The tariff classification of Esketamine (CAS No. 33643-46-8) in bulk powder form, from Brazil

N318342 April 12, 2021 CLA-2-29:OT:RR:NC:N3:138 CATEGORY: Classification TARIFF NO.: 2922.39.2500 Ms. Sheila Heerdt Ren Pharm International Ltd. 350 Jericho Turnpike, Suite 204 Jericho, NY 11753 RE: The tariff classification of Esketamine (CAS No. 33643-46-8) in bulk powder form, from Brazil Dear Ms. Heerdt: In your letter dated March 16, 2021, you requested a tariff classification ruling. Esketamine is a cyclohexanone derivative and S-enantiomer of racemic ketamine, with analgesic, anesthetic and antidepressant activities. It is indicated for the treatment of adults with treatment-resistant depression (TRD) and depressive symptoms in adults with major depressive disorder (MDD) with suicidal thoughts or actions. The applicable subheading for the Esketamine in bulk powder form will be 2922.39.2500, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Oxygen-function amino-compounds: Amino-aldehydes, amino-ketones and amino-quinones, other than those containing more than one kind of oxygen function; salts thereof: Other: Aromatic: Other: Products described in additional U.S. note 3 to section VI.” Pursuant to General Note 13, HTS, 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. Esketamine may also be subject to the Controlled Substances Act, which is administered by the U.S. Drug Enforcement Administration (DEA), Office of Diversion Control. Information on the Controlled Substances Act can be obtained by contacting the DEA at (800) 882-9539, or by visiting their website at www.dea.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