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NY N016634




September 10, 2007

CLA-2-30:RR:E:NC:N2:238

CATEGORY: CLASSIFICATION

TARIFF NO.: 3004.39.0010

Ms. Louise Rischel
Bimeda Animal Health Inc.
420 Beaverdale Road
Cambridge, ON, Canada
N2N 3A6

RE: The tariff classification of Oxytocin Injection for veterinary use imported from Canada

Dear Ms. Rischel:

In your letter dated August 17, 2007, you requested a tariff classification ruling.

The subject product, Oxytocin Injection for veterinary use, is a sterile aqueous solution of highly purified oxytocic principle derived by synthesis or obtained from the posterior lobe of the pituitary gland of healthy domestic animals used for food by humans. Oxytocin Injection contains 20 USP units of oxytocin and less than 0.4 units of presser activity per mL. Each mL of sterile solution also contains 0.9% w/v sodium chloride, 0.5% w/v chlorobutanol (as a preservative), with water for injection and pH adjusted to 3.0 to 5.0 with acetic acid. It is supplied in 100 mL multiple dose vials.

The 29th edition of Dorland’s Illustrated Medical Dictionary defines oxytocin as follows: "[a] nonapeptide secreted by the magnocellular neurons of the hypothalamus and stored in the neurohypophysis (the posterior lobe of the pituitary gland) along with vasopressin. It promotes uterine contractions and milk ejection and contributes to the second stage of labor.” Dorland’s continues: “[Oxytocin] is administered intramuscularly or by intravenous infusion to induce labor, increase the force of uterine contractions, contract uterine muscle after delivery of the placenta, control postpartum hemorrhage, or stimulate milk ejection.”

The applicable subheading for the Oxytocin Injection will be 3004.39.0010, Harmonized Tariff Schedule of the United States (HTSUS), which provides for "Medicamentsconsisting of two or more constituents which have been mixed together for therapeutic or prophylactic uses, not put up in measured doses or in forms or packings for retail sale: Containing hormones or other products of heading 2937 but not containing antibiotics: Other: For veterinary use." The rate of duty will be free.

You also enquired specifically about the regulatory status of oxytocin. Oxytocxin is not an anabolic steroid. Neither is it listed by name in any Controlled Substance Schedule. Therefore, at present, it is not subject to the requirements of the Controlled Substances Act and/or the Controlled Substances Import and Export Act, which are administered by the Drug Enforcement Administration (DEA). No DEA Permit or Notice of Arrival is required for the entry of oxytocin. For status updates and further information, you may contact the DEA at 2401 Jefferson Davis Hwy., Alexandria, VA 22301, telephone (202) 307-1000.  

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.

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 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.

Sincerely,

Robert B. Swierupski
Director,

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