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N322137 N3 Ruling Active

The tariff classification of Mesalamine Suppositories in dosage form, from Italy

Issued November 5, 2021 by U.S. Customs and Border Protection.

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N3 N322137 (November 5, 2021)

Tariff classification

HTS codes: 3004.90.9260

Headings: 3004

Product description

Mesalamine, imported in 1000 mg suppositories, belongs to a class of drugs known as aminosalicylates. It is indicated for the treatment of patients with active or mild to moderate acute exacerbations of ulcerative colitis, and for the maintenance of remission of ulcerative colitis.

CBP rationale

The applicable subheading for the Mesalamine Suppositories in dosage form will be 3004.90.9260, 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: Medicaments primarily affecting the digestive system: Other.

Full text

N322137 November 5, 2021 CLA-2-30:OT:RR:NC:N3:138 CATEGORY: Classification TARIFF NO.: 3004.90.9260 Mrs. Rhona M. Keeler NorthStar Healthcare 3300 Cork Airport Business Park Kinsale Road, Cork T12 XN72 Ireland RE: The tariff classification of Mesalamine Suppositories in dosage form, from Italy Dear Mrs. Keeler: In your letter dated October 11, 2021, you requested a tariff classification ruling. Mesalamine, imported in 1000 mg suppositories, belongs to a class of drugs known as aminosalicylates. It is indicated for the treatment of patients with active or mild to moderate acute exacerbations of ulcerative colitis, and for the maintenance of remission of ulcerative colitis. The applicable subheading for the Mesalamine Suppositories in dosage form will be 3004.90.9260, 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: Medicaments primarily affecting the digestive system: 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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