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Statement of Need:

Before 1996, two options existed for regulating the distribution of animal drugs, including drugs in animal feed: (1) over-the-counter (OTC); and (2) prescription (Rx). In 1996, the Animal Drug Availability Act (ADAA) created a new category of products called veterinary feed directive (VFD) drugs. VFD drugs are new animal drugs intended for use in or on animal feed, which are limited to use under the professional supervision of a licensed veterinarian in the course of the veterinarian's professional practice. In order for animal feed containing a VFD drug to be used in animals, a licensed veterinarian must first issue an order, called a veterinary feed directive (or VFD), providing for such use. The Food and Drug Administration (FDA, the Agency) finalized its regulation to implement the VFD-related provisions of the ADAA in December 2000. Since that time, FDA has received informal comments that the VFD process is overly burdensome. As a result, FDA began exploring ways to improve the VFD program's efficiency. To that end, FDA published an advanced notice of proposed rulemaking on March 29, 2010 (75 FR 15387), and draft text of a proposed regulation, which it published April 13, 2012 (77 FR 22247). The proposed revisions to the VFD process are also intended to support the Agency's initiative to transition certain new animal drug products containing medically important antimicrobial drugs from an OTC status to a status that requires veterinary oversight. The proposed rule, if finalized, will make the following changes to the VFD regulations at section 558.6 (21 CFR 558.6): (1) reorganize the VFD regulations to make them more user-friendly. This proposal will replace the six subsections of the existing regulations with three subsections that better identify what is expected from each party involved in the VFD process; (2) provide increased flexibility for licensed veterinarians and animal producers to align with the most recent practice standards, technological and medical advances, and practical considerations, to assure the safe and effective use of VFD drugs; (3) provide for the continued availability through the current feed mill distribution system of those Category I drugs that move to VFD dispensing status. This will prevent potential shortages of antimicrobial drugs needed by food animal producers for judicious therapeutic uses on their farms and ranches; and (4) lower the recordkeeping burden for all involved parties to align with other feed manufacturing recordkeeping requirements, thus eliminating the need for two separate filing systems.

Summary of the Legal Basis:

FDA's authority for issuing this rule is provided in the ADAA (Pub. L. 104–250), which amended the Federal Food, Drug, & Cosmetic Act (FD&C Act) by establishing section 504.

Alternatives:

An alternative to the proposed rule that would ease the burden on VFD drug manufacturers would be to allow additional time to comply with the proposed labeling requirements for currently approved VFD drugs, for example, 1 or more years after the final rule becomes effective. This would not affect any new VFD drug approvals after the effective date of the final rule, and it could provide a transition period for current VFD manufacturers to coordinate the labeling changes to the specimen labeling, representative labeling, the VFD form itself, and advertising within the usual frequency of label changes.

Anticipated Costs and Benefits:

The estimated one-time costs to industry from this proposed rule, if finalized, are the costs to review the rule and prepare a compliance plan. In addition, FDA estimates that the government will incur costs associated with reviewing the VFD drug labeling supplements that are expected to be submitted by the existing VFD drug manufacturers. The expected benefit of this proposal is a general improvement in the efficiency of the VFD process. Additionally, the reduction in veterinarian labor costs due to this rule is expected to result in an annual cost savings.

Risks:

As FDA continues to implement the judicious use principles for medically important antimicrobial drugs based on the framework set forth in Guidance for Industry #209, which published April 13, 2012, it is critical that the Agency makes the VFD program as efficient as possible for stakeholders while maintaining adequate protection for human and animal health. The provisions included in this proposed rule are based on stakeholder input received in response to multiple opportunities for public comment, and represent FDA's best effort to strike the appropriate balance between protection of human and animal health and programmatic efficiency.