The tariff classification of Activase® (Alteplase recombinant), Avastatin™ (bevacizumab), Cathflo™Activase® (Alteplase) and Herceptin® (Trastuzumab)

NY K83509 March 12, 2004 CLA-2-30:RR:NC:2:238 K83509 CATEGORY: Classification TARIFF NO.: 3004.90.9120; 3004.90.9115 Mr. Ron Reuben Danzas AEI Customs Brokerage Services 5510 West 102nd Street Los Angeles, CA 90045 RE: The tariff classification of Activase® (Alteplase recombinant), Avastatin™ (bevacizumab), Cathflo™Activase® (Alteplase) and Herceptin® (Trastuzumab) Dear Mr.Reuben: In your letter dated February 23, 2004, on behalf of your client, Genentech, Inc., you requested a tariff classification ruling. The first product, Activase® (Alteplase recombinant), is a medicament containing Alteplase, a tissue plasminogen activator (serine protease) produced by recombinant DNA technology, as the active ingredient. It is indicated for use in the management of acute myocardial infarction, acute ischemic stroke and acute massive pulmonary embolism in adults. Activase® (Alteplase recombinant) is supplied as a sterile, lyophilized powder, put up in vials. Each vial, in turn, is packaged in a paperboard box that also contains a vial of diluent and a double-sided, sterile, siliconized transfer device. The second product, Avastin™ (bevacizumab) is a medicament containing Bevacizumab, a recombinant humanized monoclonal antibody to vascular endothelial growth factor (VEGF), as the active ingredient. It is indicated for the treatment of metastatic carcinoma of the colon or rectum. Avastin™ (bevacizumab) is supplied as a sterile solution in single-use glass vials. The third product, Cathflo™Activase® (Alteplase), is a medicament containing Alteplase, a tissue plasminogen activator (serine protease) produced by recombinant DNA technology, as the active ingredient. It is indicated for the restoration of function to central venous access devices, by intracatheter instillation, as assessed by the ability to withdraw blood. Cathflo™Activase® (Alteplase) is supplied as a sterile, lyophilized powder in 2 mg vials. The fourth product, Herceptin® (Trastuzumab) is a medicament containing Trastuzumab, a recombinant DNA-derived humanized monoclonal antibody, as the active ingredient. It is indicated for the treatment of metastatic breast cancer. Herceptin® (Trastuzumab) is supplied as a lyophilized, sterile powder in multi-dose vials. Each vial, in turn, is packaged with a vial of diluent in a paperboard box. The applicable subheading for Activase® (Alteplase recombinant) and Cathflo™ Activase® (Alteplase) will be 3004.90.9120, 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: Cardiovascular medicaments.” The rate of duty will be free. The applicable subheading for Avastin™ (bevacizumab) and Herceptin® (Trastuzumab) will be 3004.90.9115, 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: Antineoplastic and immunosuppressive medicaments.” 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