It’s a New Year, and a new world for cattle producers who intend to use medicated feeds in their herds. The FDA’s expanded veterinary feed directive (VFD) rule now is in full effect, as of January 1, and while most veterinarians are at least somewhat prepared for the change, you probably have some clients who know little or nothing about it.
Veterinarians can facilitate the transition, partly by helping clients comply with the law, and by simultaneously helping them improve their overall animal-health programs through sound management and disease prevention.
During the recent Academy of Veterinary Consultants (AVC) winter conference, a panel of veterinarians close to the issue discussed common questions and practical planning for compliance with the new VFD rules. The panel included Mike Apley, DVM, PhD, Kansas State University, Marilyn Corbin, DVM, PhD, Zoetis and Guy Hufstedler, PhD, Elano Animal Health.
The expanded VFD rule ends over-the-counter (OTC) purchases of medically important feed-grade antibiotics, placing their purchase and use under the direct oversight of veterinarians.
Medically important antibiotics currently used in cattle feeds for therapeutic purposes that will require new labels under the VFD rule include chlortetracycline, chlortetracycline plus sulfamethazine, neomycin plus oxytetracycline, oxytetracycline, tylosin and virginiamycin.
Off-label use of medicated feeds is illegal, so the VFD order, which specifies the animals to be treated, the VFD drug(s) to be used, dosage, duration of use and reasons for use, must conform with product labels. Note that VFD forms specifically state that “Use of feed containing this Veterinary Feed Directive drug in a manner other than directed on the label (extra-label use) is not permitted.”
Also, FDA’s Guidance for Industry 213 asked drug-sponsor companies to voluntarily remove performance claims such as growth promotion from the labels of medically important antibiotics, and all the affected companies have changed their labels accordingly. So, while compliance on the part of companies was voluntary, compliance on the part of veterinarians and producers is required, since using any medicated feed outside label specifications is illegal.
During the discussion, several action items became clear. These include:
· A valid veterinarian-client-patient relationship (VCPR) is required by law for a veterinarian to provide a VFD order. The specific definition of a VCPR can vary between states, but the veterinarian must have first-hand familiarity with the client and the cattle involved. If you have clients or know producers with whom you do not have a relationship that meets the definition of a VCPR, make contact and explain the requirements. .
· Help your clients take an inventory of medicated feeds they have on hand. They can use VFD products with older labels, but they need to work with you to secure a VFD order. Dairy scientist Tom Earleywine, PhD, director of nutritional services at Land O'Lakes Animal Milk Products says his company and others began using transition labels in mid-year 2016, which note that use of the product would require a VFD after January 1.
· Help clients plan their future inventory management. If they purchase a VFD feed and do not use it all during the period allowed under the VFD order (six months maximum), they can still use the remaining product. They do, however, need to obtain a new VFD order.
· Determine and implement a filing system for documentation and storage of VFD orders and related records, either electronically or in paper files, and help your clients do the same. Producers, veterinarians and feed distributors need to 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, or your client’s records. Collaborate with your clients to help them understand their rights and responsibilities for providing VFD documentation. Veterinarians discussing this issue at the AVC conference agreed that an FDA inspection should be simple and painless if the veterinarian or producer can quickly supply the requested documents.
Fill and File VFD Forms
One of the panelists, Zoetis technical services veterinarian Marilyn Corbin, DVM, PhD, outlined specific suggestions for filling out VFD forms.
The VFD rule allows producers, veterinarians and feed distributors to use either paper or electronic forms for VFD orders. Regardless of the type of form, 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. Corbin notes that animal-health companies supplying VFD products, such as Zoetis, have produced VFD forms specific to each product. These forms will save time and help assure accuracy, since they already include the product name, caution statements and other information that the veterinarian or producer would need to fill in on generic forms.
At least two companies, GlobalVetLink and New Planet Technologies, provide electronic forms, distribution and filing for general use, and animal-health companies provide electronic forms for their VFD products. Besides eliminating the need for paper forms and associated storage issues, 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. All that information must comply with label specifications for the drug.
The form also includes information on the animals to be treated, including the approximate number of animals, production class and location. Corbin notes that the form asks for an “approximate” number of animals, which is important because a producer does 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. If you treat fewer animals than listed on the VFD and have feed left over, you need to file a new VFD order to use that feed in a different group of animals or beyond the time limits of 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 filing the VFD order must have a license to practice in the state where the animals are located.
