Table of Contents

Division of Compliance
About CVM
Mission Statement
Vision Statement
Guiding Principles
CVM Organization Chart
Introduction
A Brief History of CVM
Structure/Responsibility
CVM Annual Reports
Safeguarding Animal Hlth
Office of the Director (OD)
Office of Management
CVM & Budget
Ofc of New Animal Drug
Surveillance/Compliance
Office of Research
Minor Use Minor Species

Even though a new animal drug product is carefully tested before it is marketed, wider use of the product may disclose problems not evident during the pre-marketing research. Therefore, the assessment of the safety of a new drug is a continuing process that takes place throughout the development and marketing of a drug. Post-marketing surveillance is the process for assessing drug safety.

The CVM's Office of Surveillance and Compliance (OS&C), in cooperation with the FDA Field Offices, monitors marketed animal drugs, food additives, and veterinary devices to assure their safety and effectiveness. This regulatory responsibility is carried out by scientists, investigators, and analysts around the country. Also involved in these activities are the Department of Agriculture (USDA), the Environmental Protection Agency (EPA), and other State and Federal agencies. Federal field investigators and State inspectors conduct inspections of medicated feed manufacturers to assure that acceptable manufacturing procedures are followed. Violations can result in regulatory action.

Functions among the OS&C Divisions are varied, yet closely related. One Division’s function is the overseeing of medicated animal feeds. Another involves monitoring drugs used in food and non-food animals, and providing scientific expertise for legal cases. Another is to monitor antibiotic resistance in animal derived foods. Another Division’s function is to monitor Compliance of the industry by working cooperatively with the other OS&C Divisions, educational outreach to the field and industry and to pursue regulatory actions if warranted.

One of CVM's highest priorities is assuring the safety of animal derived foods. Drugs are used in food-producing animals to treat and prevent animal diseases, and to increase animal production. Contaminants in animal feeds can have an impact on human food safety.

The National Antimicrobial Resistance Monitoring System (NARMS) was established in January 1996 as a collaborative effort among the FDA, USDA, and CDC. The system was initiated in response to public health issues associated with the approval of fluoroquinolone products for use in poultry. The NARMS monitors changes in susceptibilities to 17 antimicrobial drugs of zoonotic enteric pathogens from human and animal clinical specimens, from healthy farm animals, and from carcasses of food-producing animals at slaughter.

Important augmentations of the NARMS were made possible by funding from the President’s National Food Safety Initiative (FSI). These augmentations include expanding the scope of the monitoring system and conducting follow-on research and investigations. The most important expansion of the monitoring system has been to include Campylobacter and E. coli isolate testing and reporting, in addition to Salmonella, from animal sources.

With the additional funding provided by the FSI, epidemiologic research also was initiated. This research is to characterize and reduce the incidence of foodborne disease associated with emerging and drug-resistant pathogens and includes a field study, several farm-based efforts, and molecular genetic research.

Recognizing the need to maintain a balance between the health of food animals and maintaining the safety and effectiveness of human antimicrobials, CVM/OS&C has requested drug sponsors to provide information, in the form of Post-Approval Monitoring Programs (PAMPs), during the marketing period for those food animal new animal drugs that are of public health concern. PAMPs are designed to provide FDA with information related to changes in antimicrobial susceptibility of foodborne pathogens in animals that may be exposed to the drug under actual growth conditions

The U.S. Department of Agriculture's Food Safety and Inspection Service (FSIS) is responsible for the inspection of meat and poultry products in Federally-inspected establishments and has primary responsibility for the wholesomeness of these products. FSIS reports violative residues of drugs in meat and poultry to FDA for regulatory follow-up.

FDA and State agencies, under inspectional agreements with FDA, conduct follow-up inspections of producers or others involved in the production or marketing of food animals or poultry which have tissue residue violations. The goal of CVM's Tissue Residue Program is to eliminate violative drug residues in edible tissue of food animals.

The National Drug Residue Milk Monitoring Program (NDRMMP) is another effort to ensure milk safety. The NDRMMP routinely tests raw milk for drug residues. It is a cooperative effort between FDA and State milk control officials. Milk samples are assayed for eight sulfonamide and three tetracycline drugs, chloramphenicol, and the beta lactam antibiotics. Analytical methods for more compounds are added as they are developed.

Additional functions of the OS&C include:

• Approves food additive petitions after determining their safety and utility.

• Approves Medicated Feed Mill Licenses after ensuring the sponsoring firm is operating in compliance with good manufacturing practice.

• Monitors animal feeds with regard to their safety to the animals which receive them, to the public who consume the food products derived from treated animals, and to the environment.

• Monitors approved veterinary drugs and food additives to assure their continued safety and effectiveness.

• Monitors marketed unapproved veterinary drugs and veterinary devices.

• Enforces industry compliance with the FFDCA by evaluating and coordinating legal cases brought against violators by the Agency.

• Reviews product labels and provides assessments of their status.

• Withdraws drugs and food additives from the market when conditions warrant removal, based on scientific fact concerning a lack of safety and/or effectiveness

• Assures that good laboratory practices are maintained, through the monitoring of laboratory investigators who conduct studies as part of the NADA approval process. Monitors the conduct of clinical investigators and sponsors of clinical investigations.

• Continuously monitors and evaluates reports of adverse drug experiences for animal safety and public health issues. Withdrawal of an approved drug may be recommended if it is determined to be unsafe or ineffective.

• Collaborates with USDA/FSIS on drugs and chemicals in meat and poultry.

• Develops and implements policies that affect marketed products.

   

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