The tariff classification of a medicinal preparation containing acetaminophen (CAS-103-90-2) and diphenhydramine hydrochloride (CAS-147-24-0) as the active ingredients, imported in bulk and measured-dose forms, from India

NY R04701 September 1, 2006 CLA-2-30:RR:E:NC:2:238 R04701 CATEGORY: Classification TARIFF NO.: 3003.90.0000; 3004.90.9130 Mr. Joseph Scanlon Granules USA Inc. 111 Howard Blvd. Mt. Arlington, NJ 07856 RE: The tariff classification of a medicinal preparation containing acetaminophen (CAS-103-90-2) and diphenhydramine hydrochloride (CAS-147-24-0) as the active ingredients, imported in bulk and measured-dose forms, from India Dear Mr. Scanlon: In your letter dated August 22, 2006, you requested a tariff classification ruling. The subject product consists of a medicinal preparation containing two active ingredients, namely: acetaminophen (an analgesic and antipyretic drug) and diphenhydramine hydrochloride (an antihistamine which has sedative properties). You state in your letter, inter alia, that the “generic formula (of the subject product) is …identical to that of Tylenol® PM,” which is marketed as a combined analgesic and sedative. The applicable subheading for the subject product, imported in bulk form, will be 3003.90.0000, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Medicaments…consisting of two or more constituents which have been mixed together for therapeutic or prophylactic uses, not put up in measured doses or in forms or packings for retail sale: Other.” The rate of duty will be free. Pursuant to Rule 6 of the General Rules of Interpretation, HTSUS, the applicable subheading for the subject product, imported put up in measured-dose forms (e.g., tablets, capsules, caplets), will be 3004.90.9130, 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: Other: Other: Other: Medicaments primarily affecting the central nervous system: Anticonvulsants, hypnotics and sedatives.” 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