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N292776 N2 Ruling Active

The tariff classification of Irinotecan Hydrochloride Injection in dosage form, from India

Issued January 10, 2018 by U.S. Customs and Border Protection.

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N2 N292776 (January 10, 2018)

Tariff classification

HTS codes: 3004.49.0070

Headings: 3004

Product description

Irinotecan Hydrochloride Injection is a medicinal preparation containing, Irinotecan Hydrochloride, a semisynthetic derivative of the natural alkaloid Camptothecin, as the active ingredient. It is an antineoplastic drug that is indicated for the treatment of cancer of the colon or rectum, particularly in combination with other chemotherapy agents. Irinotecan Hydrochloride Injection will be imported in 20 mg/ml single dose vials.

CBP rationale

The applicable subheading for Irinotecan Hydrochloride Injection in dosage form will be 3004.49.0070, 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 (including those in the form of transdermal administration systems) or in forms or packings for retail sale: Other, containing alkaloids or derivatives thereof: Other: Other: Other.

Full text

N292776 January 10, 2018 CLA-2-30:OT:RR:NC:N1:138 CATEGORY: Classification TARIFF NO.: 3004.49.0070 Ms. Paulina Radaczynska BluePoint Laboratories 8 Eastgate Avenue Eastgate Business Park Little Island, Cork 11111, Ireland RE: The tariff classification of Irinotecan Hydrochloride Injection in dosage form, from India Dear Ms. Radaczynska: In your letter dated December 13, 2017, you requested a tariff classification ruling. Irinotecan Hydrochloride Injection is a medicinal preparation containing, Irinotecan Hydrochloride, a semisynthetic derivative of the natural alkaloid Camptothecin, as the active ingredient. It is an antineoplastic drug that is indicated for the treatment of cancer of the colon or rectum, particularly in combination with other chemotherapy agents. Irinotecan Hydrochloride Injection will be imported in 20 mg/ml single dose vials. The applicable subheading for Irinotecan Hydrochloride Injection in dosage form will be 3004.49.0070, 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 (including those in the form of transdermal administration systems) or in forms or packings for retail sale: Other, containing alkaloids or derivatives thereof: 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 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

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