The tariff classification of IQUIX® (levofloxacin ophthalmic solution) 1.5%, imported in bulk and measured-dose forms, from Finland

NY K84218 March 16, 2004 CLA-2-30:RR:NC:2:238 K84218 CATEGORY: Classification TARIFF NO.: 3003.90.0000; 3004.90.9185 Mr. Michael J. Keegan Schenker, Inc. Alexander Court One Bay 1-5 850 Calcon Hook Road Sharon Hill, PA 19079 RE: The tariff classification of IQUIX® (levofloxacin ophthalmic solution) 1.5%, imported in bulk and measured-dose forms, from Finland Dear Mr. Keegan: In your letter dated March 4, 2004, on behalf of your client, Santen Incorporated, you requested a tariff classification ruling. IQUIX® (levofloxacin ophthalmic solution) 1.5% is an ophthalmic medicament containing the antibacterial agent, Levofloxacin hemihydrate (CAS-138199-71-0), a broad-spectrum, fluorinated quinolone, as the active ingredient. It is indicated for the treatment of corneal ulcer caused by susceptible strains of various gram-positive and gram-negative bacteria. For tariff purposes, pursuant to exclusion “(c)” to Explanatory Note 29.41, HTS, Levofloxacin hemihydrate is excluded from classification as an antibiotic within heading 2941, HTS. According to a press release dated March 2, 2004, found on your client’s website, the U.S. Food and Drug Administration (FDA) has approved the NDA (New Drug Application) for IQUIX® (levofloxacin ophthalmic solution) 1.5%. The applicable subheading for IQUIX® (levofloxacin ophthalmic solution) 1.5%, imported in bulk form, will be 3003.90.0000, Harmonized Tariff Schedule of the United States (HTS), 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. The applicable subheading for IQUIX® (levofloxacin ophthalmic solution) 1.5%, imported put up in 5 cc plastic bottles (each filled with 5 mL of IQUIX®), will be 3004.90.9185, HTS, 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 eyes, ears or respiratory system: Other: Other.” The rate of duty will be free. This merchandise may be subject to the requirements of the Federal Food, Drug, and Cosmetic Act, which is administered by the U.S. Food and Drug Administration. You may contact them at 5600 Fishers Lane, Rockville, Maryland 20857, telephone number 1-888-443-6332. 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