The tariff classification of Sumavel DosePro™ (Sumatriptan Injection) 6 mg/0.5ml in dosage form, from India

N066618 July 8, 2009 CLA-2-30:OT:RR:NC:N2:238 CATEGORY: Classification TARIFF NO.: 3004.90.9128 Mr. Matthew McGrath Ms. Courtney O’Toole Morgan Barnes, Richardson & Colburn 475 Park Avenue South New York, NY 10016 RE: The tariff classification of Sumavel DosePro™ (Sumatriptan Injection) 6 mg/0.5ml in dosage form, from India Dear Mr. McGrath and Ms. O’Toole Morgan: In your letter dated June 24, 2009, you requested a tariff classification ruling on behalf of your client Zogenix, Inc. The subject product, Sumavel DosePro™ (Sumatriptan Injection) 6 mg/0.5ml, consists of a disposable patient delivery system and a single does of Sumatriptan succinate mixed with sodium chloride and water. Per your letter, it is a pre-filled, disposable needle-free delivery system, designed to deliver a sterile aqueous does of Sumatriptan in the succinate salt form (CAS-103628-46-2) into a patient’s subcutaneous tissue. Currently, Sumavel DosePro™ is undergoing review by the Food and Drug Administration (FDA) for the treatment of migraine headaches. The applicable subheading for the Sumavel DosePro™ (Sumatriptan Injection) 6 mg/0.5ml will be 3004.90.9128, 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 (including those in the form of transdermal administration systems) or in forms or packings for retail sale: Other: Other: Other: Medicaments primarily affecting the central nervous system: Analgesics, antipyretics and nonhormonal anti-inflammatory agents: 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