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NY F84538




March 31, 2000

CLA-2-29:RR:NC:2:238 F84538

CATEGORY: CLASSIFICATION

TARIFF NO.: 2933.59.5300

Mr. Kevin R. Hussey
Schenker, Inc.
850 Calcon Hook Road
Sharon Hill, PA 19079

RE: The tariff classification of Pemirolast Potassium (CAS-100299-08-9), imported in bulk form, from Germany

Dear Mr. Hussey:

In your letter dated February 14, 2000, resubmitted on March 17, 2000, on behalf of your client, Santen Incorporated, you requested a tariff classification ruling.

The subject product, Pemirolast Potassium, is a mast cell stabilizer. It acts by inhibiting the (antigen-induced) release of inflammatory mediators from human mast cells. In addition, it inhibits the chemotaxis (movement of cells in response to chemicals) of eosinophils (leukocytes) into ocular tissue, and blocks the release of mediators from human eosinophils. It is indicated for use as an antiallergy drug to prevent itching of the eye due to allergic conjunctivitis. We note the submission with your ruling request of a New Drug Application (NDA 21-079), approved by the FDA on September 24, 1999, granting permission to your client to market Alamast™, an ophthalmic medicament containing Pemirolast Potassium as the active ingredient.

The applicable subheading for the Pemirolast Potassium, imported in bulk form, will be 2933.59.5300, Harmonized Tariff Schedule of the United States (HTS), which provides for "[H]eterocyclic compounds with nitrogen hetero-atom(s) only: Compounds containing a pyrimidine ring (whether or not hydrogenated) or piperazine ring in the structure: Other: Drugs: Aromatic or modified aromatic: Other." Pursuant to General Note 13, HTS, the 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 212-637-7068.

Sincerely,

Robert B. Swierupski

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