CDQAP Ruminations: Efficient Compliance with New Medicated Feed Rules

Dec 12, 2016

Cows Eating

Highlights: What you need to know about the new medicated feed rules…

  • On January 1, 2017 new federal rules will require that a herd veterinarian provide a Veterinary Feed Directive (VFD) order when any “medically important antibiotic” (antibiotic used in both human and veterinary medicine) is added to feed. Similar authorization will be required for use of medically important antibiotics added to water as well as some milk replacer additives.
  • Veterinary authorization for use of medically important antibiotics in feed, water, or milk replacer must originate from the herd veterinarian having drug oversight on the dairy, a practice recognized by the Food and Drug Administration as a VCPR.
  • Because “medically important antibiotics” are never fed to adult dairy cows, this rule should minimally effect dairy producers.
  • The most noticeable change for some producers will be having to obtain a VFD order for use of medicated milk replacer in hutch calves or for use of antibiotics in the feed of young-stock, such as to treat an outbreak of respiratory disease.
  • To minimize potential disruption to their operations, producers should plan ahead now with their veterinarian to ensure availability and timely delivery of medicated feeds to the dairy.
  • These changes in federal law are separate from changes in California state law which become effective 2018. CDQAP will partner with the California Department of Food and Agriculture in 2017 to help producers prepare for those changes as well.

The Veterinary Feed Directive (VFD): The Basics

The newly revised Veterinary Feed Directive (VFD) rule becomes effective on January 1st 2017. The rule applies to all food animal sectors, including cattle and swine, sheep and goats, poultry and even bees.

The collective result of this and related rules is that while “medically important antibiotics” (antibiotics used in human medicine) will still be available for use in feed and water on the farm, they will no longer be available over-the-counter.

The two most important components of these rules direct that:

  • Addition of medically important antibiotics to feed and water will no longer be permitted for non-therapeutic purposes such as “weight gain”, “growth promotion”, or “feed efficiency”.
  • The addition of any medically important antibiotics to feed or water will require a veterinarian’s authorization, either “VFD Order” for feed or a “prescription” when an antibiotic is added on the farm to water, milk or milk replacer.

Compared to other livestock and poultry producers, new Veterinary Feed Directive (VFD) regulations should minimally effect dairy producers. To avoid confusion however it’s best to plan with your veterinarian now.  For a quick, understandable review producers might start by watching the 7-minute video from the FDA covers the VFD basics.
One thing that has not changed relative to drug regulations is that it remains illegal use antibiotics off-label in feed. Put another way, feeds containing antibiotics can only be used exactly according to the label. Feeding antibiotics using a different dosage or duration of treatment, use in a different species or even for a different disease condition is a violation of the federal Food, Drug and Cosmetic Act.

Why are the VFD rules being implemented?

In order to address the problem of antibiotic resistance, the new rules promote more veterinary oversight of antibiotics important in human medicine. Expertise provided by veterinarians will help optimize antibiotic use on farms, limiting development of resistance. For this reason, the veterinary authorization must come from the herd’s veterinarian, who has oversight of the medication program on the dairy, called a VCPR (see below). Internet pharmacies do not meet these requirements. Besides helping limit resistance in humans, veterinary guidance should also aid in keeping antibiotics effective on the farm as well. Efforts to curtail resistance have not been limited just to agriculture. Human medicine has seen extensive doctor-patient education programs and, in California, hospitals are mandated to have programs to minimize antibiotic resistance.

Some bacteria, like the one on the right have become resistant to many antibiotics.

How will VFD rules affect dairy producers?

California dairy producers should experience only minimal disruption to their operations for three reasons:

  • The VFD still allows for use of medically important antibiotics in feed for the prevention, control and treatment of disease on the dairy.
  •  The only medications currently fed to adult dairy cows (monensin, some parasite and bloat preventatives) will not require a VFD order.
  • Most dairy producers already have a herd veterinarian providing prescription medications and will also be able to provide VFD orders.

