This year, Jan. 1 brought more than ‚Äë reworks, champagne toasts and resolutions. It also marked the full implementation of the Food and Drug Administration's (FDA) new veterinary feed directive (VFD) rules.
The expanded VFD rule ends over-the-counter (OTC) purchases of feeds containing medically important antibiotics, placing their purchase and use under the oversight of veterinarians.
Medically important antibiotics currently used in cattle feeds for therapeutic purposes that now require a VFD include chlortetracycline, chlortetracycline plus sulfamethazine, neomycin plus oxytetracycline, oxytetracycline, tylosin and virginiamycin. Feeds containing antimicrobials not considered medically important, such as ionophores, do not require a VFD.
Veterinarians and producers will need to work together to ensure the proper information is included on VFD forms. All the information about the drug, dosage, intended use, duration of use and withdrawal times must conform with the product label.
Producers should note VFD forms specifically state: "Use of feed containing this Veterinary Feed Directive drug in a manner other than directed on the label (extra-label use) is not permitted."
During the recent Academy of Veterinary Consultants (AVC) winter conference, a panel of three veterinarians close to the issue discussed common questions and practical planning for compliance with the new VFD rules. The panel included Mike Apley, DVM, Kansas State University, Marilyn Corbin, DVM, Zoetis and Guy Hufstedler, Elanco Animal Health.
Corbin notes the VFD rule allows producers, veterinarians and feed distributors to use either paper or electronic forms for VFD orders. Either way, each party must keep the VFD order on file for at least two years. On that basis alone, electronic filing offers logistical and storage advantages over paper.
Generic paper forms are available from the FDA and various industry organizations. Animal health companies supplying VFD products have produced VFD forms specific to each product, Corbin says. These forms will save time and help assure accuracy, because they already include product information.
At least two companies, GlobalVetLink and New Planet Technologies, provide electronic VFD services, and some animal health companies provide electronic forms for their VFD products. Besides eliminating the need for paper storage, these systems provide easy and accurate completion of forms in the field, electronic distribution of VFD orders, easy access to VFD records and options for managing non-VFD health records.
The VFD form requires the name, address and phone numbers for the producer and veterinarian, the drug to be purchased, the level at which it will be fed in grams per ton, duration of use, withdrawal time and, importantly, reason for use, which must comply with label specifications for the drug.
The form also requires information on the "approximate" number of animals to be treated, production class and location. Corbin notes a producer might not always know how many animals will require the medicated feed during the duration of the VFD order (six months maximum). In these cases, it probably is best to overestimate the number. Remember though, if you have feed left over, you will need to obtain a new VFD order before you can use that feed for other animals or time periods outside the original VFD.
The "premises" space on the form refers to the location of the animals to be treated, not the headquarters location of the farm or ranch. The veterinarian ¬≠ ling the VFD order must have a license to practice in the state where the animals are located.
Be ready for an inspection, just in case. FDA officials have indicated their enforcement activities will focus on education during the initial months as the new rules are implemented, unless they ¬≠ find violations that are severe or clearly intentional. But as veterinarians and producers complete and ¬≠file VFD forms, they should prepare for the possibility of inspection.
Corbin says FDA inspectors are most likely to conduct spot inspections of feed distributors, veterinarians and producers. Inspectors will ask for and review VFD forms and then ask a series of questions related to the forms.
It is important to note the VFD itself is not new. The FDA has required VFDs for certain medicated feeds for years. Most of those have applied to other livestock species, but for cattle, Elanco's Pulmotil (tilmicosin) product for BRD control has required a VFD since it was introduced in 1996.
Hufstedler outlined some of his company's experiences and lessons learned through marketing a VFD drug. He stresses that when a producer can quickly access and pro-vide the requested records, it inspires confidence on the part of the FDA inspector and probably results in a positive outcome.
As noted, VFD forms designed for specific products can help simplify the process. The form for Pulmotil, for example, states the indication for use as control of BRD, which is the only indication on the product label for cattle. For duration of use, the form specifies 14 days, which is the approved duration listed on the label.
Another of Elanco's products, Tylan (tylosin) Premix, now requires a VFD. Tylan is approved for continuous use for reducing the incidence and severity of liver abscesses in cattle. Hufstedler notes the "continuous use" application remains valid. Cattle feeders have expressed some concern that as feed intakes change over the feeding period, intake of Tylan could vary. Hufstedler says the FDA under-stands the variation inherent to bio-logical systems, and suggests entering a dosage range of 8 g to 10 g per ton (on a 90% dry-matter basis), as specified on the product label.
Producers, working with their veterinarians, must ensure their on-farm use of VFD drugs conforms to the VFD order and the product label. Panel members listed steps producers and veterinarians should take, if they have not already. These include:
- Establish a valid veterinarian-client-patient relationship (VCPR). It is required by law for a veterinarian to provide a VFD order. The definition of a VCPR can vary between states, but the veterinarian must have first-hand familiarity with the client and the cattle involved.
- Take an inventory of medicated feeds you have on hand. You can still use VFD products with older labels after Jan. 1, but you need to work with your veterinarian to secure a VFD order to use those products purchased prior to implementation of the new rules.
- Plan your future inventory management. If you purchase a VFD feed and do not use it all during the period allowed under the VFD order, you can still use the remaining product. You do, however, need to obtain a new VFD order.
- Determine and implement a filing system for VFD orders and related records. This can be either electronic or paper, but producers should retain VFD records for two years.
- Develop a set of standard operating procedures (SOPs) to follow in case of an FDA inspection of your VFD records. Collaborate with your veterinarian to understand your rights and your responsibilities for providing VFD documentation.
Producers need to operate in good faith. The panel members, all of whom have worked closely with the FDA on the issue, agreed that, while mistakes will be made, producers who operate in good faith and do what they can to comply with the law likely will see warnings and guidance. If, however, producers intentionally circumvent the law, FDA will see a need for more stringent enforcement.
Apley specifically warned against two ways producers might try to "game the system," both of which are illegal and likely to bring enforcement and penalties. These are:
- Acquiring VFD orders for products labeled as "hand-fed" feeds, then using those feeds in a "free-choice" manner. The hand-fed label speci¬≠fies a ¬≠fixed amount must be fed every day. You may feed a free-choice feed in a hand-fed manner (daily), but feeding a hand-fed feed in a free-choice manner is an illegal off-label use.
- Using Type A medicated articles to circumvent the VFD process. Type A medicated articles are the most concentrated form of feed-grade antibiotics, which are mixed with other ingredients to create Type B or C medicated feeds. A person may purchase a Category 1 Type A medicated article without having a VFD. However, feeding it to animals does require a VFD.
In summary, if you need to use a medicated feed, work with your veterinarian to determine the best product, dosage and duration of use to address the specific health problem. Use the product in accordance with the label and VFD form, and keep the form on ¬≠file.
Note: This story appears in the January 2017 issue of Drovers.