The tariff classification of liquid-filled glass vials ("cartridges") containing the investigational drug Exenatide (CAS-141732-76-5) as the active ingredient, and the tariff classification of a disposable pen injector fitted with a non-removable, liquid-filled glass vial ("cartridge") containing the investigational new drug Exenatide as the active ingredient, both from the United Kingdom

NY J82827 April 11, 2003 CLA-2-30:RR:NC:2:238 J82827 CATEGORY: Classification TARIFF NO.: 3004.90.9190 Mr. Ron Reuben Danzas AEI Customs Brokerage Services 5510 West 102nd Street Los Angeles, CA 90045 RE: The tariff classification of liquid-filled glass vials (“cartridges”) containing the investigational drug Exenatide (CAS-141732-76-5) as the active ingredient, and the tariff classification of a disposable pen injector fitted with a non-removable, liquid-filled glass vial (“cartridge”) containing the investigational new drug Exenatide as the active ingredient, both from the United Kingdom Dear Mr. Reuben: In your letter dated March 19, 2003, on behalf of your client, Amylin Pharmaceuticals, Inc., you requested a tariff classification ruling. The first product consists of liquid-filled glass vials, referred to as “cartridges” by your client, containing Exenatide, an investigational new drug being tested in Phase III clinical trials on patients with type 2 diabetes. The second product consists of a disposable, pen-like device, referred to as a “pen injector” by your client, for the administration of injectable medication. The “pen” is fitted with a non-removable, liquid-filled vial (“cartridge”) containing Exenatide (an investigational new drug being tested in Phase III clinical trials on patients with type 2 diabetes) as the active ingredient. Your client, during a telephone conversation with a member of my staff, indicated that the needles required to inject the medication will not be imported as part of the pen injector. Rather, they will be dispensed by the pharmacist to the patient upon presentation of a doctor’s prescription for the pen injector. The applicable subheading for both products will be 3004.90.9190, 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 (including those in the form of transdermal administration systems) or in forms or packings for retail sale: Other: Other: 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