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HQ 953124




November 17, 1994

CLA-2 CO:R:C:F 953124 EAB

CATEGORY: CLASSIFICATION

TARIFF NO.: 2934.90.2500; 3004.40.0030

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

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