Mr. Kamesh G. Venugopal
Encube Ethicals, Inc.
200 Meredith Drive
Durham, NC 27713
RE: The country of origin of Hydrocortisone Valerate Cream USP 0.2%
Dear Mr. Venugopal:
In your letter dated November 8, 2022, on behalf of Encube Ethicals Private Limited, you requested a country of origin ruling determination on Hydrocortisone Valerate Cream USP 0.2%.
Hydrocortisone Valerate Cream USP 0.2%, imported in 15 grams, 45 grams and 60 grams, is a synthetic corticosteroid for topical dermatologic use. It is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses in adult patients.
You stated that the active pharmaceutical ingredient (API), Hydrocortisone Valerate, is manufactured in France and that the finished cream in dosage form is made in India. In India, the Hydrocortisone Valerate will be mixed with various inactive ingredients to produce the final cream 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 Hydrocortisone Valerate (made in France) with the inactive ingredients into the final dosage cream in India does not result in a substantial transformation and the country of origin will be France.
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 France where the API is made and should be marked "Made in," "Product of," or other words of similar meaning with "France" as the country of origin. It is also acceptable to mark the product with Hydrocortisone Valerate as "Made in France, 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 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