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Table of Contents
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One of the highest priorities of the Center for Veterinary Medicine (CVM) is assuring the safety of animal derived foods, and assuring that safe and effective animal drugs are available. Compliance is monitoring the adherence of regulated industry with legal, administrative, and regulatory programs and policies. Within CVM the Division of Compliance monitors the activities of our stakeholders, performs educational outreach to the field and industry, and pursues regulatory actions if warranted.
Questions concerning CVM’s Compliance activities can be addressed to:
Division of Compliance (HFV-230) Office of Surveillance and Compliance Center for Veterinary Medicine U.S. Food and Drug Administration MPN IV Bldg., Room 146 7519 Standish Place Rockville, MD 20855-2773 Telephone: (240) 276-9200 FAX: (240) 276-9241
CVM Updates/FDA Talk Papers on Compliance Activities
Compliance Documents
Compliance Policy Guides (CPG) – Chapter 6 – Veterinary Medicine
Provides a convenient and organized system for statements of FDA compliance policy, including those statements which contain regulatory action guidance information.
CVM Compliance Program Guidance Manual (CPGM)
Compliance programs and program circulars (program plans and instructions) directed to field personnel for project implementation.
CVM Policy and Procedures Manual
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1240.1131 - Office of Surveillance and Compliance, Division of Compliance (Functional Statement)
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1240.2202 - Voluntary Compliance, August 11, 1992
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1240.3600 - Types of Enforcement Activities, September 18, 1998
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1240.3601 - Types of Regulatory Actions, September 18, 1998
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1240.3605 - Regulating Animal Foods with Drug Claims, September 18, 1998
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1240.3620 - Request for CGMP Establishment Inspections September 18, 1998
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1240.3622 - Good Manufacturing Practice Compliance Status, September 18, 1998
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1240.3630 - Tissue Residue Reporting, September 18, 1998
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1240.3650 - Diversion of Unfit Food to Animal Use, September 18, 1998
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1240.3660 - Development of Compliance Policy Guides Affecting Veterinary Products, September 18, 1998
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1240.3661 - Preparation of Compliance Programs and Program Circulars, September 18, 1998
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1240.3670 - Management of Formal Evidentiary Hearings, September 18, 1998
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1240.4170 - CVM Medically Necessary Veterinary Drug Product Shortage Management, April 25, 2000
CVM Compliance Guidance Documents
CVM Warning Letters
FDA Import Alerts List
Frequently Asked Compliance Questions (Compliance FAQs)
Where can I find CVM Compliance Policy Guides for Pet Foods?
Where can I find information about a valid veterinarian-client-patient relationship (VCPR)?
How do I obtain an export certificate?
Forms and instructions can be found at Form FDA 3613 - Supplementary Information Certificate to Foreign Government Requests (Expiration Date: March 31, 2009) | pdf | | doc |.
Where can I get information about importing unapproved veterinary drugs for my pet?
For assistance with importing unapproved, but medically necessary veterinary drugs for personal use for your pet, please contact Mr. Mike Zimmerman, CVM/OSC/Division of Compliance (HFV-235), at phone (240) 276-9202, Fax (240) 276-9241, or by e-mail at michael.zimmerman@fda.hhs.gov.
How does FDA regulate veterinary devices?
Information for Consumers: How FDA Regulates Veterinary Devices
Additional Information
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Bovine Spongiform Encephalopathy (BSE)
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Compounding
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CVM and Counterterrorism
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CVM and Pet Foods
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CVM Division of Compliance
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FDA/CFSAN National Drug Residue Milk Monitoring Program (NDRMMP)
The NDRMMP is designed to provide an indication of animal drug residues that may be present in milk and the extent that farmers, distributors, and veterinarians comply with the Federal Food, Drug, and Cosmetic Act, implementing regulations and applicable policies.
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FDA/CVM BSE/Ruminant Feed Inspection Program
Inspections of renderers, feed mills, ruminant feeders, protein blenders, pet food manufacturers, pet food salvagers, animal feed distributors and transporters, ruminant feeders, and others have been conducted to determine compliance with the BSE/Ruminant Feed regulations.
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FDA/ORA Bioresearch Monitoring Information (BIMO)
On-site inspections and data audits designed to monitor all aspects of the conduct and reporting of FDA regulated research. The BIMO Program was established to assure the quality and integrity of data submitted to the agency in support of new product approvals, as well as, to provide for protection of the rights and welfare of the thousands of human subjects involved in FDA regulated research.
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National Antimicrobial Resistance Monitoring System (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.
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Post-Approval Monitoring Programs (PAMPs) - 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.
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Withdrawal of Enrofloxacin in Poultry
Web Page Updated by mdt - March 26, 2008, 8:56 AM ET
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