CLA-2-29:RR:NC:2:238 L80608

Herbert J. Lynch, Esq.
Sullivan & Lynch, P.C.
56 Roland Street, Suite 303
Boston, MA 02129-1223

RE: The tariff classification of Bortezomib (CAS-179324-69-7), imported in bulk form, and VELCADE® (bortezomib) for Injection, from Canada and the United Kingdom

Dear Mr. Lynch:

In your letter dated October 22, 2004, on behalf of your client, Millennium Pharmaceuticals, Inc., you requested a tariff classification ruling.

Bortezomib is an antineoplastic agent indicated for the treatment of multiple myeloma (a cancer of the plasma cell) patients who have received at least two prior therapies and have demonstrated disease progression on the last therapy. VELCADE® (bortezomib) for Injection is a sterile, lyophilized powder, put up in single-dose vials (3.5 mg per vial), containing bortezomib as the active ingredient.

You propose that Bortezomib, when imported in bulk form, should be classified under heading 2931, HTS, within subheading 2931.00.2200, HTS, which provides for “Other organo-inorganic compounds: Aromatic: Other: Drugs.” However, in addition to a Boron atom in the structure, the Bortezomib molecule also contains an unfused pyrazine ring, as well as an unfused benzene ring. Accordingly, pursuant to note 3 to Chapter 29, HTS, it is our determination that Bortezomib, when imported in bulk form, falls under heading 2933, HTS. The applicable subheading for Bortezomib, imported in bulk form, will be 2933.99.7500, Harmonized Tariff Schedule of the United States (HTS), which provides for “Heterocyclic compounds with nitrogen hetero-atom(s) only: Other: Other: Aromatic or modified aromatic: Other: Drugs: Other.” The general rate of duty will be 6.5 percent ad valorem. At the present time, Bortezomib is not listed in the Pharmaceutical Appendix to the Tariff Schedule.

The applicable subheading for VELCADE® (bortezomib) for Injection will be 3004.90.9115, HTS, which provides for “Medicaments … consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses (including those in the form of transdermal administration systems) or in forms or packings for retail sale: Other: Other: Other: Antineoplastic and immunosuppressive medicaments.” The general 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.


Robert B. Swierupski
National Commodity
Specialist Division