by Sally Colby
Beef producers saw some of the drugs they use fall under the veterinary feed directive (VFD) on Oct. 15, but on Jan. 1, the final rule will be in full effect.
Dr. Doug Hufstedler, nutrition and beef advisor at Elanco Animal Health, provides some background on the VFD that will affect producers in just a few weeks.
“In 2003, the FDA issued Guidance #152, a risk assessment for veterinary drugs creating ‘potential’ resistance issues for human medicine,” said Hufstedler. “One of the outcomes of that guidance was that they classified antibiotics into two classes: medically important for human use and non-medically important for human use.”
In 2013, the FDA issued Guidance #213, which was the plan to make this transition by Jan. 1, 2017. “Drug sponsors would voluntarily remove any growth promotion claims and eliminate the OTC status of medically important antibiotics,” said Hufstedler. “In 2015, the final rule was published, which outlines a specific VFD requirement.”
The VFD is a written statement provided by the veterinarian, and is under the veterinarian client/patient relationship (VCPR). “You have to have a relationship with a veterinarian who knows your operation and your production practices,” said Hufstedler. “Antibiotics administered in water will require a veterinary prescription, not a VFD.”
Hufstedler says as of Oct. 1, 2015, any new antibiotics that came onto the market, even animal-only antibiotics, fell under VFD status. “There will be no more over-the-counter status for antibiotics that go through FDA approval,” he said. “Some examples include Pulmotil, Tilmovet, Kavault and Aivlosin.”
Several compounds frequently used in beef production such as ionophores will only require a VFD if they are being used in combination with a VFD compound. Other drugs that are not affected include deworming products and anticoccidials.
Dr. Mike Apley, professor of veterinary clinical sciences at Kansas State University, addresses the issue of how beef producers should work toward compliance.
“Start now,” said Apley. “Your veterinarian is the key person for success in implementing VFDs. Start with a plan that satisfies the VCPR requirement, discuss options for feed medications that include VFD medications, and how those plans will be implemented.” The other person in the loop will be the supplier of the drugs.
A VCPR is in place when the veterinarian has assumed responsibility for making medical judgments regarding herd health and the need for treatment, and the owner or caretaker agrees to follow the vet’s instructions. In a feedlot situation, the VFD is written to the caretaker, who is responsible for caring for animals for multiple owners. “It isn’t required that every owner have a VFD,” said Apley. “The caretaker will have a VFD for the animals in the feedlot.” Because VCPR standards vary from state to state, Apley suggests that producers visit the FDA website that lists each state’s requirements.
The vet must have sufficient knowledge of the animals, and they must have been recently seen by the vet who is personally acquainted with the keeping and care of the animals. The VFD requires an individual veterinarian’s signature, not that of a clinic, and it goes to one client. “If multiple people own multiple animals, that requires multiple VFDs,” said Apley. “It’s also to one feed distributer, which can be an individual, partnership or corporation. They may have multiple locations, but must be one entity.”
A VFD can cover more than one animal production site as long as those sites are under the same ownership and for one medication. “So if there are two medications that are VFD drugs used on a site, a VFD must be written for each one,” said Apley.
A valid VFD must include the following information: owner, animal location, species, number of animals, drug name, production class, indication, expiration, dosage expressed as grams/ton, withdrawal time and any special instructions. “It must be signed by a veterinarian,” said Apley. “Electronic signature and transmittal is allowed and encouraged.” The vet provides a copy of the VFD to both the client and the distributor via fax, email or hard copy. Apley added that telephone VFDs will not be allowed, and emphasized that the VFD must be in one of the approved formats. The producer, distributor and veterinarian must retain a copy of the VFD two years. A distributor is either someone who only distributes VFD feed or one who manufactures and distributes VFD feed.
Drugs that are not considered to be medically important and will not require a VFD include ionophores (monensin, lasalocid, laidlomycin), bambermycins, bacitracin, decoquinate and amprolium. A VFD will be required for medically important drugs such as chlortetracycline, oxytetracycline, tylosin, chlortetracylcline/sulfamethazine and neomycin.
Producers who manufacture feed on their own farm that will be delivered to another entity must be registered with the FDA as a distributor. “If you are producing it for use only under your VFD that authorizes the use of the final type C medicated feed, you will not need to register,” said Apley. “But if type C or B feed is created and sold to another entity not covered under your FVD, you become a distributor.”
Apley says it’s important to understand that a medicated premix is type B feed, intended to be used to manufacture a type C feed. “Feeding a type B as a type C – taking a medicated premix and putting it out as a supplement – is illegal,” he said. “You have to feed a type C feed. Some type A medicated feed articles may be obtained without a VFD, but if they are used to prepare a VFD feed, you must have a VFD to prepare that.” Extra-label use is prohibited – the only legal use of a VFD feed is exactly as authorized on the label.
If a producer has purchased a VFD feed legally but doesn’t use it all before the VFD expires, he may still possess the feed, but cannot use it to create or feed a type C feed until he has a new VFD.
There are two phrases that can cause confusion: duration and expiration. “The VFD duration of use is the time period that feed containing the VFD drug may be fed to a specific group of animals,” said Apley. “That is established as part of the drug approval process. An example would be the duration of feeding of Pulmotil is 14 days for cattle according to the label. You can’t feed it for 10 days or 18 days – you must feed it for 14 days as per the label.”
In regard to the expiration date, the duration of feeding must be completed within the period of a valid VFD. So if you start the 14-day feeding with 10 days left on the VFD, a new VFD must be in place to complete the required period of feeding.
The expiration date applies to the VFD, and it’s how long it’s valid. “That’s either specified on the product label, or it may be written by the veterinarian up to a maximum of six months,” said Apley. “The veterinarian has the discretion to decide if a limited time period is warranted. You cannot feed that VFD-drug containing feed after the VFD expiration date unless you have a new VFD in place.”
Read Part Two here.