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