The tariff classification and country of origin marking of Zilretta in dosage form, from Italy

N277890 August 17, 2016 CLA-2-30:OT:RR:NC:N2:238 CATEGORY: Classification; Marking TARIFF NO.: 3004.32.0000 Mr. Jim M. DiTolla Flexion Therapeutics, Inc. 10 Mall Road, Suite 301 Burlington, MA 01803 RE: The tariff classification and country of origin marking of Zilretta in dosage form, from Italy Dear Mr. DiTolla: In your letter dated June 13, 2016 received in this office on July 29, 2016, you requested a tariff classification and country of origin marking ruling. A marked sample was not provided with your letter. The subject product, Zilretta imported in 5 ml vials, is a medicinal preparation containing a mixture of approximately 25 percent Triamcinolone Acetonide (TCA) (CAS 76-25-5), a synthetic glucocorticoid hormone, as the active pharmaceutical ingredient (API) and 75 percent Poly (Lactide-co-Glycolide) (PLGA) (CAS 26780-50-7), a copolymer, as an excipient. In your letter, you stated that Zilretta is a non-opiate based time-released pain medication for the treatment of moderate to severe osteoarthritis (OA) pain, particularly for the knee and other joints following surgery. Currently, this product is undergoing Phase III clinical trials for the management of pain in the knee for patients with moderate OA. The applicable subheading for the Zilretta 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: Containing hormones or other products of heading 2937 but not containing antibiotics: 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 on 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. You stated that the active pharmaceutical ingredient, Triamcinolone Acetonide (TCA) is sourced in Italy and the excipient, Poly (Lactide-co-Glycolide) (PLGA) is sourced from the United States. In a follow-up to this email, you stated that the TCA will be mixed with PLGA in England and then added to the vial together. Afterwards, the finished product, Zilretta in 5 ml vials, will be exported to the United States for final packaging and labeling into a kit which includes diluent and a vial adaptor for sale in the United States. 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 TCA (Italian origin) with the excipient PLGA (U.S. origin) 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 Zilretta or the packages in which it is imported 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. If a U.S. reference appears on the imported Zilretta 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. 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 Acting Director National Commodity Specialist Division