The tariff classification of Scopolamine Transdermal System from Australia and Pitavastatin Tablets from India

N332859 June 9, 2023 CLA-2-30:OT:RR:NC:N3:138 CATEGORY: Classification TARIFF NO: 3004.49.0040; 3004.90.9220 Pradeep Shah Zydus Pharmaceuticals USA Inc. 73 Route 31 NPennington, NJ 08534 RE: The tariff classification of Scopolamine Transdermal System from Australia and Pitavastatin Tablets from India Dear Mr. Shah: In your letter dated May 11, 2023, you requested a tariff classification ruling. Scopolamine Transdermal System, imported in 1 mg/3 day patches, is a belladonna alkaloid with anticholinergic effects.  It is indicated for the treatment of nausea and vomiting associated with motion sickness and postoperative nausea and vomiting (PONV).  In your letter, you stated Scopolamine Transdermal System will be imported from India. Pitavastatin, imported in 1 mg, 2 mg, and 4 mg tablets, is in a class of medications called HMG-CoA reductase inhibitors (statins).  It is indicated as an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia and adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH). The applicable subheading for the Scopolamine Transdermal System will be 3004.49.0040, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Medicaments … 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, containing alkaloids or derivatives thereof: Other: Other: Medicaments primarily affecting the central nervous system: Other.”  The rate of duty will be free. The applicable subheading for the Pitavastatin Tablets in dosage form will be 3004.90.9220, HTSUS, which provides for “Medicaments … 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: Cardiovascular medicaments.” 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 at https://hts.usitc.gov/current. 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 and Border Protection 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, please contact National Import Specialist Judy Lee at [email protected]. Sincerely, Steven A. Mack Director National Commodity Specialist Division