CLA-2-30:OT:RR:NC:N3:138

Trish O’ Mahoney
Northstar Healthcare Ltd
3300 Cork Airport Business Park, Kinsale Road
Cork T12XN72, Ireland

RE: The tariff classification of Thiamine Hydrochloride Injection in dosage form, from India

Dear Ms. O’ Mahoney:

In your letter dated April 10, 2025, you requested a tariff classification ruling.

Thiamine Hydrochloride Injection, imported in 200 mg/2 mL (100 mg/mL) vials, is also known as vitamin B1. It is indicated for the treatment of thiamine deficiency or beriberi whether of the dry (major symptoms related to the nervous system) or wet (major symptoms related to the cardiovascular system) variety.

The applicable subheading for the Thiamine Hydrochloride Injection in dosage form will be 3004.50.5020, 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: Other: Other: Single vitamins: Other.” The rate of duty will be free.

Effective April 5, 2025, Executive Orders implemented “Reciprocal Tariffs.” All imported merchandise must be reported with either the Chapter 99 provision under which the reciprocal tariff applies or one of the Chapter 99 provisions covering exceptions to the reciprocal tariffs. Products of China, including Hong Kong and Macau, will be assessed an additional ad valorem rate of duty of 125 percent. Products from all other countries will be subject to an additional 10 percent ad valorem rate of duty. Your product falls within an excepted subheading. At the time of entry, you must report the Chapter 99 heading applicable to your product classification, i.e. 9903.01.32, in addition to subheading 3004.50.5020, HTSUS, listed above.

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