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NY 864623

September 19, 1991

CLA-2-30:S:N:N1:238 864623


TARIFF NO.: 3003.90.0000

Ms. Dody Trombley
F.W. Myers & Co.
33 West Service, P.O. Box 188
Champlain, NY 12919

RE: The tariff classification of enterically coated prilosec (omeprazole) pellets from Canada

Dear Ms. Trombley:

In your letter dated June 20, 1991, on behalf of Merck Frosst Canada, Incorporated you requested a tariff classification ruling.

Your request indicates that Merck Sharp and Dohme of West Point, N.Y. will send United States produced omeprazole pellets to your client in Canada. In Canada the pellets will be coated with an enteric solution, dried, classified by size and blended. The purpose of the enteric coating is to insure that the pellets will remain intact in the stomach but dissolve in the intestine. Once the coating process is completed the pellets will be returned to the United States for encapsulation for use as a gastric acid secretion inhibitor. You also inquire if the coated pellets would be eligible for treatment under subheading 9802.00.50 which provides for articles exported for repairs or alterations.

We are of the opinion that the enteric coating of the pellets amounts to an operation which exceeds an alteration, as it creates a new and different article and serves to finish a manufacturing process begun in the United States.

The applicable subheading for the enterically coated prilosec pellets will be 3003.90.0000, Harmonized Tariff Schedule of the United States (HTS), which provides for medicaments (excluding goods of heading 3002, 3005, or 3006) 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. The duty rate will be 6 percent ad valorem.

Goods classifiable under subheading 3003.90.0000, HTS, which have originated in the territory of Canada, will be entitled to a 4.2 percent rate of duty under the United States-Canada Free Trade Agreement (FTA) upon compliance with all applicable regulations.

This merchandise may be subject to the regulations of the Food and Drug Administration. You may contact them at 5600 Fishers Lane, Rockville, Maryland 20857, telephone number (202) 443-3380.

This ruling is being issued under the provisions of Section 177 of the Customs Regulations (19 C.F.R. 177).

A copy of this ruling letter should be attached to the entry documents filed at the time this merchandise is imported. If the documents have been filed without a copy, this ruling should be brought to the attention of the Customs officer handling the transaction.


Jean F. Maguire
Area Director

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