NY L80710 - The tariff classification of Tolevamer (code designation: GT267-004), imported in bulk form; Tolevamer 7% Oral Solution, imported put up in 45 mL single-use bottles; and Tolevamer 7% Oral Solution Placebo, imported put up in 45 mL single-use bottles, from Ireland and the United Kingdom - United States International Trade Commision Rulings

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NY L80710

November 16, 2004

CLA-2-:RR:NC:2:238 L80710

CATEGORY: CLASSIFICATION

TARIFF NO.: 3903.90.5000; 3004.90.9160; 2106.90.9998

Mr. Richard D’Innocenzo
Genzyme Corporation
One Kendall Square
Cambridge, MA 02139

RE: The tariff classification of Tolevamer (code designation: GT267-004), imported in bulk form; Tolevamer 7% Oral Solution, imported put up in 45 mL single-use bottles; and Tolevamer 7% Oral Solution Placebo, imported put up in 45 mL single-use bottles, from Ireland and the United Kingdom

Dear Mr. D’Innocenzo:

In your letter dated November 8, 2004, you requested a tariff classification ruling.

The first product, Tolevamer (code designation: GT267-004), chemically known as Poly(sodium/potassium 4-styrenesulfonate)

According to the supplied MSDS sheets, Poly(sodium/potassium 4-styrenesulfonate) is chemically modified Poly(sodium 4-styrenesulfonate) (CAS-25704-18-1), and is produced by the addition of potassium, which replaces ~30% of the sodium typically found in Poly(sodium 4-styrenesulfonate)., is an experimental drug [and the active ingredient of Tolevamer 7% Oral Solution (the second product)] presently being investigated for use in the treatment of Clostridium difficile associated diarrhea (CDAD). You indicate in your letter that “Tolevamer is a non-absorbed ionic organic polymer which binds the toxin produced by C. difficile in the human intestinal tract.” You also indicate that phase II clinical trials for Tolevamer 7% Oral Solution have been completed, with phase III clinical trials scheduled to commence shortly. The third product, Tolevamer 7% Oral Solution Placebo, is a placebo version of Tolevamer 7% Oral Solution. Absent the active ingredient (i.e., Tolevamer), the placebo has the same formulation as Tolevamer 7% Oral Solution. Finally, during a telephone conversation with a member of my staff on November 10, 2004, you stated that Tolevamer 7% Oral Solution and Tolevamer 7% Oral Solution Placebo will be imported put up in 45 mL single-use bottles.

The applicable subheading for Tolevamer (code designation: GT267-004), imported in bulk form, will be 3903.90.5000, Harmonized Tariff of the United States (HTS), which provides for “Polymers of styrene, in primary forms: Other: Other.” The rate of duty will be 6.5 percent ad valorem.

Pursuant to the General Notice entitled Guidance Concerning the Tariff Classification of Pharmaceutical Products Imported for Clinical Research (see Customs Bulletin and Decisions, dated May 24, 2000), the applicable subheading for Tolevamer 7% Oral Solution, imported put up in 45 mL single-use bottles, will be 3004.90.9160, 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: Medicaments primarily affecting the digestive system: Other.” The rate of duty will be free.

The applicable subheading for Tolevamer 7% Oral Solution Placebo will be 2106.90.9998, HTS, which provides for “Food preparations not elsewhere specified or included: Other: Other: Other: Other: Other: Other: Other: Other: Other: Other.” The rate of duty will be 6.4 percent ad valorem.

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.

Sincerely,

Robert B. Swierupski

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