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

N274632 April 20, 2016 CLA-2-30:OT:RR:NC:N2:238 CATEGORY: Classification TARIFF NO.: 3004.90.9115 Ms. Tanya Hurley BluePoint Laboratories 8 Eastgate Avenue Eastgate Business Park Little Island, Cork 1111, Ireland RE: The tariff classification of Gemcitabine Injection in dosage form, from India Dear Ms. Hurley: In your letter dated April 6, 2016, 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 38mg/ml single dose vials. The applicable subheading for Gemcitabine Injection in dosage form will be 3004.90.9115, 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, Deborah C. Marinucci Acting Director National Commodity Specialist Division