Antibiotic Stewardship for Beef Producers

ANTIBIOTIC STEWARDSHIP FOR
BEEF PRODUCERS

A SAFE, WHOLESOME AND
ANTIBIOTIC STEWARDSHIP FOR BEEF PRODUCERS
HEALTHY BEEF SUPPLY1

A Beef Producers Guide for Judicious Use of Antibiotics in Cattle
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Prevent Problems: Emphasize appropriate husbandry and hygiene, routine
health examinations, and vaccinations.
Adhere to FDA Guidance: Follow label instructions and FDA Guidance for
the use of all antibiotics. The use of antibiotics medically important in human
medicine should only be used after careful consideration. If medically
important feed grade antibiotics are used, they must be under the guidance
of a Veterinary Feed Directive (VFD).
Select and Use Antibiotics Carefully: Consult with your veterinarian on the
selection and use of antibiotics, under the premise of a valid VeterinarianClient-Patient-Relationship (VCPR). Have a valid reason to use an antibiotic.
Appropriate therapeutic alternatives should be considered prior to using
antimicrobial therapy.
Use the Laboratory to Help You Select Antibiotics: Cultures and sensitivity
test results should be used to aid in the selection of antibiotics, whenever
possible.
Combination Antibiotic Therapy Is Discouraged Unless There Is Clear
Evidence the Specific Practice Is Beneficial: Select and dose an antibiotic to
affect a cure.
Avoid Inappropriate Antibiotic Use: Confine therapeutic antibiotic use to
proven clinical indications, avoiding inappropriate uses such as for viral
infections without bacterial complication.
Treatment Programs Should Reflect Best Use Principles: Regimens
for therapeutic antimicrobial use should be optimized using current
pharmacological information and principles.
Treat the Fewest Number of Animals Possible: Limit antibiotic use to sick or
at-risk animals.
Treat for the Recommended Time Period: To minimize the potential for
bacteria to become resistant to antimicrobials.
Avoid Environmental Contamination with Antibiotics: Steps should be
taken to minimize antimicrobials reaching the environment through spillage,
contaminated ground run off or aerosolization.
Keep Records of Antibiotic Use: Accurate records of treatment and outcome
should be used to evaluate therapeutic regimens and always follow proper
meat and milk withdrawal times. Keep records for a minimum of 2 years or
longer based on state and local regulations.
Follow Label Directions: Follow label instructions and never use antibiotics
other than as labeled without a valid veterinary prescription.
Extra Label Antibiotic Use Must follow FDA Guidance: Prescriptions,
including extra label use of medications must meet the Animal Medicinal Drug
Use Clarification Act (AMDUCA) amendments to the Food, Drug, and Cosmetic
Act and its regulations. This includes having a valid VCPR.
Medically Important Antibiotic Use Should be Limited to Treat, Prevent
or Control Disease: Medically important antibiotics should not be used if
the principle intent is to improve performance. Antibiotics that are medically
important to human medicine may not be used for performance.

Guidelines developed from AVMA, AABP and AVC guidance on Appropriate Veterinary Antibiotic Use

Beef cattle producers take pride in their
responsibility to provide proper care to cattle.
The Code of Cattle Care below lists general
recommendations for care and handling of cattle:
• Provide necessary food, water and care to protect
the health and well-being of animals.
• Provide disease prevention practices to protect
herd health, including access to veterinary medical
care.
• Provide facilities that allow safe, humane, and
efficient movement and/or restraint of cattle.
• Provide personnel with training/experience to
properly handle and care for cattle.
• Make timely observations of cattle to ensure basic
needs are being met.
• Minimize stress when transporting cattle.
• Keep updated on advancements and changes in
the industry to make decisions based upon sound
production practices and consideration for animal
well-being.
• Persons who willfully mistreat animals will not be
tolerated.

