CLA-2-29:RR:NC:2:238 K88028

Mr. Joseph J. Chivini
Austin Chemical Company, Inc.
1565 Barclay Boulevard
Buffalo, Grove, IL 60089

RE: The tariff classification of Gemifloxacin (CAS-175463-14-6) imported in bulk form, from India

Dear Mr. Chivini:

In your letter dated July 7, 2004, you requested a tariff classification ruling.

The subject product, Gemifloxacin, is a synthetic, broad-spectrum, antibacterial agent. It is indicated for use as an antibacterial drug in the treatment of acute bacterial exacerbation of chronic bronchitis and community-acquired pneumonia. For the record, although Gemifloxacin is active against a wide range of gram-negative and gram-positive microorganisms, you have presented no evidence that it is closely related to any naturally occurring antibiotic. Explanatory Note 29.41, HTS.

The applicable subheading for Gemifloxacin, imported in bulk form, will be 2933.99.4600, 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: Anti-infective agents: Other.” Pursuant to General Note 4(b)(i) and (ii), the rate of duty will be 6.5 percent ad valorem. At the present time, the subject product is not listed in the Pharmaceutical Appendix to the Tariff Schedule. General Note 13, HTS.

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 1-888-443-6332.

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