The tariff classification of OCUFLOX® (ofloxacin ophthalmic solution) 0.3%

NY L80284 October 28, 2004 CLA-2-30:RR:NC:2:238 L80284 CATEGORY: Classification TARIFF NO.: 3004.90.9110 Ms. Iliana G. Fuller Allergan, Inc. 2525 Dupont Drive P.O. Box 19534 Irvine, CA 92623-9534 RE: The tariff classification of OCUFLOX® (ofloxacin ophthalmic solution) 0.3% Dear Ms. Fuller: In your letter dated October 19, 2004, you requested a tariff classification ruling. The subject product, OCUFLOX® (ofloxacin ophthalmic solution) 0.3%, is a sterile ophthalmic solution containing ofloxacin (one of the fluoroquinolone-class of synthetic antibacterial agents) as the active ingredient. OCUFLOX® is indicated for the treatment of conjunctivitis and corneal ulcers caused by strains of various gram-positive and gram-negative bacteria that are susceptible to ofloxacin. The solution is supplied in 10mL plastic bottles with dropper tips and screw-down caps. You believe that the subject product should be classified under subheading 3004.90.9185, HTS, which provides for “Medicaments primarily affecting the eyes, ears or respiratory sysytem.” However, since the product is indicated solely for the treatment of bacterial infections of the eye, we believe that it is more specifically described as an anti-infective medicament. In this respect, we note that this office, in NY J86654, issued to Allergan on July 8, 2003, ruled that a very similar product, ZYMAR™ (gatifloxacin ophthalmic solution) 0.3%, was properly classifiable, based on its intended use for the treatment of bacterial conjunctivitis, as an anti-infective medicament. The applicable subheading for OCUFLOX® (ofloxacin ophthalmic solution) 0.3% will be 3004.90.9110, Harmonized Tariff Schedule of the United States (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: Anti-infective medicaments: 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