The tariff classification of Cyclosporine USP (CAS-59865-13-3), imported in bulk form, from China

NY G81655 January 24, 2001 CLA-2-29:RR:NC:2:238 G81655 CATEGORY: Classification TARIFF NO.: 2933.90.9000 Mr. Joseph J. Chivini Austin Chemical Company, Inc. 1565 Barclay Boulevard Buffalo Grove, IL 60089 RE: The tariff classification of Cyclosporine USP (CAS-59865-13-3), imported in bulk form, from China Dear Mr. Chivini: In your letter dated August 30, 2000, you requested a tariff classification ruling. We regret the delay in responding. Cyclosporine is a cyclic peptide, consisting of 11 amino acids, produced as a metabolite by the fungus, Beauveria nivea. It is indicated for use as an immunosuppressant agent for the prevention of organ rejection in kidney, liver, and heart allogeneic transplants (i.e., transplants involving individuals who are antigenically distinct). We note that the International Nonproprietary Name (INN) for Cyclosporine is “Ciclosporin,” which is listed in Table 1 of the Pharmaceutical Appendix to the Tafiff Schedule. A report issued to this office by the U.S. Customs laboratory in New York notes the lack of any evidence in the scientific literature indicating Cyclosporine’s ability to kill other microorganisms or inhibit their growth. Accordingly, pursuant to Lonza, Inc. v. U.S. [46 F.3d 1098 (Fed. Cir. 1995)] and the Explanatory Notes to heading 2941, HTS, it is our determination that Cyclosporine is precluded from classification as an antibiotic, for tariff purposes. The applicable subheading for Cyclosporine USP, imported in bulk form, will be 2933.90.9000, Harmonized Tariff Schedule of the United States (HTS), which provides for "[H]eterocyclic compounds with nitrogen hetero-atom(s) only: Other: Other: Other: Drugs." Pursuant to General Note 13, HTS, the rate of duty will be free.  This merchandise may be subject to the requirements of the Federal Food, Drug, and Cosmetic Act, which is administered by the U.S. Food and Drug Administration. You may contact them at 5600 Fishers Lane, Rockville, Maryland 20857, telephone number 301-443-1544. 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 212-637-7068. Sincerely, Robert B. Swierupski Director, National Commodity Specialist Division