Thursday, May 3, 2007

Medically Necessary Veterinary Imports Request

Summary of Fax Cover Sheet:
From: Michael Zimmerman; (michael.zimmerman@fda.hhs.gov)
Re: Request Import Drug
Notes: Attached is a copy of the 13 questions that must be answered to consider your request to import medication for your patient(s). Please answer each question as thoroughly as possible and fax your completed request back to our office. Please call if you have any questions. Thank you.

Address and Question Sheet:

Please submit letter to:
Michael Zimmerman
Food and Drug Administration
Center for Veterinary
Division of Compliance, HFV-235
7519 Standish Place
Rockville, Maryland 20855
Or fax to 240-276-9241

Questions: (240)276-9202

Please determine the following in the initial contact:
How did the veterinarian learn of this product? If there is
any indication the product has been actively promoted in
U.S. markets it will be refused entry and an import alert will
be issued.

Please submit the following information:
1. Veterinarian's name
2. Clinic's name, address, & phone number
3. Client's name and address
4. Patient name and non-food 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, non-commercial
quantities. Please be sure to specify # of mg as well as # of
bottles (each bottle contains 100 capsules)
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:
- you will notify the animal owner that the drug is not approved
- that the drug will not be used in any food animal
- and that you agree to notify the FDA if there are any adverse reactions?
13. Please inlude your email address.

ALL REQUESTS MUST BE SIGNED BY THE VETERINARIAN AND BE ON LETTERHEAD
Please allow 3-4 weeks for processing.

Revised February 1, 2007

[Go to version formatted as letter]

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