CLA-2-30:OT:RR:NC:N3:138
William Gerard Braier
Radix Group International
Dba DHL Global Forwarding
6120 Ace Industrial Drive
Cudahy, WI 53110
RE: The tariff classification and country of origin of Naloxone Hydrochloride Injection USP 2 mg/2 mL (1 mg/mL), in dosage form
Dear Mr. Braier:
In your letter dated June 3, 2020, on behalf of Dr. Reddy’s Laboratories Incorporated, you requested a tariff classification and country of origin ruling.
Naloxone Hydrochloride Injection, imported in 2 mg/2 mL (1 mg/mL), is a synthetic morphinane alkaloid belonging to a class of drugs known as opioid antagonists. It is used to block the effects of opioids and works by reversing the depression of the central nervous system and respiratory system caused by opioids.
The applicable subheading for the Naloxone Hydrochloride Injection in dosage form will be 3004.49.0040, 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 alkaloids or derivatives thereof: Other: Other: Medicaments primarily affecting the central nervous system: 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 on the World Wide Web 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), Naloxone Hydrochloride, is manufactured in England and that the finished injection in dosage form is made in India. In India, the Naloxone Hydrochloride will be mixed with various inactive ingredients and processed into the final injection 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 processing of the active ingredient Naloxone Hydrochloride (made in England) with the inactive ingredients into the final injection form in India does not result in a substantial transformation and the country of origin will be England.
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