ANTIBIOTIC STEWARDSHIP FOR BEEF PRODUCERS

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INTRODUCTION
The Beef Quality Assurance program is rooted in a cattleman’s belief of doing the
right thing. The judicious use of antibiotic technologies is no exception to the goal of
producing high quality, wholesome, and healthy beef. BQA guidelines are designed
to make certain all beef consumers can take pride in what they purchase – and can
trust and have confidence in the entire beef industry.
BQA programs have evolved to include best practices around good record-keeping,
and protecting herd health. Antibiotic stewardship has been a commonsense practice
adopted by beef producers since before the start of the BQA program.
Responsible antibiotic use is important to ensure that animal health technologies
remain viable for the beef industry. It is key that judicious use protocols are developed
so that animals are never marketed with residues and that cattlemen responsibly
treat sick cattle. Marketing beef with antibiotic residues, even unintentionally, is illegal
and can result in significant consequences, both legally and financially.
The judicious use of antibiotics not only results in more profits for producers, but
increases consumer confidence. When healthy cattle leave the farm and reach the
marketplace, the producer, packer, and consumer all benefit.
When better quality beef reaches the supermarket,
consumers are more confident in the beef
they are buying, and this increases beef
consumption.

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ANTIBIOTIC STEWARDSHIP FOR BEEF PRODUCERS

RESIDUE
A residue refers to the presence of veterinary drugs or pesticides in meat. These
residues are usually measured in parts per million or parts per billion. The
overwhelming majority of meat products contain no residues or residues within the
government prescribed tolerance levels. Veterinary drug tolerances are established
by the U.S. Food & Drug Administration (FDA) under the Federal Food, Drug and
Cosmetic Act. Environmental Protection Agency (EPA) establishes tolerances for
registered pesticides under the Food Quality Protection Act.
The FDA approves veterinary drugs and the specific dosage rates to treat specific
diseases or conditions. Farmers, ranchers and veterinarians are required by law to
follow the FDA-approved label to administer the drug appropriately and correctly.
Animal health companies must prove that their veterinary drugs are safe and
effective for the intended animal patient, much like the drug approval process for
human antibiotics. If the intended patient is a food-producing animal, there is an
additional requirement to prove that the use of the antibiotic does not present a risk
to human health.
The prevention of illegal antibiotic residues is a continuous, coordinated effort
between government agencies, veterinarians, and livestock producers that begins
before the antibiotic is ever used in animals. The drug approval process, on-farm
antibiotic use measures and the U.S. National Residue Program are all specifically
designed to prevent animal products with illegal drug residues from entering the
food supply.

ANTIBIOTIC STEWARDSHIP FOR BEEF PRODUCERS

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The FDA also sets withdrawal times for all veterinary drugs, including antibiotics.
The withdrawal period is the time between the last dose of the antibiotic and the
time when the animal can be safely slaughtered for food (or, with dairy cattle, the
milk can be safely consumed). Practically, the withdrawal time is the amount of
time required for the drug to be reduced to a safe tolerance level; the withdrawal
time depends on the drug; but typically ranges from zero to 60 days.
The final step in protecting and preventing illegal antibiotic residues from entering
the food supply is surveillance testing conducted by the United States Department
of Agriculture (USDA) Food Safety Inspection Service (FSIS). The agency conducts
tests for chemicals—including antibiotics and various other drugs, pesticides and
environmental agents—in meat, poultry, and egg products destined for human
consumption. The surveillance program consists primarily of two tiers of testing:
scheduled and inspector generated. Scheduled antibiotic residue testing is
pre-planned to provide a large sample across different food animal industries
(beef cattle, veal calves, swine, poultry, dairy, etc.) and locations. The
development of scheduled sampling plans is a process that proceeds in the
following manner:
1. Determine which compounds are of food safety concern;
2. Use algorithms to rank the selected compounds;
3. Pair these compounds with appropriate production classes; and
4. Establish the number of samples to be collected.
Inspector generated samples are collected from animal carcasses that show signs
of previous disease or medical treatments—animals that may present an above
average risk for illegal antibiotic residues. In the rare cases when an illegal drug
residue is confirmed, the beef product is considered “adulterated” and is never
allowed to enter the food supply. The USDA and FDA then initiate a cooperative
effort to investigate the reasons for the illegal use. Depending on the severity of
the residue, the intent and history of the violations, the investigation may lead to
a variety of outcomes for the animal owner, from a warning letter to injunction to
criminal prosecution.
The FSIS Hazard Analysis Critical Control Points (HACCP) program implemented at
slaughter facilities identifies the animals most likely to have drug residues. Animals
that display lameness, injection site lesions or signs of illness are targeted for
testing. If there is any doubt about the potential for drug residues in an animal,
they should be withheld from market.

