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N046975 N0 Ruling Active

The tariff classification of 7-Ethyl-10-Hydroxycamptothecin (SN-38) (CAS-86639-52-3) in bulk form, from Finland

Issued December 22, 2008 by U.S. Customs and Border Protection.

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N0 N046975 (December 22, 2008)

Tariff classification

HTS codes: 2939.99.0000

Headings: 2939

Product description

The subject product, 7-Ethyl-10-Hydroxycamptothecin (SN-38), is the active metabolite of Irinotecan, a semisynthetic derivative of camptothecin, a quinoline-based alkaloid found in the bark of the Chinese camptotheca tree and the Asian nothapodytes tree. Although 7-Ethyl-10-Hydroxycamptothecin is up to 1,000 times more potent than Irinotecan, it has not been converted into a viable drug candidate because it is insoluble. It is presently being subjected to clinical trials in combination with other moieties which may ultimately allow it to be efficacious as an antineoplastic drug.

CBP rationale

The applicable subheading for the 7-Ethyl-10-Hydroxycamptothecin will be 2939.99.0000, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Vegetable alkaloids, natural or reproduced by synthesis, and their salts, ethers, esters and other derivatives: Other: Other.

Full text

N046975 December 22, 2008 CLA-2-29:OT:RR:NC:2:238 CATEGORY: Classification TARIFF NO.: 2939.99.0000 Ms. Robyn Addabbo Interchem Corporation 120 Route 17 North P.O. Box 1579 Paramus, NJ 07652-1579 RE: The tariff classification of 7-Ethyl-10-Hydroxycamptothecin (SN-38) (CAS-86639-52-3) in bulk form, from Finland Dear Ms. Addabbo: In your letter dated December 4, 2008, you requested a tariff classification ruling. The subject product, 7-Ethyl-10-Hydroxycamptothecin (SN-38), is the active metabolite of Irinotecan, a semisynthetic derivative of camptothecin, a quinoline-based alkaloid found in the bark of the Chinese camptotheca tree and the Asian nothapodytes tree. Although 7-Ethyl-10-Hydroxycamptothecin is up to 1,000 times more potent than Irinotecan, it has not been converted into a viable drug candidate because it is insoluble. It is presently being subjected to clinical trials in combination with other moieties which may ultimately allow it to be efficacious as an antineoplastic drug. The applicable subheading for the 7-Ethyl-10-Hydroxycamptothecin will be 2939.99.0000, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Vegetable alkaloids, natural or reproduced by synthesis, and their salts, ethers, esters and other derivatives: Other: Other.” 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 Director National Commodity Specialist Division

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