The tariff classification of Fluorouracil Injection, USP, 50 mg/mL, from India

N260492 January 26, 2015 CLA-2-30:OT:RR:NC:2:238 CATEGORY: Classification TARIFF NO.: 3004.90.9115 Ms. Tanya Hurley Bluepoint Laboratories Eastgate Business Park Eastgate Road, Building 1 Little Island, Cork Ireland RE: The tariff classification of Fluorouracil Injection, USP, 50 mg/mL, from India Dear Ms. Hurley: In your letter dated December 30, 2014 you requested a tariff classification ruling. The subject product Fluorouracil, USP, an atineoplastic antimetabolite, is a sterile, nonpyrogenic injectable solution for intravenous administration. It is indicated for the palliative management of carcinoma of the colon, rectum, breast, stomach and pancreas. You state that this product is supplied in 10 mL and 20 mL single-use vials and 50 mL and 100 mL pharmacy bulk vials. The applicable subheading for the Fluorouracil Injection, imported 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: Atineoplastic 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 http://www.usitc.gov/tata/hts/. 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, Gwenn Klein Kirschner Director National Commodity Specialist Division