Summary of Activities of the FDNCVM Advisory Committee 1984-1988

Abstract

It is an opportune time to reflect on the VM/AC activity inasmuch as four years have elapsed since the recreated committee convened. I was privileged to serve this first committee as chairman. My selection indicates in part the confidence CVM places in the AABP.

The committee was very active during the years I served as chairman. I think it acted in a manner which has been helpful to the agency as well as the regulated industries and the American public. The issues considered by the committee were primarily requested from CVM. The following is a recap of some of the issues discussed by the committee along with its recommendations.

The committee was asked to consider the efficacy and labeling requirement for antimicrobial agents used in veterinary medicine.

The committee discussed the extra-label use of drugs in food producing animals and made the following reommendations.

The committee was asked to consider ways to improve the credibility and respect for the prescription veterinary legend.

The committee was asked to critique a revision of the Rx/OTC labeling policies for Rx and OTC drugs. The committee recommended that products be approved only as Rx or OTC with none labeled as both, but if dual labeling was necessary, that CVM provide all label claims in the Rx product label for those products which are approved for both Rx and OTC designation.

The committee was asked to consider the criteria for determining Rx/OTC designation.