The tariff classification of Loperamide Hydrochloride Capsules, USP and Methylene Blue Injection, USP in dosage form, from India and Italy, respectively

N329717 December 12, 2022 CLA-2-30:OT:RR:NC:N3:138 CATEGORY: Classification TARIFF NO.: 3004.90.9260; 3004.90.9291 Mr. Pradeep Shah Zydus Pharmaceuticals USA Inc. 73 Route 31 North Pennington, NJ 08534 RE: The tariff classification of Loperamide Hydrochloride Capsules, USP and Methylene Blue Injection, USP in dosage form, from India and Italy, respectively Dear Mr. Shah: In your letter dated December 5, 2022, you requested a tariff classification ruling. Loperamide Hydrochloride, USP, imported in 2 mg capsules, is an anti-diarrheal agent. It is indicated for the control and symptomatic relief of acute nonspecific diarrhea in patients 2 years of age and older and of chronic diarrhea in adults associated with inflammatory bowel disease. Methylene Blue Injection, USP, imported in 5 mg, is indicated for the treatment of pediatric and adult patients with acquired methemoglobinemia. In your letter, you indicated this product will be imported from India. The applicable subheading for the Loperamide Hydrochloride Capsules, USP in dosage form will be 3004.90.9260, Harmonized Tariff Schedule of the United States (HTSUS), which provides for 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: Medicaments primarily affecting the digestive system: Other.” The rate of duty will be free. The applicable subheading for the Methylene Blue Injection, USP in dosage form will be 3004.90.9291, 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: 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 the World Wide Web 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 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 Judy Lee at [email protected]. Sincerely, Steven A. Mack Director National Commodity Specialist Division