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

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

RE: The tariff classification of Topiramate Extended-Release Capsules in dosage form, from India

Dear Ms. Glenny Avila:

In your letter dated October 25, 2022, you requested a tariff classification ruling.

Topiramate, imported in 25 mg, 50 mg, 100 mg, 150 mg, and 200 mg extended-release capsules is an anticonvulsant drug. It is used in the control of epilepsy and in the prophylaxis and treatment of migraines.

The applicable subheading for Topiramate Extended-Release Capsules in dosage form will be 3004.90.9230, 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: Medicaments primarily affecting the central nervous system: Anticonvulsants, hypnotics and sedatives.” 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