The tariff classification of Ketorolac Tromethamine Injection in dosage form, from Italy

N333398 July 5, 2023 CLA-2-30:OT:RR:NC:N3:138 CATEGORY: Classification TARIFF NO.: 3004.90.9228 Carol Glenny Avila NorthStar Healthcare UC 3300 Cork Airport Business Park Kinsale RoadCork T12 XN72Ireland RE:  The tariff classification of Ketorolac Tromethamine Injection in dosage form, from Italy Dear Ms. Glenny Avila: In your letter dated June 7, 2023, you requested a tariff classification ruling. Ketorolac Tromethamine Injection, imported in 15 mg/ mL, 30 mg/ mL and 60 mg/2 mL vials, is a nonsteroidal anti-inflammatory drug (NSAID).  It is indicated for the short-term (≤5 days) management of moderately severe acute pain that requires analgesia at the opioid level, usually in a postoperative setting.  It is also used to treat moderate to severe pain, rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, menstrual disorders, and headaches. The applicable subheading for the Ketorolac Tromethamine Injection in dosage form will be 3004.90.9228, 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: Medicaments primarily affecting the central nervous system: Analgesics, antipyretics and non-hormonal anti-inflammatory agents: 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 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 and Border Protection 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, please contact National Import Specialist Judy Lee at [email protected]. Sincerely, Steven A. Mack Director National Commodity Specialist Division