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NY R02465

August 31, 2005



TARIFF NO.: 3004.90.9140

Ms. Denise Demkowicz
Manager, Operations
GeneraMedix Inc.
150 Allen Road
Liberty Corner, NJ 07938

RE: The tariff classification of Ketamine Hydrochloride Injection single dose vials for intramuscular or slow intravenous use from Ireland.

Dear Ms. Demkowicz:

In your letter dated August 22, 2005 you requested a tariff classification ruling.

The subject product, Ketamine Hydrochloride Injection, is a formulation containing 5.77% or 11.54% by weight Ketamine Hydrochloride. It is presented in two forms: 500mg/10mL (50mg/mL) Single Dose Vial (10 pack); 1000mg/mL (100mg/mL) Single Dose Vial (10 pack). The vials are put up in paperboard boxes for retail sale. The approved use for Ketamine Hydrochloride in the United States is as an anesthesia for short diagnostic and surgical procedures that do not require skeletal muscle relaxation, and as a general anesthesia adjunct to supplement low-potency anesthetics such as nitrous oxide.

The applicable subheading for the three forms of Ketamine Hydrochloride Injection will be 3004.90.9140, Harmonized Tariff Schedule of the United States (HTS), 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: Other.” The rate of duty will be free.

This merchandise is currently a Drug Enforcement Administration (DEA) Schedule III Non-Narcotic Controlled Substance and may be subject to the requirements of the Controlled Substances Act and/or the Controlled Substances Import and Export Act, which are administered by the DEA. You may contact them at 2401 Jefferson Davis Hwy., Alexandria, VA 22301, telephone (202) 307-1000.

This merchandise may also be subject to the requirements of the Federal Food, Drug, and Cosmetic Act, which is administered by the U.S. Food and Drug Administration. You may contact them at 5600 Fishers Lane, Rockville, Maryland 20857, telephone number 1-888-443-6332.

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 Harvey Kuperstein at 646-733-3033.


Robert B. Swierupski

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