The tariff classification of Brexanolone (CAS No. 516-54-1) in bulk powder form, from Italy

N329294 December 5, 2022 CLA-2-29:OT:RR:NC:N3:138 CATEGORY: Classification TARIFF NO.: 2914.40.9000 Ms. Sheila Heerdt Ren Pharm International Ltd. 350 Jericho Turnpike, Suite 204 Jericho, NY 11753 RE: The tariff classification of Brexanolone (CAS No. 516-54-1) in bulk powder form, from Italy Dear Ms. Heerdt: In your letter dated November 10, 2022, you requested a tariff classification ruling. Brexanolone is also known as Allopregnanolone, a synthetic neuroactive steroid gamma-aminobutyric acid A (GABA(a)) receptor positive modulator. It is indicated for the treatment of postpartum depression (PPD) in adult women. The applicable subheading for the Brexanolone in bulk powder form will be 2914.40.9000 Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Ketones and quinones, whether or not with other oxygen function, and their halogenated, sulfonated, nitrated, or nitrosated derivatives: Ketone-alcohols and ketone-aldehydes: Other: Other: Other.” The rate of duty will be 4.8 percent ad valorem. Currently, Brexanolone is not listed in the Pharmaceutical Appendix to the Tariff 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