The tariff classification of Quetiapine Fumarate Tablets imported in dosage form, from India

N248383 December 18, 2013 CLA-2-30:OT:RR:NC:2:238 CATEGORY: Classification TARIFF NO.: 3004.90.9135 Mr. Donal O. Sullivan BluePoint Laboratories Eastgate Business Park Eastgate Road, Building 1 Little Island, Cork Ireland RE: The tariff classification of Quetiapine Fumarate Tablets imported in dosage form, from India Dear Mr. Sullivan: In your letter dated November 29, 2013, you requested a tariff classification ruling. The subject product, Quetiapine Fumarate Tablets, is a medicinal preparation in tablet form containing Quetiapine Fumarate (CAS-111974-72-2), a dibenzothiazepine derivative, as the active ingredient. In your letter, you indicated that it will be imported in various doses ranging from 25 mg to 400 mg tablets. It is indicated for the treatment of schizophrenia, acute manic or depressive episodes associated with bi-polar disorder. The applicable subheading for the Quetiapine Fumarate Tablets, imported in dosage form will be 3004.90.9135, 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 World Wide Web at http://www.usitc.gov/tata/hts/. 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 (646) 733-3033. Sincerely, Gwenn Kirschner Director National Commodity Specialist Division