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http://www.avma.org/onlnews/javma/oct09/091015h.asp
JAVMA News October 15, 2009
"The Food and Drug Administration's Center for Veterinary Medicine is no longer accepting requests nor issuing letters facilitating veterinarians' personal importation of foreign animal drugs that are not approved for use in the United States.
"The FDA had previously issued letters stating it did not object to the importation by licensed veterinarians of small amounts of unapproved animal drugs for specific patients and in special circumstances, such as when the drug posed no threat to human or animal health and there were no adequate drug substitutes available.
"Veterinarians seeking to import these types of foreign animal drugs are instead directed to FDA's guidance on the Coverage of Personal Importation, which is available at :"
http://www.fda.gov/downloads/ICECI/C.../UCM074300.pdf
When we needed Caninsulin for Lucky, it was not yet approved (Vetsulin) for use in the US, so we needed to go through this type of paperwork before he could receive it.
It appears that if the situation was happening today, and Vetsulin wasn't yet in the US, we would be able to make the arrangements with Intervet alone.
From this, it would also seem that if a vet wanted or needed 100% bovine insulin for a diabetes patient, he/she would only need to contact Pfizer about their Insuvet Neutral (R), Lente, or Protamine Zinc (PZI) insulins.
This should make getting a drug you need a lot easier and faster; while I wish this system was in place when Lucky needed Caninsulin, I'm glad to see that it will now be easier for others to import needed drugs.
Kathy
JAVMA News October 15, 2009
"The Food and Drug Administration's Center for Veterinary Medicine is no longer accepting requests nor issuing letters facilitating veterinarians' personal importation of foreign animal drugs that are not approved for use in the United States.
"The FDA had previously issued letters stating it did not object to the importation by licensed veterinarians of small amounts of unapproved animal drugs for specific patients and in special circumstances, such as when the drug posed no threat to human or animal health and there were no adequate drug substitutes available.
"Veterinarians seeking to import these types of foreign animal drugs are instead directed to FDA's guidance on the Coverage of Personal Importation, which is available at :"
http://www.fda.gov/downloads/ICECI/C.../UCM074300.pdf
When we needed Caninsulin for Lucky, it was not yet approved (Vetsulin) for use in the US, so we needed to go through this type of paperwork before he could receive it.
It appears that if the situation was happening today, and Vetsulin wasn't yet in the US, we would be able to make the arrangements with Intervet alone.
From this, it would also seem that if a vet wanted or needed 100% bovine insulin for a diabetes patient, he/she would only need to contact Pfizer about their Insuvet Neutral (R), Lente, or Protamine Zinc (PZI) insulins.
This should make getting a drug you need a lot easier and faster; while I wish this system was in place when Lucky needed Caninsulin, I'm glad to see that it will now be easier for others to import needed drugs.
Kathy