The tariff classification of Eluxadoline (CAS No. 864821-90-9) in bulk form and VIBERZI® Tablets in dosage form, from Ireland

N302614 February 15, 2019 CLA-2-29:OT:RR:NC:N3:138 CATEGORY: Classification TARIFF NO.: 2933.29.2000; 3004.90.9260 Freya S. Wilkes Allergan Sales, LLC 2525 Dupont Drive GTC: T2-2C Irvine, CA 92612 RE: The tariff classification of Eluxadoline (CAS No. 864821-90-9) in bulk form and VIBERZI® Tablets in dosage form, from Ireland Dear Mr. Wilkes: In your letter dated January 18, 2019, you requested a tariff classification ruling. Eluxadoline is a mu-opioid receptor agonist indicated for use in diarrhea-predominant irritable bowel syndrome (IBS-D). It is the active pharmaceutical ingredient (API) for Viberzi Tablets. Viberzi is a prescription medication imported in tablet form that is indicated for the treatment of diarrhea and abdominal pain in individuals with diarrhea-predominant irritable bowel syndrome (IBS-D). The applicable subheading for the Eluxadoline in bulk form will be 2933.29.2000, Harmonized Tariff Schedule of the United States (HTSUS), which provides for "Heterocyclic compounds with nitrogen hetero-atom(s) only: Compounds containing an unfused imidazole ring (whether or not hydrogenated) in the structure: Other: Aromatic or modified aromatic: Other: Drugs." The rate of duty will be 6 percent ad valorem. Currently, Eluxadoline is not listed in the Pharmaceutical Appendix to the Tariff Schedule. The applicable subheading for the Viberzi Tablets in dosage form will be 3004.90.9260, 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 digestive system: 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 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. This merchandise may also be subject to the requirements of the Controlled Substances Act, which are enforced by the U.S. Drug Enforcement Administration (DEA), Office of Diversion Control. You may contact them at 2401 Jefferson Davis Highway, Alexandria, VA 22301, telephone (800) 882-9539. 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