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HQ 952317

April 12,1994

CLA-2 CO:R:C:F 952317 JGH


TARIFF NO.: 2937.99.8050; 3822.00.50

Peter A. Martin, Esq.
Barnes, Richardson & Colburn
1819 H Street, N.W.
Washington, D.C. 20006

RE: Classification of Pentetreotide

Dear Mr. Martin:

Your letters of July 29, 1992, and July 7, and August 23, 1993, concern the tariff classification under the Harmonized Tariff Schedule of the United States (HTSUS) of Pentetreotide, the active ingredient of the diagnostic radioactive drug Indium- Pentetreotide, imported by Mallinckrodt Medical, Inc.


Pentetreotide is a synthetic polypeptide derived from octreotide, a synthetic analogue of the naturally occurring hormone, somatostatin. To create the product, a linker molecule is attached to octreotide; the linker molecule serves to bind the radioactive form of indium, Indium 111, creating the diagnostic drug, Indium-Pentetreotide. Octreotide is considered to have an inhibitory effect on human gastroenteropancreatic hormone secretions, and is used in clinical evaluations of gastrointestinal endocrine tumors. Pentetreotide is said to be capable of producing the same hormonal effect as octreotide by stopping hormonal hypersecretions.

With the use of the Indium-Pentetreotide, a radioactive isotope, large clusters of sandostatin receptors (indicating a cancerous condition) can be detected or imaged. Several types of cancer have sandostatin/pentetreotide receptors: GEP (Gastro- Endocrine-Pancreatic) tumors, small lung cancer, breast cancer, neuroendocrine tumors, Hodgkin's lymphoma and non-Hodgkin's lymphoma. - 2 -

Pentetreotide is to be imported in two forms: as a mixture in single dosage form in vials, in lyophilized kits; or in bulk as an active ingredient. In the single-dosage form it will be imported in a vial to be mixed with the radioactive Indium-111 subsequent to importation.

The lyophilized mixture, as imported in kits, is said to consist of single-dosage vials of: Pentetreotide (active ingredient), Gentisic Acid, Inositol, Citric Acid Monohydrate, and Trisodium Citrate Dihydrate.


Whether pentetreotide as a lyophilized mixture in kits is classified under the provision for composite diagnostic or laboratory reagents in subheading 3822.00.50, or as diagnostic reagents designed to be administered to the patient in subheading 3006.30.50, HTSUS; also in issue is the classification of Pentetreotide, active ingredient, in bulk.


It is argued that Pentetreotide imported in lyophilized kits, individual-dosage reaction vials, does not fall within the statutory meaning of the phrase "put up in measured doses", since before being administered to the patient it has to be mixed with the radioactive substance; the actual dosage dependent on the combined quantities of the Pentetreotide and Indium-III.

The Explanatory Notes (ENs) to heading 3822, HTSUS, state that the heading covers composite and diagnostic reagents designed to be administered to the patient, other than those of heading 3002 or 3006, HTSUS. The diagnostic reagents are those which are administered by ingestion or injection.

It is claimed that the phrase "Put up in measured doses" defined in the ENs to heading 3004 includes forms such as tablets, ampoules, capsules, cachets, drops or pastilles, or small quantities of powder ready for taking as single doses for therapeutic or prophylactic uses; in other words, products in individual doses ready to be taken in a single dose at time of importation. The Pentetreotide in kit form is a diagnostic which is not ready to take until the radioactive material is added.

While Pentetreotide in the proper strength is known for its therapeutic properties, in this case, where it is mixed in a vial with other chemicals, which are regarded as stabilizers and standardizing chemicals, its function, rather than therapeutic, is to carry the radioactive material to the tumor sites. - 3 -

The ENs to Heading 2937 state that the heading not only includes natural and synthetic hormones, but also derivatives of natural or synthetically reproduced hormones, provided that their primary use is as a hormone. Since Pentetreotide is capable of regulating the production of hormonal hypersecretions associated with some cancers, it is deemed to have a hormonal function.


Pentetreotide imported in bulk form is classifiable as other hormones, natural or reproduced by synthesis; derivatives thereof, used primarily as hormones, in subheading 2937.99.80, HTSUS.

Pentetreotide imported in kit form, in a vial, with a mixture of other chemicals used as stabilizers and standardizing chemicals, to be mixed with a radioactive substance subsequent to importation and used as a diagnostic tool, is classifiable as other composite diagnostic or laboratory reagents, other than those of heading 3002 or 3006, in subheading 3822.00.50, HTSUS.


John Durant, Director

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