CLA-2-29:RR:NC:2:238 D85968
Mr. Robert J. Leo
Meeks & Sheppard
330 Madison Avenue 39th Floor
New York, NY 10017
RE: The tariff classification of Liarozole Fumarate (CAS# 145858-52-2), 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, Liarozole Fumarate, is described as an oncolytic used in the treatment of advanced prostate cancer in patients who relapsed after first-line hormonal therapy. The CAS number you provided, 115575-11-6, is for the base compound Liarozole. The correct CAS number for Liarozole Fumarate is 145858-52-2. You assert that Liarazole Fumarate is properly classifiable as a drug and indicate that it has the U.S. Food and Drug Administration (FDA) New Drug Application (NDA) number 20-794.
This office has been advised by the FDA Drug Information Branch, Center for Evaluation and Research, that the NDA for Liarozole Fumarate has not yet been approved. Accordingly, it is our position that, until the NDA approval is granted, Liarozole Fumarate, imported in bulk form, is precluded from classification as a “drug” for tariff purposes. It is also our position that the tablets containing Liarozole Fumarate 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 Liarozole Fumarate 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 Liarozole Fumarate prior to NDA approval will be 2933.29.3500, 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 imidazole ring (whether or not hydrogenated) in the structure: [o]ther: [a]romatic or modified aromatic: [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 Liarozole Fumarate 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 Liarozole Fumarate is granted NDA approval, the applicable subheading for the bulk product will be 2933.29.2000 HTS , which provides for “[h]eterocyclic compounds with nitrogen hetero-atom(s) only: [c]ompounds containing an unfused imidazole ring (whether or not hydrogenated) in the structure: [o]ther: [a]romatic or modified aromatic: [o]ther: [d]rugs.” Pursuant to General Note 13 HTS, the rate of duty will be free.
For tablets containing NDA-approved Liarozole Fumarate as the “active” ingredient, the applicable subheading wil 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 in forms 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,
National Commodity
Specialist Division