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NY L83912




April 11, 2005

CLA-2-30:RR:NC:2:238 L83912

CATEGORY: CLASSIFICATION

TARIFF NO.: 3004.39.0050

Mr. Lynden Davis
Exel Global Logistics Inc.
230-39 Int’l Airport Center Blvd.
Suite 1000
Jamaica, NY 11413

RE: The tariff classification of GlucaGen® HypoKit from Denmark

Dear Mr. Davis:

In your letter dated March 14, 2005, 0n behalf of your client, Novo Nordisk Inc., you requested a tariff classification ruling.

The submitted sample, GlucaGen® HypoKit, consists of a plastic case containing a 2 ml glass vial and a disposable syringe. The vial is partially filled with a sterile, freeze-dried, white powder containing 1 mg of glucagon hydrochloride

Glucagon is a polypeptide hormone produced in the pancreas. It induces liver glycogen breakdown, releasing glucose from the liver. as the active ingredient. The barrel of the syringe is filled with 2 ml of sterile water, which is used to reconstitute the glucagon powder. When the glucagon powder is reconstituted with the sterile water, it forms a solution for subcutaneous, intramuscular, or intravenous injection (after which the syringe is disposed of). The product is used to treat severe hypoglycemic (low blood sugar) reactions that may occur in patients with diabetes treated with insulin. The product is also indicated for use during radiologic examinations to temporarily inhibit movement of the gastrointestinal tract.

The applicable subheading for GlucaGen® HypoKit will be 3004.39.0050, Harmonized Tariff Schedule of the United States (HTS), which provides for “Medicaments consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses (including those in the form of transdermal administration systems) or in forms or packings for retail sale: Containing hormones or other products of heading 2937 but not containing antibiotics: Other: Other.” The rate of duty will be free.

This merchandise may be subject to the requirements of the Federal Food, Drug, and Cosmetic Act, which is administered by the U.S. Food and Drug Administration. You may contact them at 5600 Fishers Lane, Rockville, Maryland 20857, telephone number 1-888-463-6332.

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

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