CLA-2-29:OT:RR:NC:2:238

Ms. Inge Forstenzer
Ren-Pharm International, Ltd.
350 Jericho Turnpike, Suite 204
Jericho, NY 11753

RE: The tariff classification of Dexmedetomidine Hydrochloride (CAS 145108-58-3), in bulk form, from Italy

Dear Ms. Forstenzer:

In your letter dated July 16, 2015, you requested a tariff classification ruling.

The subject product, Dexmedetomidine Hydrochloride, is a central alpha-2 adrenergic agonist. It is indicated for sedation of initially intubated and mechanically ventilated patients during treatment in an intensive care setting. It is also indicated for sedation of non-intubated patients prior to and/or during surgical and other procedures.

The applicable subheading for Dexmedetomidine Hydrochloride in bulk form, will be 2933.29.2000, Harmonized Tariff Schedule of the United States (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 General Note 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 World Wide Web at http://www.usitc.gov/tata/hts/.

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,

Gwenn Klein Kirschner
Director
National Commodity Specialist Division