The tariff classification of clinical trial kits from the United States

N331005 March 7, 2023 CLA-2-30:OT:RR:NC:N3:138 CATEGORY: Classification TARIFF NO.: 3002.15.0091; 3004.90.9209 Joseph Issa Merck & Co 2000 Galloping Hill RoadKenilworth, NJ 07033United States RE: The tariff classification of clinical trial kits from the United States Dear Mr. Issa: In your letter dated February 15, 2023, you requested a tariff classification ruling.  Both products will be imported from Ireland. The first product, MK-5592 clinical trial kit contains Noxafil, a brand name antifungal medication containing Posaconazole, as the active pharmaceutical ingredient (API).  The MK-5592 clinical trial kit contains the following items: 1) 300 mg PFS Sachet of Posaconazole (CAS-171228-49-2) 2) Ora-Blend SF 3) 28 mm Press In Bottle Adapter Wrapped 4) Oraldisp 3 mL Non-Ster Notch Green Plunge 5) Oral Disp 10 mL Non-Ster Blue Plunge 6) Cup Round 7/8 oz Nonsterile Hingelid The second product, MK-7962 clinical trial kit contains the API, Sotatercept, which is a potential first-in-class activin receptor type IIA-Fc (ActRIIA-Fc) fusion protein in development for the treatment of adult patients with pulmonary arterial hypertension.  The MK-7962 clinical trial kit contains the following items: 1) 60 mg vial lyophilized Sotatercept (CAS-1001080-50-7) 2) Pre-filled Syringe of Sterile Water for Injection 3) General Purpose 3 mL Syringe with Luerlock tip, 0.1 mL graduations 4) PrecisionGlide needle without Safety, 27 Gauge ½" length, Luer 5) West Pharmaceutical Swabable Vial Adapter Device-Medimop 6) Sterile Alcohol Prep Pads-Medium sized 70% lsopropyl alcohol (one for vial top, one for vial adapter, one for patient injection site) In your letter, you state these open label clinical trial kits are convenience kits and contain in addition to an active pharmaceutical ingredient, a set of ancillary supplies used by the patient for medicament preparation and delivery. You suggest that the clinical trial kits are sets and the component that imparts the essential character to the set is the API in the clinical trial kits.  Accordingly, we find the MK-5592 and MK-7962 clinical trial kits imported into the United States are sets pursuant to GRI 3(b) and both sets will be classified according to the API that imparts the essential character of the set. The applicable subheading for the MK-5592 clinical trial kit will be 3004.90.9209, 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: Anti-infective medicaments: Antifungals.”  The rate of duty will be free. The applicable subheading for the MK-7962 clinical trial kit will be 3002.15.0091, HTSUS, which provides for “Antisera, other blood fractions and immunological products, whether or not obtained by means of biotechnological processes: Immunological products, put up in measured doses or in forms or packings for retail sale: 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/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. 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