The tariff classification of Fulphila™ (Pegfilgrastim-jmdb) Injection in dosage form, from India

N300608 October 11, 2018 CLA-2-30:OT:RR:NC:N1:138 CATEGORY: Classification TARIFF NO.: 3002.15.0000 Ms. Kelly Jo Cox Mylan Pharmaceuticals Inc. 781 Chestnut Ridge Road Morgantown, WV 26505 RE: The tariff classification of Fulphila™ (Pegfilgrastim-jmdb) Injection in dosage form, from India Dear Ms. Cox: In your letter dated September 17, 2018, you requested a tariff classification ruling. Fulphila™ (Pegfilgrastim-jmdb) Injection, imported in 6 mg/0.6 mL pre-filled syringes, is a PEGylated form of the recombinant human granulocyte colony-stimulating factor (GCSF) analog filgrastim. According to the prescribing information in your submission, Fulphila is a leukocyte growth factor indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. The applicable subheading for the Fulphila™ (Pegfilgrastim-jmdb) Injection in dosage form will be 3002.15.0000, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Antisera, other blood fractions and immunological products, whether or not obtained by means of biotechnological processes: Immunological products, put up in measured doses or in forms or packings for retail sale.” The general rate of duty will be free. Duty rates are provided for your convenience and are subject to change. The text of the most recent HTSUS and the accompanying duty rates are provided on the World Wide Web at https://hts.usitc.gov/current. This merchandise may be subject to the Federal Food, Drug, and Cosmetic Act and/or The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (The Bioterrorism Act), which are administered by the U.S. Food and Drug Administration (FDA). Information on the Federal Food, Drug, and Cosmetic Act, as well as The Bioterrorism Act, can be obtained by calling the FDA at 1-888-463-6332, or by visiting their website at www.fda.gov. 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 Judy Lee at [email protected]. Sincerely, Steven A. Mack Director National Commodity Specialist Division