CLA-2-30:OT:RR:NC:N2:238
Ms. Inge Forstenzer
Ren-Pharm International, Ltd.
350 Jericho Turnpike, Suite 204
Jericho, NY 11753-1317
RE: The tariff classification of Amoxicillin Trihydrate (CAS 61336-70-7) and Clavulanate Potassium (CAS 61177-45-5) mixture with Cellulose (CAS 9004-34-6), imported in bulk powder form, from Spain
Dear Ms. Forstenzer:
In your letter dated June 10, 2016, you requested a tariff classification ruling.
The subject product, Amoxicillin Trihydrate and Clavulanate Potassium mixture with cellulose is a multiple ingredient blend of 2 parts Amoxicillin Trihydrate, 1 part Clavulanate Potassium and Cellulose, as the excipient. This product is indicated for the treatment of bacterial infections.
The applicable subheading for the Amoxicillin Trihydrate and Clavulanate Potassium mixture with cellulose in bulk powder form will be 3003.10.0000, Harmonized Tariff Schedule of the United States (HTSUS), which provides "Medicaments ... consisting of two or more constituents which have been mixed together for therapeutic or prophylactic uses, not put up in measured doses or in forms or packings for retail sale: Containing penicillins or derivatives thereof, with a penicillanic acid structure, or streptomycins or their derivatives." 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