CVM Compliance Program Guidance Manual

The Food and Drug Administration’s (FDA) Compliance Program Guidance Manual contains a series of documents, commonly called “Compliance Programs,” which are prepared and managed by each of the Centers that constitute the FDA. These documents provide guidance and instructions to FDA personnel for conducting investigations, inspections, sample collections, sample analyses and regulatory activities in specific program areas.

A Compliance Program does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations enforced by the FDA. It is intended for FDA personnel and is available electronically to the public.

The Compliance Programs currently managed by the Center for Veterinary Medicine (CVM) are on the CPG Manuals page. Other Compliance Programs which are managed by other FDA Centers can be found in electronic form on the FDA’s Office of Regulatory Affairs’ (ORA) web page - Compliance Program Guidance Manual for FDA Staff.

Chapter 68 - Approval Evaluation of Animal Drugs

7368.001 Pre-Approval Inspections: New Animal Drug Applications (NADA); Abbreviated New Animal Drug Applications (ANADA); and Investigational New Animal Drug Applications (INADA)
This program is designed to ensure that attention is focused on all aspects of the manufacturing and control procedures listed in the application, on the product formulations proposed in the applications, and on any unapproved changes in formulating and manufacturing procedures.

Chapter 71 - Post-Approval Monitoring of Animal Drugs, Feeds, and Devices

7371.001 Animal Drug Manufacturing Inspections
The goal of this compliance program is to minimize animals exposure to adulterated drug products, and human exposure to adulterated food resulting from animals treated with adulterated drug products. (Point of Contact: Jorge Christian, Sandra Washington)

7371.002 Illegal Sales of Veterinary Prescription Drugs
The goal of this compliance program is to minimize animals exposure to adulterated drug products, and human exposure to adulterated food resulting from animals treated with adulterated drug products. (Point of Contact: Mark Hackman)

7371.003 Feed Contaminants Program
This program is designed to:

1. To investigate the Contamination Response System (CRS) reports of violative feed samples.
2. To assure that the health of animals is not impaired and that human health is not compromised by contaminants in animal feed.
3. To sample and analyze animal feed for contamination by pesticides, industrial chemicals, elements, mycotoxins, and microbial agents, and were visible to generate information on levels of contaminants in the domestic and import feed supply.

7371.004 Feed Manufacturing Compliance Program
(Please note that the phone number for the Division of Animal Feeds has changed. It is now 240-453-6848.)
The purpose of this program is:

1. To conduct inspections of registered medicated feed firms and determine whether the firms are in compliance with the Federal Food, Drug, and Cosmetic Act and the implementing regulations.
2. To conduct inspections of firms (non-medicated feed mills, medicated feed mills, renderers, distributors, etc.) producing, using and feeding mammalian protein product(s) to ensure compliance with 21 CFR 589.2000.
3. To address concerns of drug residue carryover and superpotent and subpotent feeds.
4. To verify compliance with VFD requirements as needed.
5. To encourage voluntary corrective action by firms when appropriate.
6. To initiate administrative and/or regulatory action against violative firms and feed products.

7371.005 Type A Medicated Articles
This compliance program is:

1. To inspect establishments producing Type A medicated articles for compliance with 21 CFR Part 226 (Type A Medicated Article CGMP's).
2. To take regulatory action against adulterated and misbranded Type A medicated articles and violative firms.
3. To deny approval to firms in violation of CGMP\'s of pending NADA\'s for Type A medicated articles or withdrar approval of existing NADA's.
4. To determine from inspection at manufacturers repackers and relabelers the distributors of Type A medicated articles and investigate whether they, their consignees or the final users have proper authority to handle these products.

7371.006 Illegal Drug Residues in Meat, Poultry, Seafood and Other Animal Derived Foods
This compliance program addresses consumer exposure to drug residues in the edible tissues of food animals. The immediate outcome is the prevention of future residue violations through on-farm educational efforts, and/or enforcement activity as warranted. The intermediate outcome is the utilization of investigational data (from RVIS and TRIMS) for informed decision-making in future policies regarding the tissue residue area. The ultimate outcome is to protect the human food supply from violative levels of drugs. (Point of Contact: Deborah Cera, Frances Pell)

7371.009 BSE/Ruminant Feed Ban Inspections
To enhance the FDA’s uniformity in inspection and compliance of firms subject to the regulation prohibiting the utilization of specified animal proteins in ruminant feeds, 21 CFR §589.2000. The purpose of these regulations is to prevent the establishment and/or amplification of BSE within the United States. (Point of Contact: Neal Bataller, Shannon Jordre)