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N292241 N2 Ruling Active

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

Issued December 4, 2017 by U.S. Customs and Border Protection.

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N2 N292241 (December 4, 2017)

Tariff classification

HTS codes: 3004.20.0060

Headings: 3004

Product description

Doxorubicin Hydrochloride Liposome Injection is a medicinal preparation containing Doxorubicin Hydrochloride, a cytotoxic anthracycline antibiotic, as the active ingredient. It is indicated for the treatment of ovarian cancer, AIDS-related Kaposi’s sarcoma, and in combination with bortezomib for multiple myeloma. Doxorubicin Hydrochloride Liposome Injection is encapsulated in liposomes for intravenous use in dosages of 20 mg/10 ml (2 mg/ml) and 50 mg/25 ml (2 mg/ml).

CBP rationale

The applicable subheading for the Doxorubicin Hydrochloride Liposome Injection in dosage form will be 3004.20.0060, Harmonized Tariff Schedule of the United State (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 antibiotics: Other: Other.

Full text

N292241 December 4, 2017 CLA-2-30:OT:RR:NC:N1:138 CATEGORY: Classification TARIFF NO.: 3004.20.0060 Ms. Paulina P. Radaczynska BluePoint Laboratories Eastgate Business Park 8 Eastgate Avenue Little Island Cork, 11111 Ireland RE: The tariff classification of Doxorubicin Hydrochloride Liposome Injection in dosage form, from India Dear Ms. Radaczynska: In your letter dated November 21, 2017, you requested a tariff classification ruling. Doxorubicin Hydrochloride Liposome Injection is a medicinal preparation containing Doxorubicin Hydrochloride, a cytotoxic anthracycline antibiotic, as the active ingredient. It is indicated for the treatment of ovarian cancer, AIDS-related Kaposi’s sarcoma, and in combination with bortezomib for multiple myeloma. Doxorubicin Hydrochloride Liposome Injection is encapsulated in liposomes for intravenous use in dosages of 20 mg/10 ml (2 mg/ml) and 50 mg/25 ml (2 mg/ml). The applicable subheading for the Doxorubicin Hydrochloride Liposome Injection in dosage form will be 3004.20.0060, Harmonized Tariff Schedule of the United State (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 antibiotics: 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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