CLA-2-30:OT:RR:NC:N3:138
Rachel Golinsky
Sanofi
1 Discovery Drive Swiftwater, PA 18370
RE: The tariff classification of ELOCTATE® [Antihemophilic factor (recombinant), Fc fusion protein] in dosage form, from the United States
Dear Ms. Golinsky:
In your letter dated June 15, 2023, you requested a tariff classification ruling.
ELOCTATE, [Antihemophilic factor (recombinant), Fc fusion protein], is a recombinant DNA derived, antihemophilic factor indicated in adults and children with Hemophilia A (congenital Factor VIII deficiency) for the on-demand treatment and control of bleeding episodes; perioperative management of bleeding; and routine prophylaxis to reduce the frequency of bleeding episodes. Eloctate is a sterile, non-pyrogenic, white to off-white lyophilized powder for reconstitution for intravenous injection. The product is supplied in single-dose vials containing nominal potencies of 250, 500, 750, 1000, 1500, 2000, 3000, 4000, 5000 or 6000 international units (IU). B-domain deleted recombinant Factor VIII, Fc fusion protein (BDD-rFVIIIFc) is the active ingredient in ELOCTATE. BDD-rFVIIIFc is a recombinant protein consisting of a B-domain deleted analogue of human Coagulation Factor VIII covalently linked to the human immunoglobulin G1 (IgG1) Fc domain sequence. In your letter, you stated that the active bulk drug substance (BDD-rFVIIIFc) is manufactured in the United States but the final manufacturing is completed in Germany.
The applicable subheading for the ELOCTATE, [Antihemophilic factor (recombinant), Fc fusion protein] 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 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 also 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 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