The tariff classification of Exenatide (CAS-141758-74-9) and Donepezil Hydrochloride (CAS-120011-70-3) in bulk form, from China and Spain, respectively

N044081 November 21, 2008 CLA-2-29:OT:RR:NC:N2:238 CATEGORY: Classification TARIFF NO.: 2933.29.2000; 2933.39.3100 Ms. Inge Forstenzer Ren-Pharm International, Ltd. 350 Jericho Turnpike, Suite 204 Jericho, NY 11753 RE: The tariff classification of Exenatide (CAS-141758-74-9) and Donepezil Hydrochloride (CAS-120011-70-3) in bulk form, from China and Spain, respectively Dear Ms. Forstenzer: In your letter dated November 4, 2008 you requested a tariff classification ruling. The first product, Exenatide, is in a class of medications called incretin mimetics and is a synthetic peptide identified in the lizard Heloderma suspectum. It is indicated as an adjunctive therapy to improve glycemic control in patients with type 2 diabetes mellitus. The second product, Donepezil Hydrochloride, is a reversible inhibitor of the enzyme acetylcholinesterase. It is indicated for the treatment of mild to moderate dementia in patients with Alzheimer's Disease. The applicable subheading for the Exenatide in bulk form will be 2933.29.2000, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Heterocyclic compounds with nitrogen hetero-atom(s) only: Compounds containing an unfused imidazole ring (whether or not hydrogenated) in the structure: Other: Aromatic or modified aromatic: Other: Drugs.” Pursuant to GN13, HTSUS, the rate of duty will be free. The applicable subheading for the Donepezil Hydrochloride in bulk form will 2933.39.3100, Harmonized Tariff Schedule of the United States (HTSUS), which provides for "Heterocyclic compounds with nitrogen hetero-atom(s) only: Compounds containing an unfused pyridine ring (whether or not hydrogenated) in the structure: Other: Other: Drugs: Antidepressants, tranquilizers and other psychotherapeutic agents." Pursuant to GN13, 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