IACP’s EVP/CEO David G. Miller, RPh, and VP Government Affairs Sarah Dodge continue ongoing meetings with the American Veterinary Medical Association (AVMA) to determine issues of mutual concern. IACP has confirmed that AVMA will be heading a panel at IACP’s annual Compounders on Capitol Hill as part of an overview of how compounding issues are impacting and being addressed by professional organizations representing prescribers.
Several weeks ago, IACP was asked by the Animal Health Institute (AHI) to review a draft amendment they are considering proposing to any potential animal drug user fee or authorizing legislation that may move in Congress. AHI, the organization representing the veterinary pharmaceutical industry, would potentially restrict the compounding of certain Active Pharmaceutical Ingredient (API)-based preparations to a “positive” list which the FDA would create and maintain. IACP is opposed to such a list and believes that as written, the proposed AHI concept is clinically unworkable. AVMA and IACP also have discussed this amendment and the veterinary organization understands the difficulties in complying with the current FDA position that the use of APIs for non-food producing animals is prohibited; however, AVMA’s current position is that veterinarians should follow the directions given by the agency and which are spelled out in the 2003 Compliance Policy Guideline on Veterinary Compounding.
There has been significant confusion among compounders as to what, when and where this potential industry-sponsored amendment may impact veterinary compounding and the AVMA position. At the present time, AVMA is surveying its members to obtain their thoughts and feedback and a formal policy statement will be developed by the organization’s Board at a meeting scheduled for April. That statement will then, according to AVMA process, be circulated to all members for further input. Until that time, the AHI amendment and the concept of limiting API-based veterinary compounding is nothing more than a “discussion.”
Once a position statement is made, there’s still a very long way to go before anything formally happens with federal veterinary compounding legislation. Although ADUFA (the Animal Drug User Fee Act) is up for reauthorization this year, Senate staff has indicated that they would like to keep the bill focused on user fee issues (maintain a “clean” bill) and do not intend to add anything that is controversial at this point.To date, no such consensus exists. Additionally, IACP has been told that human compounding legislation is likely to move through the Senate first. IACP has been focused on those efforts to date, while keeping an eye on the veterinary compounding issue as well. Please email IACP with questions at firstname.lastname@example.org.