HQ 956784: Decision on Application for Further Review of ProtestNo. 0401-92-100657, concerning the tariff classification ofLanreotide (CAS 108736-35-2)

Native CBP ruling rendition. Applicability is fact-specific; modification/revocation relationships and original publisher date are retained. Publisher sentinel year0001 means unknown date, not a historical legal adoption.

                           HQ  956784
                                 
                          March 7, 1995


CLA-2   CO:R:C:F   956784   ASM

CATEGORY:  Classification

TARIFF NO:  2937.99.8050; 2937.99.9550   

District  Director of Customs
10 Causeway St.
Room 603
Boston, MA  02222-1059

     RE:  Decision on Application for Further Review of Protest
No. 0401-92-100657,      concerning the tariff classification of
Lanreotide (CAS 108736-35-2)

Dear Sir:

     This is a decision on an application for further review of
Protest No. 0401-92-100657, against your decision in the
classification and liquidation of Lanreotide (CAS 108736-35-2).

FACTS:

     You classified the merchandise under subheading
2934.90.2500, Harmonized Tariff Schedule of the United States
Annotated  (HTSUSA), as  "Other heterocyclic compounds:  Other: 
Aromatic or modified aromatic:  Other:  Drugs"  which is dutiable
at the general column one rate of duty, 6.9 percent ad valorem. 
The merchandise was liquidated under this classification on July
17, 1992. 

     The Protestant asserts that the subject is properly
classifiable within subheading 2937.10.0000, HTSUSA, which
provides for  "Hormones, natural or reproduced by synthesis;
derivatives thereof, used primarily as hormones; other steroids
used primarily as hormones:  Pituitary (anterior) or similar
hormones, and their derivatives," dutiable at 1.8 percent  ad
valorem.  Protestant has indicated that Lanreotide is also under
investigation for, among other things, use as a cardiovascular
drug.

     Lanreotide (also known by the trade names "Somatuline" and
"Angiopeptin") is a synthetic analogue of Somatostatin, which is
defined in Henderson's Dictionary of Biological Terms (10th
edition) as a "14-amino acid peptide hormone, produced by the
hypothalamus, inhibiting the secretion of growth hormone, insulin
and glucagon."  The USAN and the USP Dictionary of Drug Names
(1994 edition), categorizes Lanreotide as an antineoplastic drug.


                              - 2 -               


ISSUE:

     What is the proper classification of Lanreotide (CAS 108736-
35-2)?

LAW  AND ANALYSIS:

     Classification of merchandise under the Harmonized Tariff
Schedule of the United States Annotated (HTSUSA), is made in
accordance with the General Rules of Interpretation (GRI's).  The
systematic detail of the harmonized system is such that virtually
all goods are classified by application of GRI 1, that is,
according to the terms of the headings of the tariff schedule and
any relative section or chapter notes.  In the event that the
goods cannot be classified solely on the basis of GRI 1, and if
the headings and legal notes do not otherwise
require, the remaining GRI's may then be applied.  The
Explanatory Notes to the Harmonized Commodity Description and
Coding System (EN's), which represent the official interpretation
of the tariff at the international level, facilitate
classification under the HTSUSA by offering guidance in
understanding the scope of the headings and GRI's.

     In Headquarter's Ruling Letter (HRL) 952317, dated April 12,
1994, it was determined that a product named Pentetreotide, which
was described as "...a synthetic polypeptide derived from
octreotide, a synthetic analogue of the naturally occurring
hormone, somatostatin (emphasis supplied)," was classifiable an
"Other" hormone within subheading 2937.99.80, HTSUSA (now
superseded by subheading 2937.99.95, HTSUSA).   Like the product
in HRL 952317, Lanreotide is also a synthetically produced
analogue of the natural hormone Somatostatin.  Accordingly, we
have determined that Lanreotide is properly classifiable as an
"Other" hormone derivative within heading 2937, HTSUSA.

     The EN's 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.  However, based on the fact that the
hormone Somatostatin is produced by the hypothalamus, and not the
pituitary gland, and is not listed in the explanatory notes
naming anterior pituitary hormones or similar hormones (see EN's
29.37 (II)(A)), we do not believe that Lanreotide is properly
classifiable within subheading 2937.10.0000, HTSUSA, as a
derivative of an anterior pituitary or similar hormone.

     It is our determination that, based on its hormonal effect
and its derivation from the hypothalamic hormone, Somatostatin,
the product Lanreotide, should have been classified within
subheading 2937.99.8050, HTSUSA, which provides for  "Hormones,
natural or reproduced by synthesis; derivatives thereof, used
primarily as hormones; other steroids used primarily as hormones: 
Other hormones and their derivatives; other steroids used
primarily as hormones:  Other:  Other,  Other."                               - 3 -


HOLDING:

     The product identified as Lanreotide (CAS 108736-35-2), was
properly classifiable within subheading 2937.99.8050 (now
2937.99.9550), HTSUSA, which provides for "Hormones, natural or
reproduced by synthesis; derivatives thereof, used primarily as
hormones; other steroids used primarily as hormones:  Other
hormones and their derivatives; other steroids used primarily as
hormones:  Other:  Other,  Other."  The applicable duty at the
general column one rate is 3.2 percent ad valorem.

     The protest should be denied except to the extent that
classification as indicated above results in a partial refund.  A
copy of this decision should be attached to the Form 19 to be
returned to the Protestant.

     In accordance with Section 3A(11)(b) of Customs Directive
099 3550-065, dated August 4, 1993, Subject:  Revised Protest
Directive, this decision should be mailed by your office to the
protestant no later than 60 days from the date of this letter. 
Any reliquidation of the entry in accordance with the decision
must be accomplished prior to mailing of the decision.  Sixty
days from the date of the decision, the Office of Regulations and
Rulings will take steps to make the decision available to Customs
personnel via the Customs Rulings Module in ACS, and to the
public via the Diskette Subscription Service, Freedom of
Information Act and other public access channels.
                         

                         Sincerely, 





                         John Durant, Director
                         Commercial Rulings Division