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.
Organization of OS&C
The CVM's Office of Surveillance and Compliance (OSC) is responsible for regulating marketed animal drugs and animal devices for safety and effectiveness. OSC 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. OSC serves as CVM's liaisons and chief coordinators to the Office of Regulatory Affairs (ORA), the lead office for all agency field activities. OSC 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.
The Division of Pharmacovigilance and Surveillance (DPS) meets the challenges of CVM's Mission to protect human and animal health by continuously monitoring the safety, quality, and effectiveness of regulated animal drugs and devices. If new drug risks are identified through surveillance efforts, DPS develops strategies to mitigate those risks. Work activities include review and assessment of safety information (adverse event reports, medication error reports, product defect reports, and sponsor-submitted periodic drug experience reports) as well as review of promotion and advertising materials. DPS also reviews product labeling and proprietary names before new animal drugs are approved and marketed, manages CVM's Drug Product Listing (DPL) information, and maintains a database of animal drugs in commercial distribution in the United States.
SMG 1244.10 - Division of Pharmacovigilance and Surveillance
A safe animal feed supply helps ensure healthy animals and people. To that end, the Division of Animal Food Ingredients (DAFI) in the Center for Veterinary Medicine reviews pre-market animal food ingredient submissions, including approving safe food additives, evaluating Generally Recognized as Safe (GRAS) notifications, serving as the scientific review for Association of American Feed Control Officials (AAFCO) feed ingredient definitions, reviewing biotech plant notifications, and reviewing animal food labels as well as pet foods with certain claims. DAFI also provides scientific support and guidance on all animal food ingredient matters to FDA and state regulatory officials.
Safe and effective animal medical products are an important part of promoting animal health along with ensuring safe and wholesome human food that is derived from animals treated with drugs. To that end, the Division of Drug Compliance (DDC) is committed to preventing violations and enforcing the Federal Food, Drug and Cosmetic Act. Additionally, DDC makes regulatory decisions based related laws regarding animal drugs and devices, various guidance documents, outreach with industry and consumers, and other regulatory activities. Some areas include bioresearch monitoring (BIMO), current good manufacturing practice (CGMP), unapproved drugs, compounded drugs, medical devices, drug imports and exports, product jurisdiction, extra label use, illegal drug sales, and recalls.
Ensuring the safety of the animal food supply is critical to ensuring the health and safety of both animals and humans. The Division of Food Compliance (DFC) is committed to detecting animal food safety incidents and enforcing laws and regulations designed to protect the food supply including the Federal Food, Drug and Cosmetic Act and the Food Safety and Modernization Act (FSMA). DFC makes regulatory decisions based on related laws and regulations, scientific data, coordination with our FDA and state partners, outreach with industry and consumers, and other regulatory activities. Some animal food program areas overseen by DFC include regulatory and compliance program development for FSMA regulations, medicated feed, Veterinary Feed Directive (VFD), and Bovine Spongiform Encephalopathy (BSE); contaminants; imports; and complaint, emergency response and recalls.
Additional Information
- Report a Problem
- Post-approval Animal Drug Reporting Requirements
- Product Regulation
- Reportable Food Registry for Industry
- CVM accepts online applications for export certificates through the CVM Export Certification Application and Tracking System