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ANTIBIOTIC STEWARDSHIP FOR BEEF PRODUCERS

REPEAT VIOLATORS LIST
Producers who market animals that test positive for chemical residues more than
a single time will be placed on the publicly available USDA FSIS Residue Repeat
Violator List.
FSIS maintains a “Repeat Residue Violator List for Use by FSIS Inspection
Personnel” that contains the names and addresses of producers who have more
than one meat residue violation in a 12-month period in animals presented
for slaughter. Specific information about the violation can also be found in this
list, including the plant where the violation was determined, the drug residues
discovered, and their concentrations and tolerances. Violators listed may have
had multiple violations documented in the same processing facility or separate
facilities. This list is intended to aid inspectors in discovering residue tolerance
violations before they reach consumers. FSIS provides a user guide that explains
the information contained in the list.
FSIS also maintains a “Residue Repeat Violator List for Use by Livestock Markets
and Establishments” that contains similar information intended to assist plant
owners and operators in identifying residue history of livestock suppliers. This
second list documents only the source name and address information of repeat
violators, so that livestock marketers and buyers may use precaution when
marketing and processing animals from listed suppliers.

ANTIBIOTIC STEWARDSHIP FOR BEEF PRODUCERS

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TISSUE RISK ASSESSMENT CHECKLIST

L ow R i s k
• Animal history is documented, recorded and available.
• Animal never treated with drugs
OR

• Single drug administration of lactating/non -lactating animal approved drug –
AND

• Followed drug label information for dose, route of administration, duration of
therapy and withholding time.

OR
• Veterinary oversight of the use of drugs in an extra-label manner.

High Risk
• Animal is displaying lameness, injection sites, surgical evidence or has signs of illness –
AND
Any of the below apply:
• History of animal treatment not documented or not communicated to person
• sending cattle to market.
• Route of administration that was used is not as prescribed on the label.

• Multiple drug administration without veterinary oversight.
• Drug not approved for animal status, e.g. lactating.
• Doses or withholding times not followed or unknown.
• Duration of therapy not followed.
• If any of the above high risk attributes exist, consult pharmaceutical, veterinary
• or screening test experts to determine status of animal before offered for sale –
When in doubt hold it out!

•Record all treatments: Date, animal ID, serial/lot number, dose given, route of
administration, the person who administered the treatment and the withdrawal

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ANTIBIOTIC STEWARDSHIP FOR BEEF PRODUCERS

STEPS TO PREVENT A VIOLATIVE RESIDUE
• Identify and segregate all animals treated.
• Record all treatments: Date, animal ID, serial/lot number, dose given, route of

administration, the person who administered the treatment and the withdrawal time.

• Strictly follow label directions for product use.
• Use newer technology antibiotics when possible.
• Reduce unwanted depot effect. Select low volume product when available.
• Select generic medications and vaccines with an animal health professional.
• Avoid inferior products. They may cause performance loss or damage quality.
• Select with short withdrawal when antibiotic choice is equivalent.
• Never give more than 10 cc per IM injection site.
• Avoid Extra-Label Drug Use (ELDU) of antibiotics.
• Use label dose and route of administration under a valid VCPR.
• Avoid using multiple antibiotics at the same time.
• Don’t mix antibiotics in the same syringe.
• Check ALL medication/treatment records before marketing:

Don’t market cattle with less than 60 withdrawal days without examining their
treatment history.
Extend the withdrawal time if the route or location of administration is altered.
Extend the withdrawal time to the longest withdrawal period of all products given.
Extend the withdrawal for all penicillin given at doses which exceed the label dose
• Testing urine may not detect injection site residues that will test positive by the
USDA-FSIS.

