The tariff classification of Lercanidipine Hydrochloride (CAS-132866-11-6), imported in bulk and tablet forms, from Italy and Ireland

NY H80236 May 14, 2001 CLA-2-29:RR:NC:2:238 H80236 CATEGORY: Classification TARIFF NO.: 2933.39.4100; 3004.90.9020 James S. O’Kelly, Esq. Barnes, Richardson & Colburn 475 Park Avenue South New York, NY 10016 RE: The tariff classification of Lercanidipine Hydrochloride (CAS-132866-11-6), imported in bulk and tablet forms, from Italy 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. You indicate in your letter that the subject product, Lercanidipine Hydrochloride, will be imported by your client for use in parallel-running Phase I, II, and III clinical trials, in an ongoing effort at evaluating its efficacy in the treatment of hypertension. In a press release dated November 8, 2000, your client indicated that it planned to file an NDA (New Drug Application) with the FDA for marketing approval in the U.S. in mid-2001. You further indicate that Lercanidipine Hydrochloride will be imported by your client in bulk and tablet forms (5 mg, 10 mg, and 20 mg tablets). 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 Lercanidipine Hydrochloride, imported in bulk form, will 2933.39.4100, Harmonized Tariff Schedule of the United States (HTS), 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: Other.” Pursuant to General Note 13, HTS, the rate of duty will be free.  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 Lercanidipine Hydrochloride, imported in tablet form, will be 3004.90.9020, 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: Cardiovascular medicaments." 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