The tariff classification of Darunavir (CAS-206361-99-1) imported in bulk form, from Ireland

N014112 July 19, 2007 CLA-2-29:RR:E:NC:2:238 CATEGORY: Classification TARIFF NO.: 2935.00.6000 Ms. Andrea Abraham Meeks & Sheppard 1735 Post Road, Suite 4 Fairfield, CT 06824 RE: The tariff classification of Darunavir (CAS-206361-99-1) imported in bulk form, from Ireland Dear Ms. Abraham: In your letter dated July 11, 2007, you requested a tariff classification ruling on behalf of your client, Janssen Ortho LLC. The subject product, Darunavir, also known as TMC-114 per your letter is an antiviral drug. It is a protease inhibitor and is indicated for the treatment of human immunodeficiency virus-1 (HIV). The applicable subheading for the Darunavir, imported in bulk form, will be 2935.00.6000, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “ Sulfonamides: Other: Drugs: Other.” Pursuant to General Note 13, HTSUS, the rate of duty will be free. 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. 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 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