CLA-2-30:OT:RR:NC:N1:138
Mr. Sean T. Murray
Miller & Company P.C.
4929 Main Street
Kansas City, MO 64112
RE: The tariff classification of Gammagard Liquid® and Gammagard SD® from an unspecified country
Dear Mr. Murray:
In your letter dated February 23, 2018, on behalf of Shire Pharmaceuticals, you requested a tariff classification ruling. We apologize for the delay as the information was sent to our laboratory for analysis.
The first product, Gammagard Liquid is an immune globulin infusion (human) that is put up in ready-to-use form in a 10% solution for administration into a vein (intravenously) or under the skin (subcutaneously). It is indicated as replacement therapy for primary humoral immunodeficiency (PI) in adult and pediatric patients two years of age and older. It is also indicated as maintenance therapy to improve muscle strength and disability in adult patients with Multifocal Motor Neuropathy (MMN).
The second product, Gammagard S/D Immune Globulin Intravenous (Human) [IGIV] is a sterile, freeze-dried preparation of highly purified immunoglobulin G (IgG) derived from large pools of human plasma that must be reconstituted with Sterile Water for Injection (USP) before being administered intravenously. It is indicated for the treatment of primary immunodeficient states, such as: congenital agammaglobulinemia, common variable immunodeficiency, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies. Gammagard S/D is also indicated for the prevention of bacterial infections in patients with hypogammaglobulinemia, for treating recurrent bacterial infections associated with B-cell Chronic Lymphocytic Leukemia (CLL), to reduce inflammation of the blood vessels to prevent coronary artery aneurisms associated with Kawasaki Syndrome in children, and for rapidly increasing platelet count to prevent or control bleeding in patients with Idiopathic Thrombocytopenic Purpura (ITP).
In your letter, you indicated that both forms of Gammagard use identical active biologic ingredient composed of purified polyclonal antibodies, also referred to as immunoglobulins, purified from human blood. According to our laboratory, Gammagard is composed of purified polyclonal antibodies which are directly involved in the regulation of immunological processes.
The applicable subheading for the Gammagard Liquid and Gammagard S/D will be 3002.15.0000, Harmonized Tariff Schedule of the United States (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.” The general 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.
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 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