The country of origin of Flecainide Acetate Tablets, USP

N348450 May 27, 2025 OT:RR:NC:N3:138 CATEGORY: Country of Origin Pei Zhang Epic Pharma, LLC 22715 North Conduit Avenue Laurelton, NY 11413 RE: The country of origin of Flecainide Acetate Tablets, USP Dear Mr. Zhang: In your letter dated April 30, 2025, you requested a country of origin ruling on Flecainide Acetate Tablets. Flecainide Acetate, imported in 50 mg, 100 mg and 150 mg tablets, is an antiarrhythmic. It is indicated for the prevention of paroxysmal supraventricular tachycardias (PSVT), paroxysmal atrial fibrillation/flutter (PAF) associated with disabling symptoms, and documented ventricular arrhythmias. You stated that the active pharmaceutical ingredient (API), Flecainide Acetate is manufactured in Argentina and that the finished Flecainide Acetate Tablets in dosage form is made in China. In China, the Flecainide Acetate will be mixed with various inactive ingredients to produce the final Flecainide Acetate Tablets in dosage form. When determining the country of origin, the substantial transformation analysis is applicable. See, e.g., Headquarters Ruling Letter (“HQ”) H301619, dated November 6, 2018. The test for determining whether a substantial transformation will occur is whether an article emerges from a process with a new name, character, or use different from that possessed by the article prior to processing. See Texas Instruments Inc. v. United States, 681 F.2d 778 (C.C.P.A. 1982). This determination is based on the totality of the evidence. See National Hand Tool Corp. v. United States, 16 C.I.T. 308 (1992), aff’d, 989 F.2d 1201 (Fed. Cir. 1993). In this case, we find the mixing of the active ingredient Flecainide Acetate (made in Argentina) with the inactive ingredients into the final dosage Flecainide Acetate Tablets in China does not result in a substantial transformation and the country of origin will be Argentina. 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