CLA-2-30:OT:RR:NC:N3:138
Laura Walsh
Amivas US LLC
100 Tuscanney Drive, Suite B2 Frederick, MD 21702
RE: The tariff classification of Artesunate for Injection and Sterile Diluent in dosage form, from Canada
Dear Ms. Walsh:
In your letter dated June 15, 2023, you requested a tariff classification ruling.
The first product, Artesunate for Injection, imported in 110 mg vials, is an antimalarial drug indicated for the initial treatment of severe malaria in adult and pediatric patients.
The second product, Sterile Diluent for Artesunate for Injection contains 24.1 mg sodium phosphate monobasic monohydrate and 443.6 mg sodium phosphate dibasic anhydrous in water for injection. Each single-dose vial of the supplied sterile diluent contains 12 mL of a sterile diluent. Artesunate for Injection must be constituted with the supplied diluent prior to administration.
The applicable subheading for the Artesunate for Injection in dosage form will be 3004.60.0000, 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: Other, containing antimalarial active principles described in subheading note 2 to this chapter.” The rate of duty will be free.
The applicable subheading for the Sterile Diluent in dosage form will be 3004.90.9291, 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: 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 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