The country of origin of Ketoconazole Shampoo 2%

N353648 October 3, 2025 OT:RR:NC:N3:140 CATEGORY: Origin Prakash Rajendran Viona Pharmaceuticals Inc 20 Commerce Drive, Suite 340 Cranford, NJ 07016 RE: The country of origin of Ketoconazole Shampoo 2% Dear Mr. Rajendran: In your letter dated September 11, 2025, you requested a country of origin ruling The subject product, Ketoconazole Shampoo 2%, is packaged for retail sale in a 4 fluid ounce plastic bottle. It is a red-orange liquid containing the anti-fungal agent ketoconazole in a concentration of two percent. You indicate that it is for the treatment of tinea (pityriasis) versicolor. According to the product label, the shampoo is available by prescription only. In your submission, you state that the manufacturing steps will take place in India. The raw materials used to produce the shampoo will be sourced from various countries including India, Germany, the United States, and the United Kingdom. The ingredients include ketoconazole, cocodiethanolamide, disodium laureth sulfosuccinate, FD&C Red No. 40, imidurea, laurdimonium hydroxy propyl hydrolyzed collagen, PEG-120 methyl glucose dioleate, sodium chloride, sodium lauryl ether sulphate, hydrochloric acid, sodium hydroxide, and water. In India, the raw materials will undergo several mixing steps creating the bulk solution. The solution will then be filled into bottles and packaged. 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). The method of processing in India results in a substantial transformation of the raw materials into the finished shampoo. It is our opinion that the country of origin of the Ketoconazole Shampoo 2% will be India. 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, 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 Merari Ortiz at merari.ortiz@cbp.dhs.gov. Sincerely, (for) Denise Faingar Designated Official Performing the Duties of the Division Director National Commodity Specialist Division