CLA-2-30:OT:RR:NC:N3:138
Ms. Michele E. McGuire
Deloitte Tax LLP
111 South Wacker Drive
Chicago, IL 60606
RE: The tariff classification of Epidiolex® in dosage form, from the United Kingdom
Dear Ms. McGuire:
In your letter dated October 20, 2018, filed on behalf of GW Pharmaceuticals PLC, you requested a tariff classification ruling.
Epidiolex is a medicinal preparation containing Cannabidiol (CBD), as the active ingredient. Epidiolex is used as an aid in controlling various orphan pediatric epilepsy syndromes and seizure disorders in children associated with Dravet syndrome and Lennox-Gastaut syndrome. It will be available by prescription only and imported in liquid formulations of 100 ml in 105 ml bottles.
The applicable subheading for Epidiolex in dosage form will be 3004.90.9230, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Medicaments (…) consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses (…) or in forms or packings for retail sale: Other: Other: Other: Medicaments primarily affecting the central nervous system: Anticonvulsants, hypnotics and sedatives.” 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.
This merchandise may also be subject to the requirements of the Controlled Substances Act, which are enforced by the U.S. Drug Enforcement Administration (DEA), Office of Diversion Control. You may contact them at 2401 Jefferson Davis Highway, Alexandria, VA 22301, telephone (800) 882-9539.
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