Regulation of Medications

All products considered "drugs" for man and animals are regulated by the Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act (FFDCA). This act and the accompanying regulations were placed into law in order to control the quality, safety and effectiveness of drugs used in man and animals and to try to put an end to the quackery and dangerous patent medicines that were rampant years ago. One of the FDA centers is the Center for Veterinary Medicine which is responsible for administering these laws that apply to animal drugs and devices. That responsibility includes not only drugs for pets but the huge market of drugs and medicated feed additives for food animals like cows and chickens.

According to the FFDCA, if a product is labeled to treat or prevent disease in any animal or man, then it is considered a drug. It must therefore be proven safe and effective for its purpose. That almost invariably means that the sponsor is required to obtain FDA approval to legally market the product in the U.S. For animal drugs, this takes the form of an approved NADA (New Animal Drug Application). The approved NADA requires the sponsor to supply significant evidence of the product's safety, efficacy and manufacturing controls that assure purity, potency, stability and consistency. In addition, the sponsor is required to continually monitor the product for manufacturing problems, adverse reactions and other problems that might affect the product and report any such problems to the Agency.