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 Ύ- 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.