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Development, Manufacture, and Distribution of Animal Drugs

The Upjohn Company, Animal Health Research and Development, Kalamazoo, Ml 49001

ABSTRACT

Introduction

The key to wise use of drugs by the dairy producer is to follow directions of the label. Label directions are written by manufacturers, reviewed, and approved by the Food and Drug Administration in a manner consistent with the way it was researched. To deviate from label directions is an invitation to trouble with respect to both efficacy and safety of the product. To provide specifics, an example of the development of a mastitis preparation is presented. Hopefully, from this one will obtain a better understanding of why it is critical that products be used as labeled.

Formulation

Mastitis formulations which are infused intramammarily have unique requirements among parenterally used products. The formulation must be suitable as a carrier for the active drugs. It must be both chemically and physically stable. At the same time the formulation must not be so irritating to the udder that it creates more problems than it cures.