CLA-2 CO:R:C:F 953124 EAB
Mr. Desmond Flynn
Manager, Imports & Domestic Traffic
SmithKline Beecham Pharmaceuticals
One Franklin Plaza
Philadelphia, Pennsylvania 19101
Re: "Paxil"; paroxetine (CAS No. 61869-08-7) not listed; heading
2939 vegetable alkaloid; DD 878244 modified
Dear Mr. Flynn:
This is in reply to your letter dated November 19, 1992,
requesting reconsideration of Customs Ruling Letter DD 878244,
dated September 25, 1992, wherein the compounds known as "Paxil"
and paroxetine were respectively classified under subheadings
3004.90.6035 and 2934.90.2500, Harmonized Tariff Schedule of the
United States Annotated (HTSUSA).
FACTS:
Paroxetine, CAS No. 61869-08-7, a number not listed in the
Chemical Appendix to the Tariff Schedule and the preferred chemical
name of which is trans-(-)-3-[(1,3-benzodioxol-5-yloxy)methyl]-4-(4-fluorophenyl)piperidine, is a synthetic, aromatic compound
containing both oxygen and nitrogen heterocyclic groups. It is an
antidepressant and acts as a serotonin re-uptake inhibitor.
Pending FDA approval, "Paxil" is the name under which dosage
form paroxetine hydrochloride is to be marketed.
You are of the opinion that "Paxil" is classifiable under
subheading 3004.40.0030, HTSUSA.
ISSUE:
Whether "Paxil" is classifiable under subheading 3004.40.0030
or subheading 3004.90.6035, HTSUSA.
LAW AND ANALYSIS:
Merchandise imported into the U.S. is classified under the
HTSUSA. Tariff classification is governed by the principles set
forth in the General Rules of Interpretation (GRIs) and, in the
absence of special language or context which otherwise requires, by
the Additional U.S. Rules of Interpretation. The GRIs and the
Additional U.S. Rules of Interpretation are part of the HTSUSA and
are to be considered statutory provisions of law for all purposes.
GRI 1, requires that classification be determined first
according to the terms of the headings of the tariff schedule and
any relative section or chapter notes and, unless otherwise
required, according to the remaining GRIs taken in order.
The chemical structure of an organic compound that presents a
basic nitrogen ring such as pyridine, quinoline, isoquinoline and
pyrole is generally referred to in the scientific literature as an
"alkaloid," or a "vegetable alkaloid." Piperidine, found in small
quantities in black pepper, is such a "vegetable alkaloid."
Neither neurine nor procaine, The Merck Index (11th ed.) at 1025,
1230, exhibits a heterocyclic ring structure containing at least
one nitrogen as the heteroatom, yet the former, neurine, is an
"animal alkaloid," and the latter, "procaine," is a "synthetic
alkaloid," Dorland's Illustrated Medical Dictionary (25th Ed.
1992), alkaloid at 56.
Heading 2939 describes, inter alia, "vegetable alkaloids,
natural or reproduced by synthesis, and . . . [their] other
derivatives." Paroxetine is neither naturally occurring nor
reproduced by synthesis; therefore, it may not be classified under
heading 2939. We are of the opinion, however, that it is described
by the term "alkaloid," since it contains a classic "vegetable
alkaloid" ring structure, namely, piperidine.
Subheading 3004.40.0030, HTSUSA, describes in part medicaments
containing alkaloids or derivatives thereof but not containing
hormones, other products of heading 2937 or antibiotics, other,
medicaments primarily affecting the central nervous system,
antidepressants. It has been suggested that this subheading does
not describe paroxetine because the compound is not a natural or
synthetically reproduced vegetable alkaloid or derivative. We
disagree with this suggestion. As a general proposition, heading
2939 is limited as we noted above; subheading 3004.40 contains no
such limitations. The two provisions on their face are quite
different, and although "where the same word or phrase is used in
different parts of the same statute, it will be presumed, in the
absence of any clear indication of a contrary intent, to be used in
the same sense throughout the statute," Mita Copystar Corporation
v. U.S., CIT , (1993), Slip Op. 93-76, we find that there
is a clear indication that different meanings are intended:
2939 - Vegetable alkaloids, natural or
reproduced by synthesis, and their . . . other
derivatives.
3004.40 - . . . alkaloids or derivatives
thereof . . .
We are of the opinion that subheading 3004.40 is much broader
in scope than is heading 2939 and covers all alkaloids, whether or
not vegetable, whether or not natural, whether or not synthetic
derivatives of naturally occurring such compounds. The scientific
literature describes three types of alkaloids, namely, "vegetable,"
"animal" and "synthetic," and, whereas paroxetine not only contains
a piperidine ring structure but has the preferred, not merely
accepted, chemical name of trans-(-)-3-[(1,3-benzodioxol-5-yloxy)methyl]-4-(4-fluorophenyl)piperidine, we are of the opinion
that "Paxil" is classifiable under subheading 3004.40, HTSUSA.
