HQ 956623: Tariff Classification of Lansoprazole Capsules fromJapan

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.

                        November 17, 1994

                            HQ 956623


CLA-2   CO:R:C:F   956623   ASM

CATEGORY:  Classification

TARIFF NO:  3004.90.6060 

Mr. John H. Rancourt
TAP Pharmaceuticals Inc.
2355 Waukegan Road
Deerfield, IL  60015

     RE:  Tariff Classification of Lansoprazole Capsules from
Japan

Dear Mr. Rancourt:

     This letter is in response to your request for a ruling on
the tariff classification of measured doses of Lansoprazole
capsules you intend to import from Japan.

FACTS:

     A tariff classifcation ruling has been requested for
measured doses of Lansoprazole capsules which you intend to
import in metal drums, typically 50,000 capsules per drum, to be
re-packaged in bottles and blister packs for use.   You have
indicated that this product is used to treat ulcers,
gastroesophageal reflux disease and some other hypersecretory
diseases.

ISSUE:

     What is the proper classification under the Harmonized
Tariff Schedule of the United States Annotated of measured doses
of 15 mg and 30 mg Lansoprazole capsules?

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

                              - 2 -


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.

     According to your information, Lansoprazole capsules in 15
mg and 30 mg doses, have the following chemical name:  2-[[[3-
methyl-4-(2,2,2-trifluoroethoxy)-2-
pyridyl]methyl]sulfinyl]benzimidazole.    The "USAN" and "USP
Dictionary of Drug Names" (1994 edition), categorize Lansoprazole
as an anti-ulcerative drug.

     When put up in measured doses and capsules, the anti-
ulcerative drug, Lansoprazole,  constitutes a medicament for
tariff purposes.  The EN's to heading 3004, specifically state at
pg. 438, that this heading covers "... medicaments consisting of
mixed or unmixed products, provided they are:

     (a)  Put up in measured doses or in 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 use." 

HOLDING:

     The product identified under the generic name, Lansoprazole, 
in measured doses of 15 mg and 30 mg capsules, is properly
classifiable within subheading 3004.90.6060, HTSUSA, which 
provides for :  "Medicaments (excluding goods of heading 3002,
3005 or 3006) consisting of mixed or unmixed products for
therapeutic or prophylactic uses, put up in measured doses or in
forms or packings for retail sale:  Other:  Other,  Other: 
Medicaments primarily affecting the digestive system:  Other." 
The rate of duty is 6.3 percent ad valorem. 
                              Sincerely, 





                              John Durant, Director
                              Commercial Rulings Division