CLA-2-27:OT:RR:NC:N2:237
Ms. Natasha Nelson Ling
Compliance Officer
Amarin Pharma, Inc.
1430 Route 206 North - Suite 200
Bedminster, New Jersey 07921
RE: The tariff classification of medicinal grade mineral oil in capsules from various countries.
Dear Ms. Ling:
In your letter dated March 20, 2013 you requested a tariff classification ruling. You provided a Chemical Abstract Number (CAS-8042-47-5) for our review.
The product is described as a medicinal grade mineral oil (CAS-8042-47-5) in 1 gram size bovine based, TSE/BSE free capsules. The capsules are produced in the Netherlands then filled with mineral oil by a vendor who ships them to the U.S. The filled capsules will be imported for use as placebos in clinical trials on FDA approved fish oil based pharmaceutical capsules.
The applicable subheading for the medicinal grade mineral oil in capsules will be 2710.19.4530, Harmonized Tariff Schedule of the United States (HTSUS), which provides for: White mineral oil: Medicinal grade. The rate of duty will be 10.5 cents per barrel.
This merchandise is be subject to The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (The Bioterrorism Act), which is administered by the Food and Drug Administration (FDA). Information about FDA import requirements and regulations and FDA alerts and safeguards concerning Bovine Spongiform Encephalopathy (BSE) and Transmissible Spongiform Encephalopathies (TSEs) can be obtained by contacting the FDA at: Food and Drug Administration, Division of Import Operations and Policy, 5600 Fishers Lane, Rockville, Maryland 20857, Telephone: (888) 463-6332. Information on the Bioterrorism Act can be obtained by calling FDA at (301) 575-0156, or at the Web site www.fda.gov/oc/bioterrorism/bioact.html.
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 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 Frank Cantone at (646) 733-3038.
Sincerely,
Thomas J. Russo
Director
National Commodity Specialist Division