HOLDING:
DD 878244 is modified.
Paroxetine is classifiable under subheading 2934.90.2500,
HTSUSA, a provision for other heterocyclic compounds; other;
aromatic or modified aromatic; other; drugs. This classification
does not represent a change.
"Paxil" is classifiable under subheading 3004.40.0030, HTSUSA,
a provision 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: Containing alkaloids or derivatives thereof but
not containing hormones, other products of heading 2937 or
antibiotics, Other: Medicaments primarily affecting the central
nervous system: Antidepressants, tranquilizers and other
psychotherapeutic agents", subject to a general column one rate of
duty of 3.4 percent ad valorem.
Sincerely,
John Durant, Director
Commercial Rulings Division CLA-2 CO:R:C:F
953124 EAB
U.S. CUSTOMS SERVICE
GENERAL NOTICE
PROPOSED MODIFICATION OF CUSTOMS RULING LETTER
RELATING TO TARIFF CLASSIFICATION OF "PAXIL",
PAROXETINE HYDROCHLORIDE PUT UP IN MEASURED DOSES
OR IN FORMS OR PACKINGS FOR RETAIL SALE
ACTION: Notice of proposed modification of a tariff
classification ruling.
SUMMARY: Pursuant to section 625 of the Tariff Act of 1930 (19
U.S.C. 1625), as amended by section 623 of Title VI (Customs
Modernization) of the North American Free Trade Agreement
Implementation Act (Pub. L. 103-182, 107 Stat. 2057), this notice
advises interested parties that Customs intends to modify a
ruling pertaining to the tariff classification of "Paxil",
paroxetine hydrochloride put up in measured doses or in forms or
packings for retail sale.
DATE: Comments must be received on or before (30 days from the
date of publication of notice in the Customs Bulletin).
ADDRESS: Written comments (preferably in triplicate) are to be
addressed to U.S. Customs Service, Office of Regulations and
Rulings, Attention: Commercial Rulings Division, 1301
Constitution Avenue, N.W. (Franklin Court), Washington, D.C.
20229. Comments submitted may be inspected at the Commercial
Rulings Division, Office of Regulations and Rulings, located at
Franklin Court, 1099 14th Street, N.W., Suite 4000, Washington,
D.C.
FOR FURTHER INFORMATION CONTACT: Edward A. Bohannon, Food &
Chemicals Classification Branch, (202) 482-7020.
SUPPLEMENTARY INFORMATION:
BACKGROUND
Pursuant to section 625 of the Tariff Act of 1930 (19 U.S.C.
1625), as amended by section 623 of Title VI (Customs
Modernization) of the North American Free Trade Agreement
Implementation Act (Pub. L. 103-182, 107 Stat. 2057), this notice
advises interested parties that Customs intends to modify a
ruling pertaining to the tariff classification of "Paxil",
paroxetine hydrochloride put up in measured doses or in forms or
packings for retail sale.
In Customs Ruling Letter (DD) 878244 issued September 25,
1992, by the Area Director, JFK Airport, Customs held that
paroxetine was classified under subheading 2934.90.2500,
Harmonized Tariff Schedule of the United States (HTSUSA), a
provision for other heterocyclic compounds, aromatic or modified
aromatic, drugs. Customs also held in DD 878244 that "Paxil",
paroxetine hydrochloride in dosage form, was classified under
subheading 3004.90.6035, a provision for antidepressants,
tranquilizers, and other psychotherapeutic agents put up in
measured doses or in forms or packings for retail sale. A copy
of DD 878244 is set forth in Attachment A to this document.
Customs has been asked to reconsider DD 878244 in regard to
the classification of "Paxil", paroxetine hydrochloride put up in
measured doses or in forms or packings for retail sale. Upon
further consideration, Customs is of the opinion that "Paxil" is
classifiable under subheading 3004.40, HTSUSA, a provision for
medicaments put up in measured doses or in forms or packings for
retail sale, containing alkaloids or derivatives thereof. It is
Customs determination that subheading 3004.40 is not limited by
its terms to only natural or synthetically reproduced vegetable
alkaloids or derivatives thereof, but includes all forms of
alkaloids or derivatives thereof otherwise fitting the
description of the goods found in the subheading. We believe,
therefore, that DD 878244 should be modified.
Before taking this action, consideration will be given to
any written comments timely received. The proposed ruling
modifying DD 878244 is set forth in Attachment B to this
document.
Claims for detrimental reliance under section 177.9, Customs
Regulations (19 CFR 177.9), will not be entertained for actions
occurring on or after the date of publication of this notice.
Dated: September , 1994
John Durant, Director
Commercial Rulings Division