HQ 952317
April 12,1994
CLA-2 CO:R:C:F 952317 JGH
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.
FACTS:
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.
ISSUE:
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.
LAW AND ANALYSIS:
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.
HOLDING:
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.
Sincerely,
John Durant, Director
Commercial Rulings Division