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N312299 N3 Ruling Active

The tariff classification of Ertapenem for Injection in dosage form, from Italy

Issued July 2, 2020 by U.S. Customs and Border Protection.

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N3 N312299 (July 2, 2020)

Tariff classification

HTS codes: 3004.20.0060

Headings: 3004

Product description

It is indicated for the treatment of serious infections, including pneumonia, urinary tract, skin, diabetic foot, gynecological, pelvic, and abdominal (stomach area) infections, that are caused by bacteria. It is also used for the prevention of infections following colorectal surgery.

CBP rationale

The applicable subheading for the Ertapenem for Injection 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.

Full text

N312299 July 2, 2020 CLA-2-30:OT:RR:NC:N3:138 CATEGORY: Classification TARIFF NO.: 3004.20.0060 Ms. Robyn K. Brunciak Worldgen LLC 120 Route 17 North Paramus, NJ 07652 RE: The tariff classification of Ertapenem for Injection in dosage form, from Italy Dear Ms. Brunciak: In your letter dated June 8, 2020, you requested a tariff classification ruling Ertapenem for Injection, imported in 1 gram vials, is a broad spectrum carbapenem antibiotic. It is indicated for the treatment of serious infections, including pneumonia, urinary tract, skin, diabetic foot, gynecological, pelvic, and abdominal (stomach area) infections, that are caused by bacteria. It is also used for the prevention of infections following colorectal surgery. The applicable subheading for the Ertapenem for Injection 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. 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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