Veterinary Feed Directive information.

Since January 2017, provisions related to Veterinary Feed Directive (VFD) became an even more important part of feeding antimicrobial drugs. That’s when a number of over-the-counter drugs transitioned to VFD status. The VFD rule places the authority for determining when to use certain drugs – including antimicrobial drugs important for human health – under control of a veterinarian who has knowledge of the animals to be treated. As a County Agent I have been called on to advise animal producers about the VFD rule, it’s important to understand that VFD feeds are to be fed only during the time frame specified on the VFD order, i.e., before the VFD order expires. The expiration of a particular VFD order is set either specifically by regulation (e.g., for 90 days) or by default for up to 6 months. The expiration date of a VFD order is the date until which the animal producer can obtain and feed the VFD feed. Once that time period has expired, the animal producer must stop feeding the VFD feed or obtain a new VFD order. The veterinarian may shorten this time period for a particular VFD order, but cannot make it longer. In addition to the expiration date for the VFD order, another thing to keep in mind is the approved length of time, or duration, for feeding a VFD feed, which will be specified on the feed label. For example, the label can call for the VFD feed for continuous use, which means that feeding such feed is not limited in duration and could be fed to animals for long periods of time. In such case, the VFD feed could be fed for the entire period covered by an unexpired VFD order. In other cases, the label will call for the VFD feed to be used for feeding for a specific length of time (e.g., 5 days). In such case, the VFD feed could be fed to the same group of animals only one time, for a total of 5 days. There are other deadlines in the VFD requirements, too. But, whatever the situation, VFD feed must not be fed under an expired VFD order. The expiration date set in months should be calculated by the expiration month’s calendar date, not the number of days. For instance, a 6-month expiration date beginning on July 10 should end January 10 of the following year, or for a VFD issued on July 10 with a 3-month expiration date will end on October 10. Also, if the VFD order was written on August 31 for 6 months, it will expire on the last day in February (28 or 29, the last day of February), and not 2 or 3 days later in March. A question that might come up is what to do if a VFD order expires before the course of treatment is completed. Keep in mind that in no situation can you anyone can use a VFD feed beyond the expiration date on the VFD order. Instead, the client will need to contact the veterinarian to request a new VFD order, so treatment can be continued. Another requirement of the VFD rule is that a veterinarian must be working within the context of veterinarian-client-patient relationship (VCPR) before issuing a VFD. Working within that context means the veterinarian: • Must engage with the client to assume responsibility for making clinical judgments about the patients’ health • Has sufficient knowledge of the patients by virtue of the examination of the patients or visits to the facility where the patients are managed, and • Provides for any necessary follow up evaluation or care. In some cases, states will define a valid VCPR. In other cases, it will be the federal government. Here is information about state and federal VCPRs: https://www.fda.gov/AnimalVeterinary/DevelopmentApprovalProcess/ucm460406.htm. Regardless of whether a VFD was issued within the context of a valid state or federal VCPR, your producers must follow the requirements of the VFD. It’s also important that your producers keep a record of all VFDs. A veterinarian doesn’t send producers the original VFD order. Instead, the veterinarians must keep the original order, in its original format, regardless of whether it is a hardcopy or an electronic format. The veterinarian is required to produce two copies of the VFD order, one for the client and one for the distributor. The veterinarian keeps the original VFD and the client and producer keep their copies for 2 years. Veterinarians cannot call the producer or feed distributor on the phone with a VFD order. It cannot be a spoken order. It must be in writing. The written format can be hardcopy or an electronically transmitted copy. This requirement for a written VFD order is important because it documents the trail from the veterinarian to the distributor and to the animal producer or client. Another point to remember is that extralabel use of a VFD medicated feed or a combination VFD medicated feed is not permitted. Extralabel use means any use that’s not on the label. “For example,” a document published by FDA says, “feeding the animals VFD feed for a duration of time that is different from the duration specified on the label, feeding VFD feed formulated with a drug level that is different from what is specified on the label, or feeding VFD feed to an animal species different than what is specified on the label would all be considered extralabel uses.” A specific exception to this provision is for the use of VFD drugs in minor species such as sheep or bees. More information about this exception can be found at https://www.fda.gov/downloads/iceci/compliancemanuals/compliancepolicyguidancemanual/ucm529668.pdf. At any time, questions about VFD feed come up, please come to our www.FDA.gov/safefeed page and look for the VFD link. It will give you a significant amount of information about the VFD rule. Also, you can send questions to us at AskCVM@fda.hhs.gov. Center for Veterinary Medicine U.S. Food and Drug Administration