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NY L85350




June 7, 2005

CLA-2-29:RR:NC:2:238 L85350

CATEGORY: CLASSIFICATION

TARIFF NO.: 2933.39.4100; 2941.90.3000

Ms. Inge Forstenzer
Ren-Pharm International, Ltd.
350 Jericho Turnpike, Suite 204
Jericho, NY 11753

RE: The tariff classification of Loperamide Hydrochloride (CAS-34552-83-5) and Rifaximin (CAS-80621-81-4), imported in bulk form, from Italy

Dear Ms. Forstenzer:

In your letter dated May 18, 2005, you requested a tariff classification ruling.

The first product, Loperamide Hydrochloride, is indicated for the control and symptomatic relief of acute, nonspecific diarrhea, and of chronic diarrhea associated with inflammatory bowel disease. Loperamide Hydrochloride is also indicated for reducing the volume of discharge from ileostomies.

The second product, Rifaximin, is a semi-synthetic, non-systemic substance related to Rifamycin SV, a semi-synthetic antibiotic derived from Rifamycin S

The Merck Index (13th ed.) defines “Rifamycins” as a “[G]roup of antibiotics characterized by a natural ansa structure not previously found in other known antibiotics. Isoln from the fermentation broths of Streptomyces mediterranei. Among rifamycins, rifamycin B, O, S, SV and X are the more studied members.”. Rifaximin is indicated for the treatment of traveler’s diarrhea caused by noninvasive strains of Escherichia coli.

The applicable subheading for Loperamide Hydrochloride, imported in bulk form, will be 2933.39.4100, Harmonized Tariff Schedule of the United States (HTS), which provides for: : Heterocyclic compounds with nitrogen hetero-atom(s) only: Compounds containing an unfused pyridine ring (whether or not hydrogenated) in the structure: Other: Other: Drugs: Other.” Pursuant to General Note 13, HTS, the rate of duty will be free.

The applicable subheading for Rifaximin, imported in bulk form, will be 2941.90.3000, HTS, which provides for “Antibiotics: Other: Other: Aromatic or modified aromatic.” The rate of duty will be free.

This merchandise may be subject to the requirements of the Federal Food, Drug, and Cosmetic Act, which are administered by the U.S. Food and Drug Administration. You may contact them at 5600 Fishers Lane, Rockville, Maryland 20857, telephone number 1-888-463-6332.

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.

Sincerely,

Robert B. Swierupski

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