On October 1, 2015, United States Food and Drug Administration (FDA) rules changed for the use of certain antimicrobial drugs (antibiotics) commonly used in livestock production.
Craig Lewis, DVM, MPH, DACVPM, Veterinary Medical Officer, Office of the Center Director Center for Veterinary Medicine at the FDA said, “Any antimicrobial use can lead to resistance.” He urged producers to take steps now to mitigate risks of increasing the number of antibiotic-resistant bacteria in our food supply to protect human and animal health.
With a focus on public health and food security, the FDA issued a Guidance for Industry # 209 “The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals” which aims to limit medically important antibiotic drugs to theraputic purposes necessary for animal health. The guide also calls for veterinary oversight or consultation for antibiotic therapeutic use in food-producing animals.
In the FDA’s Guidance for Industry # 213, manufacturers of antimicrobial drugs delivered in livestock feed or water are requested to adjust their product labels by December 2016, voluntarily. Manufacturers are asked to remove uses to “increase rate of weight gain” or “improve feed efficiency.” These production uses will no longer be legal after the labels are changed. New antibiotic labels should only list therapeutic uses.
Off-label uses of drugs in or on animal feed or in water are already illegal.
Affected antibiotics currently used in medicated feeds include Aminoglycosides, Diaminopyrimidines, Hygromycin B, Linocosamides, Macrolides, Penicillins, Streptogramins, Sulfas and Tetracyclines. Drugs currently used in water that will be affected include Aminoglycosides, Linocosamides, Macrolides, Penicillins, Sulfas and Tetracyclines.
Drugs already requiring a prescription or VFD for judicious use include Avilamycin, Florfenicol, Tilmicosin or Rx-Tylosin. Ionophores, Bacitracin or Bambermycins and non-antibiotic drugs will not be affected.
A Veterinary Feed Directive (VFD) drug or combination of drugs is intended for use in or on animal feed under veterinary supervision. VFD drug or drug combination use is limited to that approved by the FDA’s Center for Veterinary Medicine’s (CVM) and subject to a valid VFD. Drug combinations are also subject to FDA CVM approval.
Veterinarians are legally responsible for ensuring their VFDs are complete and accurate. To be legal, the veterinarian must be licensed to practice and be operating within a valid Veterinarian Client Patient Relationship (VCPR). The VFD must state the:
- Client/owner name, business or home address and phone number
- Veterinarian’s name, address and phone number
- Species and production class and approximate number of animals to be treated
- The animals’ location
- Date of the VFD issuance
- Indication(s) being treated
- Medication(s) name and dosage/treatment or feeding rate and withdrawal times
- Expiration date of the VFD (maximum of 6 months)
- Precautionary statements or special instructions as required
- Affirmation of intent for combination – if the veterinarian is allowing combination of medications
- Statement “The use of feed containing this VFD drug in a manner other than as directed (extra label use) is not permitted”
- Veterinarian’s electronic or written signature
Veterinarians must keep their original VFDs for at least 2 years. Veterinarians can learn more about their responsibilities at www.fda.gov/AnimalVeterinary/DevelopmentApprovalProcess/ucm455416.htm.
Nathan Hubbard of Agfinity, Inc. urged veterinarians and feed mills/distributors to educate their clients on how the new VFD rules may affect their operation and their customers’ responsibilities. Educate customers via group meetings, brochures and your website. Do not wait until January 2017.
Veterinarians, producers and feed mills/distributors must carefully review and verify VFDs for completeness and accuracy. By law, a feed mill/distributor cannot fill an incomplete or inaccurate VFD. Feed mills/distributors must keep their copy of the VFDs for at least 2 years. VFD medicated feed must be properly labeled with all the required VFD information. Feed mills/distributors selling or shipping VFD medicated products to other distributors must first obtain an acknowledgment letter from the recipient distributor. .
