The tariff classification of Leflunomide (CAS-75706-12-6), imported in dosage form, from India

N189385 November 10, 2011 CLA-2-30:OT:RR:E:NC:N2:238 CATEGORY: Classification TARIFF NO.: 3004.90.9115 Ms. Martha Scott NorthStar Healthcare 3300 Cork Airport Business Park Kinsale Road, Cork Ireland RE: The tariff classification of Leflunomide (CAS-75706-12-6), imported in dosage form, from India Dear Ms. Scott: In your letter dated October 19, 2011, you requested a tariff classification ruling. The subject product, Leflunomide tablets, is a medicinal preparation containing the active ingredient, Leflunomide, an isoxazole immunomodulatory agent which inhibits dihydroorotate dehydrogenase (an enzyme involved in de novo pyrimidine synthesis) and has antiproliferative activity. Leflunomide is also in a class of medications called disease-modifying antirheumatic drugs (DMARDs) and it is indicated for the treatment of rheumatoid arthritis when administered orally. The applicable subheading for the Leflunomide tablets 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 (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 Judy Lee at (646) 733-3033. Sincerely, Robert B. Swierupski Director National Commodity Specialist Division