CLA-2-29:OT:RR:NC:N1:138

Ms. Sheila Heerdt
Ren Pharm International Ltd.
350 Jericho Turnpike, Suite 204
Jericho, NY 11753

RE: The tariff classification of Gabapentin (CAS No. 60142-96-3) in bulk powder form, from Italy

Dear Ms. Heerdt:

In your letter dated June 11, 2018, you requested a tariff classification ruling.

Gabapentin is an anticonvulsant and amyotrophic lateral sclerosis agent. It is indicated for the treatment of postherpetic neuralgia in adults and as adjunctive therapy in the treatment of partial seizures in patients over 12 years of age with epilepsy.

The applicable subheading for the Gabapentin in bulk form will be 2922.49.4950, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Oxygen-function amino-acid compounds: Amino-acids, other than those containing more than one kind of oxygen function, and their esters; salts thereof: Other: Amino acids: Other amino acids: 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