N329297

N329297 December 7, 2022 CLA-2-29:OT:RR:NC:N3:138 CATEGORY: Classification TARIFF NO.: 2933.59.5300 Ms. Sheila Heerdt Ren Pharm International Ltd. 350 Jericho Turnpike, Suite 204 Jericho, NY 11753 RE: The tariff classification of Ruxolitinib Phosphate (CAS No. 1092939-17-7) in bulk powder form, from Taiwan Dear Ms. Heerdt: In your letter dated November 10, 2022, you requested a tariff classification ruling. Ruxolitinib Phosphate is the phosphate salt form of Ruxolitinib, an orally bioavailable Janus-associated kinase (JAK) inhibitor. It is indicated for the treatment of patients with intermediate or high-risk myelofibrosis, post-polycythemia vera myelofibrosis and post-essential thrombocythemia myelofibrosis. The applicable subheading for the Ruxolitinib Phosphate in bulk powder 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 (whether or not hydrogenated) or piperazine ring in the structure: Other: Drugs: Aromatic or modified aromatic: Other.” The rate of duty will be 6.5 percent ad valorem. Currently, Ruxolitinib Phosphate is not listed in the Pharmaceutical Appendix to the Tariff Schedule. 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 judy.h.lee@cbp.dhs.gov. Sincerely, Steven A. Mack Director National Commodity Specialist Division