The tariff classification of FAH-9 (blend of MKC-1 and Eudragit® L100) in bulk form, from Belgium

N029994 June 13, 2008 CLA-2-30:OT:RR:NC:2:238 CATEGORY: Classification TARIFF NO.: 3003.90.0000 Ms. Robyn Addabbo Interchem Corporation 120 Route 17 North P.O. Box 1579 Paramus, NJ 07652-1579 RE: The tariff classification of FAH-9 (blend of MKC-1 and Eudragit® L100) in bulk form, from Belgium Dear Ms. Addabbo: In your letter dated May 22, 2008, you requested a tariff classification ruling. In a telephone conversation on June 5, 2008, you confirmed that the subject product will be imported in bulk form. The subject product, FAH-9, is a blend of investigational drug MKC-1 (original Roche Pharmaceuticals designation “Ro 31-74530”) and Eudragit® L100 methacrylic acid:methyl methacrylate copolymer. MKC-1 is currently in multiple Phase 1 and Phase 2 clinical studies in cancer. It is an orally active small molecule cell cycle inhibitor (CCI) with efficacy against a broad range of human solid tumor cell lines, including multi-drug resistant cell lines. Eudragit® L100 polymer is applied as an enteric film coating to active drug ingredients in conventional solid oral dosage forms such as tablets, capsules and small particles. It can also be used as a binder to prepare pellets, granules and sustained-release tablets. The applicable subheading for the FAH-9 will be 3003.90.0000, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Medicaments…consisting of two or more constituents which have been mixed together for therapeutic or prophylactic uses, not put up in measured doses or in forms or packings for retail sale: Other." 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