The country of origin of Potassium Chloride Extended-Release (ER) Tablets USP

N324085 February 24, 2022 CLA-2:OT:RR:NC:N3:138 CATEGORY: Country of Origin Mr. Vamsi Nama Granules Pharmaceuticals Inc. 3701 & 3725 Concorde Parkway Aldie, VA 20151 RE: The country of origin of Potassium Chloride Extended-Release (ER) Tablets USP Dear Mr. Nama: In your letter dated January 31, 2022, you requested a country of origin ruling determination on Potassium Chloride Extended-Release Tablets.Potassium Chloride, imported in 10 mEq and 20 mEq extended-release tablets, is a medicinal preparation containing Potassium Chloride, as the active ingredient. It is indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis. You stated that the active pharmaceutical ingredient (API), Potassium Chloride is manufactured in the United States and that the finished tablets in dosage form are made in India. In India, the Potassium Chloride will be mixed with various inactive ingredients to produce the final tablets in dosage form. Section 134.1(b), Customs Regulations (19 CFR 134.1(b)), defines "country of origin" as: The country of manufacture, production, or growth of any article of foreign origin entering the United States. Further work or material added to an article in another country must effect a substantial transformation in order to render such other country the "country of origin" within the meaning of this part; …. A substantial transformation occurs when an article emerges from a process with a new name, character or use different from that possessed by the article prior to processing. A substantial transformation will not result from a minor manufacturing or combining process that leaves the identity of the article intact. See United States v. Gibson-Thomsen Co., 27 C.C.P.A. 267 (1940); and National Juice Products Association v. United States, 628 F. Supp. 978 (Ct. Int’l Trade 1986). In this case, we find the mixing of the active ingredient Potassium Chloride (made in the United States) with the inactive ingredients into the final dosage tablets in India does not result in a substantial transformation and the country of origin will be the United States. 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 judy.h.lee@cbp.dhs.gov. Sincerely, Steven A. Mack Director National Commodity Specialist Division