OT:RR:NC:N3:138
Ms. Kelly O’Toole
Viona Pharmaceuticals, Inc.
20 Commerce Drive
Cranford, NJ 07016
RE: The country of origin of Diclofenac Sodium Topical Solution 1.5% and Nystatin Ointment USP in dosage form
Dear Ms. O’Toole:
In your letter dated June 10, 2020, you requested a country of origin ruling determination on Diclofenac Sodium Topical Solution 1.5% and Nystatin Ointment USP.
The first product, Diclofenac Sodium Topical Solution 1.5%, is a topical nonsteroidal anti-inflammatory drug (NSAID). It is indicated for the treatment of pain and inflammation associated with osteoarthritis, rheumatoid arthritis, ankylosing spondylitis and inflammation due to surgery or physical trauma.
The second product, Nystatin Ointment USP, is an antifungal medication indicated for the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida.
For the first product, you stated that the active pharmaceutical ingredient (API), Diclofenac Sodium, is manufactured in Italy and that the finished topical solution in dosage form is made in India. In India, the Diclofenac Sodium will be mixed with various inactive ingredients to produce the final topical solution in dosage form.
For the second product, you stated that the active pharmaceutical ingredient (API), Nystatin, is manufactured in Italy and that the finished ointment in dosage form is made in India. In India, the Nystatin will be mixed with various inactive ingredients to produce the final ointment 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 the case of the first product, we find the mixing of the active ingredient Diclofenac Sodium (made in Italy) 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.
In the case of the second product, we find the mixing of the active ingredient Nystatin (made in Italy) with the inactive ingredients into the final dosage ointment in India does not result in a substantial transformation and the country of origin will be Italy.
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].
Sincerely,
Steven A. Mack
Director
National Commodity Specialist Division