CLA-2-29:OT:RR:NC:N3:138
Ms. Yaling Lo
Pharmaports LLC
1 E Uwchlan Ave.
Exton, PA 19341
RE: The tariff classification of Trilaciclib Dihydrochloride (CAS No. 1977495-97-8) and Ruxolitinib Phosphate (CAS No. 1092939-17-7) in bulk form, from Taiwan
Dear Ms. Lo:
In your letter dated October 31, 2022, you requested a tariff classification ruling on behalf of your client, Chunghwa Chemical Synthesis & Biotech Co., Ltd.
Trilaciclib Dihydrochloride is a kinase inhibitor indicated to decrease the incidence of chemotherapy-induced myelosuppression in adult patients when administered prior to a platinum/etoposide-containing regimen or topotecan-containing regimen for extensive-stage small cell lung cancer.
Ruxolitinib Phosphate is the phosphate salt form of ruxolitinib, an orally bioavailable Janus-associated kinase (JAK) inhibitor with potential antineoplastic and immunomodulating activities.
It is indicated for the treatment of intermediate or high-risk myelofibrosis (MF), polycythemia vera (PV) and acute graft-versus-host disease (GVHD). Ruxolitinib Phosphate is also used in the treatment of atopic dermatitis and nonsegmental vitiligo.
The applicable subheading for the Trilaciclib Dihydrochloride and Ruxolitinib Phosphate 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.” The rate of duty will be 6.5 percent ad valorem. Currently, Trilaciclib Dihydrochloride and Ruxolitinib Phosphate are 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 [email protected].
Sincerely,
Steven A. Mack
Director
National Commodity Specialist Division