The applicability of duty exemption, under subheading 9801.00.10, HTSUS, to monoclonal antibodies processed in Belgium

NY A85766 July 19, 1996 CLA-2-30:RR:NC:FC:238 A85766 CATEGORY: Classification TARIFF NO.: 3002.10.0090; 9801.00.1098 Mr. Donald S. Simpson BARTHCO International, Inc. 7575 Holstein Avenue Philadelphia, PA 19153 RE: The applicability of duty exemption, under subheading 9801.00.10, HTSUS, to monoclonal antibodies processed in Belgium Dear Mr. Simpson: In your letter dated July 8, 1996, on behalf of your client, SmithKline Beecham Pharmaceuticals, you requested a ruling on the eligibility of monoclonal antibodies, processed by your client in Belgium, for duty-free treatment under subheading 9801.00.10, Harmonized Tariff System of the United States (HTSUS). Ordinarily, imported monoclonal antibodies are classifiable within subheading 3002.10.0090, HTSUS. You state in your letter that monoclonal antibodies are prepared in the United States by SmithKline Beecham Pharmaceuticals ("SKB"), and bulk shipped, in a frozen state, to their facility in Belgium. In Belgium, the antibodies are thawed, filtered to remove any impurities, freeze-dried, and repackaged into dosage form. You also state that none of the aforementioned operations change the chemical composition or structure of the product, or its intended use (in research and development). Based upon the facts presented in the instant case, we find that the processing performed in Belgium does not advance the value or improve the condition of the U.S.-made monoclonal antibodies. Therefore, the monoclonal antibodies will, upon their return to the U.S., be subject to duty-free treatment under subheading 9801.00.1098, HTSUS, which provides for: "Products of the United States when returned after having been exported, without having been advanced in value or improved in condition by any process of manufacture or other means while abroad: Other: Other." This merchandise may be subject to the regulations of the Food and Drug Administration. You may contact them at 5600 Fishers Lane, Rockville, Maryland 20857, telephone number (301) 443-6553. 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 Cornelius Reilly at 212-466-5770. Sincerely, Roger J. Silvestri Director, National Commodity Specialist Division