兽药饲料指令（Veterinary Feed Directive）

Final Rule.

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.

UNIFIED AGENDA

Veterinary Feed Directive

5 actions from March 29th， 2010 to April 2015

March 29th， 2010

ANPRM

75 FR 15387

June 28th， 2010

ANPRM Comment Period End

December 12th， 2013

NPRM

78 FR 75515

March 12th， 2014

NPRM Comment Period End

April 2015

Final Rule

TABLE OF CONTENTS

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DATES:

FOR FURTHER INFORMATION CONTACT:

SUPPLEMENTARY INFORMATION:

Executive Summary

Purpose of Final Rule

Summary of Major Provisions

Costs and Benefits

Table of Contents

I. Background

A. History

B. Judicious Use Policy for Medically Important Antimicrobials

II. Overview of the Final Rule

III. Comments on the Proposed Rule

A. Definitions Section (§ 558.3)

1. Category II Drug (§ 558.3(b)(1)(ii))

2. Veterinary Feed Directive Drug (§ 558.3(b)(6))

3. Veterinary Feed Directive (§ 558.3(b)(7))

4. Distributor (§ 558.3(b)(9))

5. Animal Production Facility (§ 558.3(b)(10))

6. Combination VFD Drug (§ 558.3(b)(12))

B. Veterinary Feed Directive Drugs (§ 558.6)

1. General Requirements Related to VFD Drugs (§ 558.6(a))

a. VFD Retention and Transmission Requirements (§ 558.6(a)(4))

b. Caution Statement on Labeling (§ 558.6(a)(6))

c. Length of Time VFD and Records Must Be Kept (§ 558.6)

2. Responsibilities of the Veterinarian Issuing the VFD (§ 558.6(b))

a. Veterinarian Oversight， Supervision and the Veterinarian Client-Patient Relationship (VCPR) (§ 558.6)(b)(1)).

b. Veterinarian Licensing Information

c. Name of Animal Drug (§ 558.6(b)(3)(vi))

d. Client Name and Address (§ 558.6(b)(3)(ii))

e. Premises at Which the Animals Specified in the VFD Are Located (§ 558.6(b)(3)(iii))

f. Expiration Date (§ 558.6(b)(3)(v))

g. Approximate Number of Animals To Be Fed the VFD Feed by the Expiration Date on the VFD (§ 558.6(b)(3))

h. Refills or Reorders Authorized on the VFD (§ 558.6(b)(3)(xii))

i. Combination Drugs (§ 558.6(b)(6)(xiv))

j. Veterinarian Must Issue a Written VFD (§ 558.6(b)(7))

k. Contents of the VFD

3. Responsibilities of Any Person Who Distributes an Animal Feed Containing a VFD Drug or a Combination VFD Drug (§ 558.6(c))

4. Other Comments

IV. Legal Authority

V. Final Regulatory Impact Analysis

VI. Paperwork Reduction Act of 1995

A. Reporting Requirements

Description of Respondents: VFD Feed Distributors， VFD Drug Sponsors