FDA Foods and Veterinary Medicine Program Strategic Plan for 2012 – 2016 Draft Targets Illegal Compounding

A draft of the FDA Foods and Veterinary Medicine Program Strategic Plan for 2012 – 2016 indicates that a new enforcement strategy to address illegal compounding of new animal drugs may be a top priority of the FDA in the future.  Cases such as Franck's and ApothCure (although not a case involving animal drugs) suggest that illegal compounding of drugs has already become a key initiative of the FDA.  The draft reads:

The FVM Program is concerned about the number of unapproved animal drug products
that are being sold and marketed to animal owners and veterinarians. To reduce the risk of
harm from substandard and illegally marketed animal drugs, the program will identify new
regulatory frameworks and enforcement strategies to combat this growing area of
concern.
Key Initiatives
7.2.1: Develop risk‐based frameworks that assure quality and safety for products
that are currently being marketed without FDA approval
7.2.2:  Develop and implement an enforcement strategy that addresses the illegal
compounding of new animal drugs and removes unsafe, ineffective or copycat
animal drugs from the market

To read the entire FDA Foods and Veterinary Medicine Program Strategic Plan for 2012-2016 click  here.