Thus, the most noticeable change for some producers will be having to obtain a VFD order either for the use of medicated milk replacer or use of antibiotics in feed to address periodic conditions of young stock such as an outbreak of respiratory disease.  Lastly, while these federal rule changes do not change the status of antibiotics given by injection, a new California law will make injectable antibiotics prescription-only in 2018.

Who can create a VFD order?

The only person who can generate a VFD order is the herd veterinarian. For California producers their veterinarian must be licensed to practice is the state and acting under a valid Veterinarian-Client-Patient-Relationship, or VCPR. Briefly, having a VCPR means that the veterinarian is overseeing the medical care of the herd’s animals and is directing the herd’s medication program. A VCPR requires first-hand familiarity with the farm’s operation and must include regular farm visits.  Again, internet pharmacies do not meet these requirements. The specific requirements for a VCPR vary by state. In California a VCPR is defined in Section 2032.1 of the State’s Code of Regulations.

Only the herd veterinarian directing the herd’s medication program can create a VFD order.

What drugs are included under the new rules?

Feed Antibiotics – All antibiotics which the FDA has determined to be important in human medicine are covered under the VFD rule and will require a VFD order for use in feed. This includes but is not limited to the penicillin family, tetracyclines, lincomycin, tylosin, tilmicosin and the “sulfa drugs”. The FDA maintains and updates a list of drugs requiring a VFD order for feed on their website.

Water Antibiotics – Products containing medically important antibiotics that are approved for use in water are handled differently than feed. Many of these products contain the same antibiotics used in feed, but also have label directions for use in water. These products  will require a veterinary prescription rather than a VFD order. The FDA maintains and updates a list of drugs which will require a prescription for use in water.

What drugs are not included under the VFD?

Some of the many tradenames and indications not covered under the VFD rule include Rumensin® for milk production efficiency, Bovatec®, Deccox® and Corid® for coccidiosis prevention and control, Safe-Guard® for internal parasite control and Bloat Guard® for bloat prevention. Importantly however, if one of these products is combined with a medically important antibiotic, the combination product must be approved by the FDA and will require a veterinarian’s VFD order. If, for instance, Bovatec® (lasalocid, which does not require a VFD) is added to a ration along with Aureomycin® (chlortetracycline, covered under the VFD rule) then the approved combination product will require a VFD. Producers should consult with their veterinarian to determine which feed additives and additive combinations require a VFD order.

Monensin and other ionophores and coccidiostats will not require a VFD order.

What about medicated milk replacers?

To purchase a milk replacer containing oxytetracycline and/or neomycin, a producer will need to have his veterinarian provide a VFD order. A caveat to this is that there are a limited number of products containing powdered neomycin labeled for on-farm mixing into milk or milk replacer. These products will require a veterinarian’s prescription. Whether use of a medicated milk replacer requires a VFD order or a prescription depends on how the label of the replacer or the medication is written. In either case however use requires some sort of veterinary authorization. Lastly, some milk replacers contain medications to control coccidiosis such as Deccox® or Bovatec®. These medications are not covered under the VFD rule and require no special authorization, so long as the medicated milk replacer doesn’t also contain a medically important antibiotic. Producers should consult with their veterinarian to determine which feed additives and feed additive combinations require a VFD order.

What are the paperwork logistics of VFD compliance?

The FDA has published guidelines detailing those components which needed to be included in a VFD. A number of template VFD orders have been posted and the American Veterinary Medical Association (AVMA) has made an electronic format available to its members. In addition to these generic VFD templates, many companies have prepared specific VFD forms for each of VFD drugs that they market. One example is the VFD order template for tilmicosin an antibiotic that is sometimes used in replacement heifers during an outbreak of respiratory disease.

A veterinarian can provide a paper copy, an electronic copy or fax transmission of the VFD order to both the producer and feed distributor. Alternatively, the veterinarian can provide his client with a VFD order which the client can then deliver to a feed distributer of his or her choosing. FDA maintains a list of companies acting as distributors listed alphabetically as well as listed by state. More than one location may be included in the same VFD order as long as the different facilities are owned by the same producer and the VFD order is for the same class of livestock and specifies the same use. A VFD order may be written to apply to an operation(s) for up to six months, but there will be an “expiration date” listed after which the VFD is no longer valid. The veterinarian, producer and distributer each must retain a copy of the VFD order for two years.

