CLA-2-29:OT:RR:NC:N3:138
Mr. Andrew Lawson
CBC America
2000 Regency Parkway
Cary, NC 27518
RE: The tariff classification of Lofexidine Hydrochloride (CAS No. 21498-08-8) in bulk powder form, from Italy
Dear Mr. Lawson:
In your letter dated May 20, 2020, you requested a tariff classification ruling.
Lofexidine Hydrochloride is a central alpha-2 adrenergic agonist. It is indicated for mitigation of opioid withdrawal symptoms to facilitate abrupt opioid discontinuation in adults.
You suggest classification in subheading 3004.49.0010, 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, containing alkaloids or derivatives thereof: Other: Other: cardiovascular medicaments.” However, Lofexidine Hydrochloride is not an alkaloid and it is not imported in measured doses, or in forms or packings for retail sale.
The applicable subheading for the Lofexidine Hydrochloride in bulk powder form will be 2933.29.2000, HTSUS, which provides for "Heterocyclic compounds with nitrogen hetero-atom(s) only: Compounds containing an unfused imidazole ring (whether or not hydrogenated) in the structure: Other: Aromatic or modified aromatic: Other: Drugs." Pursuant to GN 13, HTSUS, 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 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