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NY L85516




June 22, 2005

CLA-2-30:RR:NC:2:238 L85516

CATEGORY: CLASSIFICATION

TARIFF NO.: 3004.32.0000; 9018.39.0050

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

RE: The tariff classification of an applicator imported loaded with Posurdex®, and imported empty

Dear Ms. Fuller:

In your letter dated you requested a tariff classification ruling.

The submitted sample consists of a disposable, single-use applicator, put up in a sealed, foil packet. The applicator, which is made of plastic and resembles a pen/mechanical pencil, is fitted with a permanently attached, syringe-like needle protected by a snap-on cap (also made of plastic). The applicator is designed to deliver Posurdex®, a biodegradable, extended-release implant containing dexamethasone as the active ingredient, to the back of a patient’s eye. The implant has the physical appearance of a tiny, rod-shaped pellet, and is situated inside the barrel of the needle. Depressing an elliptical-shaped “button” on the applicator triggers the release of the implant from the needle to the targeted disease site. According to a press release located on the World Wide Web, Allergan intended to initiate Phase 3 clinical trials for Posurdex®, in early 2004, for the treatment of macular edema associated with diabetes and other conditions.

Pursuant to the General Notice entitled Guidance Concerning the Tariff Classification of Pharmaceutical Products Imported for Clinical Research, published in the Customs Bulletin, Volume 34, No. 21, dated May 24, 2000, the applicable subheading for the applicator, imported loaded with a Posurdex® implant, 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 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.

The applicable subheading for the applicator imported empty (i.e., without the Posurdex® implant)) will be 9018.39.0050, HTS, which provides for “Instruments and appliances used in medical, surgical, dental or veterinary sciences, including scintigraphic apparatus, other electro-mechanical apparatus and sight-testing instruments; parts and accessories thereof: Syringes, needles, catheters, cannulae and the like; parts and accessories thereof: Other: Other.” The rate of duty will be free.

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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