Importation of Unapproved Drugs: How to Order Azaperone and Concentrated Medetomidine
Azaperone is a tranquilizer with multiple applications in zoo medicine.1 It is used as a part of sedative combinations in elephants, giraffes, and rhinoceros. It has also been used to decrease aggression during introductions in a number of species. Concentrated (10 mg/ml) medetomidine facilitates immobilization of large carnivores and great apes.2 The medetomidine available in the United States comes as 1 mg/ml. This more dilute formula means that large volumes of drug must be delivered if it is to be used on large animals. This is frequently not practical when anesthetic agents must be delivered via dart or hand injection.
These drugs are not manufactured in the United States and permits are required to import them. There is variable information available on how to apply for and receive permits. The purpose of this presentation is to clarify and streamline the process.
Stresnil (azaperone 50 mg/ml) is currently manufactured by Midwest Veterinary Distribution, 1600 Inkster Blvd., Winnipeg, Manitoba, Canada (800-356-4799).
The product Zalpoine (medetomidine 10 mg/ml) is manufactured by Orion Pharmaceuticals, PO Box 425, Fin-20101 Turku, Finland. They can be contacted via www.orionpharma.com.
The permit required is a letter allowing "Medically Necessary Personal Veterinary Imports". It is issued by the Department of Health and Human Services, Food and Drug Administration, Office of Surveillance and Compliance. The permit application is submitted to:
Division of Compliance, HFV-236
Center for Veterinary Food and Drug Administration
Metro Park North
7500 Standish Place
Rockville, Maryland 20855
The supervisory person in the office is Kim Young. He can be contacted at: 301-827-3353.
The following information must be submitted to apply for the permit:
1. Veterinarian's name, address and phone number
2. Clinic name and address
3. Client's name and address
4. Patient name and nonfood species
5. Name of drug
6. Drug family or class
7. Name and address of drug supplier
8. Legal status of the drug in the foreign country
9. Amount of drug to be imported—must be small noncommercial quantities
10. Disease condition to be treated
11. Reason why an approved human or animal drug will not treat the disease condition
12. A statement that:
a. You will notify the animal owner that the drug is not approved
b. That the drug will not be used in any food animal
c. And that you agree to notify the FDA if there are any adverse reactions
13. How did you learn of the existence of this drug?
a. The FDA wants to verify that foreign drugs are not actively promoted in U.S. markets.
14. The veterinarian must sign at the end of the submitted information.
1. Schmitt, D.L., Bradford, J.P. and Hardy, D.A. 1996. Azaperone for standing sedation in Asian elephants. Proc. Am. Assoc. Zoo Vet. Pp. 48–51.
2. Home, W.A. In: Heard, D.J. (ed.). Jan. 2001. Veterinary Clinics of North America: Exotic Animal Practice, Analgesia and Anesthesia. W.B Saunders Co. Philadelphia, Pennsylvania. Pp.239–266.