CLA-2-30:OT:RR:NC:N3:138
William Braier
Radix Group International
dba DHL Global Forwarding Cudahy, WI 53110
RE: The tariff classification and country of origin of Difluprednate Ophthalmic Emulsion 0.05%
Dear Mr. Braier:
In your letter dated January 18, 2023, you requested a tariff classification and country of origin determination ruling.
Difluprednate Ophthalmic Emulsion 0.05%, belongs to a group of medicines known as corticosteroids. It is indicated for the treatment of inflammation and pain associated with ocular surgery.
The applicable subheading for the Difluprednate Ophthalmic Emulsion 0.05% in dosage form will be 3004.32.0000 Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Medicaments … consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses … or in forms or packings for retail sale: Other, containing hormones or other products of heading 2937: Containing corticosteroid hormones, their derivatives or structural analogues.” The rate of duty will be free.
Duty rates are provided for your convenience and are subject to change. The text of the most recent HTSUS and the accompanying duty rates are provided at https://hts.usitc.gov/current.
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.
You also requested a country of origin determination. You stated that the active pharmaceutical ingredient (API), Difluprednate, is manufactured in Italy and that the finished product in dosage form is made in India. In India, the Difluprednate will be mixed with various inactive ingredients to produce the final Difluprednate Ophthalmic Emulsion 0.05% in dosage form. You suggest that the country of origin remains Italy, the country in which the API was manufactured.
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 Difluprednate (made in Italy) with the inactive ingredients into the final Difluprednate Ophthalmic Emulsion 0.05 % in dosage form does not result in a substantial transformation and the country of origin will be Italy.
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,
Steven A. Mack
Director
National Commodity Specialist Division