high-dose methotrexate therapy in osteosarcoma and it is also indicated to diminish the toxicity and counteract the effects of impaired methotrexate elimination and of inadvertent overdosage of folic acid antagonists. The applicable subheading for the Levoleucovorin Calcium Injection in dosage form will be 3004.50.4000, 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: Containing vitamins synthesized wholly or in part from aromatic or modified aromatic industrial organic compounds: 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 [email protected]. Sincerely, Steven A. Mack Director National Commodity Specialist Division