The tariff classification of monoclonal antibodies in bulk and measured dosage forms, from England, Ireland, and Germany

N074899 September 10, 2009 CLA-2-30:OT:RR:E:NC:N2:238 CATEGORY: Classification TARIFF NO.: 3002.10.0190 Mr. Rex Spent Pfizer 700 Chesterfield Parkway West Chesterfield, MO 63017 RE: The tariff classification of monoclonal antibodies in bulk and measured dosage forms, from England, Ireland, and Germany Dear Mr. Spent: In your letter dated September 4, 2009, you requested a tariff classification ruling. The subject products, monoclonal antibodies, are currently undergoing four clinical phases. They will be imported and packaged as follows: Phase I/IIa clinical trials will be put up in measured doses and in bulk pure antibody containing buffers and stabilizers. Phase IIb and beyond clinical trials will also be put up into measured doses and in bulk pure antibody containing buffers and/or stabilizers. The applicable subheading for the Phase I/IIa and Phase IIb monoclonal antibodies imported in bulk and measured dosage form will be 3002.10.0190, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Antisera and other blood fractions and modified immunological products, whether or not obtained by means of biotechnological processes: Other.” 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