The tariff classification of Protamine Sulfate (CAS-9009-65-8), imported in bulk form, from Japan

NY K81624 December 23, 2003 CLA-2-35:RR:NC:2:238 K81624 CATEGORY: Classification TARIFF NO.: 3504.00.5000 Ms. Rachelle Smith Nippon Express USA, Inc. 95 N. Division Street Bensenville, IL 60106 RE: The tariff classification of Protamine Sulfate (CAS-9009-65-8), imported in bulk form, from Japan Dear Ms. Smith: In your letter dated November 27, 2003, on behalf of your client, Yuki Gosei Kogyo Co., Ltd., you requested a tariff classification ruling. According to the official monograph appearing in the 2003 edition of The United States Pharmacopeia (USP 26/NF 21), Protamine Sulfate is defined as “[a] purified mixture of simple protein principles obtained from the sperm or testes of suitable species of fish, which has the property of neutralizing heparin.” The 20th edition of Remington, The Science and Practice of Pharmacy (at page 422) indicates that Protamines, along with Albumins, Globulins, Glutelins, Prolamines, Albuminoids and Histones, belong to the class of proteins referred to as “Simple proteins.” Protamine Sulfate is indicated for use in the formulation of various insulin preparations for the treatment of diabetes, and as a heparin antidote. You indicate in your letter that the subject product will be imported in 1 kg and 10 kg sealed polyethylene bags. The 1 kg bags will, in turn, be packed in sealed polyethylene bottles with screw-down caps, while the 10 kg bags will, in turn, be packed in sealed tin cans with tin caps. You opine that the subject product should be classified as “Extracts of glands or other organs or of their secretions” in subheading 3001.20.0000. We disagree. In our opinion, Protamine Sulfate is properly classified as an other protein substance, based on its being structurally akin (i.e., a simple protein) to several of the exemplars (i.e., simple proteins) enumerated in Explanatory Note 35.04(B), HTS [see, for example, exemplars “(1)” thru “(4)”]. The applicable subheading for Protamine Sulfate, imported in bulk form, will be 3504.00.5000, Harmonized Tariff Schedule of the United States (HTS), which provides for, inter alia, other protein substances and their derivatives, not elsewhere specified or included. The rate of duty will be 4 percent ad valorem. The rate of duty will remain the same in 2004, 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