CLA-2-29:OT:RR:NC:N2:238

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

RE: The tariff classification of Tasimelteon (CAS No. 609799-22-6) in bulk powder form, from Italy

Dear Ms. Heerdt:

In your letter dated April 19, 2017, you requested a tariff classification ruling. We apologize for the delay as the information was sent to our laboratory for analysis.

Tasimelteon is a selective agonist for the melatonin receptors MT1 and MT2. It is indicated for the treatment of non-24-hour sleep/wake disorder.

The applicable subheading for the Tasimelteon in bulk form will be 2937.90.9000, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Hormones, prostaglandins, thromboxanes and leukotrienes, natural or reproduced by synthesis; derivatives and structural analogues thereof, including chain modified polypeptides, used primarily as hormones: Other: Other.” 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 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