CLA-2-29:OT:RR:NC:N1:138
Ms. Freya S. Wilkes
Allergan Sales, LLC
2525 Dupont Drive, P.O Box 19534
Irvine, CA 92623
RE: The tariff classification of Ubrogepant (CAS No. 1374248-77-7) in bulk form from China and in dosage form from Ireland
Dear Ms. Wilkes:
In your letter dated January 10, 2018, you requested a tariff classification ruling.
Ubrogepant is a calcitonin gene-related peptide (CGRP) receptor antagonist for migraines. Currently, Ubrogepant is an experimental drug candidate used in Phase III clinical trials for the treatment of acute migraines. It will be imported in bulk form and in final dosage form.
The applicable subheading for the Ubrogepant in bulk form will be 2933.79.0800, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Heterocyclic compounds with nitrogen hetero-atom(s) only: Lactams: Other lactams: Aromatic or modified aromatic: Other: Products described in additional U.S. note 3 to section VI." The general rate of duty will be 6.5 percent ad valorem. Currently, Ubrogepant is not listed in the Pharmaceutical Appendix to the Tariff Schedule.
The applicable subheading for the Ubrogepant in dosage form will be 3004.90.9228, HTSUS, which provides for “Medicaments … consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses … or in forms or packings for retail sale: Other: Other: Other: Medicaments primarily affecting the central nervous system: Analgesics, antipyretics and non-hormonal anti-inflammatory agents: Other.” 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 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