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HQ 962902




July 24, 2000

CLA-2 RR:CR:GC 962902 AM

CATEGORY: CLASSIFICATION

TARIFF NO.: 3004.90.90

Port Director
U.S. Customs Service
C/o Chief, Residual Liquidation and Protest Branch #1 La Puntilla
San Juan, PR 00901

RE: Protest 4909-99-100036; Prucalopride succinate tablets

Dear Port Director:

This is in regard to protest 4909-99-100036, concerning your classification of prucalopride succinate tablets under the Harmonized Tariff Schedule of the United States (HTSUS). Protestant argues that prucalopride succinate tablets should be classified under subheading 3004.90.90, HTSUS.

FACTS:

Prucalopride succinate tablets are imported from Belgium in 1mg, 2 mg and 4 mg tablets of active and inert ingredients for use in Food and Drug Administration (FDA) clinical trials. 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 that protestant intends to be used in the treatment of chronic idiopathic constipation. The merchandise entered the United States during September of 1998 and the entry was liquidated on February 19, 1999, under the subheading 3824.90.90 HTSUS, . . . chemical products and prepartations of chemical or allied industries (including those consisting of mixtures of natural products), not elsewhere specified or included . . . Other . . . Other. A protest was timely filed May 17, 1999. At that time, prucalopride succinate was in Phase III of clinical trials required by the Food and Drug Administration (FDA).

ISSUE:

Is prucalopride succinate, mixed with certain pharmaceutically inactive ingredients, imported as tablets 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 that 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).

In NY D83726, dated December 2, 1998, Customs ruled that tablets containing prucalopride succinate as the active ingredient were classified in subheading 3824.90.50, HTSUS, the ultimate residual provision for preparations of the chemical or allied industries not elsewhere specified or included.

In the CUSTOMS BULLETIN, dated May 24, 2000, Vol. 35, 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 pharmaceutical products imported in dosage form for use in clinical trials as "medicaments" of heading 3004, HTSUS.

Thereafter, notice of a proposed revocation of NY D83726 was published in June 7, 2000, CUSTOMS BULLETIN, Vol. 34, No. 23. Final revocation was published on July 26, 2000 (CUSTOMS BULLETIN, Vol. 34, No. 30). See HQ 962562 dated July 11, 2000. Here, Prucalopride succinate tablets in Phase III of the clinical trial process 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 medicament when in tablet form.

HOLDING:

Tablets containing prucalopride succinate as their active ingredient are classified in subheading 3004.90.90, HTSUS, as “other” medicaments. The protest is 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

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