The tariff classification of Epinastine Hydrochloride (CAS-108929-04-0), imported in bulk form, from Germany

NY J80235 February 5, 2003 CLA-2-29:RR:NC:2:238 J80235 CATEGORY: Classification TARIFF NO.: 2933.99.2600 Ms. Iliana G. Fuller Allergan, Inc. 2525 Dupont Drive P.O. Box 19534 Irvine, CA 92623-9534 RE: The tariff classification of Epinastine Hydrochloride (CAS-108929-04-0), imported in bulk form, from Germany Dear Ms. Fuller: In your letter dated January 20, 2003, you requested a tariff classification ruling. You indicate in your letter that the subject product, Epinastine Hydrochloride, is intended for use as the active ingredient in the manufacture of Epinastine 0.05% Ophthalmic Solution, an antihistaminic medicament for which Allergan has filed an NDA (New Drug Application) with the FDA. The applicable subheading for Epinastine Hydrochloride, imported in bulk form, will be 2933.99.2600, Harmonized Tariff Schedule of the United States (HTS), which provides for “Heterocyclic compounds with nitrogen hetero-atom(s) only: Other: Other: Aromatic or modified aromatic: Other: Drugs: Antihistamines.” Pursuant to General Note 13, HTS, 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 646-733-3033. Sincerely, Robert B. Swierupski Director, National Commodity Specialist Division