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
