The tariff classification of Cariprazine Hydrochloride (CAS No. 1083076-69-0) in bulk form and Vraylar® Capsules in dosage form, from Ireland

N301099 November 5, 2018 CLA-2-29:OT:RR:NC:N1:138 CATEGORY: Classification TARIFF NO.: 2933.59.4600; 3004.90.9235 Ms. Freya S. Wilkes Allergan Sales, LLC 2525 Dupont Drive Irvine, CA 92612 RE: The tariff classification of Cariprazine Hydrochloride (CAS No. 1083076-69-0) in bulk form and Vraylar® Capsules in dosage form, from Ireland Dear Ms. Wilkes: In your letter dated October 11, 2018, you requested a tariff classification ruling. The first product, Cariprazine Hydrochloride is an atypical antipsychotic that is indicated for the treatment of schizophrenia and bipolar mania. The second product, Vraylar Capsules, is a medicinal preparation containing Cariprazine Hydrochloride, an atypical antipsychotic, as the active ingredient. It is indicated for the treatment of schizophrenia in adults and acute treatment of manic or mixed episodes associated with bipolar 1 disorder in adults. The applicable subheading for the Cariprazine Hydrochloride in bulk form will be 2933.59.4600, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Heterocyclic compounds with nitrogen hetero-atom(s) only: Compounds containing a pyrimidine ring (whether or not hydrogenated) or piperazine ring in the structure: Other: Drugs: Aromatic or modified aromatic: Antidepressants, tranquilizers and other psychotherapeutic agents.” Pursuant to General Note 13, HTS, the rate of duty will be free. The applicable subheading for the Vraylar Capsules in dosage form will be 3004.90.9235, HTS, 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 central nervous system: Antidepressants, tranquilizers, and other psychotherapeutic agents.” The rate of duty will be free. 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. 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). 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