Table of Contents

Compliance Documents
Warning Letters
FDA Import Alerts List
Compliance FAQs
Additional Information
CVM and Compliance
Compliance Programs
Turtle Regulations
CVM CPGM
FDA CPGM

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

• 1240.1131 - Office of Surveillance and Compliance, Division of Compliance (Functional Statement)

• 1240.2202 - Voluntary Compliance, August 11, 1992

• 1240.3600 - Types of Enforcement Activities, September 18, 1998

• 1240.3601 - Types of Regulatory Actions, September 18, 1998

• 1240.3605 - Regulating Animal Foods with Drug Claims, September 18, 1998

• 1240.3620 - Request for CGMP Establishment Inspections September 18, 1998

• 1240.3622 - Good Manufacturing Practice Compliance Status, September 18, 1998

• 1240.3630 - Tissue Residue Reporting, September 18, 1998

• 1240.3650 - Diversion of Unfit Food to Animal Use, September 18, 1998

• 1240.3660 - Development of Compliance Policy Guides Affecting Veterinary Products, September 18, 1998

• 1240.3661 - Preparation of Compliance Programs and Program Circulars, September 18, 1998

• 1240.3670 - Management of Formal Evidentiary Hearings, September 18, 1998

• 1240.4170 - CVM Medically Necessary Veterinary Drug Product Shortage Management, April 25, 2000

CVM Compliance Guidance Documents

• Guidance for Industry #68: Small Entities Compliance Guide for Protein Blenders, Feed Manufacturers, and Distributors, February 1998

• Guidance for Industry #69: Small Entities Compliance Guide for Feeders of Ruminant Animals with On-Farm Feed Mixing Operations, February 1998

• Guidance for Industry #70: Small Entities Compliance Guide for Feeders of Ruminant Animals without On-Farm Feed Mixing Operations, February 1998

• Guidance For Industry #76: Questions and Answers BSE Feed Regulations, July 1998

• Guidance for Industry #102: "Manufacture and Distribution of Unapproved Piperazine Products" - Revised, August 27, 1999

CVM Warning Letters

• FDA Warning Letter Index for CVM

• Warning Letters issued jointly with Other Centers

  • Shanghai Medical Ltd., | htm | | pdf | February 10, 2004

FDA Import Alerts List

• FDA Imports Alerts List for Animal Drugs and Feeds

• Import Alert #71-02, 1/21/04, Import Alert #71-02, "Detention Without Physical Examination of Animal Feeds and Feed Ingredients that May Contain Ingredients of Animal Origin" , Attachment April 3, 2007

• Import Alert #99-29, Detention without Physical Examination of All Vegetable Protein Products from China for Animal for Human Food Use Due to the Presence of Melamine and/or Melamine Analogs, IA#99-29, July 31, 2007

Frequently Asked Compliance Questions (Compliance FAQs) 

Where can I find CVM Compliance Policy Guides  for Pet Foods?

• Pet Food Labeling

• Canned Pet Food

• Water and Gravy in Pet Food

• Uncooked Meat for Animal Food

• Rodent Contaminated Pet Food

• Salmonella Contamination of Dry Dog Food

Where can I find information about a valid veterinarian-client-patient relationship (VCPR)?

• Definition – 21 CFR 530.3(i)

• Compounding of Drugs for Use in Animals

• FDA and the Veterinarian

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  

• Bovine Spongiform Encephalopathy (BSE)

• Compounding

• CVM and Counterterrorism

• CVM and Pet Foods

• CVM Division of Compliance  

• 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.

• 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.

• 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.

• 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.

• 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.

• Withdrawal of Enrofloxacin in Poultry

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