FDA's Final Strategic Plan: Key Initiatives Relating to Compounding

The FDA's Final Strategic Plan for the Foods and Veterinary Program, which was announced on April 23, 2012, provides the following initiatives related to compounding:

7.2 – Reduce availability of substandard and illegally marketed animal drugs.
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 animal drug 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.

FDA Announces Final Strategic Plan for the Foods and Veterinary Medicine Program

April 23, 2012
The U.S. Food and Drug Administration (FDA) announces the release of the final Strategic Plan for the Foods and Veterinary Medicine Program (FVM) for 2012-2016. The plan addresses the responsibilities of the Center for Food Safety and Applied Nutrition and the Center for Veterinary Medicine while including activities supported by the Office of Regulatory Affairs. The plan illustrates the breadth and complexity of the program’s work and identifies priority initiatives. It outlines seven strategic program goals, each encompassing its own key objectives, as well as nearly 100 specific initiatives aimed at achieving goals and objectives.
The draft Strategic Plan was published on September 30, 2011, with a thirty-day comment period. The FDA carefully reviewed and considered all submitted comments before issuing this final Strategic Plan.

Click here to view the final plan.

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.