CLA-2-30:OT:RR:NC:N3:138
Terri Fetters
Cordavis
2 Dublin Landings, North Wall Quay
Dublin D01 V4A3
Ireland
RE: The tariff classification of Hyrimoz® (adalimumab-adaz) Injection in dosage form, from Austria
Dear Ms. Fetters:
In your letter dated October 2, 2023, you requested a tariff classification ruling.
Hyrimoz® (adalimumab-adaz) Injection is a monoclonal anti-tumor necrosis factor alpha antibody. It is used in the treatment of a wide variety of inflammatory conditions such as rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis and plaque psoriasis. Hyrimoz® (adalimumab-adaz) Injection will be available in single-dose prefilled pens (40 mg/0.8 mL and 40 mg/0.4 mL) and single-dose prefilled syringes with needle guard (40 mg/0.8 mL and 40 mg/0.4 mL).
The applicable subheading for the Hyrimoz® (adalimumab-adaz) Injection in dosage form will be 3002.15.0011, 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: Immunological products, put up in measured doses or in forms or packings for retail sale: Containing monoclonal antibodies.” 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.
The holding set forth above applies only to the specific factual situation and merchandise description as identified in the ruling request. This position is clearly set forth in Title 19, Code of Federal Regulations (CFR), Section 177.9(b)(1). This section states that a ruling letter is issued on the assumption that all of the information furnished in the ruling letter, whether directly, by reference, or by implication, is accurate and complete in every material respect. In the event that the facts are modified in any way, or if the goods do not conform to these facts at time of importation, you should bring this to the attention of U.S. Customs and Border Protection (CBP) and submit a request for a new ruling in accordance with 19 CFR 177.2. Additionally, we note that the material facts described in the foregoing ruling may be subject to periodic verification by CBP.
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