N326055 N3 Ruling Active

The tariff classification of Emtricitabine/Tenofovir Disoproxil Fumarate Tablets in dosage form, from India

Issued June 2, 2022 by U.S. Customs and Border Protection.

Tariff classification

HTS codes: 3004.90.9207

Headings: 3004

Product description

Emtricitabine/Tenofovir Disoproxil Fumarate, imported in 200 mg/300 mg tablets is a fixed-dose combination tablet containing Emtricitabine and Tenofovir Disoproxil Fumarate. Emtricitabine and Tenofovir are in a class of medications called nucleoside and nucleotide reverse transcriptase inhibitors (NRTIs). It is used in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 17 kg.

CBP rationale

The applicable subheading for the Emtricitabine/Tenofovir Disoproxil Fumarate Tablets in dosage form will be 3004.90.9207, 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: Other: Other: Anti-infective medicaments: Antivirals.

Full text

N326055 June 2, 2022 CLA-2-30:OT:RR:NC:N3:138 CATEGORY: Classification TARIFF NO.: 3004.90.9207 Mrs. Rhona M. Keeler NorthStar Healthcare 3300 Cork Airport Business Park Kinsale Road, Cork T12 XN72 Ireland RE: The tariff classification of Emtricitabine/Tenofovir Disoproxil Fumarate Tablets in dosage form, from India Dear Mrs. Keeler: In your letter dated May 12, 2022, you requested a tariff classification ruling. Emtricitabine/Tenofovir Disoproxil Fumarate, imported in 200 mg/300 mg tablets is a fixed-dose combination tablet containing Emtricitabine and Tenofovir Disoproxil Fumarate. Emtricitabine and Tenofovir are in a class of medications called nucleoside and nucleotide reverse transcriptase inhibitors (NRTIs). It is used in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 17 kg. The applicable subheading for the Emtricitabine/Tenofovir Disoproxil Fumarate Tablets in dosage form will be 3004.90.9207, 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: Other: Other: Anti-infective medicaments: Antivirals.” 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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