Hi all! My apologies if you receive this twice...I tried forwarding the message I got and forgot that attachments don't always go through to the list! Anyway, this is just the response I got from the veterinary division of the FDA concerning the importation of VO! My apologies, too, if this info has already been posted (big thanks to Nina for being the trail-blazer!), but I just thought I'd share!
Dear Ms. Meyer: This is in response to your e-mail inquiry to the Center for Veterinary Medicine home page concerning the importation of a drug that is not approved in the U.S. FDA's Center for Veterinary Medicine grants permission on limited basis to allow small amounts of unapproved animal drugs to enter the U.S. Permission to import drugs for patient use will be granted subject to the unavailability of suitable FDA approved (human or veterinarian) drugs; either because of shortages; or because drugs are unavailable in the U.S. to give a suitable therapeutic result. Secondly, permission is only granted in those instances where the drug is considered as medically necessary veterinary drug. A veterinarian would need to make a formal request in writing to import the drug. It is also important to note that to import a drug; the animal must be under professional medical care through a valid veterinarian-client-patient relationship. Prescription orders will be limited to a 90-day supply/pet. Prescription renewals will need to be re-requested this office for additional 90-day supplies. The letter should include the veterinarian clinic's letterhead, his or her signature and the following information: Veterinarian name, address and phone number Clinic name and address Client's name and address Patient name and species Name of Drug Drug Family or class Name and address of drug supplier Legal status of the drug in the foreign country Amount to be imported (non-commercial quantity) Disease condition to be treated Reason why an approved human or animal drug will not treat the disease condition A statement that: o you will notify the owner that the drug is not approved o that the drug will not be use of food animals And that you will notify FDA if the are any adverse reactions How did you learn about the existence of this drug? As part of FDA's regulatory discretion FDA may cancel permission at any time. Generally, rescinding permission to import medically necessary drugs is based upon new scientific information and knowledge about new or current therapies available in the U.S. such as new drug approvals. Please refer all inquiries and status questions at the address below: Ms. Toni Wooten Division of Compliance, HFV-236 Center for Veterinary Medicine Food & Drug Administration Metro Park North 7500 Standish Place Rockville, MD 20855 301-594-0796 FAX 301-827-1498 I hope this is helpful. Sincerely yours, FDA/CVM Home Page
