The tariff classification of Clofarabine Injection in dosage form, from India

N282480 February 7, 2017 CLA-2-30:OT:RR:NC:N2:238 CATEGORY: Classification TARIFF NO.: 3004.90.9215 Mr. Pradeep Shah Zydus Pharmaceuticals USA Inc. 73 Route 31 North Pennington, NJ 08534 RE: The tariff classification of Clofarabine Injection in dosage form, from India Dear Mr. Shah: In your letter dated January 10, 2017, you requested a tariff classification ruling. The subject product, Clofarabine injection, imported in 20mg/20mL dosage form, is a medicinal preparation containing Clofarabine, a purine nucleoside metabolic inhibitor with antineoplastic activity, as the active ingredient. It is indicated for the treatment of acute lymphoblastic leukemia in pediatric patients. The applicable subheading for the Clofarabine Injection 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 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