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 Difelikefalin Acetate (CAS No. 1024829-44-4) in bulk form, from Taiwan
Dear Ms. Lo:
In your letter dated January 5, 2022, on behalf of Chunghwa Chemical Synthesis & Biotech Co, Ltd., you requested a tariff classification ruling.
Difelikefalin Acetate (also known under the brand name Korsuva) is a kappa opioid receptor agonist indicated for the treatment of moderate-to-severe pruritus associated with chronic kidney disease (CKD-aP) in adults undergoing hemodialysis (HD).
The applicable subheading for the Difelikefalin Acetate in bulk form will be 2933.39.4100, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Heterocyclic compounds with nitrogen hetero-atom(s) only: Compounds containing an unfused pyridine ring (whether or not hydrogenated) in the structure: Other: Other: Drugs: Other.” The rate of duty will be 6.5 percent ad valorem. Currently, Difelikefalin Acetate 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 [email protected].
Sincerely,
Steven A. Mack
Director
National Commodity Specialist Division