The tariff classification of Imipenem (CAS-74431-23-5) mixed with Cilastatin Sodium and Sodium Carbonate, imported in bulk form, from Taiwan

N057819 April 23, 2009 CLA-2-30:OT:RR:NC:N2:238 CATEGORY: Classification TARIFF NO.: 3003.20.0000 Ms. Inge Forstenzer Ren-Pharm International Ltd. 350 Jericho Turnpike, Suite 204 Jericho, NY 11753 RE: The tariff classification of Imipenem (CAS-74431-23-5) mixed with Cilastatin Sodium and Sodium Carbonate, imported in bulk form, from Taiwan Dear Ms. Forstenzer: In your letter dated March 25, 2009, you requested a tariff classification ruling. The subject product, a formulation of Imipenem (thienamycin antibiotic) mixed with Cilastatin Sodium (inhibitor of the renal dipeptidase, dehydropeptidase I) and Sodium Carbonate, is used intravenously as a board spectrum antibiotic to treat serious infections. The applicable subheading for the Imipenem mixed with Cilastatin Sodium and Sodium Carbonate imported in bulk form will be 3003.20.0000, 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: Containing other antibiotics.” 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