OT:RR:NC:N3:138
Prakash Rajendran
Viona Pharmaceuticals, Inc.
20 Commerce Drive, Suite 340
Cranford, NJ 07016
RE: The country of origin of Nystatin and Triamcinolone Acetonide Ointment, USP
Dear Mr. Rajendran:
In your letter dated June 25, 2025, you requested a country of origin ruling on Nystatin and Triamcinolone
Acetonide Ointment.
Nystatin and Triamcinolone Acetonide Ointment is a medicinal preparation containing Nystatin (antifungal)
and Triamcinolone Acetonide (synthetic corticosteroid), as the active ingredients. It is indicated for the
topical treatment of cutaneous candidiasis (yeast infection of the skin).
In your letter, you stated Nystatin and Triamcinolone Acetonide Ointment contains two active
pharmaceutical ingredients (APIs). The Nystatin is made in Italy and the Triamcinolone Acetonide is made in
India. In India these two APIs will be mixed with inactive ingredients to produce the final topical o intment 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 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 does not result in a
substantial transformation of the product. See, e.g., Headquarters Ruling (“HQ”) 561975, dated April 3,
2002; HQ 561544, dated May 1, 2000; HQ 735146, dated November 15, 1993; HQ H267177, dated
November 5, 2016; HQ H233356, dated December 26, 2012; and, HQ 561975, dated April 3, 2002.
However, where the processing from bulk form into measured doses involves the combination of two or more
APIs, and the resulting combination offers additional medicinal benefits compared to taking each API alone,
CBP has held that a substantial transformation occurred. See, e.g., HQ 563207, dated June 1, 2005.
In this instance we note that the two APIs serve different purposes. Here, as in HQ 563207, two separate
APIs are mixed to create a fixed combination drug that offers additional medicinal benefits compared to
taking each API alone. Nystatin, an antifungal, eliminates the yeast and clears the infection, while the
anti-inflammatory action of Triamcinolone Acetonide, a corticosteroid, reduces inflammation, itching, and
redness associated with the infection.
In this case, we find the mixing of the active ingredients Nystatin (made in Italy) and Triamcinolone A
cetonide (made in India) with the inactive ingredients into the final topical ointment in dosage form in India
results in a substantial transformation and the country of origin will be 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).
The holding set forth above applies only to the specific factual situation and merchandise description as
identified in the ruling request. This position is clearly set forth in Title 19, Code of Federal Regulations
(CFR), Section 177.9(b)(1). This section states that a ruling letter is issued on the assumption that all of the
information furnished in the ruling letter, whether directly, by reference, or by implication, is accurate and
complete in every material respect. In the event that the facts are modified in any way, or if the goods do not
conform to these facts at time of importation, you should bring this to the attention of U.S. Customs and
Border Protection (CBP) and submit a request for a new ruling in accordance with 19 CFR 177.2.
Additionally, we note that the material facts described in the foregoing ruling may be subject to periodic
verification by CBP.
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 [email protected].
Sincerely,
(for)
James Forkan
Acting Director
National Commodity Specialist Division