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HQ 953426




April 7,1994

CLA-2 CO:R:C:F 953426 JGH

CATEGORY: CLASSIFICATION

TARIFF NO.: 3822.00.5000

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

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