Legal issues in the pharmaceutical management of bovine reproduction

Abstract

The ability for the bovine practitioner to implement reproductive management 8 programs is scientifically well-based and clinically proven. However, as is being 9 encountered in many areas of food animal medicine, science is no longer the major 10 determinant of how a veterinarian practices or how a producer manages. Extra-label drug 11 use (ELDU) allowed under the Animal Medicinal Drug Use Clarification Act was not 12 extended to drugs used for production purposes, such as reproduction. Therefore, ELDU 13 of drugs for reproductive purposes is not technically allowed in the Code of Federal 14 Regulations (CFR). Compounding of drugs from raw pharmaceutical agents, except for a 15 few specifically listed antidotes, is a violation of the CFR. Further, the use of illegally 16 compounded products in food animals is ill-advised not only due to the legal and liability 17 issues, but also because of a potential consumer perception issue. A final point to 18 consider is the consumer reaction when current bovine reproductive management 19 programs are presented to the consuming public by anti-agriculture activists.