The tariff classification of Proguanil Hydrochloride (CAS-637-32-1) and Lapatinib Ditosylate Monohydrate (CAS-388082-78-8) in bulk form, from India

N065850 June 29, 2009 CLA-2-29:OT:RR:NC:N2:238 CATEGORY: Classification TARIFF NO.: 2925.29.2000; 2934.99.3000 Mr. Michael Tartaro Byron Chemical Company, INC. 40-11 23rd Street Long Island City, NY 11101 RE: The tariff classification of Proguanil Hydrochloride (CAS-637-32-1) and Lapatinib Ditosylate Monohydrate (CAS-388082-78-8) in bulk form, from India Dear Mr. Tartaro: In your letter dated June 19, 2009, you requested a tariff classification ruling. The first product, Proguanil Hydrochloride, is a prophylactic antimalarial drug usually taken in combination with another anti-malarial drug. It works by stopping the malaria parasite, Plasmodium falciparum and Plasmodium vivax, from reproducing once it is in the red blood cells. The second product, Lapatinib Ditosylate, is an antineoplastic drug indicated for use in patients with advanced metastatic breast cancer. The applicable subheading for the Proguanil Hydrochloride in bulk form will be 2925.29.2000, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Carboxyimide-function compounds (including saccharin and its salts) and imine-function compounds: Imides and their derivatives; salts thereof: Imines and their derivatives; salts thereof: Other: Aromatic: Other: Drugs.” Pursuant to General Note 13, HTSUS, the rate of duty will be free. The applicable subheading for the Lapatinib Ditosylate in bulk form will be 2934.99.3000, Harmonized Tariff Schedule of the United States (HTSUS), which provides for "Nucleic acids and their salts, whether or not chemically defined; other heterocyclic compounds: Other: Other: Aromatic or modified aromatic: Other: Drugs." The rate of duty will be 6.5 percent ad valorem. At the present time, the suffix “ditosylate” is not listed in Table 2 of the Pharmaceutical Appendix to the Tariff Schedule. General Note 13, HTSUS, noted. 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