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NY M82580




April 18, 2006

CLA-2-29:RR:NC:2:238 M82580

CATEGORY: CLASSIFICATION

TARIFF NO.: 2934.99.4700

Ms. Inge Forstenzer
Ren-Pharm International, Ltd.
350 Jericho Turnpike, Suite 204
Jericho, NY 11753

RE: The tariff classification of Tacrolimus [CAS-109581-93-3; CAS-104987-11-3 (anhydrous)], imported in bulk form, from Taiwan

Dear Ms. Forstenzer:

In your letter dated April 6, 2006, you requested a tariff classification ruling.

The subject product, Tacrolimus (a macrolide isolated from Streptomyces tsukubaensis), is indicated for use as an immunosuppressant drug. For the record, we are unable to find any evidence in the scientific literature that Tacrolimus has the ability to kill or inhibit the growth of microorganisms. Accordingly, pursuant to Lonza, Inc. v. U.S. [46 F.3d 1098 (Fed. Cir. 1995)] and the Explanatory Notes to heading 2941, HTSUS, it is our determination that Tacrolimus is precluded from classification as an antibiotic, for tariff purposes.

The applicable subheading for Tacrolimus, imported in bulk form, will be 2934.99.4700, HTSUS, which provides for “Nucleic acids and their salts, whether or not chemically defined; other heterocyclic compounds: Other: Other: Other: Drugs.” Pursuant to General Note 13, HTS, the rate of duty will be free.

Duty rates are provided for your convenience and are subject to change. The text of the most recent HTSUS and the accompanying duty rates are provided on World Wide Web at http://www.usitc.gov/tata/hts/.

This merchandise may be subject to the Federal Food, Drug, and Cosmetic Act and/or The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (The Bioterrorism Act), which are administered by the U.S. Food and Drug Administration (FDA). Information on the Federal Food, Drug, and Cosmetic Act, as well as The Bioterrorism Act, can be obtained by calling the FDA at 1-888-463-6332, or by visiting their website at www.fda.gov.

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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