CLA-2-29:OT:RR:NC:N2:238
Ms. Freya Wilkes
Allergan Sales, Inc.
2525 Dupont Drive
Irvine, CA 92612
RE: The tariff classification of Ulipristal Acetate (CAS No.126784-99-4) in bulk form and Esmya® tablets in dosage form, from Hungary
Dear Ms. Wilkes:
In your letter dated July 11, 2017, you requested a tariff classification ruling.
Ulipristal acetate is a selective progesterone receptor modulator (SPRM) used for emergency contraception and for the treatment of uterine fibroids.
Esmya imported in 5 mg tablets is a medicinal preparation containing, Ulipristal Acetate, as the active ingredient. In your letter, you indicated that Esmya is used only for the treatment of uterine fibroids and is not intended for use as an oral contraceptive.
The applicable subheading for the Ulipristal Acetate in bulk form will be 2937.29.9095, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Steroidal hormones, their derivatives and structural analogues: Other: Other: Other.” The rate of duty will be free.
The applicable subheading for the Esmya tablets in dosage form will be 3004.39.0050, HTSUS, which provides for "Medicaments … consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses (including those in the form of transdermal administration systems) or in forms or packings for retail sale: Other, containing hormones or other products of heading 2937: 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