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HQ 961666




April 14, 1998

CLA-2 RR:CR:GC 961666 JGB

CATEGORY: CLASSIFICATION

TARIFF NO.: 3004.40.0040

Ms. Maryanne S. Zebrowski
Wyeth-Ayerst
Lederle Laboratories
401 Middletown Road
Pearl River, NY 10965

RE: Classification of "Prostep", a nicotine Transdermal Delivery System from Ireland; NY 868637 Revoked

Dear Ms. Zebrowski:

This is in reference to New York Ruling Letter (NY) 868637 issued to you on November 26, 1991, regarding the classification under the Harmonized Tariff Schedule of the United States Annotated (HTSUSA) of "Prostep", a nicotine Transdermal Delivery System from Ireland. We have reviewed this ruling and determined that Customs erred in NY 868637 by classifying "Prostep" in subheading 3005.10.1000, HTSUSA.

This letter is to inform you that NY 868637 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 a similar ruling, NY 881926, relying on the same transdermal administration principle, was published February 25, 1998, in the Customs Bulletin, Vol 32, No. 8. Our position is set forth below.

FACTS:

"Prostep", a nicotine Transdermal Delivery System. The product consists of an adhesive patch containing nicotine as the active ingredient. When the patch is affixed to the skin "Prostep" is designed to provide continuous, controlled release of nicotine for people attempting to break nicotine dependency usually associated with smoking. The reduction of nicotine administered is intended to provide relief from nicotine withdrawal symptoms. Unlike a bandage that would be placed over a wound, cut, or break in the skin, the "Prostep" in use is held
against the skin by the adhesive to permit the absorption of the nicotine through the skin. A number of areas on the skin are particularly suitable for application of the "Prostep."

ISSUE:

Whether "Prostep" 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, adhesive plasters and poultices") that function when applied to a particular area of the skin. By contrast, the "Prostep"
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 peripheral and central nervous systems. 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 3004.40.0040, 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: Containing alkaloids or derivatives thereof but not containing hormones, other products of heading 2937 or antibiotics, Other: Medicaments primarily affecting the central nervous system: Other", free of duty under column one.

HOLDING:

"Prostep" is classified in subheading 3004.40.0040, 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: Containing alkaloids or derivatives thereof but not containing hormones, other products of heading 2937 or antibiotics, Other: Medicaments primarily affecting the central nervous system: Other", free of duty under column one.

NY 868637 is revoked.

Sincerely,

John Durant, Director
Commercial Rulings Division


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