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HQ 083650


March 13, 1990

CLA-2:CO:R:C:G 083650 SER

CATEGORY: CLASSIFICATION

TARIFF NO.: 3003.90.0000

Mr. Alvin Silvey
Silvey Shipping Co., Inc.
130 William Street
Suite 807
New York, NY 10048

RE: Vasodilator drug chemicals

Dear Mr. Silvey:

This is in reference to your request for classification under the Harmonized Tariff Schedule of the United States Annotated (HTSUSA) of chemicals from Italy, on behalf of Gyma Laboratories of America Incorporated.

FACTS:

The merchandise at issue are chemicals which are used in the manufacture of vasodilator drugs. They are as follows:

1. Isosorbide dinitrate 25 percent with 75 percent lactose.

2. Pentaerythritol tetranitrate 20 percent with 80 percent lactose.

3. Nitroglycerin 10 percent with 90 percent lactose.

The lactose used in these products has two main purposes. Since the nitrogen compounds in these preparations are explosive in the pure state they must be diluted with a stabilizer for safe transportation. Lactose is the stabilizer in this product. In addition, after importation, retail products containing the nitrogen products also require the use of lactose as a diluent.

ISSUE:

Whether the products as properly classified as single chemical compounds in Chapter 29, HTSUS, or as mixed drugs in Chapter 30, HTSUS.

LAW AND ANALYSIS:

Classification of goods under the HTSUSA is governed by the General Rules of Interpretation (GRI's), taken in order. GRI 1 provides that classification shall be determined according to the terms of the headings and relative Section or Chapter Notes.

One possible area of classification is Chapter 29, HTSUS, which covers organic chemicals. But, the Explanatory Notes, which constitute the official interpretation at the international level, to Chapter 29, limit the classification of goods in this Chapter. The Explanatory Notes provide in General Note (A):

[a] separate chemically defined compound is a single chemical compound of known structure, which does not contain other substances deliberately added during or after its manufacture. . . . Accordingly, a product consisting of saccharin mixed with lactose, for example, to render the product suitable for use as a sweetening agent is excluded from this Chapter.

The products at issue would clearly be excluded from classification in Chapter 29, HTSUS.

Heading 3003, HTSUS, 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 forms or packings for retail sale." The Explanatory Notes to Heading 3003, HTSUS, provide that this heading covers medicinal preparations for use in the internal or external treatment or prevention of human ailments. Further, Note (2) of the Explanatory Notes to Heading 3003, HTSUS, state that preparations containing a single pharmaceutical substance together with an excipient, are included in this heading. The product at issue would clearly fall within this heading.

HOLDING:

The merchandise at issue is properly classified in subheading 3003.90.0000, HTSUSA, which provides for medicaments consisting of two or more constituents which may have been mixed together for therapeutic or prophylactic uses: other. The rate of duty is 6 percent ad valorem.

Sincerely,

John Durant, Director
Commercial Rulings Division

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