The Bureau of Veterinary Medicine and the Bovine Practitioner

Abstract

Regulatory control over new animal drugs and medicated feeds originated in 1938, under the new drug provisions of the Federal Food, Drug and Cosmetic Act. These provisions enabled FDA to pre-vent the marketing of both new animal drugs and medicated feeds until their safety had been demonstrated.

In 1962, the Act was amended to re-quire demonstration also of the effectiveness of the drugs and the medicated feeds containing them. In 1968, Congress enacted the animal drug amendments which created a section of law dealing exclusively with animal drugs and medicated feeds. Prior to these amendments, which became effective in 1969, animal feed drugs were regulated as new drugs and food additives; the latter under the Food Additives Amendment of 1958. The 1968 amendments retained all of the new drug requirements of the 1938 law, as amended in 1962, requiring adequate proof of safety and effectiveness of new drugs before their marketing.

Under the 1968 amendments, a new animal drug is deemed to be unsafe with respect to any particular use or intended use, and therefore, adulterated if the drug is not covered by an approved new animal drug application (NADA).

If such anew unapproved animal drug is used to produce a medicated animal feed, the feed is also deemed to be an adulterated drug. The Federal Food, Drug and Cosmetic Act prohibits the interstate shipment of such adulterated drugs or their use in the manufacture of other animal feeds.

If you were a lawyer, you would have immensely enjoyed those opening remarks and the vast implications entailed thereof. But being a bovine practitioner, it probably means little to you. Because of the increasing importance and impact that FDA has and will have on food animal production, I believe it is imperative that you have a better understanding of 58 the prov1s10ns of the FD&C Act and associated regulations as regards your role as a bovine practitioner. Thus, my discussion this morning has two objectives:

1. To present the role of the Bureau of Veterinary Medicine (BVM) in regulating food animal drugs, principally in the bovine, a species in which you are most interested.
2. Delineate the role that research plays in this procedure, which is a function with which I am most familiar.