In case of a state or FDA inspection, Hubbard recommends veterinarians’, feed mills/distributors’ and producers’ VFD records be organized and easily accessible. Some states require record archiving beyond the Federal minimum of 2 years. Producers can learn about their legal obligations at www.fda.gov/AnimalVeterinary/DevelopmentApprovalProcess/ucm455413.htm. The FDA and CVM are currently working with State and local officials, veterinarians, industry leaders and experts, feed mills/distributors and the public to help ensure a smooth and seamless transition under the new Rule.
Some treatment courses may require two VFDs to complete treatment. For treatment duration and permitted refills, see www.fda.gov/AnimalVeterinary/Products/AnimalFoodFeeds/MedicatedFeed/BlueBirdLabels/default.htm
Not all medicated feeds will require a VFD, even after Guidance # 213 is fully implemented (target of January 2017). There are a number of non-antibiotic medicated feeds. There are also feed with antibiotics, which not deemed “medically important” in humans.
Producers must only feed VFD medicated feeds with a valid VFD and follow VFD instructions exactly. Do not transfer medicated feed to other animals, animal types or feed past the VFD expiration date. Be sure to follow withdrawal periods before processing. Do not mix medicated feed with other feed unless authorized in the VFD. Keep VFD records at least 2 years and have records available for possible inspection.
Producers do not have to take delivery of all medicated feed at once. Keep records to allocate multiple medicated feed shipments to a single VFD. If the number of animals drops and medicated feed is left over after the VFD period, the producer should discuss with their veterinarian whether they are allowed to continue feeding (under a new VFD) or wait for new symptoms to warrant medicated feed.
Veterinarians must specifically prohibit substitution with a generic drug on their VFD or feed mills/distributors may substitute a generic version of the VFD specified drug. Most OTC drugs transitioning to VFDs have generic counterparts.
Veterinarians do not have to personally administer every drug to every animal. Veterinarians must maintain a good Veterinarian Client Patient Relationship (VCPR) with producers and their livestock. Veterinarians writing VFDs must have sufficient knowledge of patients via:
- Patient exam or familiarity with the production site and management team though past visits
- Engage with clients and assume responsibility for decision-making on patient health
- Provide follow-up evaluation or care as needed
Many states have formal requirements for VCPR. The federal definition will guide states without their own definition. VCPR guidelines may be inconsistent across state lines. This could challenge producers working in multiple states or selling across state lines.
View the FDA Guidance for Industry # 120 “Guidance for Industry Veterinary Feed Directive Regulation” at www.fda.gov/AnimalVeterinary/NewsEvents/CVMUpdates/ucm464633.htm.
Kevin Ochsner of the Adayana Agribusiness Group summarized the initial findings from the Farm Foundation’s survey on the impact of these new FDA rules. There are nearly an equal number of respondents who believe these changes will have a positive impact on the livestock industry as those who believe the new policy will negatively influence the livestock industry. Some respondents said antibiotic use has been a crutch and believe this change will encourage more emphasis on stockmanship, stewardship and preventative medicine. Other respondents predicted increased animal disease and death and ultimately, higher food prices for consumers. Two thirds of the 30 responding producers said the new rules would drive significant changes in their livestock management.
The biggest impact most respondants anticipate is the increased paperwork involved with VFDs. All stakeholders see a need for more producer, distributor and veterinarian education.
Some producers complained about additional paperwork with VFDs. They asked who would be responsible for producer, distributor and veterinarian education.
A workshop called “Stewardship of Medically-Important Antimicrobial Drug Use in Food Animals: Understanding the FDA Guidances and Veterinary Feed Directive” was held in Denver, Colorado on September 28, 2015. View the recorded workshop at http://livestream.com/BarnMedia/events/4339142. Learn more about the Farm Foundation’s workshop series at http://farmfoundation.org/webcontent/Stewardship-of-medically-important-antimicrobial-drug-use-in-food-animals-1901.aspx.
A similar story ran in Country Folks.