The tariff classification and country of origin marking of AVONEX® (interferon beta-1a), imported put up in disposable, single-chamber syringes, from Germany

NY I81061 May 3, 2002 CLA-2-30:RR:NC:2:238 I81061 CATEGORY: Classification TARIFF NO.: 3004.90.9140 Herbert J. Lynch, Esq. Sullivan & Lynch, P.C. 156 State Street Boston, MA 02109-2508 RE: The tariff classification and country of origin marking of AVONEX® (interferon beta-1a), imported put up in disposable, single-chamber syringes, from Germany Dear Mr. Lynch. : In your letter dated April 11, 2002, on behalf of your client, Biogen, Inc., you requested a tariff classification ruling. The imported product will consist of disposable, single-chamber syringes containing AVONEX® (interferon beta-1a). The 2001 edition of the USP Dictionary of USAN and International Drug Names defines interferon beta-1a as “[a] glycosylate polypeptide consisting of 166 amino acid residues produced from cultured Chinese Hamster ovary cells containing the engineered gene for human interferon beta.” AVONEX® is indicated for the treatment of relapsing forms of multiple sclerosis. You present the following set of facts in your letter: Biogen will supply U.S.-made AVONEX® (produced by them), in bulk form, to a pharmaceutical company in Germany. The German pharmaceutical company will mix the AVONEX® with excipients and then fill disposable, single-chamber, German-made syringes with the resulting product. The filled syringes will then be exported to the U.S. After injection of its contents into the patient, the syringe will be discarded. The applicable subheading for the imported product 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 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 301-443-1544. You assert, citing HQ 733248, HQ 559136, NY C85112, etc., that the imported product is not a result of the substantial transformation of the U.S.-produced AVONEX®. On the basis of the information provided, and the above-cited ruling letters, we agree that the processing of the AVONEX® in Germany (see above) does not result in a substantial transformation. Therefore, we find that the country of origin of the imported product is the U.S., and that the country of origin marking requirements under 19 U.S.C. 1304 do not apply to the imported product. With respect to the marking requirements for the syringe, we also agree, for the reasons enunciated in HQ 559136, that the syringe in which the AVONEX® is housed is a “disposable container,” as defined in 19 CFR 134.24(a) and (d), and therefore does not have to be marked with its own country of origin. 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