CLA-2-30:OT:RR:NC:N2:238
Mr. Sean T. Murray
Miller & Company P.C.
4929 Main Street
Kansas City, MO 64112
RE: The tariff classification of Advate®, Obizur® and Vonvendi® imported in dosage form
Dear Mr. Murray:
In your letter dated February 16, 2017, on behalf of Shire, you requested a tariff classification ruling.
The first product, Advate®, contains human recombinant Antihemophilic Factor VIII, as the active ingredient. It is indicated for the treatment of hemophilia A (congenital factor VIII deficiency) in children and adults. Specifically, it is used to replace clotting factor VIII that is missing in people with hemophilia A. Advate is available in dosage form as a lyophilized powder put up in vials that must be reconstituted with sterile water before administration by intravenous injection.
The second product, Obizur®, contains Antihemophilic Factor VIII – recombinant (Porcine Analogue (rpFVIII), as the active ingredient. It is indicated for the treatment of bleeding episodes in adults with acquired Hemophilia A. Like Advate, Obizur works by temporarily raising levels of Antihemophilic Factor VIII in the blood to aid in clotting except Obizur contains recombinant porcine (pig) Factor VIII instead of recombinant human factor VIII. Obizur is available in dosage form as a lyophilized powder and put up in single-use vials.
The last product, Vonvendi®, contains recombinant human von Willebrand Factor (rVWF), as the active ingredient. It is indicated for the treatment and control of bleeding in adults with von Willebrand Disease, an inherited bleeding disorder due to deficiency or defect in von Willebrand Factor which is a critical protein for normal blood clotting. Vonvendi is available as a lyophilized powder in single-use vials in two different dosage strengths and must be reconstituted with sterile water for administration by intravenous injection.
The applicable subheading for Advate®, Obizur® and Vonvendi® vials in dosage form will be 3002.12.0090, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Antisera, other blood fractions and immunological products, whether or not modified or obtained by means of biotechnological processes: Antisera and other blood fractions: 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 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.
This merchandise may be subject to the rules and regulations of the U.S. Department of Health and Human Services, Centers for Disease Control and Prevention. You may contact them at 1600 Clifton Road, Atlanta, GA 30333, telephone number (404) 633-5313 or (800) CDC-INFO, or at the Web address [email protected].
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