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NY J83358




March 18, 2003

CLA-2-30:RR:NC:2:238 J83358

CATEGORY: CLASSIFICATION

TARIFF NO.: 3002.10.0190

Ms. Tracey L. Hess
Unitrans International Corporation
461 Littlefield Avenue
South San Francisco, CA 94080-6106

RE: The tariff classification of Rituximab (CAS-174722-31-7) from Spain

Dear Ms. Hess:

In your letter dated March 5, 2003, on behalf of Genentech, Inc., you requested a tariff classification ruling.

The subject product [nonproprietary (USAN) name and international nonproprietary name (INN): Rituximab, brand name: Rituxan®] is a genetically engineered monoclonal antibody. It is indicated for the treatment of patients with relapsed or refractory, low-grade follicular, CD20-positive, B-cell non-Hodgkin’s lymphoma.

Although you opine that the subject product is classified under subheading 3002.90.5150, HTS, we note that, pursuant to Note 2 to Chapter 30, HTS, and Explanatory Note 30.02(C)(2), HTS, monoclonal antibodies are considered to be “modified immunological products,” for tariff purposes. As such, they fall within subheading 3002.10.01, HTS, which lists, inter alia, “[m]odified immunological products,” by name.

The applicable subheading for Rituximab will be 3002.10.0190, Harmonized Tariff Schedule of the United States (HTS), which provides for “Antisera and other blood fractions and modified immunological products, whether or not obtained by means of biotechnological processes: Other.” The rate of duty will be free.

This merchandise may be subject to the requirements of the Federal Food, Drug, and Cosmetic Act, which is administered by the U.S. Food and Drug Administration. You may contact them at 5600 Fishers Lane, Rockville, Maryland 20857, telephone number 301-443-1544.

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 646-733-3033.

Sincerely,

Robert B. Swierupski

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