Confused about the various communications you’ve seen about what AVMA is or is not doing on compounding? We wanted to take a moment to dispel myths about compounding, as well as update you on the AVMA’s current activities on the subject.
• The AVMA is not being pressured by outside groups to take any actions on compounding. Veterinarians “in the field” (many of whom are practitioners) who serve on AVMA’s volunteer governance groups are discussing the current legal status of bulk compounds and reviewing AVMA’s policies on the topic. Part of that discussion is with various groups – including compounding pharmacy groups – to understand their perspectives.
• Catalyzed by recent human health concerns related to compounding, there is a sense of urgency to this issue due to Congressional interest in introducing and passing compounding legislation this year. Our Governmental Relations Division veterinarians utilize AVMA’s policies in communicating with members of Congress about legislation.
• The Food and Drug Administration (FDA) says nothing in its regulations permits compounding from bulk (raw pharmaceutical ingredient) drugs. It also has a Compliance Policy Guide on the subject. Some pharmacists might say otherwise, but AVMA is going by the FDA’s rules since they’re the federal authority.
• Compounding is necessary sometimes, but be cautious. We believe veterinarians should know that compounding, including formulation in a novel drug delivery system (e.g. transdermal), may impact the absorption and depletion of a drug. This may result in drug concentrations that are above or below the therapeutic range and lead to the development of an adverse drug event, including therapeutic failure.
• Compounds are not generics. Some compounds are manufactured and might even look like a generic drug, but could very well be an unapproved manufactured mimic (i.e., an ever-so-slightly different version) of an FDA-approved drug. There is typically a New Animal Drug Application (NADA) number or Abbreviated New Animal Drug Application (ANADA) number on FDA-approved animal drugs to help you determine whether a drug is approved or not.
• Clearly there are situations in which the need for therapy from compounding is great and the risk is small. Along with many other factors, liability is one to consider when contemplating use of a compound. For example, use of a mimic (a drug that looks like it’s approved, but really isn’t) could expose you to unnecessary liability.
Stay tuned as the AVMA’s volunteer governance groups continue discussing this topic that is so important in the daily lives of practicing veterinarians.