The tariff classification of MLN518, imported in bulk and measured-dose forms, for use in Phase 1 clinical trials, from the United Kingdom and Canada

NY J87697 August 14, 2003 CLA-2-29:RR:NC:2:238 J87697 CATEGORY: Classification TARIFF NO.: 2933.59.7000; 3004.90.9115 Herbert J. Lynch, Esq. Sullivan & Lynch, P.C. 156 State Street Boston, MA 02109-2508 RE: The tariff classification of MLN518, imported in bulk and measured-dose forms, for use in Phase 1 clinical trials, from the United Kingdom and Canada Dear Mr. Lynch: In your letter dated July 23, 2003, on behalf of your client, Millennium Pharmaceuticals, Inc., you requested a tariff classification ruling. According to your letter, MLN518 is an investigational new drug which will be imported in bulk and measured-dose forms for use in FDA-regulated, Phase 1 clinical trials, in order to evaluate its efficacy for future use as an antineoplastic drug. You have indicated that the chemical compound presently designated as “MLN518” does not have a Chemical Abstracts Sevice (CAS) registry number at this time. You opine in your letter that MLN 518, when imported in bulk form, is classified in subheading 2934.99, HTS, which, inter alia, provides for “[o]ther heterocyclic compounds.” However, we note that MLN518 contains only nitrogen hetero-atoms in the structure - in the form of an unfused, hydrogenated pyridine ring, an hydrogenated piperazine ring and a (fused) pyrimidine ring. Pursuant to the General Notice entitled Guidance Concerning the Tariff Classification of Pharmaceutical Products Imported for Clinical Research (see Customs Bulletin and Decisions, dated May 24, 2000) and Section VI, Additional U.S. Note 3, HTS, the applicable subheading for MLN5188, imported in bulk form, will be 2933.59.7000, Harmonized Tariff Schedule of the United States (HTS), which provides for “Heterocyclic compounds with nitrogen hetero-atom(s) only: Compounds containing a pyrimidine ring (whether or not hydrogenated) or piperazine ring in the structure: Other: Other: Aromatic or modified aromatic: Other: Other: Products described in additional U.S. note 3 to section VI.” The general rate of duty will be 7.2 percent ad valorem. Pursuant to the General Notice entitled Guidance Concerning the Tariff Classification of Pharmaceutical Products Imported for Clinical Research (see Customs Bulletin and Decisions, dated May 24, 2000), the applicable subheading for MLN518, imported put up in measured doses, will be 3004.90.9115, HTS, which provides for “Medicaments…consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses (including those in the form of transdermal administration systems) or in forms or packings for retail sale: Other: Other: Other: Antineoplastic and immunosuppressive medicaments.” 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