The tariff classification of TheraCLEC-Total™, put up in capsule form, from Canada

NY I80150 April 16, 2002 CLA-2-30:RR:NC:2:238 I80150 CATEGORY: Classification TARIFF NO.: 3004.90.9160 Mr. James F. Morgan PBB Global Logistics 883-D Airport Park Road Glen Burnie, MD 21061 RE: The tariff classification of TheraCLEC-Total™, put up in capsule form, from Canada Dear Mr. Morgan: In your letter dated March 28, 2002, on behalf of your client, Patheon Inc., you requested a tariff classification ruling. The subject product, TheraCLEC-Total™, is an enzyme preparation, put up in capsule form, containing three pancreatic enzymes as the active ingredients. You indicate in your letter that the product will be imported for use in Phase I clinical trials to evaluate its effectiveness in the treatment of pancreatic insufficiency, a condition that affects most people with cystic fibrosis. 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 the subject product will be 3004.90.9160, 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 digestive system: Other.” The general 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