CLA-2-30:OT:RR:NC:N3:138
Ms. Carol Shelsy
Karen A. Busenburg, CHB
375 Airport Drive
Worcester, MA 01602
RE: The tariff classification of Talicia® Capsules in dosage form, from Sweden
Dear Ms. Shelsy:
In your letter dated December 23, 2019, on behalf of RedHill BioPharma, Inc., you requested a tariff classification ruling.
Talicia is a medicinal preparation in capsule form containing three active ingredients. Talicia capsule is a fixed-oral combination therapy of two antibiotics (Amoxicillin 250 mg and Rifabutin 2.5 mg) and a proton pump inhibitor (Omeprazole 10 mg). It is indicated for the treatment and eradication of Helicobacter pylori (H. pylori) infection.
The applicable subheading for the Talicia Capsules in dosage form will be 3004.10.5045, Harmonized Tariff Schedule of the United States (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: Containing penicillins or derivatives thereof, with a penicillanic acid structure, or streptomycins or their derivatives: Other: Other: Combination antibiotics.” 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 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