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, country of origin and marking of Isosorbide Mononitrate Extended-Release Tablets in dosage form, from Italy
Dear Mr. Braier:
In your letter dated April 2, 2019, on behalf of Ingenus Pharmaceuticals, LLC, you requested a tariff classification ruling.
Isosorbide Mononitrate, imported in 30 mg, 60 mg and 120 mg extended release tablets, is a vasodilator. It is indicated for the prevention of angina pectoris due to coronary disease.
You suggest classification in subheading 3004.49.0010, 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: cardiovascular medicaments.” However, Isosorbide Mononitrate is not an alkaloid and is precluded from this subheading.
The applicable subheading for the Isosorbide Mononitrate Extended-Release Tablets in dosage form will be 3004.90.9220, 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: Other: Other: Cardiovascular medicaments." 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), Isosorbide-5-Mononitrate, is manufactured in Italy. In Italy, Isosorbide Isosorbide-5-Mononitrate is mixed with lactose, a diluent to produce Isosorbide-5- Mononitrate 60% in Lactose. The Isosorbide-5- Mononitrate 60% in Lactose is then shipped to India where it will be mixed with various inactive ingredients to produce the final tablets 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 Isosorbide-5-Mononitrate (Italian origin) with the inactive ingredients into the final dosage tablets in India does not result in a substantial transformation and the country of origin will be Italy.
You also submitted pictures of labels marked with the country of origin for our review.
With regard to the permanency of a marking, section 134.41(a), Customs Regulations (19 CFR 134.41(a)), provides that as a general rule marking requirements are best met by marking worked into the article at the time of manufacture. For example, it is suggested that the country of origin on metal articles be die sunk, molded in, or etched. However, section 134.44, Customs Regulations (19 CFR 134.44), generally provides that any marking that is sufficiently permanent so that it will remain on the article until it reaches the ultimate purchaser unless deliberately removed is acceptable.
In order to meet the marking requirements, the Isosorbide Mononitrate Extended-Release Tablets must be conspicuously, legibly and permanently marked with the country of origin in satisfaction of the marking requirements of 19 U.S.C. 1304 and 19 CFR Part 134. Since the tablets are incapable of being marked, they are excepted from being marked (19 C.F.R. Section 134.32(a)). Accordingly marking the outer most container “Product of Italy” in which the Isosorbide Mononitrate Extended-Release Tablets are imported and sold to the ultimate purchaser is an acceptable country of origin marking.
Based upon the labels provided, the subject product does not appear to be legally marked with the proper country of origin. The label indicates that the product is made in India. However, the country of origin is Italy and should be marked “Made in”,” Product of,” or other words of similar meaning with “Italy” as the country of origin.
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