Compounding: Understanding FDA draft guidance

Animal drugs compounded from bulk drug substances aren’t FDA-approved. However, the FDA recognizes that compounded drugs can serve an important medical need for animal patients when no FDA-approved or indexed drug is available. In November 2019, FDA’s Center for Veterinary Medicine issued new draft guidance for animal drug compounding: Guidance for Industry (GFI) #256, Compounding Animal Drugs from Bulk Drug SubstancesJoin FDA veterinarian Dr. Amber McCoig for an overview of the draft guidance and the policies that impact veterinarians and our teams.

Participants can expect to learn about:

  • Why the FDA cannot assure the safety, effectiveness, or quality of bulk drug substances  
  • How draft Guidance for Industry #256 attempts to balance the risks of animal drugs compounded from bulk substances when no FDA-approved drug is available for treatment 
  • Policies included in the draft guidance and how they impact veterinary practice

Dr. Amber McCoig began working in public health at the U.S. Food and Drug Administration (FDA) since 2008. During that time, she has worked for the Center for Food Safety and Applied Nutrition (CFSAN) and as a deputy director for the division of compliance at the Center for Veterinary Medicine (CVM). Before joining the FDA, she worked in clinical veterinary practice. She earned her DVM from the University of Missouri and a master’s degree in public health from Johns Hopkins University.