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How Monographs are Developed
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How USP Developed Veterinary Pharmaceutical

Information Monographs

USP developed veterinary pharmaceutical information monographs by an intensive process of compiling approved product label information on drug use and also collecting and analyzing publicly available data on each drug from research studies and clinical reports. Careful attention is paid to differentiating species-specific information. Each draft chapter or monograph is then put through a review process that includes USP Veterinary Medicine Advisory Panel members, regulatory representatives, pharmaceutical manufacturers, ad hoc specialists, and public review. Click here for a complete description of this process as presented at the 2008 Workshop on Companion Animal Antimicrobials, including the development of evidence tables.

The resulting resource provides practitioners with a wide range of information about the use of each particular medication in animals. It distinguishes between uses that are included in product labeling for specific animal species from those that are extra-label (off-label), but are considered generally Accepted on a scientific or clinical basis. If evidence is limited or conflicting, label and extra-label uses may be listed as Acceptance not established indications. Drug uses that are not currently considered scientifically sound are listed under an Unaccepted heading. The goal of each monograph is to provide information to aid practitioners in making therapeutic decisions.

In addition to species-specific indications, each monograph contains carefully evaluated information about many aspects of drug use, including dosing, regulatory considerations, chemistry information, comprehensive pharmacology and pharmacokinetic data, drug interactions, medical considerations/contraindications, side/adverse effects, overdose, brand names, and withdrawal times.

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