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HQ 953954


June 16, 1993

CLA-2 CO:R:C:F 953954 EAB

CATEGORY: CLASSIFICATION

TARIFF NO.: 3003.90.0000

Mr. Robert K. Imbur
Import Manager
Miles, Inc.
P.O. Box 40
Elkhart, Indiana 46515-0040

RE: Nimodipine; 1,4-dihydro-2,6-dimethyl-4-(3-nitrophenyl)-3,5- pyridinedicarboxylic acid 2-methoxyethyl 1-methylethyl ester; isopropyl (2-methoxyethyl) 1,4-dihydro-2,6-dimethyl-4-(3- nitrophenyl)-3,5-pyridinedicarboxylate; CAS No. 66085-59-4 not listed; FTZ

Dear Mr. Imbur:

This is in reply to your letter dated April 19, 1993, in which you request a binding ruling on the classification of merchandise under the Harmonized Tariff Schedule of the United States Annotated (HTSUSA).

In your letter you claim confidential treatment for information with respect to the pharmacological formulation and processing of your product. Following telephone conversations in particular reference to information contained in your letter, yet duplicated in the product insert enclosed therewith, you have withdrawn your request for confidential treatment of the duplicate information.

FACTS:

Foreign made nimodipine in pure bulk form is shipped to a U.S. foreign trade subzone where your company mixes it with polyethylene glycol, glycerin, peppermint oil and purified water. The resulting mixture of nimodipine, the active ingredient, with excipients is indicated for the improvement of neurological outcome by reducing the incidence and severity of ischemic deficits in patients with subarachnoid hemorrhage from ruptured congenital aneurysms who are in good neurological condition post-ictus.

ISSUE:

What is the proper classification under the HTSUSA of nimodipine, the chemical name of which is 1,4-dihydro-2,6-dimethyl- 4-(3-nitrophenyl)-3,5-pyridinedicarboxylic acid 2-methoxyethyl 1- methylethyl ester, CAS No. 66085-59-4, a number not listed in the Chemical Appendix to the Tariff Schedule, also known as isopropyl (2-methoxyethyl) 1,4-dihydro-2,6-dimethyl-4-(3-nitrophenyl)-3,5- pyridinedicarboxylate, mixed with excipients?

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 GRI's taken in order.

Less exceptions not pertinent to this decision, heading 3003, HTSUSA, describes medicaments consisting of two or more constitu- ents which have been mixed together for therapeutic purposes, not put up for retail sale, which description, we believe, is of the subject merchandise.

HOLDING:

Nimodipine, 1,4-dihydro-2,6-dimethyl-4-(3-nitrophenyl)-3,5- pyridinedicarboxylic acid 2-methoxyethyl 1-methylethyl ester, CAS No. 66085-59-4, a number not listed in the Chemical Appendix to the Tariff Schedule, also known as isopropyl (2-methoxyethyl) 1,4- dihydro-2,6-dimethyl-4-(3-nitrophenyl)-3,5-pyridinedicarboxylate, mixed in a U.S. foreign trade subzone with excipients, is classifiable under subheading 3003.90.00, HTSUSA, a provision for medicaments (excluding goods of heading 3002, 3005 or 3006) consisting of two or more constituents which have been mixed together for therapeutic or prophylactic uses, not put up in measured doses or in forms or packings for retail sale; other.

Merchandise classifiable under the foregoing subheading for the year 1993 is dutiable at the column one general rate of 6 percent ad valorem.

Sincerely,

John Durant, Director

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