CLA-2-29:OT:RR:NC:N3:138
Carol Shelsy
Euro-American Air Freight Forwarding Co., Inc.
375 Airport Drive, Building 5
Worcester, MA 01602
RE: The tariff classification of Ensifentrine (CAS No. 1884461-72-6) in bulk powder form, from Portugal
Dear Ms. Shelsy:
In your letter dated July 21, 2023, on behalf of Verona Pharma, Inc., you requested a tariff classification ruling.
Ensifentrine is a novel, selective, dual phosphodiesterase (PDE)3 and PDE4 inhibitor with bronchodilator and anti-inflammatory effects. It is an investigational drug indicated for the treatment of Chronic Obstructive Pulmonary Disorder (COPD). In a follow-up email to this office, you stated Ensifentrine has completed phase 3 clinical trials and submitted a new drug application to the FDA in June of this year.
The applicable subheading for the Ensifentrine 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, Ensifentrine 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 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 and Border Protection 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, please contact National Import Specialist Judy Lee at [email protected].
Sincerely,
Steven A. Mack
Director
National Commodity Specialist Division