Compounding is an important treatment option that is used every day by practicing veterinarians. Consistent with the Food and Drug Administration (FDA) Extra-Label Drug Use regulations, compounding is the customized manipulation of an FDA-approved drug(s) by a veterinarian, or by a pharmacist upon the prescription of a veterinarian, to meet the needs of a particular patient.
Compounding has come under federal scrutiny due to a lethal fungal meningitis outbreak in humans that occurred last fall. Any new legislation or regulations that are put forward could impact how veterinarians are able to compound in the future.
At the AVMA, we agree that we need to ensure that the needs of animal patients and their doctors are met, which is why we are very carefully reviewing our current Compounding and Compounding from Unapproved (Bulk) Substances policies. We need to be able to communicate AVMA policies that best reflect the needs of the veterinary profession. The policies will serve as the basis for our positions on legislation, which the Governmental Relations Division will advocate in Washington, D.C.
Most significantly for veterinary medicine is the issue of compounding from “bulk” to create medicines for use in animals. Compounding from bulk involves the use of unapproved, raw, active ingredients, a practice that is currently illegal per the FDA.
It is important that AVMA members review the Compounding and Compounding from Unapproved (Bulk) Substances proposed revisions and provide feedback on the NOAH Discussion Groups during the next 30 days. After review of member feedback and the concepts that have been brought forward by our volunteer governance groups (AVMA members volunteer their time on AVMA’s entities that are designed to review member needs, scientific reports, and existing laws and regulations, and bring expert opinions together), the AVMA’s Executive Board will consider any recommended policy revisions, probably in early summer 2013.
We thank you for your interest and engagement on this issue and encourage you to provide feedback on the proposed policy revisions.