The herd veterinarian will provide a copy of the VFD to the producer, but at the farmer’s request may also transmit another copy by email or fax directly to the feed distributor.  

What about medicated feed left over from deliveries during 2016?

As of January 1, 2017, all products covered by the VFD rule being fed on the farm will need a VFD order. So, if after December 31 2016, farmers have left-over medicated feed on hand which is labeled for over-the-counter purchase, they must work with their veterinarian to obtain a VFD order before feeding those products to their animals.

How can I prepare for a seamless transition to VFD implementation?

In order to prevent disruption to your dairy’s operation you should plan ahead to ensure timely delivery of medicated feeds you anticipate using. To this end:

  • Discuss with your veterinarian your dairy’s medicated feed program and confirm that those medicated feeds currently used will still be available through a VFD order.
  • Make arrangements for your veterinarian to generate a VFD for any medicated feed left over from deliveries in 2016 that is still on your dairy.
  • Make accommodation in your record-keeping system for VFD documentation.

What about the future?

These changes in federal law are separate from changes in California state law which become effective on January 1st 2018. The California Department of Food and Agriculture will partner with CDQAP in 2017 to help producers prepare for those changes as well.

Veterinary Feed Directive Resources

Videos & Webinars:

  • FDA video: Veterinary Feed Directive for Veterinarians  The best place for a veterinarian looking for basic information.
  • The Beef Cattle Institute  (in collaboration with Kansas State University)  Although primarily directed at the beef industry this website contains links to more than 30 videos related to specific VFD topics from “What will the VFD cost me” to “Who is responsible for enforcement?”
  • Understanding the Veterinary Feed Directive (VFD)  An hour-long webcast from Bovine Veterinarian Magazine sponsored by Zoetis
  • Preparing to Implement Veterinary Feed Directives  From Feedstuffs magazine includes Dr. Apley from KSU and sponsored by Elanco

Brochures Produced by the FDA (click on “Printer Friendly Brochure” versions):

Various VFD & Feed Safety Homepages:

  • The Food and Drug Administration VFD Homepage  Includes links to final rules and Guidance documents, fact sheets, notices, Q&A documents, PowerPoint presentations and some Spanish language versions.
  • Farm Foundation Antibiotic Stewardship Page  The Farm Foundation has worked closely with FDA and many industry groups to clarify the new VFD regulations.
  • American Association of Bovine Practitioners  In particular, this site contains links of interest to bovine veterinarians.
  • The Veterinary Feed Directive – How It Affects Milk Replacers  This blog from “Calf Sessions” a contains a link at the bottom of page to a video that examines how the VFD will affect milk replacers. The video in particular explains the difference between Type A, B, and C medicated articles and how it effects labeling.
  • The Food Animal Residue Avoidance Databank  Importantly this homepage this contains FARAD’s most frequently asked VFD questions, information for veterinarians and a feed drug calculator tool. This site also contains a searchable database for all food animal drugs, including feed medications.
  • FARAD Species Pages
  • Poultry page
  • VFD Page
  • Dairy Page
  • CA SB 27 Page
  • California’s Feed Inspection Program  Inspectors and Investigators located throughout the state conduct routine sampling and inspections, quality assurance inspections of feed manufacturing facilities, respond to consumer complaints, and enforce the laws and regulations that govern the manufacturing distribution of livestock feed. The program helps ensure both food safety as well as that product received by producers is the quality and quantity as marketed by the manufacturer. This program is funded through licensing fees and inspection fee based on tonnage sold.
  • California’s Safe Animal Feed Education Program  The Safe Animal Feed Education (SAFE) program of California uses outreach, education, and a comprehensive Voluntary Quality Assurance program to lead the nation in ensuring a safe and wholesome supply of commercial feed.