The tariff classification of Sodium Phenylacetate and Sodium Benzoate injection vials in dosage form, from India

N281040 November 25, 2016 CLA-2-30:OT:RR:NC:N2:238 CATEGORY: Classification TARIFF NO.: 3004.90.9190 Ms. Kelley Jo Cox Mylan 781 Chestnut Ridge Road Morgantown, WV 26505 RE: The tariff classification of Sodium Phenylacetate and Sodium Benzoate injection vials in dosage form, from India Dear Ms. Cox: In your letter dated November 3, 2016, you requested a tariff classification ruling. The Sodium Phenylacetate and Sodium Benzoate 10% /10% is a sterile concentrated aqueous solution supplied in 50 ml single dose vials. Each vial contains 100 mg of sodium phenylacetate and 100 mg of sodium benzoate and water for injection. The Sodium Phenylacetate and Sodium Benzoate solution is used in the treatment of hyperammonemia, a condition in which there is too much ammonia in the blood. The applicable subheading for the Sodium Phenylacetate and Sodium Benzoate solution imported in single dose vials will be 3004.90.9190, 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 World Wide Web at https://hts.usitc.gov/current. This ruling is being issued under the provisions of Part 177 of the Customs Regulations (19 C.F.R. 177). 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. 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