SAFETY EFFICACY: WHAT A DRUG LABEL DOES DOES NOT TELL YOU

摘要

The information that must be provided on the labels of medications that have been approved by the Food and Drug Administration - Center for Veterinary Medicine (FDA-CVM) is strictly regulated. The authority of the agency to regulate label content is provided for in the Federal Food, Drug and Cosmetic Act (FFDCA) and the Code of Federal Regulations.1,2 The regulatiot are very specific on what information must be provided on the label and what is not allowed. In addition, there are some differences between products that require a prescription (RX) and those available over the counter (OTC), those that are administered orally versus parenterally, and all of these products and Type B and C Medicated Feeds. The label, the package insert, and the Freedomof Information (FOI) Summary provide a plethora of information that is often not utilized by clinicians. It is important to understand what information is provided on medication labels and how to interpret it.