The tariff classification of Lumilash (Bimatoprost solution) 0.03%, put up with a sterile applicator, from Ireland

N047179 December 23, 2008 CLA-2-30:OT:RR:E:NC:2:238 CATEGORY: Classification TARIFF NO.: 3004.39.0050 Ms. Iliana G. Fuller Allergan, Inc.2525 Dupont Drive P.O. Box 19534 Irvine, CA 92623-9534 RE: The tariff classification of Lumilash (Bimatoprost solution) 0.03%, put up with a sterile applicator, from Ireland Dear Ms. Fuller: In your letter dated December 15, 2008, you requested a tariff classification ruling. The subject merchandise, Lumilash, is a 0.03% solution of Bimatoprost, a synthetic prostamide structurally related to prostaglandin F2a (PGF2a). It is the active ingredient in Lumigan™ (Bimatoprost ophthalmic solution) 0.03%, which is U.S. Food and Drug Administration (FDA)-approved drug for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension. This office believes that Lumilash is the subject of FDA New Drug Application 22-369, in which the 0.03% Bimatoprost ophthalmic solution is proposed for the treatment of hypotrichosis (an abnormal deficiency of hair) of the eyelids. While the application of such a product appears to be cosmetic, it is our opinion that its regulatory process and its principal use as a glaucoma medicament permit classification within the medicament subheadings of the Harmonized Tariff Schedule of the United States (HTSUS). The applicable subheading for the Lumilash (Bimatoprost solution) 0.03% will be 3004.39.0050, (HTSUS), 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. 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 Harvey Kuperstein at (646) 733-3033. Sincerely, Robert B. Swierupski Director National Commodity Specialist Division