Regulatory Brief

 Use of AVMA Policies in Regulation of Compounding

Excerpts from the AVMA Response:

Recognizing that compounding is a key regulatory priority for FDA Center for Veterinary Medicine (CVM), we underscore the value of the FDA's extralabel drug use rules and FDA's Compliance Policy Guide (CPG) 608.400 in FDA's facilitation of enforcement against egregious use of bulk ingredients, including mimics of commercially available FDA-approved drugs, as well as compounding for food-producing animals which is a food safety concern. We continue to support enforcement against such acts. We also recognize and support FDA's enforcement discretion for very specific, limited circumstances of compounding in food animals.

However, the current regulations and guidances have a significant shortcoming. They do not offer enforcement discretion for the limited use of medically necessary preparations compounded from bulk ingredients for non-food animals. We therefore recommend incorporation of two new concepts for FDA's consideration as it considers new ways forward with regard to regulation of compounding for use in animals:

  • Use of a set of circumstances, not a prescribed list, for compounding from bulk in non-food animals. In lieu of what has been called a 'positive list', AVMA instead asserts there should be three general sets of circumstances (see attachment), in which compounding from bulk pharmaceutical ingredients may be medically necessary and should be allowed within the context of a Veterinarian-Client-Patient Relationship (VCPR) in non-food animals.
  • Office stock provisions. The AVMA asserts veterinarians should be able to legally maintain sufficient quantities of compounded preparations in their office for urgent administration needs or emergency situations. If current federal statute does not allow FDA CVM to identify its enforcement plan regarding office stock, we understand from state stakeholders that it would be helpful for FDA CVM to provide its interpretation of the current federal status on office stock and anticipatory veterinary prescribing.

While recognizing the current focus on compounding has been the creation of 'lists' of acceptable bulk drugs for use of compounding in animals, we contend that the FDA's regulations can be made stronger through a shift towards the opportunity for veterinarians to compound in accordance with our policies.

Background Documents:


Related AVMA Policies: