Office of Surveillance and Compliance
Vision
We champion the health of every animal and human.
Mission
We serve the public by protecting and promoting animal and human health. We are strategic and dynamic in our approach to public health challenges. We make informed decisions guided by science and law. We collaborate and leverage relationships with our stakeholders.
OSC Leadership Philosophy
OS&C is an inclusive community of devoted, resourceful, and reliable stewards of public health. We are motivated by our critical role in continuously improving animal and human health. Each of us makes a difference by contributing to the success of the office and each other. We believe that the performance of the office is enhanced by investing in the growth and development of the individual. We openly communicate and strive to make decisions collaboratively, providing space for creativity and innovation.
CVM's Office of Surveillance and Compliance (OS&C) is responsible for regulating marketed animal drugs and animal devices for safety and effectiveness. OS&C is also responsible for overseeing animal food safety programs including reviewing food additives, evaluating Generally Recognized as Safe (GRAS) notifications, and monitoring the safety of animal food; including pet food and medicated feed. These regulatory responsibilities are carried out by veterinarians, animal scientists, toxicologists, consumer safety officers, regulatory counsels and other scientific experts. OS&C serves as CVM’s liaisons and chief coordinators to the Office of Regulatory Affairs (ORA), the lead office for all agency field activities. OS&C provides direction and scientific support for these field activities which include: inspecting regulated products and manufacturers, conducting sample analyses of regulated products, and reviewing imported products that may enter into the United States.
OS&C has primary responsibility for compliance-related actions, post-approval monitoring, pharmacovigilance, and animal food safety. These major functions of OS&C are implemented through:
- Conducting compliance education, outreach and enforcement to the regulated industries.
- Monitoring the safety and effectiveness of marketed animal drugs and devices by overseeing: violative drug residues in edible tissue of food animals, drug promotion and advertising, product labeling, and manufacturing.
- Monitoring and evaluating adverse events and product quality problems reported for marketed animal drugs, animal food, and animal devices to identify new safety issues.
- Assuring the safety of animal food by reviewing new animal food ingredients, evaluating risks of food contaminants, and by ensuring industry take steps to appropriately prevent and address animal food hazards.
OS&C provides compliance education through various inspection programs for regulated industries and utilizes regulatory tools such as recalls, market withdrawals, safety alerts, import alerts, and advisory actions to ensure compliance. OS&C also coordinates the Center’s enforcement functions involving regulated products, such as injunctions and actions to withdraw drug approvals.
OS&C is responsible for regulating a wide range of products for use in animals once they are on the market. These products include approved and unapproved drugs, animal devices, and animal food. Even though an approved animal drug product is carefully tested before it is marketed, wider use of the product may reveal issues not evident during the pre-approval review. Analysis of adverse event data can lead to the detection of safety signals which may indicate a problem with a product, or problems with how it is being used. If further review of detected safety signals confirms issues of concern, several actions are possible, including: product safety alerts, product label or packaging changes, recalls, or even approval withdrawal if the product is determined to be unsafe or ineffective. Assessment of the safety and effectiveness of an animal drug is a continuing process that takes place throughout the life cycle of a drug.
Post-approval surveillance includes assessing how a drug is marketed. OS&C regulates the promotion and advertising (prescription drugs only) of approved animal drugs to ensure the materials are truthful and not misleading. Other post-approval surveillance activities include: monitoring the quantity and use of marketed approved animal drugs, particularly those used in food-producing animals to inform efforts that mitigate antimicrobial resistance; and taking steps to prevent and mitigate animal drug shortages, particularly those affecting medically necessary veterinary products.
OS&C is responsible for assuring the safety of animal derived foods. When drugs are approved for food producing animals, safe residue tolerances are established. Working with the U.S. Department of Agriculture and state agencies, OS&C monitors the occurrence of unsafe drug residues in meat, milk, and poultry products, and guides efforts to protect consumers through educational and enforcement activities related to drug residues. OS&C has a broad range of responsibilities in regulating animal food both before and while it is marketed. The Office conducts various programs to protect the animal food supply from contamination by toxic materials such as mycotoxins, pesticides, heavy metals, and industrial chemicals. OS&C approves food additives for use in animal food, evaluates notifications that ingredients are GRAS for an intended use in animal food, and reviews new plant varieties for safety. OS&C administers the feed mill licensing and Veterinary Feed Directive distributor registration programs and coordinates risk-based inspections of animal food manufacturers.
Additional Information