The tariff classification of Genasense™ (oblimersen sodium), imported put up in single-use 10 mL glass vials for IV infusion, from Germany

NY J87909 August 22, 2003 CLA-2-30:RR:NC:2:238 J87909 CATEGORY: Classification TARIFF NO.: 3004.90.9115 Mr. Stephen Chace Aventis Pharmaceuticals 8333 Hickman Mills Drive Kansas City, MO 64132 RE: The tariff classification of Genasense™ (oblimersen sodium), imported put up in single-use 10 mL glass vials for IV infusion, from Germany Dear Mr. Chace: In your letter dated August 5, 2003, you requested a tariff classification ruling. The subject product consists of a medicinal preparation, put up in single-use 10 mL glass vials for IV infusion, containing the investigational drug Genasense™ as the active ingredient. Genasense™, which has the nonproprietary (USAN) name Oblimersen Sodium (CAS-190977-41-4), is presently being evaluated in multiple (i.e., Phase I, II, & III) FDA-regulated clinical trials for its efficacy in the treatment of various malignancies. Pursuant to the General Notice entitled Guidance Concerning the Tariff Classification of Pharmaceutical Products Imported for Clinical Research (see Customs Bulletin and Decisions, dated May 24, 2000) the applicable subheading for the subject product 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 301-443-1544. 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