CLA-2-28:OT:RR:NC:N3:136
Ciara Horgan
NorthStar Healthcare UC
3300 Cork Airport Business Park Cork T12XN72 Ireland
RE: The tariff classification of Oxaliplatin from Germany
Dear Ms. Horgan:
In your letter dated October 29, 2024, you requested a tariff classification ruling on Oxaliplatin (CAS # 61825-94-3).
Your submission indicates that the product at issue is an organic precious metal compound in liquid form, mixed with water. You state that Oxaliplatin is a platinum-based chemotherapy agent used to treat carcinoma of the colon, rectum, or stage III colon cancer via intravenous infusion. This product will be imported into the United States in injectable 50mg and 100mg vials in retail form. You further state that this product’s formulation is 5% Oxaliplatin and 95% water, its IUPAC naming is [(1R,2R)-cyclohexane-1,2-diamine](ethanedioato-O,O’)platinum(II), and its chemical formula is C8H14N2O4Pt. This product is a single compound in aqueous solution; there are no other excipients or active ingredients in the formulation.
Oxaliplatin (CAS # 61825-94-3) is currently listed in the pharmaceutical appendix of the Harmonized Tariff Schedule of the United States (HTSUS).
In accordance with Section VI, Notes 1(b) and 2, HTSUS, because the subject product is described in heading 2843, HTSUS, it is to be classified there and in no other heading of this section.
The applicable subheading for Oxaliplatin (CAS # 61825-94-3) will be 2843.90.0000, HTSUS, which provides for Colloidal precious metals; inorganic or organic compounds of precious metals, whether or not chemically defined; amalgams of precious metals: Other compounds; amalgams. Pursuant to General Note 13, HTSUS, the rate of duty will be free.
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.
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/.
The holding set forth above applies only to the specific factual situation and merchandise description as identified in the ruling request. This position is clearly set forth in Title 19, Code of Federal Regulations (CFR), Section 177.9(b)(1). This section states that a ruling letter is issued on the assumption that all of the information furnished in the ruling letter, whether directly, by reference, or by implication, is accurate and complete in every material respect. In the event that the facts are modified in any way, or if the goods do not conform to these facts at time of importation, you should bring this to the attention of U.S. Customs and Border Protection (CBP) and submit a request for a new ruling in accordance with 19 CFR 177.2. Additionally, we note that the material facts described in the foregoing ruling may be subject to periodic verification by CBP.
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 Nuccio Fera at [email protected].
Sincerely,
Steven A. Mack
Director
National Commodity Specialist Division