Mr. Robert J. Leo
Meeks & Sheppard
330 Madison Avenue 39th Floor
New York, NY 10017
RE: The tariff classification of Lubeluzole (CAS# 144665-07-6), imported in bulk and injection dosage 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, Lubeluzole, is described as a neuroprotective agent indicated for ischemic stroke. You assert that Lubeluzole is properly classifiable as a drug and indicate that it has the U.S. Food and Drug Administration (FDA) New Drug Application (NDA) number 20-861.
This office has been advised by the FDA Drug Information Branch, Center for Evaluation and Research, that the NDA for Lubeluzole has not yet been approved. Accordingly, it is or position that, until the NDA approval is granted, Lubeluzole, imported in bulk form, would be precluded from classification as a “drug” should there be a “drug” subheading available as an option. It is also our position that injectable dosage vials containing Lubeluzole 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 Lubeluzole as a marketable drug, this office will provide classifications for dosage form Lubeluzole both before and subsequent to the awaited approval. The post-approval classification is 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).
Since there is no “drug” subheading available in the classification of bulk Lubeluzole, classification for the merchandise will be the same prior to and after NDA approval. The applicable subheading for the bulk Lubeluzole regardless of NDA approval status will be 2934.20.4000, Harmonized Tariff Schedule of the United States (HTS), which provides for “[n]ucleic acids and their salts; other heterocyclic compounds: [c]ompounds containing a benzothiazole ring-system (whether or not hydrogenated), not further fused: [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 injection dosage vials containing Lubeluzole 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.
For injection dosage vials containing NDA-approved Lubeluzole as the “active” ingredient, the applicable subheading will be 3004.90.9020 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: [c]ardiovascular medicaments.” The rate of duty will be free.
Use of the drug classification for the injection dosage vials containing Lubeluzole 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.
Robert B. Swierupski