The country of origin of Fluocinolone Acetonide Topical Solution USP, 0.1 % in dosage form

N310206 March 26, 2020 OT:RR:NC:N3:138 CATEGORY: Country of Origin Kamesh G. Venugopal Encube Ethicals, Inc. 200 Meredith Drive Durham, NC 27713 RE: The country of origin of Fluocinolone Acetonide Topical Solution USP, 0.1 % in dosage form Dear Mr. Venugopal: In your letter dated February 27, 2020, on behalf of Encube Ethicals Private Ltd., you requested a country of origin ruling determination on Fluocinolone Acetonide Topical Solution USP, 0.1 %. Fluocinolone Acetonide Topical Solution is a synthetic corticosteroid. It is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses. You indicated that the active pharmaceutical ingredient (API), Fluocinolone Acetonide, is manufactured in Italy and that the finished Fluocinolone Acetonide Topical Solution in dosage form is made in India. In India, the Fluocinolone Acetonide will be mixed with various inactive ingredients to produce the final topical solution 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 Fluocinolone Acetonide (Italian origin) with the inactive ingredients into the final dosage topical solution in India does not result in a substantial transformation and the country of origin will be Italy. You also submitted pictures of labels marked with the country of origin for our review. With regard to the permanency of a marking, section 134.41(a), Customs Regulations (19 CFR 134.41(a)), provides that as a general rule marking requirements are best met by marking worked into the article at the time of manufacture. For example, it is suggested that the country of origin on metal articles be die sunk, molded in, or etched. However, section 134.44, Customs Regulations (19 CFR 134.44), generally provides that any marking that is sufficiently permanent so that it will remain on the article until it reaches the ultimate purchaser unless deliberately removed is acceptable. In order to meet the marking requirements, the Fluocinolone Acetonide Topical Solution USP, 0.1 %, must be conspicuously, legibly and permanently marked with the country of origin in satisfaction of the marking requirements of 19 U.S.C. 1304 and 19 CFR Part 134. Since the solution is incapable of being marked, they are excepted from being marked (19 C.F.R. Section 134.32(a)). Accordingly marking the outer most container “Product of Italy” in which the Fluocinolone Acetonide Topical Solution are imported and sold to the ultimate purchaser is an acceptable country of origin marking. If a U.S. reference appears on the imported Fluocinolone Acetonide Topical Solution USP, 0.1% or the packages when they are imported into the U.S., it is necessary to consider the necessity for additional marking. Section 134.46, Customs Regulations (19 CFR 134.46), deals with cases in which the words “United States,” or “American,” the letters “U.S.A.,” any variation of such words or letters, or the name of any city or locality in the United States, or the name of any foreign country or locality other than the country or locality in which the article was manufactured or produced, appears on an imported article or its container, and those words, letters or names may mislead or deceive the ultimate purchaser as to the actual country of origin. In such a case, there shall appear, legibly and permanently, in close proximity to such words, letters, or name, and in at least a comparable size, the name of the country of origin preceded by “Made in,” Product of,” or other words of similar meaning. The purpose of this requirement is to prevent the possibility of misleading or deceiving the ultimate purchaser of an article as to the actual origin of the imported good. 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 Italy and should be marked “Made in”,” Product of,” or other words of similar meaning with “Italy” as the country of origin. 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 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