The tariff classification of Solriamfetol (CAS No. 178429-62-4) in bulk powder form, from Italy

N300527 October 1, 2018 CLA-2-29:OT:RR:NC:N1:138 CATEGORY: Classification TARIFF NO.: 2924.29.6250 Ms. Sheila Heerdt Ren Pharm International Ltd. 350 Jericho Turnpike, Suite 204 Jericho, NY 11753 RE: The tariff classification of Solriamfetol (CAS No. 178429-62-4) in bulk powder form, from Italy Dear Ms. Heerdt In your letter dated, September 11, 2018, you requested a tariff classification ruling. Solriamfetol is a selective dopamine and norepinephrine reuptake inhibitor with wake-promoting effects. It is currently in phase III clinical trials for the treatment of excessive sleepiness associated with narcolepsy and sleep apnea (OSA). The applicable subheading for the Solriamfetol in bulk form will be 2924.29.6250, Harmonized Tariff Schedule of the United States (HTSUS), which provides for "Carboxyamide-function compounds; amide-function compounds of carbonic acid: Cyclic amides (including cyclic carbamates) and their derivatives; salts thereof: Other: Aromatic: Other: Drugs: Other: Other." The rate of duty will be 6.5 percent ad valorem. Currently, Solriamfetol is not listed in the Pharmaceutical Appendix to the Tarriff Schedule. 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