CLA-2-30:OT:RR:NC:N3:138
Tanya Hurley
BluePoint Laboratories
8 Eastgate Avenue, Little Island
Cork T45 NF24
Ireland
RE: The tariff classification of Leucovorin Calcium Injection in dosage form, from Switzerland
Dear Ms. Hurley:
In your letter dated March 10, 2025, you requested a tariff classification ruling.
Leucovorin Calcium Injection, imported in 100 mg/10 mL, 200 mg/20 mL, and 350 mg/17.5 mL vials, is a
derivative of folic acid indicated for rescue after high-dose methotrexate therapy in osteosarcoma. It is also
indicated for diminishing the toxicity and counteracting the effects of impaired methotrexate elimination and
of inadvertent overdosages of folic acid antagonists. Leucovorin Calcium is also indicated in the treatment of
megaloblastic anemias due to folic acid deficiency when oral therapy is not feasible.
The applicable subheading for the Leucovorin Calcium Injection in dosage form will be 3004.50.4000,
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, containing vitamins or other products of heading 2936: Containing vitamins
synthesized wholly or in part from aromatic or modified aromatic industrial organic compounds: 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/.
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