The Following Is Information on the New Animal Drug Regulations to Implement the Veterinary

The following is information on the new animal drug regulations to implement the veterinary feed directive (VFD). There are links to 5 sites with more information.

Veterinary Feed Directive

Summary

The Food and Drug Administration (FDA) is amending its animal drug regulations regarding veterinary feed directive (VFD) drugs. FDA's current VFD regulation established requirements relating to the distribution and use of VFD drugs and animal feeds containing such drugs. This amendment is intended to improve the efficiency of FDA's VFD program while protecting human and animal health.

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Veterinary Feed Directive (VFD)

The Food and Drug Administration (FDA) has amended the new animal drug regulations to implement the veterinary feed directive (VFD) drugs section of the Animal Drug Availability Act of 1996 (ADAA). On June 3, 2015, the FDA published in the Federal Register the final rule revising the VFD regulations in 21 CFR Part 558. The final rule becomes effective in120 days. At the same time, FDA revised Guidance for Industry #120, Veterinary Feed Directive Regulation. The draft guidance is available for comment.

A VFD drug is intended for use in animal feeds, and such use of the VFD drug is permitted only under the professional supervision of a licensed veterinarian.

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Guidance for Industry

New Animal Drugs and New Animal Drug Combination Products Administered in or on Medicated Feed or Drinking Water of Food-Producing Animals: Recommendations for Drug Sponsors for Voluntarily Aligning Product Use Conditions with GFI #209

This Guidance covers the following:

I. Introduction

II. Background

A. Therapeutic Uses that Help Assure the Health of Animals

B. Veterinary Oversight

III. Medically Important Antimicrobial Drugs

IV. Voluntary Adoption of Judicious Use Principles

A. Voluntarily Phasing out Production Uses

B. Need for Veterinary Oversight of Medically Important Antimicrobial Drugs Used in

the Feed or Water of Food-Producing Animals

C. Additional Considerations.

V. Timeline for Voluntarily Implementing Changes

VI. Supplemental New Animal Drug Applications

A. Removing Production Uses/Changing Marketing Status

B. Adding New Therapeutic Indications

VII. Generic Drugs and Combinations

A. Generic Applications

B. Combination New Animal Drugs

VIII. References

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Guidance for Industry

The Judicious Use of Medically Important Antimicrobial Drugs in Food -Producing Animals Contains Nonbinding Recommendations 2

This Guidance covers the following:

I. Executive Summary

II. Introduction

III. Key Reports and Peer-Reviewed Scientific Literature on the Issue

IV. Strategies for Controlling Antimicrobial Resistance Are Needed

V. Current Regulatory Framework

VI. Status of FDA’s Current Activities

VII. Recommended Principles Regarding Judicious Use in Animals

VIII. Conclusion

IX. References

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Veterinary Feed Directive Requirements for Veterinarians

This site is a Q/A on VFD and covers the following topics:

VFD Statement

VFD Drug and Combination VFD Drug

VFD Drugs and Prescription Drugs

Veterinarians' Responsibilities

Major and Minor Animal Species

VFD Transmitting and Other Topics

VFD and VCPR, Client

Reorders (Refills)

A Lawful VFD Has to be Complete

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