The tariff classification of Nystatin Topical Powder, Fluocinonide Cream USP, 0.1% and Doxorubicin Hydrochloride Liposome Injection in dosage form, from India
Issued March 13, 2020 by U.S. Customs and Border Protection.
Tariff classification
HTS codes: 3004.32.0000, 3004.20.0060
Headings: 3004
Product description
The first product, Nystatin Topical Powder, is an antifungal medication indicated for the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other susceptible Candida species. The second product, Fluocinonide Cream USP, 0.1% is a synthetic corticosteroid that is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses in patients 12 years of age or older. The third product, Doxorubicin Hydrochloride Liposome Injection, imported in 20 mg and 50 mg, is a cytotoxic anthracycline antibiotic. It is indicated for the treatment of patients with ovarian cancer, AIDS-related Kaposi’s sarcoma, and in combination with bortezomib for multiple myeloma.
CBP rationale
The applicable subheading for the Nystatin Topical Powder in dosage form will be 3004.20.0060, 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 antibiotics: Other: Other. The applicable subheading for the Fluocinonide Cream USP, 0.1% in dosage form will be 3004.32.0000, 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 hormones or other products of heading 2937: Containing corticosteroid hormones, their derivatives or structural analogues. The applicable subheading for the Doxorubicin Hydrochloride Liposome Injection in dosage form will be 3004.20.0060, 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
N309854 March 13, 2020 CLA-2-30:OT:RR:NC:N3:138 CATEGORY: Classification TARIFF NO.: 3004.20.0060; 3004.32.0000 Mr. Pradeep Shah Zydus Pharmaceuticals USA Inc. 73 Route 31 North Pennington, NJ 08534 RE: The tariff classification of Nystatin Topical Powder, Fluocinonide Cream USP, 0.1% and Doxorubicin Hydrochloride Liposome Injection in dosage form, from India Dear Mr. Shah: In your letter dated February 14, 2020, you requested a tariff classification ruling. The first product, Nystatin Topical Powder, is an antifungal medication indicated for the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other susceptible Candida species. The second product, Fluocinonide Cream USP, 0.1% is a synthetic corticosteroid that is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses in patients 12 years of age or older. The third product, Doxorubicin Hydrochloride Liposome Injection, imported in 20 mg and 50 mg, is a cytotoxic anthracycline antibiotic. It is indicated for the treatment of patients with ovarian cancer, AIDS-related Kaposi’s sarcoma, and in combination with bortezomib for multiple myeloma. The applicable subheading for the Nystatin Topical Powder in dosage form will be 3004.20.0060, 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 antibiotics: Other: Other.” The rate of duty will be free. The applicable subheading for the Fluocinonide Cream USP, 0.1% in dosage form will be 3004.32.0000, 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 hormones or other products of heading 2937: Containing corticosteroid hormones, their derivatives or structural analogues.” The rate of duty will be free. The applicable subheading for the Doxorubicin Hydrochloride Liposome Injection in dosage form will be 3004.20.0060, 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 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
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