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February 18, 1999

CLA-2-29:RR:NC:2:238 D85971

CATEGORY: CLASSIFICATION

TARIFF NO.: 2933.39.6100; 3824.90.2800; 2933.39.4100; 3004.90.9060

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

RE: The tariff classification of Domperidone (CAS# 57808-66-9), 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, Domperidone, is described as an anti-emetic for the relief of upper gastrointestinal symptoms including nausea, vomiting, abdominal pain, bloating, and early satiety in patients with diabetes. You assert that Domperidone is properly classifiable as a drug and indicate that it has the U.S. Food and Drug Administration (FDA) New Drug Application (NDA) number 19-472.

This office has been advised by the FDA Drug Information Branch, Center for Evaluation and Research, that the NDA for Domperidone has not yet been approved. Accordingly, it is our position that, until the NDA approval is granted, Domperidone, imported in bulk form, is precluded from classification as a “drug” for tariff purposes. It is also our position that the tablets containing Domperidone 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 Domperidone 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 bulk Domperidone prior to NDA approval will be 2933.39.6100, Harmonized Tariff Schedule of the United States (HTS), which provides for “[h]eterocyclic compounds with nitrogen hetero-atom(s) only: [c]ompounds containing an unfused pyridine ring (whether or not hydrogenated) in the structure: [o]ther: [o]ther: [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 the formulated tablets containing Domperidone as the “active” ingredient will be 3824.90.2800 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: [m]ixtures containing 5 percent or more by weight of one or more aromatic or modified aromatic substances: [o]ther.” The rate of duty will be 1.8 cents per kilogram plus 10 percent ad valorem.

If and when Domperidone is granted NDA approval, the applicable subheading for the bulk product will be 2933.39.4100 HTS, which provides for “[h]eterocyclic compounds with nitrogen hetero-atom(s) only: [c]ompounds containing an unfused pyridine ring (whether or not hydrogenated) in the structure: [o]ther: [o]ther: [d]rugs: [o]ther.” Pursuant to General Note 13 HTS, the rate of duty will be free.

For tablets containing NDA-approved Domperidone as the “active” ingredient, the applicable subheading will be 3004.90.9060 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 in forms or packings for retail sale: [o]ther: [o]ther: [o]ther: [m]edicaments primarily affecting the digestive system: [o]ther.” 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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