The tariff classification of ANTEGREN® (natalizumab) mixed with excipients and imported in bulk form, and ANTEGREN® (natalizumab) mixed with excipients and imported put up in single-dose vials, from Germany and other countries

NY K86861 June 18, 2004 CLA-2-30:RR:NC:2:238 K86861 CATEGORY: Classification TARIFF NO.: 3003.90.0000; 3004.90.9140 Herbert J. Lynch, Esq. Sullivan & Lynch, P.C. 56 Roland Street, Suite 303 Boston, MA 02129-1223 RE: The tariff classification of ANTEGREN® (natalizumab) mixed with excipients and imported in bulk form, and ANTEGREN® (natalizumab) mixed with excipients and imported put up in single-dose vials, from Germany and other countries Dear Mr. Lynch: In your letter dated June 3, 2004, on behalf of your client, Biogen Idec Inc., you requested a tariff classification ruling. The subject products consist of ANTEGREN® (natalizumab) mixed with excipients and imported in bulk form, and ANTEGREN® (natalizumab) mixed with excipients and imported put up in single-dose vials. ANTEGREN® is the registered trade name for an investigational drug having the nonproprietary (generic) name: natalizumab, a humanized monoclonal antibody designed to inhibit the migration of immune cells into chronically inflamed tissue where these cells may cause or maintain inflammation. You indicate in your letter that, on May 25, 2004, your client submitted a Biologics License Application (BLA) to the FDA, based on data obtained and analyzed from the first year of FDA-regulated Phase lll clinical trials, for the approval of ANTEGREN® (natalizumab) for the treatment of multiple sclerosis (MS). You further indicate that ANTEGREN® (natalizumab) is currently in FDA-regulated Phase lll clinical trials to evaluate its efficacy for use in the treatment of Crohn’s disease, and in FDA-regulated Phase ll clinical trials to evaluate its efficacy for use in the treatment of rheumatoid arthritis. Pursuant to the General Notice entitled Guidance Concerning the Tariff Classification of Pharmaceutical Products Imported for Clinical Research (see Customs Bulletin and Decisions, Vol. 34, No. 21, May 24, 2000), the applicable subheading for ANTEGREN® (natalizumab) mixed with excipients and imported in bulk form will be 3003.90.0000, Harmonized Tariff Schedule of the United States (HTS), which provides for “Medicaments … consisting of two or more constituents which have been mixed together for therapeutic or prophylactic uses, not put up in measured doses or in forms or packings for retail sale: Other.” The rate of duty will be free. Pursuant to the General Notice entitled Guidance Concerning the Tariff Classification of Pharmaceutical Products Imported for Clinical Research (see Customs Bulletin and Decisions, Vol. 34, No. 21, May 24, 2000), the applicable subheading for ANTEGREN® (natalizumab) mixed with excipients and imported put up in single-dose vials will be 3004.90.9140, Harmonized Tariff Schedule of the United States (HTS), which provides for “Medicaments … consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses (including those in the form of transdermal administration systems) or in forms or packings for retail sale: Other: Other: Other: Medicaments primarily affecting the central nervous system: Other.” 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 1-888-443-6332. 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