The U.S. Food and Drug Administration (FDA) is taking a new approach on the judicious use of medically important (to treat human illness) antibiotics in food-animal production. It involves voluntary cooperation by all sectors. Here’s a snapshot of FDA’s time line to implement these changes.
Guidance 209: In 2010, FDA outlined its intent and recommendations regarding growth promotion uses of medically important antibiotics in food-animal production. This action applies to both feed-grade and water-based antibiotics. FDA also specified that veterinarian oversight will increase for the remaining therapeutic applications (prevention, treatment and control) of medically important antibiotics.
Guidance 213: On Dec. 11, 2013, FDA initiated a three-year transition process to complete its food-animal antibiotic strategy. This action requests animal-health companies to outline intentions to voluntarily remove any production/growth-promotion uses from product labels of medically important antibiotics. The guidance also eliminates over-the-counter status of these medications and increases veterinary oversight for on-farm therapeutic use by requiring a veterinary feed directive (VFD) for feed applications and a prescription for water treatments. Jan. 1, 2017, is when implementation begins.
Final VFD Rule: On June 3, 2015, FDA announced the final VFD rule. According to the agency, the final rule outlines specific details of the VFD process for medically important (to treat human infections) feed-grade antibiotics.
There are still many questions about the new antibiotic guidelines that will come in effect on Jan. 1, 2017. To help answer some of the questions regarding how to prepare and what to expect we have enlisted the help of two experts: Dr. Laura Bruner DVM, Swine Vet Center and Dr. Liz Wagstrom, DVM, Chief Veterinarian, National Pork Producers Council.
1. What medications will need a VFD on January 1, 2017?
Dr. Wagstrom: All antibiotics will require a VFD on
January 1, 2017 EXCEPT:
• Bacitracin (BMD)
• Bambermycin (Flavomycin)
• Carbadox (Mecadox)
• Tiamulin (Denagard)
• Narasin (Skycis)
2. What are the major changes that will happen because of the revised VFD rule?
|PREVIOUS RULE||REVISED RULE|
|2 year record retention||2 year record retention|
|Original document to feed mill||May email or fax document|
|No extra-label use||No extra-label use|
|Order for tons of feed||Order for number of days|
|No refills, unless on label||No refills, unless on label|
|Written for one group of animals on a premise||Attached list of premises for each mill|
|VCPR required||State or Federal VCPR|
|Max of 6 mo. Expiration|
3. Can antibiotic inventory that was purchased prior to January 1, 2017 that now require a VFD be administered without a VFD?
Dr. Bruner : All feed grade antibiotics that were deemed medically important for human medicine will require a VFD, regardless of the date that the antibiotic was purchased.
For example, if I purchased Tylan 40 medication in November 2016, any pigs being fed that medication starting January 1, 2017 will require a VFD before it can be fed to pigs.
4. How will on-farm feed manufacturing be impacted?
Dr. Wagstrom: If a producer has an on-farm feed mill and only mixes for themselves they will need to have a VFD to present to the distributer to buy medicated ingredients. They will need to have a current VFD on file to feed medicated feed to pigs.
If a producer is making feed that will be given or sold to a neighbor or contract grower (another person besides themselves; pigs not on their farm). They will need to register with the FDA as a distributer which requires a one-time written letter to the FDA. This letter will need to be kept on file. A VFD will be needed for every batch of medicated feed.
5. What do you anticipate one of the biggest challenges will be as a result of the revised VFD rules?
Dr. Bruner: The logistics of getting medicated feed on short notice to animals that are sick is going to be one of the biggest challenges.
For example: A producer orders feed in the morning and during the day chores does not see the symptoms of Ileitis. Night chores reveal clinically ill pigs with Ileitis. The feed mill will be making the feed early the next morning, so a VFD has to be made in a short amount of time. In that situation, you will need to contact your veterinarian immediately so the VFD can be issued before close of the day or very early the next morning before the feed has been made. Medicated feed such as Tylan or Linco to treat ileitis, will require a VFD before it can be made.
Most vet clinics have an after hour phone number and most swine veterinarians are used to taking calls from clients past 5:00pm. Web based sites that veterinarians can access and issue a VFD from any location are available and a VFD can be emailed to the feed mill and to the producer.
6. Will vets be able to write a VFD for an entire flow of pigs if there is a known health challenge?
Dr. Bruner: One of the main goals of the new regulations in 2017 is that there is more veterinarian oversight in the medication decisions of food animals. A VCPR
(vet-client-patient relationship) is the federal and state’s measure of veterinary oversight. Each state has its own version of a VCPR. In general, the VCPR states that the veterinarian must have sufficient knowledge of the pigs that they are medicating. As long as the veterinarian has sufficient knowledge of a flow of pigs, a VFD could be written for a flow of pigs at multiple sites within one VFD.
The best example is a sow farm that weans into multiple wean to finish barns. If the veterinarian has spent sufficient time in this herd to gain knowledge of the health challenges, a VFD can be written for medication and it can be written for multiple sites as long as all pigs are being fed out of the same feed mill. If the barns are fed out of multiple feed mills, each feed mill needs that VFD.
Another example is a sow farm that weans into one nursery and then in turn goes into multiple finishers. The veterinarian, as long as they assume responsibility for veterinary oversight, can write a VFD for that nursery for a period of no longer than 6 months.
7. How will guidelines impact the injectable use of antibiotics?
Dr. Bruner: At this time, nothing will change with injectable antibiotics in January 2017.
8. What is the typical duration of a VFD?
Dr. Wagstrom: No longer than 6 months at your vet’s discretion
9. How will the new guidelines impact antibiotics administered through water?
Dr. Bruner: Water antibiotics will now go to a prescription process.
Prescriptions will also be required for the water. Each veterinary clinic may handle the prescription process a little differently. One thing that can be most helpful to a producer in order to avoid a delay in treatment is to contact vet clinics immediately if they know that they are going to require a prescription water med. Vet clinics can then start the process of getting that prescription ordered. It is somewhat similar to ordering prescriptions for a human pharmacy and picking them up later.
Veterinary clinics are still in the development phase of what that will look like at each of their practices. These prescriptions will also only be valid for 6 months at a time so if there is a
known disease that is happening such as Strep in the nursery, prescriptions can be written for clients for a period of 6 months.
Water antibiotics fall under the same requirements for VCPR or vet-client-patient relationship.
10. What can farmers do to prepare for the guideline changes?
Dr. Wagstrom: It is really important to have an established relationship with your veterinarian. You need to sit down with your vet and make sure that you have a valid VCPR. Otherwise it is against the regulations to write a VFD without an established VCPR.
You also need to talk to your feed mill to make sure that you understand the way they want to handle the new guidelines so you are all on the same page.