The country of origin of VTAMA® (Tapinarof) cream

N334470 August 31, 2023 OT:RR:NC:N3:138 CATEGORY: Origin Michael Taylor King & Spalding LLP 1700 Pennsylvania Ave NW, Suite 900 Washington, DC 20006 RE: The country of origin of VTAMA® (Tapinarof) cream Dear Mr. Taylor: In your letter dated August 4, 2023, on behalf of Dermavant Sciences, Inc., you requested a country of origin ruling on VTAMA® (Tapinarof) cream. VTAMA® (Tapinarof) cream, 1% is a medicinal preparation containing Tapinarof, an aryl hydrocarbon receptor agonist, as the active ingredient. It is indicated for use as a once-daily, steroid-free topical cream for the treatment of plaque psoriasis and atopic dermatitis. You requested a country of origin determination. You stated that the active pharmaceutical ingredient (API), Tapinarof, is manufactured in Ireland and the finished topical cream is made in the United Kingdom. In the United Kingdom, the Tapinarof will be mixed with various inactive ingredients and processed into the final VTAMA topical cream. 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). You claim that the addition of the inactive ingredients and the manufacturing processing in the United Kingdom substantially transforms the Tapinarof into the VTAMA cream and the country of origin should be the United Kingdom. We disagree. In determining whether a substantial transformation occurs in the manufacture of chemical products such as pharmaceuticals, CBP has consistently examined the complexity of the processing, and whether the final article retains the essential identity and character of the raw material. To that end, CBP has generally held that the processing of pharmaceutical products from bulk form into measured doses, filtering and packaging does not result in a substantial transformation. See Headquarters Ruling Letter (HQ) H215656, dated January 11, 2013; HQ H197582, dated August 9, 2012; HQ H073995, dated October 29, 2009; HQ 561975, dated April 3, 2002; and HQ 561544, dated May 1, 2000. In this case, we find the mixing and processing of the active pharmaceutical ingredient Tapinarof (made in Ireland) with the inactive ingredients into the final dosage cream in the United Kingdom does not result in a substantial transformation and the country of origin will be Ireland. 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