The frequency with which new drug monographs are included in Plumb’s Veterinary Drugs is dependent upon research, development, and release by pharmaceutical companies. Once a drug has been chosen, a monograph is written by an expert in the field for which the drug is commonly prescribed. The monograph is then peer reviewed and published within 60 days.
Veterinary Labeled Drugs
When a new drug is approved by the FDA for veterinary use, information is gathered to prepare a monograph. The content of the monograph is compiled from the new animal drug application (NADA), the Freedom of Information (FOI) Summary, and pre-approval studies. The monograph is published once Brief Media receives communication from the manufacturer that the drug is available commercially.
Extra-Label Drugs
Many of the drugs approved for use in humans are used in an extra-label manner in veterinary medicine. The Animal Medicinal Drug Use Clarification Act of 1994 (AMDUCA) permits veterinarians to prescribe extra-label uses of certain approved new animal drugs and approved human drugs for animals under certain conditions.
Extra-label use refers to the use of an approved drug in a manner that is not in accordance with the approved label directions. This includes, but is not limited to, use in species not listed in the labeling, use for indications (disease or other conditions) not listed in the labeling, use at dosage levels, frequencies, or routes of administration other than those stated in the labeling, and deviation from the labeled withdrawal time based on these different uses.
Under AMDUCA and its implementing regulations published at Title 21, Code of Federal Regulations, Part 530 (21 CFR 530), any extra-label use of an approved new animal or human drug must be by or on the lawful order of a veterinarian within the context of a veterinarian-client-patient relationship (VCPR). There are additional specific conditions that must be met for extra-label use of approved animal drugs and approved human drugs in food-producing animals. Once substantial clinical evidence exists in the peer-reviewed literature for the safe use of an extra-label drug, a monograph is created. The decision to publish extra-label drug information is made by the Editor-in-Chief.
Regulatory Information
Plumb’s publishes food animal withdrawal times according to US label information. Users are encouraged to verify all statements with their local authorizing agents. Appendix items are available for users to understand some of the regulatory requirements enforced by the Food and Drug Administration (FDA) as well as extra-label use of these drugs.
International Drugs
Some drugs and drug formulations are available in countries outside the United States. Use of these drugs may be considered extra-label in the United States. When using the Plumb’s reference, users must incorporate the information with local regulations related to legal drug use in the applicable country(ies). It is important to note that drugs may be labeled with different indications, dosages, contraindications, and withdrawal times in each country. While Plumb’s aims to provide accurate information regarding all products, it is ultimately the responsibility of the product user to understand the safe and legal use of the applicable drug in their jurisdictions.