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N285019 N2 Ruling Active

The tariff classification of Brinzolamide Ophthalmic Suspension 1.0% vials in dosage form, from India

Issued April 21, 2017 by U.S. Customs and Border Protection.

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N2 N285019 (April 21, 2017)

Tariff classification

HTS codes: 3004.90.9285

Headings: 3004

Product description

Brinzolamide Ophthalmic Suspension 1.0% in 10 ml vials is a medicinal preparation containing Brinzolamide, a carbonic anhydrase inhibitor, as the active ingredient. It decreases the pressure in the eye and is indicated for the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma. In your letter, you indicated that you will be importing 600 vials for in vivo testing.

CBP rationale

The applicable subheading for the Brinzolamide Ophthalmic Suspension 1.0% in 10 ml vials in dosage form will be 3004.90.9285, 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 (…) Other: Other: Other: Medicaments primarily affecting the eyes, ears or respiratory system: Other: Other.

Full text

N285019 April 21, 2017 CLA-2-30:OT:RR:NC:N2:238 CATEGORY: Classification TARIFF NO.: 3004.90.9285 Mr. Thomas M. Speace Sentiss Pharmaceuticals LLC 107 Avenida de la Estrella, Suite 102 San Clemente, CA 92672 RE: The tariff classification of Brinzolamide Ophthalmic Suspension 1.0% vials in dosage form, from India Dear Mr. Speace: In your letter dated April 3, 2017, you requested a tariff classification ruling. Brinzolamide Ophthalmic Suspension 1.0% in 10 ml vials is a medicinal preparation containing Brinzolamide, a carbonic anhydrase inhibitor, as the active ingredient. It decreases the pressure in the eye and is indicated for the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma. In your letter, you indicated that you will be importing 600 vials for in vivo testing. The applicable subheading for the Brinzolamide Ophthalmic Suspension 1.0% in 10 ml vials in dosage form will be 3004.90.9285, 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 (…) Other: Other: Other: Medicaments primarily affecting the eyes, ears or respiratory system: 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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