The tariff classification of Salmeterol Xinafoate (CAS-94749-08-3), imported in bulk form, SEREVENT® (salmeterol xinafoate) Inhalation Aerosol, and SEREVENT® DISKUS® (salmeterol xinafoate inhalation powder), from the United Kingdom, France, Italy, Canada, Singapore, etc.

NY F86524 June 30, 2000 CLA-2-29:RR:NC:2:238 F86 CATEGORY: Classification TARIFF NO.: 2922.50.2500; 3004.90.9085 Robert L. Eisen, Esq. Christopher E. Pey, Esq. Coudert Brothers 1114 Avenue of the Americas New York, NY 10036-7703 RE: The tariff classification of Salmeterol Xinafoate (CAS-94749-08-3), imported in bulk form, SEREVENT® (salmeterol xinafoate) Inhalation Aerosol, and SEREVENT® DISKUS® (salmeterol xinafoate inhalation powder), from the United Kingdom, France, Italy, Canada, Singapore, etc. Dear Messrs. Eisen and Pey: In your letter dated April 25, 2000, on behalf of your client, Glaxo Wellcome Inc., you requested a tariff classification ruling. We regret the delay in responding. The first product, Salmeterol Xinafoate, is a bronchodilator drug used in the treatment of asthma. According to the Physicians’ Desk Reference, the second product, SEREVENT® (salmeterol xinafoate) Inhalation Aerosol, “is a pressurized, metered-dose aerosol unit for oral inhalation. It contains a microcrystalline suspension of salmeterol xinafoate, in a mixture of two chlorofluorocarbon propellants, with lecithin.” According to the Physicians’ Desk Reference, the third product, SEREVENT® DISKUS® (salmeterol xinafoate inhalation powder), “is a specially designed plastic device containing a double-foil blister strip of a powder formulation of salmeterol xinafoate intended for oral inhalation only. Each blister on the double-foil strip within the device contains 50 mcg of salmeterol as the xinafoate in 12.5 mg of formulation containing lactose. When a blister containing medication is opened by activating the device, the medication is dispersed into the air stream created when the patient inhales through the mouthpiece.”  The applicable subheading for Salmeterol Xinafoate, imported in bulk form, will be 2922.50.2500, Harmonized Tariff Schedule of the United States (HTS), which provides for "[O]xygen-function amino-compounds: Amino-alcohol-phenols, amino-acid-phenols and other amino-compounds with oxygen function: Aromatic: Other: Drugs: Other: Other." Pursuant to General Note 13, HTS, the rate of duty will be free. The applicable subheading for SEREVENT® (salmeterol xinafoate) Inhalation Aerosol, and SEREVENT® DISKUS® (salmeterol xinafoate inhalation powder) will be 3004.90.9085, HTS, which provides for “[M]edicaments … 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 eyes, ears or respiratory system: Other: 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 212-637-7068. Sincerely, Robert B. Swierupski Director, National Commodity Specialist Division