• Never inject gentamicin or neomycin. The estimated withdrawal is more than 24 months
• Testing urine may not detect a kidney that will test positive by the USDA-FSIS.
• Don’t market cattle that have relapsed without examining the treatment history.
• Don’t market cattle with suspected liver or kidney damage without examining
the treatment history.

• Don’t market cattle with antibiotic injection site knots without examining the
treatment history

Screen the urine for antibiotics of all cattle identified in the above steps. It is best to use
broad spectrum microbial inhibition test such as the Pre-Harvest Antibiotic Screening
Test (PHAST), a microbial growth inhibition test which uses B. megaterium as the test
organism. Test results should be compared to FDA-Center for Veterinary Medicine
(CVM) violative residue tolerances (Maximum Residue Limit).
ANTIBIOTIC STEWARDSHIP FOR BEEF PRODUCERS

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Food Animal Residue Avoidance Databank (FARAD)
FARAD is a national, USDA-sponsored, cooperative project, with a
primary mission to prevent or mitigate illlegal residues of drugs,
pesticides and other chemicals in foods of animal origin. Producers
should work with the veterinarian with whom they have a valid
VCRP for drug residue information first. The veterinarian is the ideal
resource to discuss FARAD-specific information regarding withdrawal
times, especially for extra-label drug use.
FARAD provides the following services
• Advice on residue avoidance or mitigation
• VetGram search for required withdrawal times for
approved food animal drugs
• FARAD-recommended withdrawal intervals for extra-label use of
approved food animal drugs
Visit www.farad.org for more information.

CLASSIFICATION
There are three classes of animal drugs: Over-the-Counter (OTC), Prescription (Rx),
and Veterinary Feed Directive (VFD). OTC drugs can be sold by any person or
establishment without a veterinary prescription. Rx drugs can only be sold to the
farmer by a veterinarian or pharmacist, and only with a veterinary prescription. VFD
is a drug intended for use in or on feed which is limited by an approved application
to use under the professional supervision of a veterinarian who is licensed in the
state where the animals are being kept. It is illegal to use any VFD drugs in an extralabel manner.

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ANTIBIOTIC STEWARDSHIP FOR BEEF PRODUCERS

REGULATIONS REGARDING ANIMAL HEALTH PRODUCTS
VCPR
The veterinarian-client-patient relationship (VCPR) is the basis for interaction
among veterinarians, their clients, and their patients and is critical to cattle
health and well-being. There is a federal definition for a VCPR and state
definitions for VCPRs exist under the state veterinary practice acts. In reference
to the VFD, FDA has identified a list of the VCPR jurisdiction for the state or
federal definition at the following link: http://www.fda.gov/AnimalVeterinary/
DevelopmentApprovalProcess/ucm460406.htm
In general, a VCPR exists when:

• The veterinarian has assumed the responsibility for making clinical judgments

regarding the health of the animal and the need for medical treatment, and the
client has agreed to follow the veterinarian’s instructions.

• The veterinarian has sufficient knowledge of the animal to initiate at least a

general or preliminary diagnosis of the medical condition of the animal. This
means the veterinarian has recently seen and is personally acquainted with the
keeping and care of the animal by virtue of an examination of the animal or the
medically appropriate and timely visits to the premises where the animal is kept.

• The veterinarian is responsible for maintaining and evaluating case and treatment
records, and is readily available for follow up evaluation in the event of adverse
reactions or failure of the treatment regimen.

ANTIBIOTIC STEWARDSHIP FOR BEEF PRODUCERS

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According to the American Association of Bovine Practitioners (AABP) the following areas
are considered critical components for establishing and maintaining a valid VCPR:
Written Agreement

• A veterinary practice or individual should establish a written agreement with the
client that identifies the farm veterinarian who is accountable for drug use and
treatments administered to the cattle on the farm operation. If more than one
veterinarian or veterinary practice has a working relationship on the
operation, then the agreement should establish which one has the overall
responsibility for treatment protocols, drug inventories, prescriptions, personnel
training, oversight and drug use on the operation. The identified veterinarian is
referred to as the Veterinarian of Record.

