CLA-2-30:OT:RR:NC:N2:238
Ms. Inge Forstenzer
Ren-Pharm International, Ltd.
350 Jericho Turnpike, Suite 204
Jericho, NY 11753
RE: The tariff classification of Omega-3-acid ethyl esters (CAS-308081-97-2) in bulk oil form, from Italy
Dear Ms. Forstenzer:
In your letter dated June 24, 2009, you requested a tariff classification ruling.
The subject product, Omega-3-acid ethyl esters, is a lipid regulating agent, and is indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with very high triglyceride levels. You also indicated in a telephone conversation, this product will be imported in bulk oil form and will be the pharmaceutical ingredient for the drug called Lovaza®, which can only be dispensed by prescription. Per additional information received by this office, Omega-3-acid ethyl esters has two major components, 48% EPA ethyl ester, 38% DHA ethyl ester and 8% of other omega-3-acid ethyl esters and the remaining 6% are impurities and water.
The applicable subheading for the Omega-3-acid ethyl esters in bulk oil form will be 3003.90.0000, Harmonized Tariff Schedule of the United States (HTSUS), 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