The tariff classification of Dexmedetomidine Hydrochloride Sterile Injection Solution, 0.5mg/mL in dosage form, from Italy

N329468 December 9, 2022 CLA-2-30:OT:RR:NC:N3:138 CATEGORY: Classification TARIFF NO.: 3004.90.9203 Mr. Pradeep Shah Zydus Pharmaceuticals USA Inc. 73 Route 31 North Pennington, NJ 08534 RE: The tariff classification of Dexmedetomidine Hydrochloride Sterile Injection Solution, 0.5mg/mL in dosage form, from Italy Dear Mr. Shah: In your letter dated November 21, 2022, you requested a tariff classification ruling. Dexmedetomidine Hydrochloride Sterile Injection Solution is a central alpha-2 adrenergic agonist. It is indicated for use as a sedative and analgesic in dogs and cats to facilitate clinical examinations, clinical procedures, minor surgical procedures, and minor dental procedures. Dexmedetomidine Hydrochloride Sterile Injectable Solution is also indicated for use as a preanesthetic to general anesthesia in dogs and cats. In your letter, you stated this product will be imported from Australia. The applicable subheading for the Dexmedetomidine Hydrochloride Sterile Injection Solution in dosage form will be 3004.90.9203, 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: For veterinary use.” 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