The Animal Health Institute praised action taken by the Food and Drug Administration in the US to protect animal health and stop the illegal manufacture and sale of unapproved animal drugs.
The FDA is seeking a permanent injunction in a lawsuit filed in federal court against a company involved in the interstate sale of unapproved animal drugs under the guise of pharmacy compounding.
Compounding is a process by which an otherwise unavailable medication is tailored for the needs of a particular patient under a licensed veterinarian’s prescription. FDA has a strict policy on how a veterinarian or state licensed pharmacist can legally compound drugs for use in specific situations for individual animal patients without violating the laws regarding drug manufacturing. However, too often compounding companies undermine the strict limits of legal compounding by manufacturing drugs from bulk active ingredients for widespread sale across state lines.
“Illegal compounding undermines FDA’s animal drug approval process and threatens animal health,” said AHI President and CEO Alexander S. Mathews. “We fully support this action by FDA hope it will send a message to others engaged in this illegal practice.” FDA cited the deaths of 21 polo ponies last year before a match in the US Open Polo Championships in Florida as an example of the health threat posed by illegal compounding.