The tariff classification of Fludarabine Phosphate (CAS-75607-67-9) Injection in dosage form, from Romania

N036235 August 29, 2008 CLA-2-30:OT:RR:E:NC:N2:238 CATEGORY: Classification TARIFF NO.: 3004.90.9115 Mr. Colm Moynihan NorthStar Healthcare Ltd. 3300 Cork Airport Business Park Kinsale Road, Cork Ireland RE: The tariff classification of Fludarabine Phosphate (CAS-75607-67-9) Injection in dosage form, from Romania Dear Mr. Moynihan: In your letter dated August 22, 2008, you requested a tariff classification ruling. The subject product, Fludarabine Phosphate Injection, is a medicinal preparation, containing Fludarabine Phosphate, as the active ingredient. According to your letter, it will be imported in the form of injectable vials ready for retail sale in the United States. It is indicated for the treatment of adult patients with B-cell chronic lymphocytic leukemia (CLL). The applicable subheading for the Fludarabine Phosphate Injection in dosage from 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 (including those in the form of transdermal administration systems) 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 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 Harvey Kuperstein at (646) 733-3033. Sincerely, Robert B. Swierupski Director National Commodity Specialist Division