The tariff classification of AMO®Vitrax® Solution (Sodium Hyaluronate), put up in single-use, glass syringes, from Ireland

NY H89822 April 4, 2002 CLA-2-30:RR:NC:2:238 H89822 CATEGORY: Classification TARIFF NO.: 3004.90.1000 Ms. Iliana G. Fuller Allergan, Inc. 2525 Dupont Drive P.O. Box 19534 Irvine, CA 92623-9534 RE: The tariff classification of AMO®Vitrax® Solution (Sodium Hyaluronate), put up in single-use, glass syringes, from Ireland Dear Ms. Fuller: In your letter dated March 18, 2002, you requested a tariff classification ruling. The subject product, AMO®Vitrax® Solution (Sodium Hyaluronate), consists of a sterile, non-pyrogenic, viscoelastic preparation of a highly purified, non-inflammatory fraction of sodium hyaluronate (the active ingredient), dissolved in a physiological-balanced salt solution. AMO®Vitrax® is indicated for use as a surgical aid in various ophthalmic surgical procedures, such as cataract removal, secondary intraocular lens implantation, and corneal transplantation. AMO®Vitrax® is supplied in single-use, glass syringes, each of which is put up packed for retail sale, along with a 23 gauge, blunt-tip cannula, in a paperboard container. The applicable subheading for the subject product will be 3004.90.1000, 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: Containing antigens or hyaluronic acid or its sodium salt.” 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