CLA-2-30:OT:RR:E:NC:N2:238
Mr. Mark Huntebrinker
Forest Pharmaceuticals, Inc.
13600 Shoreline Drive
Earth City, MO 63045
RE: The tariff classification of MONUROL® imported in dosage form, from Switzerland
Dear Mr. Huntebrinker:
In your letter dated December 16, 2011, you requested a tariff classification ruling.
The subject product, MONUROL®, imported in single-dose sachet is a medicinal preparation containing Fosfomycin Tromethamine (CAS-78964-85-9), a synthetic, broad-spectrum antibiotic, as the active ingredient. It is indicated only for the treatment of uncomplicated urinary tract infections (acute cystitis) in women due to susceptible strains of Escherichia coli and Enterococcus faecalis.
The applicable subheading for the MONUROL® imported 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 (…) 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 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 Judy Lee at (646) 733-3033.
Sincerely,
Thomas J. Russo
Director
National Commodity Specialist Division