The tariff classification of Penicillin G Potassium for Injection in dosage form, from Italy

N337746 February 13, 2024 CLA-2-30:OT:RR:NC:N3:138 CATEGORY: Classification TARIFF NO.: 3004.10.1020 Trish O’ Mahoney NorthStar Healthcare 3300 Cork Airport Business Park Kinsale Road, Cork T12XN72Ireland RE:  The tariff classification of Penicillin G Potassium for Injection in dosage form, from Italy Dear Ms. O’ Mahoney: In your letter dated January 25, 2024, you requested a tariff classification ruling. Penicillin G Potassium for Injection, imported in 5,000,000 units and 20,000,000 units per vial, is the potassium salt form of penicillin G, a broad-spectrum penicillin antibiotic. It is indicated for the treatment of serious infections caused by susceptible strains of the designated microorganisms causing septicemia, empyema, pneumonia, pericarditis, endocarditis, meningitis, anthrax, actinomycosis, botulism, diphtheria, erysipelothrix, endocarditis and fusospirochetosis. The applicable subheading for the Penicillin G Potassium for Injection in dosage form will be 3004.10.1020, 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: Containing penicillins or derivatives thereof, with a penicillanic acid structure, or streptomycins or their derivatives: Containing penicillin G salts: Other: Singles.” 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. The holding set forth above applies only to the specific factual situation and merchandise description as identified in the ruling request. This position is clearly set forth in Title 19, Code of Federal Regulations (CFR), Section 177.9(b)(1). This section states that a ruling letter is issued on the assumption that all of the information furnished in the ruling letter, whether directly, by reference, or by implication, is accurate and complete in every material respect. In the event that the facts are modified in any way, or if the goods do not conform to these facts at time of importation, you should bring this to the attention of U.S. Customs and Border Protection (CBP) and submit a request for a new ruling in accordance with 19 CFR 177.2. Additionally, we note that the material facts described in the foregoing ruling may be subject to periodic verification by CBP. 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 judy.h.lee@cbp.dhs.gov. Sincerely, Steven A. Mack Director National Commodity Specialist Division