The tariff classification of Sterile Diluent for Treprostinil Injection, imported in single-dose vials, from Slovenia

N303839 May 3, 2019 CLA-2-30:OT:RR:NC:N3:138 CATEGORY: Classification TARIFF NO.: 3004.90.9290 Ms. Luz E. Hernandez Sandoz Inc. 2555 West Midway Blvd. Broomfield, CO 80020 RE: The tariff classification of Sterile Diluent for Treprostinil Injection, imported in single-dose vials, from Slovenia Dear Ms. Hernandez: In your letter dated April 5, 2019, you requested a tariff classification ruling. The Sterile Diluent for Treprostinil Injection will be imported in 50 ml single-dose vials and is available by prescription only. Each vial contains 94 mg glycine, 73.3 mg sodium chloride, sodium hydroxide (added to adjust pH), and water for injection, USP. This product is a drug diluent for use only with intravenous infusion of Treprostinil injection, which is a vasodilator used to treat pulmonary arterial hypertension. The applicable subheading for the Sterile Diluent for Treprostinil in single-dose vials will be 3004.90.9290, 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: Other: 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 [email protected]. Sincerely, Steven A. Mack Director National Commodity Specialist Division