Implementing VFD rules
Changes were made in how the U.S. Food & Drug Administration (FDA) regulates most of the feed-grade and water-soluble antibiotics you use. On January 1, 2017, many antibiotics used in U.S. animals shifted from over-the-counter status to being available only under veterinary oversight through the VFD rule. With several months of implementation complete, this is a good time to evaluate your process to ensure you continue to stay in compliance.
“While it is critical to educate yourself on the VFD rules, there is no need to be afraid of them,” said Jeff Verzal, Compliance Investigator, Iowa Department of Agriculture. “VFDs provide an opportunity to re-evaluate the protocols you’ve had for years to make sure they are effective in accomplishing your animal health goals and ensure judicious use of medically-important antimicrobial drugs for use in food-producing animals.”
Audits: what to expect
The FDA has been conducting VFD audits, and as a part of his role, Verzal observes the inspection process.
“At the highest level, the audits boil down to referencing the VFD and making sure all parties comply with the rule,” said Verzal. “The FDA has implemented a trace-back and trace-forward approach, starting with the distributor and tracking the VFD back to the veterinarian and forward to the producer.”
Some of the things that FDA may look at include:
- Distributor — Ensured the feed additive medication mets its approved label, including drug level, indications for use, species, etc.; maintained a copy of the VFD and manufacturing records if necessary; and notified FDA of their intent to distribute VFD products
- Veterinarian — Checked that a valid veterinarian-client-patient relationship (VCPR) existed, that the VFD was filled out correctly, that the veterinarian is licensed in the state of which the animals being treated reside and that they have kept the original and shared copies with the distributor and producer
- Producer — Followed the approved labeled directions on the VFD, including feeding the animals detailed on the VFD, not feeding the VFD feed after the expiration date and maintaining a copy of the VFD for at least two years
Verzal also notes that all three parties involved must keep copies of VFD orders for at least two years.
The essentials: documentation and communication
Preparation can go a long way in ensuring you are ready should you be selected for a VFD audit. Documentation and communication are the two most important factors in that preparation.
“It doesn’t matter if you have a few head or a large operation, record keeping is critical. You should be able to demonstrate that you are documenting the process that you follow to be in compliance with the VFD rule, including maintaining those records for two years,” said Verzal.
Verzal adds, “Communication is critical to making sure each party can properly implement the VFD. The three parties — veterinarian, distributor and producer — should be on the same page and understand the goal at hand.”
Visit VFD Central at www.feedstuffs.com/vfd-central for more information on VFD rules and implementation best practices.
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