The tariff classification of Azathioprine Tablets, Haloperidol Tablets, and Paroxetine Tablets from India

NY M82455 April 24, 2006 CLA-2-30:RR:NC:2:238 M82455 CATEGORY: Classification TARIFF NO.: 3004.90.9115; 3004.90.9135; 3004.40.0030 Mr. Pradeep Shah Zydus Pharmaceuticals (USA) Inc. 508 Carnegie Center, 1st Floor Princeton, NJ 08540 RE: The tariff classification of Azathioprine Tablets, Haloperidol Tablets, and Paroxetine Tablets from India Dear Mr. Shah: In your letter dated April 13, 2006, you requested a tariff classification ruling. The first product, Azathioprine tablets, is a medicinal preparation containing Azathioprine (CAS-446-86-6), an immunosuppressive antimetabolite, as the active ingredient. Azathioprine is indicated as an adjunct for the prevention of rejection in renal homotransplantation. It is also indicated for the management of severe, active rheumatoid arthritis, unresponsive to rest, aspirin or other nonsteroidal anti-inflammatory drugs, or to agents in the class of which gold is an example. The second product, Haloperidol Tablets, is a medicinal preparation, in tablet form, containing Haloperidol, an antipsychotic drug, as the active ingredient. Haloperidol is indicated for the management of symptoms of psychotic disorders and the control of tics and vocal utterances of Tourette’s Disorder. The third product, ParoxetineTablets, is a medicinal preparation, in tablet form, containing Paroxetine, an orally administered psychotropic drug, as the active ingredient. Paroxetine tablets are indicated for the treatment of major depressive disorder, social anxiety disorder, obsessive-compulsive disorder, panic disorder, generalized anxiety disorder, and posttraumatic stress disorder. The applicable subheading for Azathioprine Tablets will be 3004.90.9115, 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 (including those in the form of transdermal administration systems) or in forms or packings for retail sale: Other: Other: Other: Antineoplastic and immunosuppressive medicaments.” The rate of duty will be free. The applicable HTSUS subheading for Haloperidol Tablets will be 3004.90.9135, HTSUS, which provides for “Medicaments…consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses (including those in the form of transdermal administration systems) 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. Pursuant to Headquarters Ruling Letter 953124, dated November 17, 1994, the applicable subheading for Paroxetine Tablets will be 3004.40.0030, HTSUS, which provides for “Medicaments…consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses (including those in the form of transdermal administration systems) or in forms or packings for retail sale: Containing alkaloids or derivatives thereof but not containing hormones, other products of heading 2937 or antibiotics.” 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 Harvey Kuperstein at 646-733-3033. Sincerely, Robert B. Swierupski Director, National Commodity Specialist Division