The tariff classification of Memantine Hydrochloride (CAS-41100-52-1), imported in tablet form, from Germany and Ireland

NY H80248 May 10, 2001 CLA-2-30:RR:NC:2:238 H80248 CATEGORY: Classification TARIFF NO.: 3004.90.9040 James S. O’Kelly, Esq. Barnes, Richardson & Colburn 475 Park Avenue South New York, NY 10016 RE: The tariff classification of Memantine Hydrochloride (CAS-41100-52-1), imported in tablet form, from Germany and Ireland Dear Mr. O’Kelly: In your letter dated April 24, 2001, on behalf of your client, Forest Laboratories, Inc., you requested a tariff classification ruling. The subject product, Memantine Hydrochloride, in tablet form, consists of tablets containing Memantine Hydrochloride as the active ingredient. According to the website of the Alzheimer Research Forum (www.alzforum.org), Memantine Hydrochloride is currently in Phase III clinical trials in an ongoing effort at evaluating its efficacy in the treatment of Alzheimer’s disease. Further to the aforementioned, a press release by your client, dated January 30, 2001, indicates that “[F]orest intends to prepare an NDA (New Drug Application) for submission (to the FDA) around the end of 2001, but will also begin additional Phase III studies this spring in both mild to moderate and moderately severe Alzheimer’s Disease.” Pursuant to the General Notice entitled Guidance Concerning the Tariff Classification of Pharmaceutical Products Imported for Clinical Research (see Customs Bulletin and Decisions, Vol. 34, No. 21, May 24, 2000), the applicable subheading for Memantine Hydrochloride, imported in tablet form, will be 3004.90.9040, 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 or in forms or packings for retail sale: Other: Other: Other: Medicaments primarily affecting the central nervous system: 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 301-443-1544. 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 212-637-7068. Sincerely, Robert B. Swierupski Director, National Commodity Specialist Division