Wednesday, May 2, 2012
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.
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.