CLA-2-30:OT:RR:NC:N2:238

Mr. Thomas M. Speace
Sentiss Pharmaceuticals LLC
107 Avenida de la Estrella, Suite 102
San Clemente, CA 92672

RE: The tariff classification of Brimonidine Tartrate Ophthalmic Solution 0.1% vials in dosage form, from India

Dear Mr. Speace:

In your letter dated April 3, 2017, you requested a tariff classification ruling.

Brimonidine Tartrate Ophthalmic Solution 0.1% in 10 ml vials is a medicinal preparation containing Brimonidine Tartrate, an alpha-adrenergic receptor antagonist, as the active ingredient. It is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. In your letter, you indicated that you will be importing 500 vials for in vivo testing.

The applicable subheading for the Brimonidine Tartrate Solution 0.1% 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