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From Health Law Daily, June 3, 2015

FDA moves to ensure judicious use of antimicrobials in food-producing animals

By Harold M. Bishop, J.D.

The FDA has announced the Veterinary Feed Directive (VFD) Final rule, an important piece of its strategy to promote the careful use of antimicrobials in food-producing animals. The Final rule revises the FDA’s VFD regulations to improve the efficiency of the program, while continuing to protect human and animal health, by bringing the use of antimicrobials under veterinary supervision so that they are prescribed only when needed to assure animal health.

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. Any animal feed containing a VFD drug can only be fed to animals based upon an order, called a VFD, issued by a licensed veterinarian in the course of the veterinarian’s professional practice. The FDA published VFD regulations to implement the VFD-related provisions of the Animal Drug Availability Act of 1996 (ADAA) (P.L. 104-250) in 2000 (see 21 C.F.R. sec. 558.6) (65 FR 76924, December 8, 2000).

FDA policy framework. The VFD Final rule is the third of three core documents that the FDA is using to announce and implement its policy framework for the judicious use of medically important antimicrobial drugs in food-producing animals.

The first document, Guidance for Industry (GFI) #209, entitled "The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals," published April 2012, set forth several key measures for ensuring the judicious use of medically important antimicrobial drugs in food-producing animals, including eliminating the feed and water use of medically important antimicrobial drugs for production purposes in food-producing animals and bringing all remaining therapeutic uses under the oversight of licensed veterinarians.

The second document, entitled "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," published December 2013, outlined a detailed process and timeline for implementing the measures identified in GFI #209. Once GFI #213 is fully implemented, affected feed-use antimicrobial drugs are expected to transition from over-the-counter (OTC) to VFD marketing status.

Final rule summary. The Final rule includes important controls regarding the distribution and use of VFD drugs and updates the VFD requirements to improve the efficiency of the process. The FDA believes that these enhancements are important for facilitating the transition of a large number of OTC feed-use antimicrobial drugs to their new VFD status.

The FDA intends to phase-in enforcement of the Final rule as OTC drugs become VFD drugs under GFI #213. First, the FDA will provide education and training for stakeholders such as veterinarians, animal producers, feed mill distributors, and other distributors. Second, the FDA plans to engage in risk-based general surveillance, as well as for-cause inspection assignments. Specifically, the Final rule:

  • clarifies that the veterinarian is required to keep the original VFD (in hardcopy or electronically) and the distributor and animal producer must keep a copy of the VFD (in hardcopy or electronically);

  • specifies that the current requirement that copies of the VFD and records of the receipt and distribution of VFD feed must be kept for a period of two years is retained instead of being changed to one year as was proposed (see FDA to make the Feed Directive program more user friendly, 78 FR 75515, December 12, 2013);

  • provides that the veterinarian must issue the VFD in the context of a valid veterinarian-client-patient relationship (VCPR) as defined by the state where the veterinarian practices;

  • provides that in states that lack appropriate VCPR requirements applicable to VFDs, the veterinarian must issue the VFD consistent with the federally defined VCPR standard, set forth in the FDA’s regulations at 21 CFR 530.3(i);

  • provides that the VFD expiration date is the date that authorization to feed the VFD feed to animals expires;

  • clarifies how the VFD requirement for approximate number of animals should be determined;

  • clarifies the affirmation of intent statements to be used in VFDs issued by licensed veterinarians to indicate whether a VFD drug may be used in conjunction with another drug in an approved, conditionally approved, or indexed combination VFD feed; and

  • clarifies that the recordkeeping requirements to be kept for distributors who manufacture VFD feed and those who do not manufacture the VFD feed.

The Final rule is effective October 1, 2015.

Q&A guidance. Contemporaneously with the issuance of the VFD Final rule, the FDA announced the availability of a draft revised guidance entitled "Veterinary Feed Directive Regulation Questions and Answers" (Notice, 80 FR 31520, June 3, 2015). The draft guidance describes the current VFD requirements for veterinarians, feed manufacturers and other distributors, animal producers, and other parties involved in the distribution or use of medicated feed containing a VFD drug feed.

Comments on the draft guidance may be submitted through August 3, 2015.

MainStory: TopStory DrugNews DrugBiologicNews FoodNews FDCActNews FoodSafetyNews PrescriptionDrugNews VetNews

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