The tariff classification of Tapentadol Hydrochloride (CAS-175591-09-0) in bulk powder form, from Italy

N058190 May 5, 2009 CLA-2-29:OT:RR:NC:N2:238 CATEGORY: Classification TARIFF NO.: 2922.29.2700 Ms. Inge Forstenzer Ren-Pharm International Ltd. 350 Jericho Turnpike, Suite 204 Jericho, NY 11753 RE: The tariff classification of Tapentadol Hydrochloride (CAS-175591-09-0) in bulk powder form, from Italy Dear Ms. Forstenzer: In your letter dated April 17, 2009, you requested a tariff classification ruling. The subject product, Tapentadol Hydrochloride, is a novel, investigational, centrally acting analgesic with a dual mechanism of action involving mu-opioid receptor agonism and norepinephrine reuptake inhibition. It is used in the relief of moderate to severe acute pain. Currently, this drug is in the final stages of regulatory review in the United States. The U.S. Drug Enforcement Administration (DEA) has proposed Tapentadol (INN) to be placed into Schedule II of the Controlled Substances Act (CSA). The applicable subheading for the Tapentadol Hydrochloride in bulk form will be 2922.29.2700, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Oxygen-function amino-compounds: Amino-naphthols and other amino-phenols, their ethers and esters, other than those containing more than one kind of oxygen function; salts thereof: Other: Other: Drugs.” Pursuant to GN13, HTSUS, the rate of duty will be free. Duty rates are provided for your convenience and are subject to change. The text of the most recent HTSUS and the accompanying duty rates are provided on World Wide Web at http://www.usitc.gov/tata/hts/. This merchandise may be subject to the requirements of the Controlled Substances Act, which are enforced by the U.S. Drug Enforcement Administration (DEA), Office of Diversion Control. You may contact them at 2401 Jefferson Davis Highway, Alexandria, VA 22301, telephone (800) 882-9539. This merchandise may be subject to the Federal Food, Drug, and Cosmetic Act and/or The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (The Bioterrorism Act), which are administered by the U.S. Food and Drug Administration (FDA). Information on the Federal Food, Drug, and Cosmetic Act, as well as The Bioterrorism Act, can be obtained by calling the FDA at 1-888-463-6332, or by visiting their website at www.fda.gov. 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