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HQ 962562




July 10, 2000

CLA-2 RR:CR:GC 962562 MGM

CATEGORY: CLASSIFICATION

TARIFF NO.: 2934.90.30; 3004.90.90

Mr. Robert J. Leo
Meeks & Sheppard
330 Madison Avenue
39th Floor
New York, N.Y. 10017

RE: Prucalopride Succinate; Reconsideration of NY D83726

Dear Mr. Leo:

This is in response to your letter of February 3, 1999, in which you request reconsideration of New York Ruling Letter (NY) D83726, issued to you by the Customs National Commodity Specialist Division. That ruling concerns the classification, under the Harmonized Tariff Schedule of the United States (HTSUS), of two types of merchandise: 1) prucalopride succinate imported in bulk and 2) tablets, suitable for administration to humans, that contain prucalopride succinate along with several pharmaceutically inactive ingredients. NY D83726 held that prucalopride succinate imported in bulk was classified in subheading 2934.90.39, HTSUS, as an aromatic heterocyclic compound other than pesticides, photographic chemicals or drugs. That ruling also held that tablets which contain prucalopride succinate were classified in subheading 3824.90.90, HTSUS, the ultimate residual provision for preparations of the chemical or allied industries. You seek classification of prucalopride succinate imported in bulk in subheading 2934.90.39, HTSUS, as an aromatic heterocyclic drug and classification of tablets containing prucalopride succinate in subheading 3004.90.90, HTSUS, the residual provision for medicaments put up in dosage form.

Pursuant to section 625(c), Tariff Act of 1930, as amended (19 U.S.C. 1625(c)), notice of the proposed revocation of NY D83726 was published on June 7, 2000, in the Customs Bulletin, Volume 34, Number 23. One comment was received that agreed with the revocation.

FACTS:

The classification of two types of merchandise is at issue: 1) prucalopride succinate (also known as prucalopride butanedioate) imported in bulk and 2) tablets, suitable for administration to humans, that contain prucalopride succinate along with several pharmaceutically inactive ingredients. Prucalopride succinate is registered with the Chemical Abstract Service (CAS) under the number 179474-85-2, and has the chemical formula C18H26ClN3O3 C4H6O4. It has the chemical name “4-amino-5-chloro-2,3-dihydro-N-[1-(3-methoxypropyl)-4-piperdinyl]-7-benzofurancarboxamide butanedioate (1:1).”

Prucalopride succinate is a medicinal compound which the protestant intends to be used in the treatment of chronic idiopathic constipation. As of the time your request for reconsideration of NY D83726, prucalopride succinate was in Phase III of clinical trials required by the Food and Drug Administration (FDA).

ISSUE:

Is prucalopride succinate, imported in bulk for FDA clinical trials, a “drug” as that term is used in Chapter 29, HTSUS?

Is prucalopride succinate, mixed with certain pharmaceutically inactive ingredients, put up in dosage form for FDA clinical trials, a “medicament” of heading 3004, HTSUS?

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).

NY D83726 classified prucalopride succinate, in bulk form, in subheading 2934.90.39, HTSUS. This provision provides as follows:

2934 Nucleic acids and their salts; other heterocyclic compounds: 2934.90 Other
Aromatic or modified aromatic:
Other
Pesticides
2934.90.20 Photographic chemicals
2934.90.30 Drugs
Other
2934.90.39 Products described in additional U.S. note 3 to section VI 2934.90.44 Other

Prucalopride contains both benzofuran and piperidine structures. Compounds which contain benzofuran structures typically fall within heading 2932, HTSUS, as heterocyclic compounds with oxygen hetero-atoms only, while compounds containing piperidine structures are typically classified within heading 2933, HTSUS as heterocyclic compounds with nitrogen hetero-atoms only. Thus one might initially infer that prucalopride should be classified in heading 2933 by operation of Note 3, Ch. 29 (which directs that compounds which could be included in either of two headings are to be classified in the latter heading). However, the presence of the oxygen hetero-atom in benzofuran excludes prucalopride from heading 2933; similarly the nitrogen hetero-atom in piperidine excludes this compound from heading 2932. Thus prucalopride falls to heading 2934 as an “other heterocyclic compound[ ].”

Within heading 2934, you argue that prucalopride succinate is a drug and should therefore be classified in subheading 2934.90.30, HTSUS. 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, prucalopride succinate is in Phase III of the clinical trial process. It is administered to patients suffering from a specific ailment (chronic idiopathic constipation), so as to relieve such condition. Thus it is used as a medicine and should be classified as a drug.

In addition to your position that prucalopride succinate is a drug, you also maintain that tablets containing prucalopride succinate, along with certain pharmaceutically inactive ingredients, are medicaments of heading 3004, HTSUS, rather than preparations of the chemical or allied industries of heading 3824, HTSUS. Heading 3824 provides for, among other things, “chemical products and preparations of the chemical or allied industriesnot elsewhere specified or included.” Thus, if a chemical preparation is described by any other heading of the tariff, it is excluded from heading 3824. Heading 3004 provides for the following:

3004 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.

In the “Guidance Concerning the Tariff Classification of Pharmaceutical Products Imported for Clinical Research,” referred to above, Customs announced its intention to classify pharmaceutical products, put up in dosage form, which are imported for use in any stage of clinical trials as “medicaments” of heading 3004, HTSUS. Here, the tablets containing prucalopride were imported for use in Phase III clinical trials, thus they fall within heading 3004. Within heading 3004, HTSUS, prucalopride succinate is classified under subheading 3004.90.9050, HTSUS (Annotated), as a laxative.

It is noted that Prucalopride was added to Table 1 of the Pharmaceutical Appendix on July 1, 1999. Presidential Proclamation 7207, July 1, 1999, 64 Fed. Reg. 36549. It is further noted that “succinate” is included in Table 2 of the Pharmaceutical Appendix, which lists prefixes and suffixes representing chemical moieties which do not act to exclude a compound, otherwise included, from 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. Thus prucalopride succinate, unmixed with other compounds, entered after July 1, 1999, may be entitled to duty-free entry.

HOLDING:

Prucalopride succinate imported in bulk for Phase III of FDA clinical trials is classified in subheading 2934.90.30, HTSUS. Tablets containing prucalopride succinate along with several pharmaceutically inactive ingredients imported for Phase III of FDA clinical trials are classified in subheading 3004.90.90, HTSUS.

NY D83726 is revoked.

Sincerely,

John Durant, Director
Commercial Rulings Division

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