Veterinary Oversight

• The Veterinarian of Record is the responsible party for providing appropriate

oversight of drug use on the farm operation. Such oversight is a critical component
of establishing, maintaining and validating a VCPR. This oversight should include,
but may not be limited to, establishment of treatment protocols, training of
personnel, review of treatment records, monitoring drug inventories, and assuring
appropriate labeling of drugs

• Veterinary oversight of drug use should include all drugs used on the farm
regardless of the distribution of the drugs to the farm. Regular farm visits
are an essential component to providing such oversight, however this can be
supplemented through laboratory data evaluation, records evaluation, and
telephonic and electronic communication. The timeliness of farm visits should
be determined by the Veterinarian of Record based on the type and size of the
operation.
Relationship with Consultants and other Veterinarians

• If a veterinarian who is not the Veterinarian of Record provides professional

services in any type of consultative or advisory capacity, then it is incumbent
on that veterinarian to ensure that the Veterinarian of Record is contacted and
informed of their findings and recommendations. No protocols or procedures
that have been established by the Veterinarian of Record should be changed
unless or until there is an agreement by all parties about such changes. The
agreement between the Veterinarian of Record and the client should establish
which management groups of the farm operation are covered in the agreement
For instance, reproduction, milk quality, youngstock/replacement, feedlot, cowcalf, and sick animal treatments are possible identifiable areas.

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ANTIBIOTIC STEWARDSHIP FOR BEEF PRODUCERS

Treatment Protocols

• Protocols and treatment guidelines for commonly occurring, easily recognizable
conditions should be established in writing and agreed upon by all parties
involved, signed and dated. Training of personnel authorized to use drugs on the
operation should be undertaken and periodically reviewed. The frequency of such
training and review should be determined by the size and type of the operation,
the rate of personnel turnover, and the changes in protocols and procedures.
The treatment protocols and procedures should include all drugs used on the
operation (over the-counter, prescription, extra-label, Veterinary Feed Directive,
water soluble). All protocols should clearly define when to quit treating and seek
professional help (poor response, increase in severity of signs).
Written/Electronic Treatment Record

• Written/electronic treatment records of all animals or groups of animals treated

are an essential component of maintaining and establishing the VCPR and to
decrease the risk of violative drug residues. Such records should include, at a
minimum, the date, identification of animal(s), drug(s) used, frequency, duration,
dose, route, appropriate meat/milk withdrawal intervals, and the person
administering the treatment. Periodic and timely review of the treatment records,
drug inventories and usage is an important part of oversight by the Veterinarian
of Record.

Prescription Drugs

• Provision of drugs or drug prescriptions should be for specific time frames
appropriate to the scope and type of operation involved and only for the
management groups within the operation for which the Veterinarian of Record
has direct involvement and oversight. Additionally, failure to follow agreed upon
protocols and procedures should be grounds for denial of provision of drugs
or prescriptions except for an individual patient needing treatment at the time
of examination. Routine examination of drug inventories on farm and product
purchase records (pricing information is unnecessary) review are recommended.
Cooperation with distributors is encouraged. Establishment of a VCPR for the
sole purpose of the sale of drugs or increased sales of a particular brand of drug
product is not a valid or ethical reason for having a VCPR.

ANTIBIOTIC STEWARDSHIP FOR BEEF PRODUCERS

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VETERINARIAN/CLIENT/PATIENT RELATIONSHIP
VALIDATION FORM

Producer
Product Name: ______________________________________________________________________
Address: ___________________________________________________________________________
City: __________________________________State:__________________Zip: ___________________
Farm Name and Location: _____________________________________________________________
Section: ____________________________ Township: ______________________________________
County: ____________________________________
Premises ID Number (optional): _______________________________
Producer Signature: __________________________________________
Date: ______________________________

Veterinarian
Product Name: ______________________________________________________________________
Address: ___________________________________________________________________________
City: __________________________________State:__________________Zip: ___________________
Clinic Name: ________________________________________________________________________
Phone Number: (_____________)________________________
I hereby certify that a valid Veterinarian/Client/Patient Relationship (VCPR) is established for the above
listed owner and will remain in force until canceled by other party.
Veterinarian Signature: __________________________________________
Date: ______________________________
Adapted from the Center for Dairy Excellence

