The tariff classification of Cyclosporine (CAS-59865-13-3), imported in bulk form, from Switzerland

NY R04986 October 10, 2006 CLA-2-29:RR:E:NC:2:238 R04986 CATEGORY: Classification TARIFF NO.: 2933.79.8500 Ms. Iliana Fuller Allergan, Inc. 2525 Dupont Drive P.O. Box 19534 Irvine, CA 92623-9534 RE: The tariff classification of Cyclosporine (CAS-59865-13-3), imported in bulk form, from Switzerland Dear Ms. Fuller: In your letter dated September 28, 2006, you requested a tariff classification ruling. The subject product, Cyclosporine, is a cyclic peptide consisting of 11 amino acids, produced as a metabolite by (the fungus) Beauveria nivea. When administered systemically, Cyclosporine is used as an immunosuppressive agent for the prevention of organ rejection in, e.g., kidney and liver transplants. You indicate in your letter that Allergan will use Cyclosporine as the active ingredient in a topically administered ophthalmic medicament intended to increase tear production in patients whose tear production is presumed to be suppressed due to ocular inflammation associated with chronic dry eye disease (keratoconjunctivitis sicca). The applicable subheading for Cyclosporine, imported in bulk form, will be 2933.79.8500, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Heterocyclic compounds with nitrogen hetero-atom(s) only: Lactams: Other lactams: Other: Other.” Pursuant to General Note 13, HTSUS, 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