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

N294401 March 13, 2018 CLA-2-30:OT:RR:NC:N1:138 CATEGORY: Classification TARIFF NO.: 3004.90.9215 Ms. Paulina Radaczynska BluePoint Laboratories Eastgate Business Park 8 Eastgate Avenue Little Island, Cork Ireland RE: The tariff classification of Gemcitabine Injection in dosage form, from India Dear Ms. Radaczynska: In your letter dated February 15, 2018, you requested a tariff classification ruling. The subject product, Gemcitabine Injection, is a medicinal preparation containing Gemcitabine Hydrochloride, an analogue of the antimetabolite nucleoside deoxycytidine, as the active ingredient. It is an antineoplastic drug that is indicated for the treatment of ovarian cancer, breast cancer, non-small cell lung cancer and pancreatic cancer. Gemcitabine Injection will be imported in dosages of 200 mg/2 ml, 1 g/10 ml, 1.5 g/15 ml and 2 g/20 ml. The applicable subheading for the Gemcitabine 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 ruling is being issued under the provisions of Part 177 of the Customs Regulations (19 C.F.R. 177). 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. 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