HQ 953426
April 7,1994
CLA-2 CO:R:C:F 953426 JGH
Lynn S. Baker, Esq.
Katten Muchin & Zavis
525 West Monroe Street
Suite 1600
Chicago, Illinois 60661-3693
RE: Classification of Amersham's Ceretec Cold Kit
Dear Ms. Baker:
This is in reference to your letters of January 28 and
December 30, 1993, on the classification, under the Harmonized
Tariff Schedule of the United States (HTSUS), of Ceretec cold
kits made in the United Kingdom, imported by Amersham
Corporation, and used as diagnostic radiopharmaceuticals.
FACTS:
Ceretec is described as a kit used for the preparation of
Technetium Tc99m Exametazine injection. The kit is supplied as
packs of 5 single-dose vial units for use in the preparation
of a Technetium Tc99m exametazime intravenous injection. They
are used as diagnostic radiopharmaceuticals, as an adjunct in the
detection of altered region cerebral perfusion. Cold kits, so-
called because the radioactive material is added subsequent to
importation, are also available for bone, kidney, or heart pool
imaging (depending on the constitution of the injection).
As imported, each Ceretec vial is said to contain
exametazime (a neutral, lipophilic compound), stannous chloride,
and sodium chloride. Subsequent to importation, when the
injection is to be used on the patient, Ceretec is reconstituted
in the vial with the addition of radioactive technetium Tc99m
solution; with the mixture in the vial precipitating a chemical
reaction with the radioactive material, Ceretec becomes a
radiotracer useful for cerebral perfusion imaging. The images
are said to demonstrate physiologic abnormalities in the brain. - 2 -
ISSUE:
Whether cold kits are classifiable under the provision for
diagnostic reagents designed to be administered to the patient,
in subheading 3006.30.5000, HTSUS, or as composite diagnostic or
laboratory reagents, other than those of heading 3002 or 3006, in
subheading 3822.00.5000, HTSUS.
LAW & ANALYSIS:
It is argued that since, as imported, the cold kits cannot
be administered to the patient, they can not be classifiable in
subheading 3006.30; they only become a radioactive tracer when
the technetium Tc99m is added. It is also contended that they
can not be considered incomplete articles within the meaning of
GRI 2 (a), since as imported they lack the ingredient which gives
the product its essential character as a radiopharmaceutical.
Chapter Note 3(d), Chapter 30, HTSUS, provides that heading
3006 includes diagnostic reagents designed to be administered to
the patient, being unmixed products put up in measured doses or
products consisting of two or more ingredients mixed together for
such uses.
The provision (3822.22.5000), in which it is contended that
the imports are classifiable, covers other composite diagnostic
or laboratory reagents, other than those of heading 3002 or 3006.
Since, following chapter note 3(d), Chapter 30, to be
classifiable in 3006 the mixture has to be used for diagnostic
purposes, which, since it lacks the radioactive material, it can
not be, and classification in 3006 is not applicable. The cold
kits fit the definition of laboratory reagents found in 3822
because of their composition. While the incomplete nature of the
kits is felt to be a hindrance to classification in 3006, no such
obstacle is perceived for classification in 3822.22.5000, HTSUS.
The Explanatory Notes to Heading 3004 state that the phrase
"put up in measured doses" includes such forms as tablets,
ampoules, capsules, cachets, drops or pastilles, or small
quantities of powder ready for taking as single doses for
therapeutic or prophylactic uses. Although the vials as imported
are designed to be taken as single dosage form, they can not be
said to be ready for taking until the radioactive material is
added. Thus, as imported, the cold kits are not in measured
doses designed to be administered to the patient. - 3 -
HOLDING:
Ceretec cold kits are classifiable under the provision for
other composite or laboratory reagents, other than those of
hading 3002 or 3006, in subheading 3822.00.50, HTSUS.
Sincerely,
John Durant, Director
Commercial Rulings Division