CLA-2-30:OT:RR:NC:N2:238
Ms. Robyn K. Brunciak
World Gen LLC
120 Route 17 North
Paramus, NJ 07652
RE: The tariff classification of Vabormere vials imported in dosage form, from Italy
Dear Ms. Brunciak:
In your letter dated June 20, 2017, you requested a tariff classification ruling.
Vabormere is a medicinal preparation containing Meropenem (antibiotic) and Vaborbactam (beta- lactamase inhibitor), as the active ingreidents. It is indicated for the treatment of complicated urinary tract infections (cUTIs) and will be imported in 1g/50 ml vials.
The applicable subheading for Vabormere vials 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: Other, containing 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 [email protected].
Sincerely,
Steven A. Mack
Director
National Commodity Specialist Division