The tariff classification of Cenicriviroc (CAS No. 497223-25-3) in bulk and dosage form, from Canada

N289919 September 27, 2017 CLA-2-29:OT:RR:NC:N2:238 CATEGORY: Classification TARIFF NO.: 2933.29.2000; 3004.90.9290 Ms. Freya S. Wilkes Allergan Sales, LLC 2525 Dupont Drive Irvine, CA 92612 RE: The tariff classification of Cenicriviroc (CAS No. 497223-25-3) in bulk and dosage form, from Canada Dear Ms. Wilkes: In your letter dated August 31, 2017, you requested a tariff classification ruling. Cenicriviroc is an inhibitor of CCR2 and CCR5 receptors that function as an entry inhibitor which prevents the AIDS virus from entering into a human cell. Inhibition of CCR2 may also have an anti-inflammatory effect. Currently, Cenicriviroc is an investigational drug that is being studied for the treatment of HIV infection and HIV-associated neurocognitive disorders (HAND). Cenicriviroc is also undergoing phase 2b clinical trials for the treatment of liver fibrosis in patients with nonalcoholic steatophepatitis (NASH). The applicable subheading for Cenicriviroc 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, Cenicriviroc is not listed in the Pharmaceutical Appendix to the Tariff Schedule. The applicable subheading for Cenicriviroc in dosage form will be 3004.90.9210, 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: Anti-infective medicaments: 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 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. In your letter, you stated that the API is made in Canada and the finished drug product is made in the United States. If you wish to ask for the country of origin of the finished drug product, please submit a step by step manufacturing flow chart along with the operations performed in each country. Include a component breakdown by weight of all ingredients with their respective country or countries of origin. 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