The tariff classification of Imipenem and Cilastatin for Injection in dosage form, from Italy

N322506 November 24, 2021 CLA-2-30:OT:RR:NC:N3:138 CATEGORY: Classification TARIFF NO.: 3004.20.0060 Mrs. Robyn K. Brunciak WorldGen LLC 120 Route 17 North Paramus, NJ 07652 RE: The tariff classification of Imipenem and Cilastatin for Injection in dosage form, from Italy Dear Mrs. Brunciak: In your letter dated October 28, 2021, you requested a tariff classification ruling. Imipenem and Cilastatin for Injection, imported in 500 mg/500 mg vials, is a medicinal preparation containing Imipenem (thienamycin antibiotic) and Cilastatin (inhibitor of the renal dipeptidase, dehydropeptidase I), as the active ingredients. It is indicated for the treatment of serious bacterial infections including endocarditis (infection of the heart lining and valves), respiratory tract (including pneumonia), urinary tract, abdominal (stomach area), gynecological, blood, skin, bone, and joint infections. The applicable subheading for the Imipenem and Cilastatin for Injection in dosage form will be 3004.20.0060, 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 antibiotics: 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