CLA-2-30:OT:RR:NC:N2:238
Mr. Mark Pinchok
Bayer International Trade
Services Corporation
651 Colliers Way, Suite 414
Weirton, WV 26062
RE: The tariff classification of Betaseron® (interferon beta-1b) injectable in dosage form, from Germany
Dear Mr. Pinchok:
In your letter dated June 10, 2013, you requested a tariff classification ruling on behalf of Bayer HealthCare Pharmaceuticals Inc.
The subject product, Betaseron® (interferon beta-1b), is a purified, sterile, lyophilized protein produced by recombinant DNA techniques. Interferon beta-1b is manufactured by bacterial fermentation of a strain of Escherichia coli that bears a genetically engineered plasmid containing the gene for human interferon betaser17. It is indicated for the treatment of relapsing forms of multiple sclerosis to reduce the frequency of clinical exacerbations. It will be imported in disposable syringes and administered to patients by subcutaneous injections.
The applicable subheading for the Betaseron® (interferon beta-1b) injectable in dosage form will be 3002.02.1090, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Human blood; animal blood prepared for therapeutic, prophylactic or diagnostic uses; antisera, other blood fractions and immunological products, whether or not modified or obtained by means of biotechnological processes; vaccines, toxins, cultures of micro-organisms (excluding yeasts) and similar products: Antisera, other blood fractions and immunological products, whether or not obtained by means of biotechnological processes: Other.” The rate of duty will be free.
In your letter, you suggest classification in subheading 3004.90.9140, 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: Medicaments primarily affecting the central nervous system: Other.” However, pursuant to Chapter 30 Note 2, Betaseron® (interferon beta-1b) injectable, is an immunological product that is classifiable in heading 3002 and therefore it is excluded from heading 3004 by the heading language which states “Medicaments (excluding goods of heading 3002, 3005 or 3006) consisting of mixed or unmixed products for therapeutic or prophylactic uses....”
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 http://www.usitc.gov/tata/hts/.
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 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 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 (646) 733-3033.
Sincerely,
Thomas J. Russo
Director
National Commodity Specialist Division