The tariff classification of Teceleukin [Recombinant Human Interleukin-2 (rIL-2)] (CAS-94218-75-4), imported in bulk form, from China

NY I87235 October 22, 2002 CLA-2-29:RR:NC:2:238 I87235 CATEGORY: Classification TARIFF NO.: 2933.29.2000 Mr. Joseph J. Chivini 1565 Barclay Boulevard Buffalo Grove, IL 60089 RE: The tariff classification of Teceleukin [Recombinant Human Interleukin-2 (rIL-2)] (CAS-94218-75-4), imported in bulk form, from China Dear Mr. Chivini: In your letter dated September 25, 2002, you requested a tariff classification ruling. The subject product, Teceleukin, which you refer to as “Interleukin-2,” is a recombinant form of human Interleukin-2, which is described in The Merck Index, Thirteenth Edition, as follows: “Soluble immunoenhancing glycoprotein (lymphokine) produced by T-lymphocytes following activation by antigens or mitogens in the presence of IL-1 (Interleukin-1). Induces T-cell growth and proliferation; enhances natural killer cell activity. Potentiates the release of ?- interferon, B-cell growth factor, and B-cell differentiation factor. Restores T-cell function in immunodeficient disease states.” According to the FDA’s Orphan Products Designations and Approvals List (updated through Monday, October 7, 2002), Teceleukin is indicated for the treatment of metastatic renal cell carcinoma. For the record, we note that the CAS number assigned to Interleukin-2, per se, is 85898-30-2. We further note that another recombinant form of human Interleukin-2, namely: Aldesleukin, is assigned CAS number 110942-02-4, and (under the registered tradename Proleukin®) is currently on the market for the treatment of adults with metastatic renal cell carcinoma and metastatic melanoma. The applicable subheading for Teceleukin, imported in bulk form, will be 2933.29.2000, Harmonized Tariff Schedule of the United States (HTS), which provides for Heterocyclic compounds with nitrogen hetero-atom(s) only: Compounds containing an unfused imidazole ring (whether or not hydrogenated) in the structure: Other: Aromatic or modified aromatic: Other: Drugs.” The rate of duty will be 6% ad valorem. We note that, at the present time, the subject product is not listed in the Pharmaceutical Appendix to the Tariff Schedule. 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 646-733-3033. Sincerely, Robert B. Swierupski Director, National Commodity Specialist Division