The tariff classification of Cyclosporine Ophthalmic Emulsion 0.05% in dosage form, from Turkey

N304226 May 22, 2019 CLA-2-30:OT:RR:NC:N3:138 CATEGORY: Classification TARIFF NO.: 3004.90.9285 Ms. Katia Demeire Devatis Inc. 2800 West State Road 84, Suite 118 Dania, FL 33312 RE: The tariff classification of Cyclosporine Ophthalmic Emulsion 0.05% in dosage form, from Turkey Dear Ms. Demeire: In your letter dated May 6, 2019, you requested a tariff classification ruling. Cyclosporine Ophthalmic Emulsion 0.05% is an ophthalmic medicament containing the active ingredient, cyclosporine, an immunomodulator with anti-inflammatory effects (when administered topically), as well as an immunosuppressive agent (when administered systemically). It is indicated to increase tear production in patients whose tear production is presumed to be suppressed due to eye inflammation associated with keratoconjunctivitis sicca (chronic dry eye disease). In a follow-up email to this office, you stated Cyclosporine Ophthalmic Emulsion 0.05% will be imported in 0.4 mL single-use vials, packed in shelf-pack cartons each measuring 30 individual units and 60 individual units ready for retail sale. The applicable subheading for the Cyclosporine Ophthalmic Emulsion 0.05% in dosage form will be 3004.90.9285, 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 … 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 the World Wide Web at https://hts.usitc.gov/current. 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 [email protected]. Sincerely, Steven A. Mack Director National Commodity Specialist Division