CLA-2-30:OT:RR:NC:N3:138
Ms. Kelly Jo Cox
Mylan
781 Chestnut Ridge Road
Morgantown, WV 26505
RE: The tariff classification of Ogivri ™ (Trastuzumab-dkst for Injection) in dosage form, from India
Dear Ms. Cox:
In your letter dated November 7, 2019, you requested a tariff classification ruling.
Ogivri (Trastuzumab-dkst for Injection) imported in 150 mg single dose vials and 420 mg multi-dose vials, is a humanized IgG1 kappa monoclonal antibody. It is indicated for the treatment of HER2-overexpressing breast cancer and HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.
The applicable subheading for the Ogivri ™ (Trastuzumab-dkst for 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 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