CLA-2-30:OT:RR:NC:N3:138
Paul Vroman
DHL Global Forwarding
2660 20th St Port Huron, MI 48060
RE: The tariff classification and country of origin of Treprostinil Injection in dosage form
Dear Mr. Vroman:
In your letter dated August 29, 2024, filed on behalf of Dr. Reddy's Laboratories, Incorporated, you requested a tariff classification and country of origin determination ruling.
Treprostinil Injection, imported in solution vials is a medicinal preparation containing Treprostinil, a synthetic analog of prostacyclin (PGI2), as the active ingredient. It is a prostacyclin vasodilator indicated for the treatment of pulmonary arterial hypertension.
The applicable subheading for the Treprostinil Injection in dosage form will be 3004.39.0050, 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: Other: Other. 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/.
You stated that the active pharmaceutical ingredient (API), Treprostinil, is manufactured in England and that the finished injection solution in dosage form is made in India. In India, the Treprostinil will be mixed with inactive ingredients to produce the final Treprostinil Injection 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, Treprostinil (made in England), with the inactive ingredients into the final injection solution in dosage form in India does not result in a substantial transformation and the country of origin will be England.
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.
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,
Steven A. Mack
Director
National Commodity Specialist Division