Veterinary Feed Directive
To help combat antimicrobial resistance and protect human safety, the FDA took action by eliminating claims for production use of medically important antimicrobials (MIAs) and by increasing veterinary oversight by transitioning MIAs from over the counter (OTC) to Veterinary Feed Directive (VFD) or Prescription (Rx).
MIAs for use in or on feeds that were■ BOX 45.3
Conditions Necessary for Extralabel Drug Use
1. Extralabel drug use (ELDU) is permitted only by or on the order of a veterinarian.
2. The veterinarian judges on-label treatments to be unavailable or ineffective.
3. ELDU uses only U.S. Food and Drug Administration (FDA)-approved animal and human drugs, not drugs imported from foreign countries or compounded from bulk sources. When treating food animals, approved food animal drugs should be used before approved animal drugs, which should be used before approved human drugs.
4. A valid veteπnaπan-client-patient relationship (VCPR) exists in which the veterinarian:
• Oversees medical treatment decisions on the farm
• Is familiar with animal care through appropriate and timely visits
• Has sufficient knowledge to initiate a diagnosis
• Is available for follow-up care as needed
5. ELDU is for therapeutic or humane purposes only, not to increase production or manipulate reproductive cycles in normal animals.
6. ELDU applies only to administration to individual animals and in water, not in feed.
7. Animal identification and treatment records are sufficient to identify treated animals and their treatment history and are maintained for 2 years.
8. The veterinarian establishes an extended drug withdrawal period protective of human health supported by scientific evidence. ELDU resulting in violative or dangerous food residues is not permitted.
9. Drug labels list the name and address of the prescribing veterinarian, animals to be treated, and the drug name, disease indication, dose, frequency, duration, cautions, and withdrawal periods associated with treatment.
10. Certain extralabel uses specifically prohibited by the FDA are not used (see Box 45.4).
previously OTC now require a VFD, while MIAs as a water additive became prescription only. A list of MIAs is provided in Appendix A of the FDA's Guidance for Industry #152 (https://www.fda.gov/downloads/AnimalVeterinary/Guidance ComplianceEnforcement/GuidanceforIndustry/U CM052 519.pdf). Drug classes not affected by these changes include ionophores, bacitracins, and coccidiostats. These changes became effective on January 1, 2017.
A VFD is a written statement issued by a veterinarian with a valid VCPR for the use of a VFD drug or VFD combination drug in or on animal feed. A list of sponsor applications being affected by the FDA rulings can be found at https://www.fda.gov/ AnimalVeterinary/SafetyHealth/AntimicrobialResistance/ JudiciousUseofAntimicrobials/ucm390429.htm. A list of drugs and approved VFD drug combinations can be found on the FARAD website (http://www.farad.org/vfd-drug-combinations.html). For a veterinarian to write a VFD, the veterinarian must be licensed to practice in the state the animals reside in, have a valid VCPR, and issue the VFD in compliance with the drug's approved labeling and conditions. Extralabel use of VFD drugs is prohibited.
California Senate Bill 27
In the state of California, Senate Bill 27 (SB 27) became effective on January 1, 2018. SB 27 was created to address antimicrobial resistance. It is similar to the federal regulations on judicious use of MIAs, but it extends veterinary oversite of MIAs further. For animals being treated in California, all forms of MIAs, including oral, injectable, topical, and intramammary, now require a prescription from a veterinarian. This means that MIA formulations that are designated as OTC at the federal level will be designated as prescription in the state of California. The prescription status for medications affected by this ruling can be found on VetGRAM on the FARAD website. In addition to increasing veterinary oversite of MIAs, SB 27 requires the California Department of Food and Agriculture to collect data on MIA drug sales and usage, antimicrobial resistant bacteria, and livestock management practice.
Extralabel Drug Use of Medicated Feeds in Minor Species
Even though AMDUCA prohibits the extralabel use of medications in feed, a Compliance Policy Guide (CPG) 615.115 for extralabel use of medicated feeds for minor animal species does exist.5 The AMDUCA prohibition of extralabel use of medications in feed was generated because of concerns of antibiotic resistance. AMDUCAs Section 530.11 specifically prohibits the “extralabel use of an approved new animal drug or human drug in or on an animal feed.” As a matter of enforcement discretion, the CVM generally has not objected to mixing a drug with an individual animal's feed, but extralabel mass medication in feed is prohibited “without limitation or exception.” Veterinarians may, however, be called on to treat minor food animal species such as farmed exotic ruminants, fish, or game birds. The CVM has found that for many of these species, very few approved drugs exist. In addition, the CVM recognizes that some minor food animal species (such as fish and game birds) cannot be practically medicated in any way other than through the use of medicated feeds. In such situations, a veterinarian may determine that extralabel use of medicated feeds (approved for use in other species) can prevent suffering and death in these minor species.
Although AMDUCA prohibits ELDU in feed, in the previously described circumstances the CVM “ordinarily will not consider regulatory action” against the veterinarian or animal producer provided that certain criteria listed in Box 45.4 are met.5 The CVM policy being implemented in these cases is akin to that of ELDU by veterinarians before the 1994 passing of AMDUCA. The drug use is still illegal, but the CVM will apply regulatory discretion relative to taking enforcement action. A critical aspect of the CVM's regulatory discretion in this practice is that labeled treatment alternatives are not available. The best resource to aid practitioners in determining what treatments are approved for minor food animal species is the Minor Use Animal Drug Program website (http://www.nrsp-7.org).