The country of origin of Testosterone Gel, 1.62% in dosage form

N356159 December 11, 2025CLA-2:OT:RR:NC:N3:138 CATEGORY: OriginKamesh VenugopalEncube Ethicals, Inc.200 Meredith DriveDurham, NC 27713RE: The country of origin of Testosterone Gel, 1.62% in dosage formDear Mr. Venugopal:In your letter dated November 18, 2025 , you requested a country of origin ruling on Testosterone Gel, 1.62%.Testosterone Gel 1.62% is indicated for replacement therapy in adult males for conditions associated with adeficiency or absence of endogenous testosterone. It will be imported in net quantity of 88 grams in ametered-dose pump.You stated that the active pharmaceutical ingredient (API), Testosterone USP, is manufactured in the UnitedStates and that the finished gel in dosage form is made in India. In India, the Testosterone will be mixed withvarious inactive ingredients to produce the final Testosterone Gel, 1.62% 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 asubstantial 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 Testosterone (made in the United States) with theinactive ingredients into the final dosage Testosterone Gel, 1.62% in India does not result in a substantialtransformation 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 ,Indiawhich appears to be incorrect since the country of origin is the United States. Goods determined to be anarticle 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 inquiriesregarding the use of such phrases reflecting U.S. origin should be directed to the FTC, at the followingaddress: 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 byvisiting their website at .www.fda.govThis 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 ControlledSubstances Act can be obtained by contacting the DEA at (800) 882-9539, or by visiting their website at .www.dea.govThe holding set forth above applies only to the specific factual situation and merchandise description asidentified 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 theinformation furnished in the ruling letter, whether directly, by reference, or by implication, is accurate andcomplete in every material respect. In the event that the facts are modified in any way, or if the goods do notconform to these facts at time of importation, you should bring this to the attention of U.S. Customs andBorder 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 periodicverification by CBP.This ruling is being issued under the provisions of Part 177 of the Customs and Border ProtectionRegulations (19 C.F.R. 177).A copy of the ruling or the control number indicated above should be provided with the entry documentsfiled at the time this merchandise is imported. If you have any questions regarding the ruling, please contactNational Import Specialist Judy Lee at judy.h.lee@cbp.dhs.gov. Sincerely, (for)Deborah MarinucciDesignated Official Performing the Duties of the Division DirectorNational Commodity Specialist Division