The tariff classification of Synvisc® Hylan G-F 20 solution put up in single-use glass syringes

N022307 January 29, 2008 CLA-2-30:OT:RR:E:NC:2:238 CATEGORY: Classification TARIFF NO.: 3004.90.1000 Ms. Fabiola Alcerreca Genzyme Corporation One Kendall Square Cambridge, MA 02139 RE: The tariff classification of Synvisc® Hylan G-F 20 solution put up in single-use glass syringes Dear Ms. Alcerreca: In your letter dated January 23, 2008, you requested a tariff classification ruling. According to the insert you submitted, Synvisc® Hylan G-F 20 contains hylan A (average molecular weight 6,000,000) and hylan B hydrated gel in a buffered physiological sodium chloride solution supplied in a 2.25 mL glass syringe containing 2 mL Synvisc. Each syringe of Synvisc contains: Hylan polymers (hylan A + hylan B) 16 mg Sodium chloride 17 mg Disodium hydrogen phosphate 0.32 mg Sodium dihydrogen phosphate monohydrate 0.08 mg Water for injection q.s. to 2.0 mL Hylans are derivatives of hyaluronan (sodium hyaluronate), a substance that comes from, among other sources, chicken combs. Synvisc® Hylan G-F 20 is indicated for the treatment of pain in osteoarthritis of the knee in patients who have failed to respond adequately to conservative nonpharmacologic therapy and simple analgesics. Synvisc® is intended to be administered by intra-articular injection once a week (one week apart) for a total of three injections. The applicable subheading for the Synvisc® Hylan G-F 20 put up in syringes will be 3004.90.1000, 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: Containing antigens or hyaluronic acid or its sodium salt." 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 Harvey Kuperstein at 646-733-3033. Sincerely, Robert B. Swierupski Director, National Commodity Specialist Division