The tariff classification and country of origin of Quetiapine Fumarate Extended Release Tablets in dosage form, from Italy

N298302 July 23, 2018 CLA-2-30:OT:RR:NC:N1:138 CATEGORY: Classification; Marking TARIFF NO.: 3004.90.9235 Mr. 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 Quetiapine Fumarate Extended Release Tablets in dosage form, from Italy Dear Mr. Braier: In your letter dated June 25, 2018, on behalf of Ingenus Pharmaceuticals, LLC, you requested a tariff classification ruling. The subject product, Quetiapine Fumarate Tablets, is a medicinal preparation in tablet form containing Quetiapine Fumarate (CAS No. 111974-72-2), a dibenzothiazepine derivative, as the active ingredient. In your letter, you indicated that it will be imported in various doses ranging from 25 mg to 400 mg tablets. It is indicated for the treatment of schizophrenia, acute manic or depressive episodes associated with bi-polar disorder. The applicable subheading for the Quetiapine Fumarate Extended Release Tablets in dosage form will be 3004.90.9235, 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: Other: Other: Medicaments primarily affecting the central nervous system: Antidepressants, tranquilizers, and other psychotherapeutic agents." 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 inquired about the country of origin marking requirements and have provided pictures of the labels with the country of origin marking. You stated that the active pharmaceutical ingredient (API), Quetiapine Fumarate is manufactured in Italy and the finished tablets in dosage form are made in China. In China, Quetiapine Fumarate will be mixed with various inactive ingredients to produce the final extended release tablets in dosage form. You suggest that the country of origin remains Italy, the country from where the API was manufactured. The marking statute, section 304 Tariff Act of 1930, as amended (19 U.S.C. 1304), provides that, unless excepted, every article of foreign origin (or its container) imported into the U.S. shall be marked in a conspicuous place as legibly, indelibly and permanently as the nature of the article (or its container) will permit, in such a manner as to indicate to the ultimate purchaser in the United States the English name of the country of origin of the article. Part 134, Customs Regulations (19 CFR Part 134) implements the country or origin marking requirements and exceptions of 19 U.S.C. 1304. 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 Quetiapine Fumarate (Italian origin) with the inactive ingredients into the final extended release tablets does not result in a substantial transformation and the country of origin will be Italy. 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 Quetiapine Fumarate 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 Quetiapine Fumarate Tablets are imported and sold to the ultimate purchaser is an acceptable country of origin marking. If a U.S. reference appears on the imported Quetiapine Fumarate Tablets or the packages when they are imported into the U.S., it is necessary to consider the necessity for additional marking. Section 134.46, Customs Regulations (19 CFR 134.46), deals with cases in which the words “United States,” or “American,” the letters “U.S.A.,” any variation of such words or letters, or the name of any city or locality in the United States, or the name of any foreign country or locality other than the country or locality in which the article was manufactured or produced, appears on an imported article or its container, and those words, letters or names may mislead or deceive the ultimate purchaser as to the actual country of origin. In such a case, there shall appear, legibly and permanently, in close proximity to such words, letters, or name, and in at least a comparable size, the name of the country of origin preceded by “Made in,” Product of,” or other words of similar meaning. The purpose of this requirement is to prevent the possibility of misleading or deceiving the ultimate purchaser of an article as to the actual origin of the imported good. 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 manufactured in China. 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 judy.h.lee@cbp.dhs.gov. Sincerely, Steven A. Mack Director National Commodity Specialist Division