The country of origin of Adapalene Gel USP 0.3%

N333892 July 28, 2023 OT:RR:NC:N3:138 CATEGORY: Origin Kamesh Venugopal Encube Ethicals, Inc. 200 Meredith DriveDurham, NC 27713 RE:  The country of origin of Adapalene Gel USP 0.3% Dear Mr. Venugopal: In your letter dated July 10, 2023, on behalf of Encube Ethicals Private Limited, you requested a country of origin ruling on Adapalene Gel USP 0.3%. Adapalene Gel USP 0.3%, imported in 45 grams tubes, is a topical retinoid. It is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older. You indicated that the active pharmaceutical ingredient (API), Adapalene, is manufactured in Spain and that the finished Adapalene Gel 0.3% in dosage form is made in India.  In India, the Adapalene will be mixed with various inactive ingredients to produce the final Adapalene 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 Adapalene (made in Spain) with the inactive ingredients into the final Adapalene Gel 0.3% in dosage form does not result in a substantial transformation and the country of origin will be Spain. Based upon the labels provided, the subject product does not appear to be legally marked with the proper country of origin. The labels state the product is manufactured in India and distributed in the United States. However, the country of origin is Spain where the API is made and should be marked “Made in,” “Product of,” or other words of similar meaning with “Spain” as the country of origin. It is also acceptable to mark the product with Adapalene Gel as “Made in Spain, formulated in 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, 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 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 Judy Lee at judy.h.lee@cbp.dhs.gov. Sincerely, Steven A. Mack Director National Commodity Specialist Division