Rumors About AVMA Prohibiting Compounding?
There has been quite a bit of confusion about where the American Veterinary Medical Association (AVMA) is or is going as it relates to veterinary compounding. Much of that is due to conflicting information about proposed legislative language that the Animal Health Institute (AHI) has circulated and for which they are seeking AVMA's support. The AHI is the association for the pharmaceutical companies that manufacture veterinary medications.
AVMA always has accepted and educated its members that the Food and Drug Administration's (FDA) position prohibits the compounding of any animal drug from APIs (active pharmaceutical ingredients/bulk products). Their position is based upon the FDA regulations and the Veterinary Compounding Compliance Policy Guidance issued in 2003 by the Agency. As IACP members know, that CPG was issued on an emergency basis in 2003 by the agency without public input or comments. Since then, and despite three letters from Congress demanding action and a public announcement in 2004 that the CPG would be "reconsidered," the document remains unchanged.
While IACP and compounders continue to fight for veterinarians to prescribe medications prepared from APIs, the AVMA takes a very strict view to protect its members, and that is that the FDA prohibits the use of APIs for both major and minor non-food producing species.
The proposal from AHI which IACP has seen and reviewed would change the existing federal law to permit some compounding with APIs for animal use. However, while that might seem like a positive step forward, the manner in which AHI is recommending that be done is too restrictive and would have significant impact on the clinical care of animals as well as further confusing the "can we/can we not" dilemma which pharmacists and vets currently face. IACP continues to meet with AVMA's legislative team to discuss the pros and cons of the AHI proposal as well as the need for great clarity for all practitioners in whether or not APIs should or should not be used.
Part of the confusion is also due to a lack of understanding of the AVMA's policy development process. As with other associations, internal committees of members provide input on recommendations to their Board. The AVMA Board then adopts a policy which is then circulated back to the entire membership for input. The Board policy may change after that or may be discussed and voted upon through the association's House of Delegates process at their July 2013 meeting in Chicago. Rumors in the compounding community that an AVMA Board vote was 'imminent" and that a formal AVMA policy on the use of APIs or even the AHI proposal was occurring this month are unfounded and only served to create confusion among vets and pharmacists. The AVMA Board will not take this issue up until they meet formally in June.