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NY E89447




December 1, 1999

CLA-2-39:RR:NC:2:237 E89447

CATEGORY: CLASSIFICATION

TARIFF NO.: 3914.00.6000

Ms. Toni Chancellor, Ph.D.
GelTex Pharmaceuticals, Inc.
153 Second Avenue
Waltham, MA 02451

RE: The tariff classification of Colesevelam hydrochloride ion-exchange resins in bulk form (CAS-182815-44-7) from Austria.

Dear Ms. Chancellor:

In your letter dated November 1, 1999, you requested a tariff classification ruling.

Colesevelam hydrochloride is described as an ion-exchanger whose structure is represented as a terpolymer of the amines: allylamine; N-decylallylamine; N-(6-tremethylammoniumhexyl) allylamine; and N,N’-diallyl-1,3-diamino-2-hydroxypropane. The product is a bile acid sequestrant, which binds with bile acids in the intestine, impeding their absorption. The product is intended as the bulk active pharmaceutical ingredient in the formulation of a cholesterol-lowering agent. Colesevelam hydrochloride is classifiable in subheading 3914.00.6000, Harmonized Tariff Schedule of the United States (HTS), which provides for other ion-exchanger based on polymers of headings 3901 to 3913, in primary forms. The rate of duty will be 3.9 percent ad valorem.

Pursuant to General Note 13, HTS, we note that colesevelam hydrochloride is listed by its INN name (i.e., colesevelam) in Table 1 of the Pharmaceutical Appendix, HTS, and is suffix (i.e., hydrochloride) is listed in table 2 of the Pharmaceutical Appendix, HTS. Accordingly, it is eligible for duty-free treatment, under the Agreement on Trade in Pharmaceutical Products.

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) 443-6553.

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 Frank Cantone at 212-637-7018.

Sincerely,

Robert B. Swierupski
Director,

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