The tariff classification of Tobramycin and Dexamethasone Ophthalmic Suspension 0.3%/ 0.1%, 5 mL vials in dosage form, from India

N283787 March 17, 2017 CLA-2-30:OT:RR:NC:N2:238 CATEGORY: Classification TARIFF NO.: 3004.20.0060 Mr. Thomas M. Speace Sentiss Pharmaceuticals LLC 107 Avenida de la Estrella, Suite 102 San Clemente, CA 92672 RE: The tariff classification of Tobramycin and Dexamethasone Ophthalmic Suspension 0.3%/ 0.1%, 5 mL vials in dosage form, from India Dear Mr. Speace: In your letter dated February 21, 2017, you requested a tariff classification ruling. Tobramycin and Dexamethasone Ophthalmic Suspension is a combination medicinal preparation consisting of 0.3 % Tobramycin (an antibiotic) and 0.1 % Dexamethasone (a corticosteroid), as the active ingredients. It is indicated for the treatment of bacterial eye infections. In a follow-up email to this office, you state that you will import approximately 1,000 vials of Tobramycin and Dexamethasone Ophthalmic Suspension for in-vitro testing purposes only and will not be marketed for human use. The applicable subheading for the Tobramycin and Dexamethasone Ophthalmic Suspension 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 (including those in the form of transdermal administration systems) or in forms or packings for retail sale: Containing other 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 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 judy.h.lee@cbp.dhs.gov. Sincerely, Steven A. Mack Director National Commodity Specialist Division