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

Carol Glenny Avila
NorthStar Healthcare UC
3300 Cork Airport Business Park, Kinsale Road Cork T12 XN72 Ireland

RE: The tariff classification of Labetalol Hydrochloride Injection in dosage form, from Italy

Dear Ms. Glenny Avila:

In your letter dated March 30, 2023, you requested a tariff classification ruling.

Labetalol Hydrochloride Injection, imported in 5 mg/mL vials, is an adrenergic receptor blocking agent.  It is indicated for control of blood pressure in severe hypertension.

The applicable subheading for the Labetalol Hydrochloride Injection in dosage form will be 3004.90.9220, 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: Cardiovascular medicaments.” 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.

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