United States International Trade Commision Rulings And Harmonized Tariff Schedule
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November 17, 1994

HQ 956623

CLA-2 CO:R:C:F 956623 ASM


TARIFF NO: 3004.90.6060

Mr. John H. Rancourt
TAP Pharmaceuticals Inc.
2355 Waukegan Road
Deerfield, IL 60015

RE: Tariff Classification of Lansoprazole Capsules from Japan

Dear Mr. Rancourt:

This letter is in response to your request for a ruling on the tariff classification of measured doses of Lansoprazole capsules you intend to import from Japan.


A tariff classifcation ruling has been requested for measured doses of Lansoprazole capsules which you intend to import in metal drums, typically 50,000 capsules per drum, to be re-packaged in bottles and blister packs for use. You have indicated that this product is used to treat ulcers, gastroesophageal reflux disease and some other hypersecretory diseases.


What is the proper classification under the Harmonized Tariff Schedule of the United States Annotated of measured doses of 15 mg and 30 mg Lansoprazole capsules?


Classification of merchandise under the Harmonized Tariff Schedule of the United States Annotated (HTSUSA), is made in accordance with the General Rules of Interpretation (GRI's). The systematic detail of the harmonized system is such that virtually all goods are classified by application of GRI 1, that is, according to the terms of the headings of the tariff schedule and any relative section or chapter notes. In the event that the goods cannot be classified solely on the basis of GRI 1, and if the headings and legal notes do not otherwise
require, the remaining GRI's may then be applied. The Explanatory Notes to the Harmonized Commodity Description and Coding System (EN's), which represent the official interpretation of the tariff at the international level, facilitate classification under the HTSUSA by offering guidance in understanding the scope of the headings and GRI's.

According to your information, Lansoprazole capsules in 15 mg and 30 mg doses, have the following chemical name: 2-[[[3- methyl-4-(2,2,2-trifluoroethoxy)-2- pyridyl]methyl]sulfinyl]benzimidazole. The "USAN" and "USP Dictionary of Drug Names" (1994 edition), categorize Lansoprazole as an anti-ulcerative drug.

When put up in measured doses and capsules, the anti- ulcerative drug, Lansoprazole, constitutes a medicament for tariff purposes. The EN's to heading 3004, specifically state at pg. 438, that this heading covers "... medicaments consisting of mixed or unmixed products, provided they are:

(a) Put up in measured doses or in forms such as tablets, ampoules... capsules, cachets, drops or pastilles, or small quantities of powder, ready for taking as single doses for therapeutic or prophylactic use."


The product identified under the generic name, Lansoprazole, in measured doses of 15 mg and 30 mg capsules, is properly classifiable within subheading 3004.90.6060, HTSUSA, which provides for : "Medicaments (excluding goods of heading 3002, 3005 or 3006) consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses or in forms or packings for retail sale: Other: Other, Other: Medicaments primarily affecting the digestive system: Other." The rate of duty is 6.3 percent ad valorem. Sincerely,

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