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NY J83525




April 15, 2003

CLA-2-30:RR:NC:2:238 J83525

CATEGORY: CLASSIFICATION

TARIFF NO.: 3004.32.0000

Ms. Iliana G. Fuller
Allergan, Inc.
2525 Dupont Drive
P.O. Box 19534
Irvine, CA 92623-9534

RE: The tariff classification of FML® (fluorometholone ophthalmic ointment) 0.1%

Dear Ms. Fuller:

In your letter dated April 7, 2003, you requested a tariff classification ruling.

The subject product, FML® (fluorometholone ophthalmic ointment) 0.1%, is an ophthalmic medicament containing fluorometholone (CAS-426-13-1), a synthetic corticosteroid, as the active ingredient. The product is indicated for the treatment of steroid-responsive inflammation of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the eyeball. The oinment is supplied in a collapsible aluminum tube with a plastic screw cap.

The applicable subheading for the subject product will be 3004.32.0000, Harmonized Tariff Schedule of the United States (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: Containing hormones or other products of heading 2937 but not containing antibiotics: Containing corticosteroid hormones, their derivatives and structural analogues.” 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 646-733-3033.

Sincerely,

Robert B. Swierupski

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