The country of origin of Testosterone Gel 1% in dosage form

N324647 March 31, 2022 CLA-2:OT:RR:NC:N3:138 CATEGORY: Country of Origin Mr. Kamesh G. Venugopal Encube Ethicals, Inc. 200 Meredith Drive Durham, NC 27713 RE: The country of origin of Testosterone Gel 1% in dosage form Dear Mr. Venugopal: In your letter dated March 5, 2022, on behalf of Encube Ethicals Private Limited, you requested a country of origin ruling determination on Testosterone Gel 1%. Testosterone Gel 1% is indicated for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone. It will be imported in 30-unit dose packets containing 50 mg of testosterone in 5 grams of gel per unit dose. You stated that the active pharmaceutical ingredient (API), Testosterone, is manufactured in the United States and that the finished gel in dosage form is made in Germany. In Germany, the Testosterone will be mixed with various inactive ingredients to produce the final gel 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 Testosterone (made in the United States) with the inactive ingredients into the final gel in Germany does not result in a substantial transformation and the country of origin will be the United States. You provided pictures of labels for our review. The labels indicate the product is manufactured in Germany, which appears to be incorrect since the country of origin is the United States. Goods determined to be an article of U.S. origin are not subject to the country of origin marking requirements of 19 U.S.C. §1304. Whether an article may be marked with the phrase “Made in the USA” or similar words denoting U.S. origin, is an issue under the authority of the Federal Trade Commission (FTC). Consequently, any inquiries regarding the use of such phrases reflecting U.S. origin should be directed to the FTC, at the following address: Federal Trade Commission, 600 Pennsylvania Avenue, NW, Washington, D.C. 20580. 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 merchandise may also be subject to the Controlled Substances Act, which is administered by the U.S. Drug Enforcement Administration (DEA), Office of Diversion Control. Information on the Controlled Substances Act can be obtained by contacting the DEA at (800) 882-9539, or by visiting their website at www.dea.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