FDA no longer issuing letters for importation of unapproved animal drugs
|Posted Oct. 1, 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 (see JAVMA, Aug. 15, 2005).
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 www.fda.gov/downloads/ICECI/ComplianceManuals/RegulatoryProceduresManual/UCM074300.pdf.
2015 American Veterinary Medical Association