N007488 N0 Ruling Active

The tariff classification of Plerixafor (CAS-110078-46-1), imported in bulk form, from the United Kingdom

Issued March 9, 2007 by U.S. Customs and Border Protection.

Tariff classification

HTS codes: 2933.99.7500

Headings: 2933

Product description

According to information found on the website of the Multiple Myeloma Research Foundation, the subject product, Plerixafor (Mozobil™, AMD3100) is an investigational new drug (IAD) that increases the number of stem cells that can be collected prior to transplant. “By blocking CXCR4, a specific cellular receptor, Mozobil™ triggers the rapid movement of stem cells out of the bone marrow and into the circulating blood. The efficacy of a mobilization regimen of Mozobil™ in combination with G-CSF (Granulocyte colony-stimulating factor) is currently being compared with G-CSF alone in Phase III trials in patients with myeloma undergoing autologous transplant.” Id.

CBP rationale

The applicable subheading for Plerixafor (Mozobil™, AMD3100), imported in bulk form, will be 2933.99.7500, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Heterocyclic compounds with nitrogen hetero-atom(s) only: Other: Other: Aromatic or modified aromatic: Other: Drugs: Other.

Full text

N007488 March 9, 2007 CLA-2-29:RR:E:NC:2:238 CATEGORY: Classification TARIFF NO.: 2933.99.7500 Mr. Richard M. D’Innocenzo Genzyme Corporation 675 West Kendall Street, 5th Floor Cambridge, MA 02176 RE: The tariff classification of Plerixafor (CAS-110078-46-1), imported in bulk form, from the United Kingdom Dear Mr. D’Innocenzo: In your letter dated February 26, 2007, you requested a tariff classification ruling. According to information found on the website of the Multiple Myeloma Research Foundation, the subject product, Plerixafor (Mozobil™, AMD3100) is an investigational new drug (IAD) that increases the number of stem cells that can be collected prior to transplant. “By blocking CXCR4, a specific cellular receptor, Mozobil™ triggers the rapid movement of stem cells out of the bone marrow and into the circulating blood. The efficacy of a mobilization regimen of Mozobil™ in combination with G-CSF (Granulocyte colony-stimulating factor) is currently being compared with G-CSF alone in Phase III trials in patients with myeloma undergoing autologous transplant.” Id. The applicable subheading for Plerixafor (Mozobil™, AMD3100), imported in bulk form, will be 2933.99.7500, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Heterocyclic compounds with nitrogen hetero-atom(s) only: Other: Other: Aromatic or modified aromatic: Other: Drugs: Other.” Pursuant to General Note 13, HTSUS, 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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