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 Elagolix Sodium (CAS No. 832720-36-2) in bulk powder form, from Spain
Dear Ms. Heerdt:
In your letter dated January 8, 2018, you requested a tariff classification ruling. We apologize for the delay as the information was sent to our laboratory for analysis.
Elagolix Sodium is a synthetic gonadotropin-releasing hormone (GnRH) antagonist indicated for the treatment of endometriosis and uterine fibrosis. According to our laboratory, the instant product is neither a derivative nor structural analogue of the natural gonadotropin-releasing hormone.
The applicable subheading for Elagolix Sodium in bulk powder form will be 2933.59.5300, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Heterocyclic compounds with nitrogen hetero-atom(s) only: Compounds containing a pyrimidine ring (whether or not hydrogenated) or piperazine ring in the structure: Other: Drugs: Aromatic or modified aromatic: Other.” 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 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