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HQ 963153




June 21, 2000

CLA-2 RR:CR:GC 963153 MGM

CATEGORY: CLASSIFICATION

TARIFF NO.: 2933.90.75

Port Director
U.S. Customs
#1 La Puntilla
San Juan, PR 00901

RE: Idoxifene; Protest 4909-99-100059

Dear Port Director:

This is in regard to protest 4909-99-100059 against your classification of idoxifene under subheading 3824.90.28, Harmonized Tariff Schedule of the United States (HTSUS). Protestant argues that idoxifene should be classified under subheading 2933.90.75, HTSUS.

FACTS:

Idoxifene is imported in bulk form, then mixed with inert ingredients and tabletized for use in Food and Drug Administration (FDA) clinical trials. It is being investigated for use in the treatment of osteoporosis. The idoxifene imported under this entry was for use in phase III of (FDA) clinical trials. Idoxifene has the chemical formula C28H30INO and the CAS registry #116057-75-1. It contains three benzene rings, one of which has an iodine appended to it, one pyrrolidine ring and an ether group. The Material Safety Data Sheet for idoxifene, required by regulations of the Occupational Safety and Health Administration (see 29 CFR 1910.1200(g)), indicates that it is 99% pure.

The merchandise in question was entered on September 16, 1998. This entry was liquidated May 21, 1999, under subheading 3824.90.28, HTSUS, as a residual product of the chemical or allied industries, and timely protested August 18, 1999.

ISSUE:

What is the correct classification of idoxifene?

LAW AND ANALYSIS:

Merchandise imported into the United States is classified under the HTSUS. 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 requires otherwise, by the Additional U.S. Rules of Interpretation. The GRIs and the Additional U.S. Rules of Interpretation are part of the HTSUS 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 their appropriate order. GRI 6 requires that the classification of goods in the subheadings of headings shall be determined according to the terms of those subheadings, any related subheading notes and mutatis mutandis, to the GRIs. In understanding the language of the HTSUS, the Explanatory Notes (ENs) of the Harmonized Commodity Description and Coding System may be utilized. The ENs, although not dispositive or legally binding, provide a commentary on the scope of each heading, and are generally indicative of the proper interpretation of the HTSUS. See, T.D. 89-80, 54 Fed. Reg. 35127 (August 23, 1989).

Idoxifene contains a pyrrole moiety. Pyrrole is a five-membered ring structure which has four carbon atoms and one nitrogen atom. Accordingly, compounds containing pyrrole rings (and which are not classifiable in some latter subheading of Chapter 29) fall within heading 2933, HTSUS, which provides for “[h]eterocyclic compounds with nitrogen hetero-atom(s) only.” Within this heading are provisions for compounds containing pyrazole, imidazole, pyridine, quinoline, isoquinoline, pryimidine, piperazine or triazine rings, and lactams as well as “other” nitrogen containing ring structures. As pyrrole is not included in any of the more specific provisions, it falls to the “other,” or residual provision, subheading 2933.90, HTSUS. This six-digit provision is divided into compounds containing aromatic or modified aromatic ring structures and those which lack such structures (see Additional U.S. Note 2, Section VI, HTSUS regarding aromaticity). As idoxifene contains several benzene rings, it is an aromatic compound.

This provision for other aromatic nitrogen containing compounds is further subdivided into a number of specific compounds listed eo nomine and a residual provision. Idoxifene is not listed eo nomine, thus it falls to the residual provision.

This residual provision is again subdivided into pesticides, photographic chemicals, drugs and a residual provision. In the May 24, 2000, CUSTOMS BULLETIN, Vol. 34, No. 21, Customs published a document entitled “Guidance Concerning the Tariff Classification of Pharmaceutical Products Imported for Clinical Research.” There, Customs announced its intention to classify organic compounds, imported in bulk, for use in Phase II or Phase III of clinical trials described in 21 CFR 312.21 as “drugs” of Chapter 29, HTSUS. Here, idoxifene is in Phase III of the clinical trial process. It is administered to patients suffering from a specific ailment (osteoporosis), so as to relieve such condition. Thus it is used as a medicine and should be classified as a drug.

In the protestant’s submission, it is noted that idoxifene is included in Table 1 of the Pharmaceutical Appendix. General Note 13, HTSUS, provides that whenever a rate of duty of “Free” followed by the symbol “K” in parentheses appears in the “Special” subcolumn for a subheading, any product classifiable in such provision shall be entered free of duty, provided that such product is included in the Pharmaceutical Appendix to the tariff schedule. The “Special” subcolumn of subheading 2933.90.75, HTSUS, has a rate of duty of “Free” followed by the symbol “K.” Thus idoxifene, unmixed with other compounds, may be entitled to duty-free entry.

HOLDING:

Idoxifene is classified in subheading 2933.90.75, HTSUS.

The protest should be ALLOWED. In accordance with Section 3A(11)(b) of Customs Directive 099 3550065, dated August 4, 1993, Subject: Revised Protest Directive, you are to mail this decision, together with the Customs Form 19, to the protestant no later than 60 days from the date of this letter. Any reliquidation of the entry or entries in accordance with the decision must be accomplished prior to mailing the decision.

Sixty days from the date of the decision, the Office of Regulations and Rulings will make the decision available to Customs personnel, and to the public on the Customs Home Page on the World Wide Web at www.customs.gov, by means of the Freedom of Information Act, and other methods of public distribution.

Sincerely,

John Durant, Director
Commercial Rulings Division

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