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February 18, 1999

CLA-2-29:RR:NC:2:238 D85969

CATEGORY: CLASSIFICATION

TARIFF NO.: 2933.90.7900; 3824.90.9050; 2933.90.7500; 3004.90.9015

Mr. Robert J. Leo
Meeks & Sheppard
330 Madison Avenue 39th Floor
New York, NY 10017

RE: The tariff classification of Vorozole (CAS# 129731-10-8), imported in bulk and tablet forms, from Belgium

Dear Mr. Leo:

In your letter dated December 10, 1998, you requested a tariff classification ruling on behalf of your client, Janssen Pharmaceutica, Inc.

The subject merchandise, Vorozole, is described as an oncolytic for the treatment of advanced breast cancer in postmenopausal women with disease progression following antiestrogen therapy. You assert that Vorozole is properly classifiable as a drug and indicate that it has the U.S. Food and Drug Administration (FDA) New Drug Application (NDA) number 20-817.

This office has been advised by the FDA Drug Information Branch, Center for Evaluation and Research, that the NDA for Vorozole has not yet been approved. Accordingly, it is our position that, until the NDA approval is granted, Vorozole, imported in bulk form, is precluded from classification as a “drug” for tariff purposes. It is also our position that the tablets containing Vorozole as the “active” ingredient are precluded from classification as a “medicament” for tariff purposes.

Since you requested that this ruling be issued conditioned upon FDA approval of Vorozole as a marketable drug, this office will provide classifications for bulk and tablet forms of the substance both before and subsequent to the awaited approval. The post-approval classifications are predicated upon the fact that, at the time of importation, NDA approval has been obtained from the FDA, and that there were no changes in the structure, formulation or indicated applications of the merchandise as described in your presentation. In establishing these conditions, we note 19 C.F.R. 177.9(b)(1) and (2).

The applicable subheading for the bulk Vorozole prior to NDA approval will be 2933.90.7900, Harmonized Tariff Schedule of the United States (HTS), which provides for “[h]eterocyclic compounds with nitrogen heter-atom(s) only: [o]ther: [a]romatic or modified aromatic: [o]ther: [p]roducts described in additional U.S. note 3 to section VI.” Pursuant to General Note 13 HTS, the rate of duty will be free.

The applicable subheading, prior to NDA approval, for tablets containing Vorozole as the “active” ingredient will be 3824.90.9050 HTS, which provides for ”[p]repared binders for foundry molds or cores; chemical products and preparations of the chemical and allied industries (including those consisting of mixtures of natural products), not elsewhere specified or included; residual products of the chemical and allied industries, not elsewhere specified or included: [o]ther: [o]ther: [o]ther: [o]ther: [o]ther: [o]ther.” The rate of duty will be 5 percent ad valorem.

If and when Vorozole is granted NDA approval, the applicable subheading for the bulk product will be 2933.90.7500 HTS, which provides for “[h]eterocyclic compounds with nitrogen hetero-atom(s) only: [o]ther: [a]romatic or modified aromatic: [o]ther: [d]rugs: [o]ther.” Pursuant to General Note 13 HTS, the rate of duty will be free.

For tablets containing NDA-approved Vorozole as the “active” ingredient, the applicable subheading will be 3004.90.9015 HTS, which provides for “[m]edicaments (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 packings for retail sale: [o]ther: [o]ther: [o]ther: [a]ntineoplastic and immunosuppressive medicaments.” The rate of duty will be free.

Use of the drug classifications may result in a request by the Port of Entry for a copy of the FDA letter of NDA approval.

This ruling is being issued under the provisions of Part 177 of the Customs Regulations (19 C.F.R. 177).

A copy of the ruling or the control number indicated above should be provided with the entry documents filed at the time this merchandise is imported. If you have any questions regarding the ruling, contact National Import Specialist Harvey Kuperstein at 212-637-7068.

Sincerely,

Robert B. Swierupski
Director,

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