The tariff classification of RESTASIS™ (cyclosporine ophthalmic emulsion) 0.05%, imported put up in single-use vials, from Ireland

NY J80550 February 12, 2003 CLA-2-30:RR:NC:2:238 J80550 CATEGORY: Classification TARIFF NO.: 3004.90.9185 Ms. Iliana G. Fuller Allergan, Inc. 2525 Dupont Drive P.O. Box 19534 Irvine, CA 92623-9534 RE: The tariff classification of RESTASIS™ (cyclosporine ophthalmic emulsion) 0.05%, imported put up in single-use vials, from Ireland Dear Ms. Fuller: In your letter dated January 30, 2003, you requested a tariff classification ruling. The subject product, RESTASIS™ (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). RESTASIS™ 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). An aricle found on Allergan’s website indicates that, on December 23, 2002, the FDA approved Allergan’s NDA (New Drug Application) for RESTASIS™, which will become available (by prescription only) in April 2003. The applicable subheading for the subject product will be 3004.90.9185, 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 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 301-443-1544.  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