Inspection Process – Be Ready
FDA officials have indicated their enforcement activities will focus on education during the initial months as the new rules are implemented in 2017, unless they find violations that are severe or clearly intentional. But as veterinarians and producers complete and file their VFD forms, they should consider the possibility of inspection and prepare for it.
Corbin says FDA inspectors likely will initiate a VFD inspection at the feed distributor. Inspectors will use a checklist to guide them through a list of questions related to the VFD form. At the feed distributor, the inspector will ask to review three randomly selected VFD forms. Next, she says, the inspector will select one form to follow back to the veterinarian who submitted the form, and one form to follow forward to the producer who received the VFD feed. At those locations, the inspector might ask to review VFD forms and ask a series of questions related to the forms.
Questions specific to veterinarians include:
· Does the veterinarian have a valid license in those states where VFD feed is being fed?
· Does the veterinarian know that either the state or federal requirements for veterinary client patient relationship (VCPR) apply in each state?
· Can the veterinarian show any medical record(s) for the client’s animals named on the VFD?
· Does the veterinarian keep copies of VFD orders for at least 2 years?
It is important to note that 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.
Elanco Animal Health technical services specialist Guy Hufstedler, PhD, outlined some of his company’s experiences and lessons learned through marketing a VFD drug.
First, he says, teamwork is critical for animal-health management and for ensuring compliance with the VFD rules. Producers need to work closely with their veterinarians, nutritionists and feed suppliers, and also look to the companies that market VFD products for information and advice. All parties involved need to make their best efforts to comply with the law, and not look for loopholes or “work-arounds.”
As noted, product-specific VFD forms can help simplify the process. The form for tilmicosin, 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 popular products, Tylan (tylosin) Premix, will require a VFD beginning on January 1. Tylosin 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 cattle feed intakes change over the feeding period, intake of tylosin could vary. Hufstedler says the FDA understands the variation inherent to biological systems, and he suggests entering a dosage range of eight to 10 grams per ton (on a 90% dry-matter basis), as specified on the product label.
VFD Covers Milk Replacers
Earleywine notes some confusion regarding VFD requirements and medicated milk replacers. While the new rules require a veterinarian prescription for antibiotics added to drinking water, FDA rules categorize milk replacers as feeds, so they fall under the VFD.
Oxytetracycline and neomycin often are used in combination in milk replacer. That combination, for prevention or control of disease, will remain available with a VFD. However, use of those or any other medically important antimicrobials at continuous low levels in milk replacer for performance purposes violates the label and the law, Earleywine says.
Earleywine also notes that medicated milk replacers must be mixed according to the drug labels. If the label specifies the medicated product be blended with dry ingredients prior to mixing with water, prepare it that way.
In many cases, Earleywine says, producers can use various non-drug alternatives such as prebiotics or probiotics to help reduce disease issues. He encourages veterinarians and nutritionists to study the research on these products though, as their efficacy can be can be limited to specific pathogens or management environments. Ongoing improvements in disease diagnostics will allow veterinarians to use a more targeted approach to the use of antimicrobials or non-drug options for disease control.
Enforcement: 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, the 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 possible 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 specifies that 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 off-label use and is illegal.
· Using Type A medicated articles used 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, possess, and sell a Category 1 (no withdrawal drug) Type A medicated article without registering as a VFD distributor, having a feed mill license, or having a VFD. However, feeding that to animals will require a VFD.
The bottom line: If your clients see a need to use a medicated feed, work with them to determine the best products, dosage and duration of use to address the specific health problem, and file a VFD order.
The upcoming changes to antibiotic regulations in animal agriculture do not represent the end of the process. Veterinarians believe the FDA will continue to assess management practices, monitor antibiotic-resistance trends and make additional changes toward a goal of improving stewardship.
During a panel discussion at the AVC conference, Kansas State University veterinarian Mike Apley, DVM, PhD, outlined some issues FDA is likely to evaluate in the coming months and years. These include:
· Continuous feeding of a medically important antimicrobial with no defined duration. FDA recently issued a Federal Register notice it plans to reexamine indications for VFD drugs that currently have undefined durations of use.
· “Pulsing” in the use of medicated feeds.
· Action on the remaining OTC antimicrobials.
· Distribution of Type A medicated articles. 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.