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HQ 961177




April 14, 1998

CLA-2 RR:CR:GC 961177 JGB

CATEGORY: CLASSIFICATION

TARIFF NO.: 3004.90.9020

Mr. Jack Ryan
3M Center, Transportation Dept.
P.O. Box 33250
St. Paul, MN 55133-3250

RE: Classification of "Minitran", a nitroglycerin Transdermal Delivery System from Italy; NY 881926 Revoked

Dear Mr. Ryan:

This is in reference to New York Ruling Letter (NY) 881926 issued to you on January 22, 1993, regarding the classification under the Harmonized Tariff Schedule of the United States Annotated (HTSUSA) of "Minitran", a nitroglycerin Transdermal Delivery System from Italy. We have reviewed this ruling and determined that Customs erred in NY 881926 by classifying "Minitran" in subheading 3005.10.1000, HTSUSA.

This letter is to inform you that NY 881926 no longer reflects the view of Customs. Pursuant to section 625(c)(1), Tariff Act of 1930, as amended, and section 177.9(d) of the Customs Regulations (19 CFR 177.9(d)), notice of proposed revocation of NY 881926 was published February 25, 1998, in the Customs Bulletin, Vol 32, No. 8. Our position, set forth below, incorporates the substance of the one comment received in response to the notice as to the correct subheading within Heading 3004.

FACTS:

"Minitran", is a nitroglycerin Transdermal Delivery System. The product consists of a plastic film patch coated with an acrylate based polymer adhesive containing nitroglycerin as the active ingredient. When the patch is affixed to the skin "Minitran" is designed to provide continuous, controlled release of nitroglycerin for people suffering from chronic angina.

Unlike a bandage that would be placed over a wound, cut, or break in the skin, the "Minitran" in use is held against the skin by the adhesive to permit the absorption of the nitroglycerin through the skin. A number of areas on the skin are particularly suitable for application of the "Minitran."

ISSUE:

Whether "Minitran" is classifiable as "Wadding, gauze bandages or similar articles" in heading 3005 or as "Medicaments (excluding goods of heading 3002, 3005 or 3006)" in heading 3004, HTSUSA.

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 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.

Heading 3005 provides for "Wadding, gauze, bandages and similar articles (for example, dressings, adhesive plasters, poultices), impregnated or coated with pharmaceutical substances or put up in forms or packings for retail sale for medical, surgical, dental or veterinary purposes:." Heading 3004 provides for "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."

Based on the exclusionary form of heading 3004, it is necessary to rule out the stated headings, in particular heading 3005, before heading 3004 can be considered. In our view, heading 3005 can be ruled out because the heading is inherently limited to articles ("bandages", "gauze", "wadding", "dressings, - 3 -
adhesive plasters and poultices") that function when applied to a particular area of the skin. By contrast, the "Minitran" functions by being placed in contact with the skin in an area where it may be absorbed, so that the medicament will be accepted by the whole organism and eventually arrive at a place in the body where it can be effective. In this instance, that area is the heart. Therefore, at the heading level, 3005 does not describe the entire product, requiring classification in heading 3004.

Heading 3004 covers this product not only by default from heading 3005, but also by its function of dispensing medication in "measured doses." The product is specifically covered by subheading 3004.90.9020, HTSUSA, the provision for "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: Other: Other, Other: Cardiovascular medicaments", free of duty under column one.

HOLDING:

"Minitran" is classified in subheading 3004.40.0010, HTSUSA, the provision for "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: Other: Other, Other: Cardiovascular medicaments", free of duty under column one.

NY 881926 is revoked.

Sincerely,

John Durant, Director
Commercial Rulings Division


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