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NY L80574




November 1, 2004

CLA-2-30:RR:NC:2:238 L80574

CATEGORY: CLASSIFICATION

TARIFF NO.: 3004.20.0060

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

RE: The tariff classification of POLYTRIM® (trimethoprim sulfate and polymyxin B sulfate ophthalmic solution) sterile, supplied in 10mL plastic bottles with dropper tips and screw-down caps.

Dear Ms. Fuller:

In your letter dated October 25, 2004, you requested a tariff classification ruling.

The subject product, POLYTRIM® (trimethoprim sulfate and polymyxin B sulfate ophthalmic solution) sterile, is a sterile antimicrobial solution for topical ophthalmic use. POLYTRIM® contains trimethoprim sulfate (a synthetic antibacterial drug) and polymyxin B sulfate (the sulfate salt of polymyxin B, a naturally occurring antibiotic) as the active ingredients. The product is indicated for use in the treatment of surface ocular bacterial infections, including acute bacterial conjunctivitis and blepharoconjunctivitis, caused by susceptible strains of various pathogenic bacteria. The solution is supplied in 10mL plastic bottles with dropper tips and screw-down caps.

You assert that this product should be classified within subheading 3004.39.0050, HTS, which provides for medicaments containing hormones or other products of heading 2937, but not containing antibiotics. However, since the product does not contain any hormone(s), but does, in fact, contain an antibiotic (i.e., polymyxin B sulfate), we find your assertion to be without merit.

The applicable subheading for POLYTRIM® (trimethoprim sulfate and polymyxin B sulfate ophthalmic solution) sterile , imported put up in 10mL plastic bottles with dropper tips and screw-down caps, will be 3004.20.0060, 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 other antibiotics: Other: Other:” 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 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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