CLA-2-30:OT:RR:NC:N2:238
Ms. Inge Forstenzer
Ren-Pharm International Ltd.
350 Jericho Turnpike, Suite 204
Jericho, New York 11753
RE: The tariff classification of Clavulanate Potassium (CAS-61177-45-5) mixed with Syloid (CAS-63231-67-4) imported in bulk form, from Turkey
Dear Ms. Forstenzer:
In your letter dated October 20, 2009, you requested a tariff classification ruling.
The subject product, Clavulanate Potassium, is the potassium salt of clavulanic acid. Structurally, it is a ß-lactam that functions as a ß-lactamase inhibitor by binding to these particular enzymes (produced by a wide range of pathogenic microorganisms) and inactivating them. When combined with ß-lactam antibiotics, such as Amoxicillin, in various medications, the ß-lactamase activity of Clavulanate Potassium serves to prevent the destruction of the ß-lactam antibiotics, which are substrates for these enzymes. This activity thus allows the antibiotic to kill or inhibit the growth of the targeted microorganisms. When Clavulanate Potassium is mixed with the excipient, one part Syloid, it acts as both a glidant (to increase the flowability of Potassium clavulanate during the preparation, after importation, of oral suspension products) and a stabilizer (to lessen the hazardous nature of Potassium clavulanate during transport and storage).
The applicable subheading for the Clavulanate Potassium mixed with Syloid in bulk form will be 3003.90.0000, Harmonized Tariff Schedule of the United States (HTS), which provides for “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: 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 http://www.usitc.gov/tata/hts/.
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 Harvey Kuperstein at (646) 733-3033.
Sincerely,
Robert B. Swierupski
Director
National Commodity Specialist Division