CLA-2 CO:R:C:F 952478 EAB
Ms. Patricia I. Littman
Girindus Corporation
5415 Mariner Street, Suite 106
Tampa, Florida 33609
Re: Polymer Blend II; medicaments; 2920; EN 30.03(2); HQ 083650;
NY 845004 affirmed
Dear Ms. Littman:
This is in reply to your letters dated July 28, 1992 and
August 6, 1992, in which you request reconsideration of NY 845004
(September 8, 1989), concerning the classification under the
Harmonized Tariff Schedule of the United States Annotated
(HTSUSA) of your company's product "Polymer Blend II."
FACTS:
In the aforementioned ruling, you were advised that Polymer
Blend II would be classifiable under subheading 3003.90.0000,
HTSUSA, and bear duty at the column 1 general rate of 6 percent
ad valorem.
You now state that the product is not a cardiovascular drug,
but an intermediate used in the preparation of such a drug by a
company to which you supply Polymer Blend II.
From Girindus Corporation's (David A. Laurain, Marketing
Manager) letter dated July 13, 1989, relied upon in NY 845004, we
incorporate, for purposes of this decision, the following:
"The imported Polymer Blend II * * * contains Nitroglycerin.
Once the Polymer Blend II undergoes several more processing
steps, in the U.S., the Nitroglycerin will be the active
drug substance and will find its ultimate use in a
transdermal (Patch) system. * * * The * * * polymer
emulsions which serve as binders and adhesives, [are]
inactive substances.
"[I]t is our position that the relevant Tariff
Classification is 3003.90.00 (6% ad Valorem), based upon the
following reasons:
"A. Material is a medicament * * *.
"B. [The c]onstituents have been mixed together to form an
intermediate for therapeutic use.
"C. [The product] is not put up in measured doses or in a
form for retail sale."
ISSUE:
What is the proper classification under the HTSUSA of
Polymer Blend II, a mixture of nitroglycerin and binders and
adhesives to be used in the manufacture of a transdermal
cardiovascular system?
LAW AND ANALYSIS:
Merchandise imported into the U.S. is classified under the
HTSUSA. Tariff classification is governed by the principles set
forth in the General Rules of Interpretation (GRIs) and, in the
absence of special language or context which otherwise requires,
by the Additional U.S. Rules of Interpretation.
GRI 1 requires that classification be determined first
according to the terms of the headings of the tariff schedule and
any relative section or chapter notes and, unless otherwise
required, according to the remaining GRI's taken in order.
Explanatory Notes (ENs) to the Harmonized Commodity
Description and Coding System represent the official
interpretation of the Customs Cooperation Council on the scope of
each heading, and, although neither binding upon the contracting
parties to the Harmonized System Convention nor considered to be
dispositive interpretations, they should be consulted on the
proper scope of the System.
As a general rule, goods classifiable under any of the
headings of chapter 29 must be separate chemically defined
compounds. 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.
We find that Polymer Blend II is not a separate chemically
defined compound, namely nitroglycerin, because the "polymer
emulsions which serve as binders and adhesives" clearly have been
deliberately added.
Heading 3003 covers in part medicaments consisting of two or
more constituents mixed for therapeutic purposes and not put up
in measured doses or for retail sale. Included are preparations
containing a single pharmaceutical substance together with an
excipient, agglomerating agent, etc. See EN 30.03(2).
We find that Polymer Blend II is a preparation containing
single pharmaceutical substance, nitroglycerin, together with
polymer emulsions which serve as binders and adhesives, i.e.,
excipients, agglomerating agents, etc., and is, therefore, a
medicament consisting of two or more constituents mixed for
therapeutic purposes and put up neither in measured doses nor in
forms or packings for retail sale. See also HQ 083650 (March 13,
1990); ten percent nitroglycerin with ninety percent lactose
classifiable under subheading 3003.90.000, HTSUSA.
HOLDING:
Polymer Blend II, a mixture of nitroglycerin and binders and
adhesives to be used in the manufacture of a transdermal
cardiovascular system is classifiable under subheading
3003.90.0000, HTSUSA, a provision 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; other.
NY 845004 is affirmed.
Sincerely,
John Durant, Director
Commercial Rulings Division