CLA-2-29:OT:RR:NC:N2:138

Mr. Gnanapragasam L Jeyaraj
SST Corporation
635 Brighton Road
Clifton, NJ 07012

RE: The tariff classification of Imatinib (CAS No. 152459-95-5) and Tofacitinib Citrate (CAS No. 540737-29-9) in bulk powder form, from Italy

Dear Mr. Jeyaraj:

In your letter dated February 21, 2019, you requested a tariff classification ruling.

The first product, Imatinib is a tyrosine kinase inhibitor. It is indicated for the treatment of chronic myeloid leukemia and malignant gastrointestinal stromal tumors.

The second product, Tofacitinib Citrate belongs to a class of drugs called Janus kinase (JAK) inhibitors. It is indicated for the treatment of moderately to severely active rheumatoid arthritis, active psoriatic arthritis and active ulcerative colitis in adults.

The applicable subheading for the Imatinib in bulk form will be 2933.59.5300, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Heterocyclic compounds with nitrogen hetero-atom(s) only: Compounds containing a pyrimidine ring (…) or piperazine ring in the structure: Other: Drugs: Aromatic or modified aromatic: Other.” Pursuant to General Note 13, HTS, the rate of duty will be free.

The applicable subheading for the Tofacitinib Citrate in bulk form will be 2933.59.5900, HTSUS, which provides for “Heterocyclic compounds with nitrogen hetero-atom(s) only: Compounds containing a pyrimidine ring (…) or piperazine ring in the structure: Other: Drugs: Other.” Pursuant to General Note 13, HTS, 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