What pork producers need to know about FDA's antibiotic changes
On January 1, 2017, the U.S Food and Drug Administration's (FDA) new regulation addressing on-farm antibiotic use in food-animal production will take effect. The purpose of this publication is to identify which swine medications will be affected by these changes. FDA's effort is aimed to eliminate the use of medically important (to human illness) antibiotics for growth promotion purposes in food-animal production and to bring therapeutic use of antibiotics in feed and water - to treat, control, or prevent specific disease - under additional veterinary oversight. The new requirements will affect producers, veterinarians, feed mills and suppliers.
What does "medically important" mean?
An antibiotic is considered medically important if it is used, or antibiotics in the same family of medications, is used in human or animal medicine.
FDA's new antibiotic regulations defined
- Medically important antibiotics will be limited to the therapeutic purposes of treatment, control, and prevention of specific diseases.
- Non-therapeutic use of medically important antibiotics will not be permitted. Antibiotics will no longer be labeled for growth promotion.
- Veterinary oversight will increase for the remaining therapeutic applications of treatment, control, and prevention. This applies to both in-feed and water-delivered antibiotics.
- Over-the-counter usage of medically important antibiotics used in mass medication (feed or water) will be eliminated. A veterinary feed directive (VFD) will be needed to purchase medication feed and a prescription (Rx) will be needed to purchase water medication.
- Medication feed cannot be used in extra label fashion so manufacturers' labels on in-feed medications must be followed.
What is a Veterinary Feed Directive (VFD)?
A veterinary feed directive (VFD) is a written statement issued by a licensed veterinarian authorizing the use of a VFD medication in an animal feed. A veterinarian is responsible for filling out the VFD form correctly and sending a copy to the producer and distributor (feed mill).
Take-home message for producers
Many of the antibiotics used in swine feed and/or delivered via the water will be changing in the method they are marketed to producers. Medically important antibiotics used in feed will be changing from over-the-counter (OTC) to VFD. Water soluble medications will be changing from OTC to prescription. Producers need to talk to their veterinarians now about using any antibiotics that fall under the new antibiotic regulations. Producers should not wait until January, 2017 to work out their plans for dealing with these changes! Both VFDs and water Rx medications will require a veterinarian- client- patient relationship. The antibiotic changes do not apply to injectable antibiotics.
What does it mean to have a veterinarian-client-patient relationship?
A veterinarian-client-patient relationship is commonly referred to as a VCPR. A VCPR can be defined by each state. Federal minimum requirements state that a veterinarian must be engaged with producers to assume responsibility for making clinical judgements about the animals' health in the producers’ herds. The veterinarian must have sufficient knowledge of the animals by examination of the animals or visits to the facility where the animals are managed or both. The veterinarian must be available to provide any needed follow-up evaluation or care. Minnesota’s VCPR requirements align with the federal requirements mentioned.
Water soluble medications transitioning from over-the-counter to Rx
A list of affected feed medications that will be changing from OTC to Rx can be found on FDA's website. A fact sheet listing the affected water soluble medications in relation to their trade name can be found here.
Feed medications transitioning from over-the-counter to VFD
A list of affected feed medications that will be changing from OTC to VFD can be found on FDA's website. A fact sheet listing the affected water soluble medications in relation to their trade name can be found here.
Changes with revised VFD rule
|Previous rule||Revised rule|
|Records must be kept for 2 years||Records must be kept for 2 years|
|Original document to mill||Email or fax documentation okay|
|No extra-label use||No extra-label use|
|Order for tons of feed||Order for approximate number of animals or days to feed|
|No refills, unless on label||No refills, unless on label|
|Written for one group of animals on a premise||Can be written for multiple premises if pigs are under same ownership and fed by same mill|
|VCPR required||State/Federal VCPR required
VFD will expire within 6 months of issuance
Producers' responsibility when feeding VFD's
These producer responsibilities also apply to any youth swine projects.
- Any animal feed containing a VFD drug can only be fed with a valid VFD issued by a licensed veterinarian. This includes any medicated feed inventory that was purchased prior to January 1, 2017 that the producer may have on hand or in feed bins.
- VFD feed left after an issued VFD has expired cannot be fed.
- VFD records must be kept for 2 years.
How will on-farm feed manufacturing be impacted?
If a producer has an on-farm feed mill and only mixes for themselves, they just need to have a VFD to give to the distributor when buying their medicated ingredients. The producer will need to have a current VFD on file to feed the medicated feed to their pigs.
If a producer is mixing feed that will be given or sold to a neighbor or contract grower, then the producer is considered a distributor and they need to submit a one-time acknowledgment letter to FDA. The letter will need to be kept on file. A current VFD will be needed for every batch of medicated feed.
USCARE: Checklist for antibiotic success
The Pork Checkoff has created the acronym US CARE as an easy way to remember the 6 key steps producers should do to ensure successful compliance with FDA's new antibiotic regulations.
- Understand come January 1, 2017 only therapeutic use (treatment, control, prevention) for specific animal health condition will be allowed only under direction of veterinarian.
- Strengthen your veterinary-client-patient relationship (VCPR).
- Communicate with your feed mill: ensure the mill personnel understand and are prepared to implement new VFD record-keeping procedures.
- Assess your herd health and welfare strategies.
- Renew your commitment to responsible antibiotic use - stay up to date with Pork Quality Assurance (PQA).
- Ensure your record-keeping compliance: records for VFD must be kept for 2 years and prescription records for 1 year.
References and additional resources