The tariff classification of several active pharmaceutical ingredients (API), from various countries

N254336 June 26, 2014 CLA-2-29:OT:RR:NC: 2:238 CATEGORY: Classification TARIFF NO.: 2925.19.4200; 2930.90.2900; 2933.79.0800; 2934.99.4700 Ms. Gina Fischer Celgene Corporation 86 Morris Avenue Summit, NJ 07901 RE: The tariff classification of several active pharmaceutical ingredients (API), from various countries Dear Ms. Fischer: In your letter dated June 11, 2014, you requested a tariff classification ruling. The subject products are six different active pharmaceutical ingredients which you state will be imported as single ingredients in small samples. Thalidomide (CAS 50-35-1) is the active pharmaceutical ingredient contained in the drug called THALOMID®. It is indicated for the treatment of Multiple Myeloma (MM) and cutaneous manifestations of moderate to severe Erythema Nosodum Leprosum (ENL). This product will be imported from Switzerland and Germany. Lenalidomide (CAS 191732-72-6) is the active pharmaceutical ingredient contained in the drug called Revlimid. It is indicated for the treatment of relapsed or refractory Mantle Cell Lymphoma (MCL), Myelodysplastic Syndromes (MDS) and Multiple Myeloma. This product will be imported from the United Kingdom. Apremilast (CAS 608141-41-9) is the active pharmaceutical ingredient contained in the drug called OTEZLA®. It is indicated for the treatment of Psoriatic Arthritis (PsA). This product will be imported from Switzerland. Pomalidomide (CAS 19171-19-8) is the active pharmaceutical ingredient contained in the drug called POMALYST®. It is indicated for the treatment of Multiple Myeloma (MM). This product will be imported from Switzerland Romidepsin (CAS 128517-07-7) is the active pharmaceutical ingredient contained in the drug called ISTODAX®. It is indicated for the treatment of Peripheral T-cell Lymphoma (PTCL) and Cutaneous T-cell Lymphoma (CTCL). This product will be imported from Austria. Azacitidine (CAS 320-67-2) is the active pharmaceutical ingredient contained in the drug called Vidaza. It is indicated for the treatment of Myelodysplastic Syndromes (MDS). This product will be imported from Switzerland. The applicable subheading for the Thalidomide and the Pomalidomide will be 2925.19.4200, Harmonized Tariff Schedule of the United States (HTSUS), which provides for Carboxyimide-function compounds (including saccharin and its salts) and imine-function compounds: Imides and their derivatives; salts thereof: Other: Aromatic: Other. Pursuant to GN 13, HTSUS, the rate of duty will be free. The applicable subheading for the Apremilast will be 2930.90.2900, HTSUS, which provides for Organo-sulfur compounds: Other: Aromatic: Other: Other. Pursuant to GN 13, HTSUS, the rate of duty will be free. The applicable subheading for the Lenalidomide will be 2933.79.0800, HTSUS, which provides for Heterocyclic compounds with nitrogen hetero-atom(s) only: Lactams: Other lactams: Aromatic or modified aromatic: Other: Products described in additional U.S. note 3 to section VI. Pursuant to GN 13, HTSUS, the rate of duty will be free. The applicable subheading for the Romidepsin and the Azacitidine will be 2934.99.4700, HTSUS, which provides for Nucleic acids and their salts, whether or not chemically defined; other heterocyclic compounds: Other: Other: Other: Drugs. Pursuant to GN 13, 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 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 Judy Lee at [email protected]. Sincerely, Gwenn Klein Kirschner Director National Commodity Specialist Division