Regulatory Brief

 Veterinary Feed Directive

Formal Title: [Docket Number: FDA-2010-N-0155] Veterinary Feed Directive

Brief Description: 

The Food and Drug Administration (FDA) is proposing to amend its animal drug regulations regarding veterinary feed directive (VFD) drugs.  FDA's VFD regulation, which became effective on January 8, 2001, established requirements relating to the distribution and use of VFD drugs and animal feeds containing such drugs.  This proposed amendment is intended to improve the efficiency of FDA's VFD program.

Excerpts from the AVMA response:

The AVMA commends the FDA for its initiative in proposing to amend veterinary feed directive drug regulations to improve the efficiency of the VFD program, providing information (Guidance for Industry #213) to sponsors of certain antimicrobial new animal drug products to revise conditions of use for those products consistent with GFI #209, and setting timelines for stakeholders to comply.

Historically, the AVMA has collaborated with the FDA and other stakeholders to develop principles and processes that encourage the appropriate and judicious therapeutic use of medically important antimicrobials by veterinarians. Recognizing that the framework for implementation of judicious use principles has been set forth in GFI #209, the AVMA Steering Committee for FDA Policy on Veterinary Oversight of Antimicrobials has been engaged with the FDA Center for Veterinary Medicine on multiple discussions related to increasing veterinary oversight and the execution of the new VFD program to achieve that mutual goal. We greatly appreciate the FDA’s willingness to engage with the veterinary profession on this topic. Our membership has a strong, vested interest in ensuring that the VFD regulations be an efficient and appropriate mechanism for veterinary use of antimicrobial-medicated feed in food producing animals. We commend the FDA for its diligence in ensuring that regulations for the distribution and use of VFD drugs are updated and streamlined to facilitate the transition of certain new animal drug products from over-the-counter status to a status that requires veterinary oversight.

Recognizing that VFDs represent the regulatory means to achieve greater veterinary oversight of antimicrobials in feed, the AVMA is fully supportive of the FDA’s efforts. The AVMA also appreciates the emphasis within the FDA’s approach in regulating veterinary professional conduct by reiteration of the VFD definition under general requirements and veterinary responsibility sections of the proposed regulations. We are highly appreciative of the FDA’s collaboration and engagement of key stakeholders to ensure that feedback is received, concerns are heard, and potential problems are addressed. The AVMA is especially pleased that its recommendations were thoughtfully considered and that many are reflected in the proposed rule.

The FDA’s recognition of the complex scientific and regulatory issues involved in the changes to the VFD regulations and the potential impacts they may have on stakeholders is evident and highly regarded by our leadership. We applaud the FDA’s efforts to safeguard public health and animal health and well-being.

Background Documents:

Relevant AVMA Policy: