The country of origin of Selamectin Topical Solution

N337734 February 20, 2024 OT:RR:NC:N3:140 CATEGORY: Origin Pradeep Shah Zydus Pharmaceuticals USA Inc. 73 Route 31 NPennington, NJ 08534 RE:  The country of origin of Selamectin Topical Solution Dear Mr. Shah: In your letter dated January 24, 2024, you requested a country of origin ruling on Selamectin Topical Solution. Selamectin, imported as a topical solution in dosages of 0.25 mL (15 mg), 0.75 mL (45 mg), 1 mL (60 mg), 0.25 mL (30 mg), 0.50 mL (60 mg), 1.0 mL (120 mg), 2.0 mL (240 mg) and 3.0 mL (360 mg), is a topical parasiticide. You state that the active pharmaceutical ingredient (API), Selamectin, is made in China and that the finished topical solution is made in India. In India, the Selamectin will be mixed with inactive ingredients from various countries to produce the final topical solution in dosage form. The "country of origin" is defined in 19 CFR 134.1(b) 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." 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, 69 C.C.P.A. 151 (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 that the mixing of the active ingredient, Selamectin (made in China), with the inactive ingredients in India does not result in a substantial transformation. The country of origin will be China, where the API is made. 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 Merari Ortiz at [email protected]. Sincerely, Steven A. Mack Director National Commodity Specialist Division