Mr. Robert J. Leo
Meeks & Sheppard
330 Madison Avenue 39th Floor
New York, NY 10017
RE: The tariff classification of Levocabastine HCL (CAS# 79547-78-7), imported in bulk and measured dose 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, Levocabastine HCL, is described as a histamine antagonist for the relief of seasonal allergic rhinitis. It is the active ingredient in Livostin® suspension nasal spray. You indicate the CAS# 79516-68-0. That number refers to the base product Levocabastine. The CAS number for the hydrochloride salt is 79547-78-7. You assert that Levocabastine HCL is properly classifiable as a drug and indicate that it has the U.S. Food and Drug Administration (FDA) New Drug Application (NDA) number 20-739.
This office has been advised by the FDA Drug Information Branch, Center for Evaluation And Research, that the NDA for Levocabastine HCL has not yet been approved. Accordingly, it is our position that, until the NDA approval is granted, Levocabastine, imported in bulk form, is precluded from classification as a “drug” for tariff purposes. It is also our position that a nasal spray for measured dose application containing Levocabastine HCL as the “active” ingredient is precluded from classification as a “medicament” for tariff purposes.
Since you requested that this ruling be issued conditioned upon FDA approval of Levocabastine HCL as a marketable drug, this office will provide classifications for bulk and measured dose 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 Levocabastine HCL 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 nasal spray in dosage form containing Levocabastine HCL 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 Levocabastine HCL 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 a nasal spray designed for measured doses containing NDA-approved Levocabastine HCL, the applicable subheading will be 3004.90.9080 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 eyes, ears or respiratory system: [o]ther: [a]ntihistamines.” 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.
Robert B. Swierupski