The tariff classification of ZYPRED® (0.3 % gatifloxacin and 1% prednisolone acetate ophthalmic suspension) in dosage form, from Brazil

N235987 December 19, 2012 CLA-2-30:OT:RR:NC:2:238 CATEGORY: Classification TARIFF NO.: 3004.90.9185 Mr. Daniel Hong Allergan 2525 Dupont Drive T2-2C Irvine, CA 92612 RE: The tariff classification of ZYPRED® (0.3 % gatifloxacin and 1% prednisolone acetate ophthalmic suspension) in dosage form, from Brazil Dear Mr. Hong: In your letter dated November 30, 2012, you requested a tariff classification ruling. The subject product, ZYPRED® (0.3 % gatifloxacin and 1% prednisolone acetate ophthalmic suspension), is a combination medicament containing gatifloxacin (antibacterial agent) and prednisolone acetate (corticosteroid), as the active ingredients. It is indicated for the treatment and prevention of eye infections. ZYPRED® will be available in various doses, ranging from 1.5 ml to 10 ml and packaged in plastic bottles. The applicable subheading for the ZYPRED® (0.3 % gatifloxacin and 1% prednisolone acetate ophthalmic suspension) in dosage form will be 3004.90.9185, 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: Medicaments primarily affecting the eyes, ears or respiratory system: Other: 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 Judy Lee at (646) 733-3033. Sincerely, Thomas J. Russo Director National Commodity Specialist Division