The tariff classification of Quetiapine Extended-Release (ER) Tablets in dosage form, from India

N321427 September 29, 2021 CLA-2-30:OT:RR:NC:N3:138 CATEGORY: Classification TARIFF NO.: 3004.90.9235 Ms. Paulina Radaczynska BluePoint Laboratories 8 Eastgate Avenue Little Island, Cork, T45 NF24 Ireland RE: The tariff classification of Quetiapine Extended-Release (ER) Tablets in dosage form, from India Dear Ms. Radaczynska: In your letter dated September 7, 2021, you requested a tariff classification ruling. Quetiapine, imported in 50 mg, 150 mg, 200 mg, 300 mg and 400 mg extended release tablets, is a medicinal preparation containing Quetiapine Fumarate (CAS No. 111974-72-2), a dibenzothiazepine derivative, as the active ingredient. It is indicated for the treatment of schizophrenia, acute manic or depressive episodes associated with bi-polar disorder, and major depressive disorder (MDD). The applicable subheading for the Quetiapine Extended-Release (ER) Tablets in dosage form will be 3004.90.9235 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: Medicaments primarily affecting the central nervous system: Antidepressants, tranquilizers, and other psychotherapeutic agents.” 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