The tariff classification of the Dexrazoxane imported in dosage form, from India

N192275 November 28, 2011 CLA-2-30:OT:RR:E:NC:N2:N238 CATEGORY: Classification TARIFF NO.: 3004.90.9120 Ms. Amanda Tolbert Mylan 781 Chestnut Ridge Road Morgantown, WV 26505 RE: The tariff classification of the Dexrazoxane imported in dosage form, from India Dear Ms. Tolbert: In your letter dated November 7, 2011, you requested a tariff classification ruling. The subject product, Dexrazoxane, imported in 250 mg and 500 mg vials is a cardioprotective agent for use in conjunction with doxorubicin. You state in your letter that Dexrazoxane is a sterile injectable drug presented as a powder cake which must be reconstituted as directed with Sodium Lactate Injection. It is indicated for reducing the incidence and severity of cardiomyopathy associated with doxorubicin administration in women with metastatic breast cancer. The applicable subheading for Dexrazoxane imported in 250 mg and 500 mg vials will be 3004.90.9120, Harmonized Tariff Schedule of the United States (HTSUS), which provides for "Medicaments … consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses … or in forms or packings for retail sale: Other: Other: Other: Cardiovascular medicaments." 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 Judy Lee at (646) 733-3033. Sincerely, Robert B. Swierupski Director National Commodity Specialist Division