Mr. Kamesh G. Venugopal
Encube Ethicals, Inc.
200 Meredith Drive
Durham, NC 27713

RE: The country of origin of Fluocinonide Topical Solution USP, 0.05%

Dear Mr. Venugopal:

In your letter dated November 14, 2022, on behalf of Encube Ethicals Private Limited, you requested a country of origin ruling determination on Fluocinonide Topical Solution USP, 0.05%.

Fluocinonide Topical Solution, imported in 60 mL bottles, is a topical corticosteroid. It is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

You stated that the active pharmaceutical ingredient (API), Fluocinonide, is manufactured in Italy and that the finished topical solution in dosage form is made in India. In India, the Fluocinonide will be mixed with various inactive ingredients to produce the final Fluocinonide 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 Fluocinonide (made in Italy) with the inactive ingredients into the final dosage Fluocinonide Topical Solution in India does not result in a substantial transformation and the country of origin will be Italy.

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. 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 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 [email protected].


Steven A. Mack
National Commodity Specialist Division