CLA-2-29:OT:RR:NC:N3:138

Mr. Matthew A. Clark
Kuehne+Nagel Inc.
1001 Busse Road
Elk Grove Village, IL 60007

RE: The tariff classification of Tolperisone Hydrochloride (CAS No. 3644-61-9) in bulk form, from Mexico and Austria

Dear Mr. Clark:

In your letter dated October 30, 2021, on behalf of Nuerana Pharmaceuticals, Inc., you requested a tariff classification ruling.

Tolperisone Hydrochloride is a muscle relaxant used for the symptomatic treatment of spasticity and painful muscle movements. It will be imported in bulk form and used in the manufacture of a finished drug product for the treatment of painful muscle spasms.

You point out that Tolperisone Hydrochloride is a ketone, and you recommend classification in subheading 2914.39.9000, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Ketones and quinones, whether or not with other oxygen function, and their halogenated, sulfonated, nitrated, or nitrosated derivatives: Aromatic ketones without other oxygen function: Other: Other.” Based on the chemical structure of the subject compound, Tolperisone Hydrochloride also contains a hydrogenated pyridine ring which is provided for in heading 2933, HTSUS. Therefore, pursuant to note 3 to Chapter 29, HTSUS, Tolperisone Hydrochloride is classified in the provision shown below.

The applicable subheading for the Tolperisone Hydrochloride in bulk form will be 2933.39.4100, HTSUS, which provides for “Heterocyclic compounds with nitrogen hetero-atom(s) only: Compounds containing an unfused pyridine ring (whether or not hydrogenated) in the structure: Other: Other: Drugs: Other.” Pursuant to General Note 13, HTSUS, 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 on the World Wide Web 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 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 [email protected].

Sincerely,

Steven A. Mack
Director
National Commodity Specialist Division