The tariff classification of Alprostadil (CAS-745-65-3), imported in bulk form, and MUSE® (alprostadil) urethral suppository

NY J88601 September 19, 2003 CLA-2-29:RR:NC:2:238 J88601 CATEGORY: Classification TARIFF NO.: 2937.50.0000; 3004.39.0050 Ms. Marta Moss EGL Global Brokerage 385 Valley Drive Brisbane, CA 94005 RE: The tariff classification of Alprostadil (CAS-745-65-3), imported in bulk form, and MUSE® (alprostadil) urethral suppository Dear Ms. Moss: In your letter dated August 20, 2003, on behalf of your client, Vivus, Inc., you requested a tariff classification ruling. The first product, Alprostadil, is defined in Dorland’s Illustrated Medical Dictionary, 29th Edition, as follows: “name for Prostaglandin E1 when used pharmaceutically as a vasodilator and platelet aggregation inhibitor; used for the temporary maintenance of patent ductus arteriosus until corrective or palliative surgery can be performed in neonates with congenital heart defects; administered intravenously or intra-arterially. It is also administered by intracavernosal injection to facilitate erection in men with impotence and by intra-arterial infusion to enhance visualization in pharmacoangiography.” The second product, MUSE® (alprostadil) urethral suppository, is described in your client’s monograph, found in the 2003 Physicians’ Desk Reference (PDR®), as follows: “MUSE® (alprostadil) is a single use, medicated transurethral system for the delivery of alprostadil to the male urethra. Alprostadil is suspended in polyethylene glycol 1450 (as excipient) and is formed into a medicated pellet (microsuppository measuring 1.4 mm in diameter by 3 mm or 6 mm in length) that resides in the tip of a translucent hollow applicator. MUSE is administered by inserting the applicator stem into the urethra after urination. The pellet containing alprostadil is delivered by pressing the applicator button. The components of the delivery system are constructed from medical grade polypropylene. Each MUSE system is packaged in an individual foil pouch.” “MUSE is indicated for the treatment of erectile dysfunction.” Id. The applicable subheading for Alprostadil, imported in bulk form, will be 2937.50.0000, Harmonized Tariff Schedule of the United States (HTS), which provides for “Prostaglandins, thromboxanes and leukotrienes, their derivatives and structural analogues.” The rate of duty will be free. The applicable subheading for the MUSE® (alprostadil) urethral suppository will be 3004.39.0050,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: Containing hormones or other products of heading 2937 but not containing antibiotics: Other: Other.” The 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