CLA-2-30:OT:RR:NC:N3:138
Ms. Rhona M. Keeler
NorthStar Healthcare
3300 Cork Airport Business Park
Kinsale Road, Cork T12 XN72
Ireland
RE: The tariff classification of Imatinib Mesylate Tablets in dosage form, from India
Dear Ms. Keeler:
In your letter dated April 1, 2019, you requested a tariff classification ruling.
Imatinib Mesylate, imported in 100 mg and 400 mg tablets, is a tyrosine kinase inhibitor with antineoplastic activity. It is indicated for the treatment of Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML), Ph+ Acute Lymphoblastic Leukemia (ALL), Myelodysplastic/Myeloproliferative Diseases (MDS/MPD), Aggressive Systemic Mastocytosis (ASM), Hypereosinophilic Syndrome (HES) and/or Chronic Eosinophilic Leukemia (CEL), Dermatofibrosarcoma Protuberans (DFSP) and Gastrointestinal Stromal Tumors (GIST).
The applicable subheading for Imatinib Mesylate Tablets in dosage form will be 3004.90.9215, Harmonized Tariff Schedule of the United States (HTSUS), 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: Antineoplastic and immunosuppressive medicaments." 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