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HQ 963172




August 10, 2000

CLA-2 RR:CR:GC 963172 AM

CATEGORY: CLASSIFICATION

TARIFF NO.: 3004.40.00

Diane L. Weinberg
Meeks & Sheppard
330 Madison Avenue, 39th Floor
New York, N.Y. 10017

RE: Reminyl™ Tablets and Galantamine Hydrobromide

Dear Ms. Weinberg:

This is in response to your letter of August 17, 1999, on behalf of Janssen Pharmaceutica, Inc., addressed to the Director, National Commodity Specialist Division, (NCSD) in which you request a ruling for the classification of Reminyl™ tablets and Galantamine Hydrobromide imported in bulk. As indicated in New York Ruling Letter (NY) E86041, issued to you on August 30, 1999, by the NCSD, Galantamine Hydrobromide, imported in bulk form, is classifiable in subheading 2939.90.50, Harmonized Tariff Schedule of the United States (HTSUS), which provides for "[V]egetable alkaloids, natural or reproduced by synthesis, and their salts, ethers, esters, and other derivatives: Other: Other." Your request for the classification under the HTSUS of Reminyl™ tablets for use in FDA clinical trials was forwarded to this office for disposition. We regret the delay in responding.

FACTS:

Reminyl™ (Galantamine Hydrobromide) tablets are currently undergoing Food and Drug Administration (FDA) clinical trials for use in the treatment of mild to moderate dementia, particularly in the case of Alzheimer's disease. Galantamine Hydrobromide, also known as Galanthamine Hydrobromide, is a semisynthetic derivative of Galantamine, a naturally occurring vegetable alkaloid obtained from the Caucasian snowdrop Galanthus woronowii (a white flower of early spring) and closely related species. Galantamine Hydrobromide is a cholinesterase inhibitor used in the former USSR to treat myasthenia, myopathy, and sensory and motor dysfunction associated with disorders of the central nervous system. Dorland's Illustrated Medical Dictionary (28th edition). Galantamine Hydrobromide has been assigned the CAS registry number 1953-04-4 which is not listed in the Chemical Appendix to the HTSUS.

ISSUE:

Is Galantamine Hydrobromide, 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 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).

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 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 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 Galantamine Hydrobromide are currently imported for use in FDA clinical trials, thus they fall within heading 3004, HTSUS.

Galantamine Hydrobromide is a vegetable alkaloid. Thus, tablets containing Galantamine Hydrobromide as their active ingredient are classified under subheading 3004.40.00, HTSUS, as a "Medicament . . . put up in measured doses . . . Containing alkaloids . . . but not containing hormones."

HOLDING:

Reminyl™ tablets containing Galantamine Hydrobromide, along with several pharmaceutically inactive ingredients, imported for use in FDA clinical trials, are classified in subheading 3004.40.00, HTSUS.

Sincerely,

John Durant, Director

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