N328795

N328795 November 15, 2022 CLA-2-30:OT:RR:NC:N3:138 CATEGORY: Classification TARIFF NO.: 3004.39.0050 Mrs. Rhona M. Keeler NorthStar Healthcare 3300 Cork Airport Business Park Kinsale Road, Cork T12 XN72 Ireland RE: The tariff classification of Leuprolide Acetate Injection Kit in dosage form, from the Netherlands Dear Mrs. Keeler: In your letter dated October 17, 2022, you requested a tariff classification ruling. Leuprolide Acetate Injection is a synthetic nonapeptide analog of naturally occurring gonadotropin releasing hormone (GnRH or LH-RH). It is indicated in the palliative treatment of advanced prostatic cancer. In a follow-up email to this office, you stated Leuprolide Acetate Injection is a sterile solution supplied in a 2.8 mL multiple-dose vial. The vial is packaged as a 14-day patient administration kit with 14 disposable syringes with fixed needles and 28 alcohol swabs. In this case, the essential character of the kit is imparted by the Leuprolide Acetate. The applicable subheading for the Leuprolide Acetate Injection kit in dosage form will be 3004.39.0050, 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 hormones or other products of heading 2937: 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 judy.h.lee@cbp.dhs.gov. Sincerely, Steven A. Mack Director National Commodity Specialist Division