The tariff classification of Thymoglobulin® [Anti-thymocyte Globulin (Rabbit)] Sterile Lyophilized Preparation from France

NY L80355 October 28, 2004 CLA-2-30:RR:NC:2:238 L80355 CATEGORY: Classification TARIFF NO.: 3004.90.9115 Mr. Richard D’Innocenzo Genzyme Corporation One Kendall Square Cambridge, MA 02139 RE: The tariff classification of Thymoglobulin® [Anti-thymocyte Globulin (Rabbit)] Sterile Lyophilized Preparation from France Dear Mr. D’Innocenzo: In your letter dated October 19, 2004, you requested a tariff classification ruling. The subject product, Thymoglobulin® [Anti-thymocyte Globulin (Rabbit)] Sterile Lyophilized Preparation, is a medicament, for intravenous administration, put up in a package containing two 7 mL vials. Vial 1 contains a sterile, freeze-dried powder consisting of Thymoglobulin® [Anti-thymocyte Globulin (Rabbit)] (the active ingredient) mixed with several excipients. Vial 2 contains sterile water for injection (the diluent), which is used to reconstitute the freeze-dried powder in Vial 1. Thymoglobulin® [Anti-thymocyte Globulin (Rabbit)], is a purified, pasteurized, gamma immune globulin, obtained by immunization of rabbits with human thymocytes, containing cytotoxic antibodies directed against antigens expressed on human T-lymphocytes. Thymoglobulin® [Anti-thymocyte Globulin (Rabbit)] is indicated for the treatment of renal transplant acute rejection, in conjunction with concomitant immunosuppression. The applicable subheading for Thymoglobulin® [Anti-thymocyte Globulin (Rabbit)] Sterile Lyophilized Preparation will be 3004.90.9115, Harmonized Tariff Schedule of the United States (HTS), 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. This merchandise may be subject to the requirements of the Federal Food, Drug, and Cosmetic Act, which is administered by the U.S. Food and Drug Administration. You may contact them at 5600 Fishers Lane, Rockville, Maryland 20857, telephone number 1-888-443-6332. 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