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NY C84680




March 4, 1998

CLA-2-30:RR:NC:2:238 C84680

CATEGORY: CLASSIFICATION

TARIFF NO.: 3004.31.0000

Peter S. Herrick, Esq.
3520 Crystal View Court
Miami, FL 33133

RE: The tariff classification of Humulin L, Humulin N, and Humulin R, imported put up in vials, from the Dominican Republic

Dear Mr. Herrick:

In your letter dated May 12, 1997, on behalf of your client, Aero Fresh Cargo, Inc., you requested a tariff classification ruling.

The three subject products, namely: Humulin L, Humulin N, and Humulin R, consist of medicaments containing human insulin of recombinant DNA origin. All three products are indicated for use in the treatment of diabetes, and are put up in vials for administration by injection. Humulin L is described in the 1998 edition of the Physicians' Desk Reference ("PDR ") as " ... an amorphous and crystalline suspension of human insulin with zinc ... ", while Humulin N is described as " ... a crystalline suspension of human insulin with protamine and zinc ... ." Finally, Humulin R is described in the PDR as consisting of " ... zinc-insulin crystals dissolved in a clear fluid."

The applicable subheading for the three subject products will be 3004.31.0000, 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 or in forms or packings for retail sale: Containing hormones or other products of heading 2937 but not containing antibiotics: Containing insulin." 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 (301) 443-6553.

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 212-466-5770.

Sincerely,

Robert B. Swierupski

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