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ANTIBIOTIC STEWARDSHIP FOR BEEF PRODUCERS

Guidance 209 and 213
The FDA published Guidance for Industry (GFI) 213 in December 2013, establishing
procedures for voluntarily phasing out growth promotion indications for medically
important antibiotics in alignment with GFI 209. In GFI 209, published in April 2012,
animal pharmaceutical companies will voluntarily revise the FDA-approved use
conditions for these products to remove production indications.
GFI 209 limits the use of the medically important antimicrobial drugs used in feed
and water for animals to these uses:

• Considered necessary for assuring animal health (therapy, prevention, and

control issues) and not for feed efficiency or growth promotion.

• That include veterinary oversight or consultation.

GFI 213 defines the implementation of GFI 209 to include that by December 31, 2016
Drug Sponsors will change drug labels so production uses will be removed. With
label changes, it will no longer be legal to use the medically important antibiotics
in feed/water for feed efficiency uses. Therapeutic Uses (treatment, control,
and prevention) will be retained. Beginning January 1, 2017 GFI 213 requires a
transition to Veterinary Oversight including a prescription for water soluble products
(medicated drinking water) and a Veterinary Feed Directive (VFD) for medically
important antibiotics used in or on feed and requires use to be authorized by a
licensed veterinarian in context of a VCPR. After implementation of GFI 209/213 on
January 1, 2017, it will be necessary for all producers to have established a VCPR
with a veterinarian to obtain these products.

ANTIBIOTIC STEWARDSHIP FOR BEEF PRODUCERS

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On Farm Practices for Antibiotic Use
Needle Selection and Care

• Needles contribute to injection site defects. Use needles that are no larger than
necessary to adequately complete the injection, but large enough to prevent needle
bending or breaking off in muscle tissue. The leading cause of needle bending
is improper restraint, but using dull, damaged or poor quality needles may also
contribute to the problem. Under no circumstances can animals with broken needles
in them be sent to a harvest facility.
Primary considerations in needle selection

• Route of administration
• Size of animal
• Location or site of injection (BQA requires all injections be given in the neck,
unless directed otherwise by a veterinarian or per label instruction)

Secondary consideration in needle selection
• Viscosity and volume/amount of fluid injected

Route of Administration
Injectable
Viscosity
Thin
Example:
Most Vaccines

Thick
Example:
Thick Antibiotics

SQ

IM

IV

(1½ to ¾ inch needle)

(¾ to 1 inch needle)

(1 to 1½ inch needle)

Cattle Weight

Cattle Weight

Cattle Weight

< 300 300-700 < 700

< 300 300-700 < 700 < 300 300-700 < 700

18
gauge

18-16
gauge

16
gauge

20
18-16
gauge gauge

18-16
gauge

18-16
gauge

16-14 18-16
gauge gauge

18-16
gauge

18-16 18-16
gauge gauge

18-16
gauge

16-14
gauge

16-14 18-16
gauge gauge

18-16
gauge

16-14
gauge

Select the needle to fit the cattle size (use the smallest practical size with out fear of bending).

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ANTIBIOTIC STEWARDSHIP FOR BEEF PRODUCERS

Needle Guidelines
Needle selection and use in a nut shell:
• Use proper restraint and high quality needles
• Select needle size to fit the size of the cattle
• Diameter (gauge) to fit the viscosity, adjusted to the cattle weight
• Length to fit the route of administration, adjusted to the cattle weight
Change needles
• Immediately if the needle bends (DO NOT USE A BENT NEEDLE)
• If needles become contaminated with feces, dirt, or irritating chemicals
• If the needle point is damaged/burr develops
• Before the needle becomes dull
• Between cattle with KNOWN blood borne infectious disease
•Under the instruction of the herd veterinarian
Needle care
• Protect needles from contamination (feces, dirt or irritating chemicals)
• Store unused needles in protected area
Needle disposal
• Follow local, state, and federal EPA guidelines for disposal of used needles
• and other Sharps
• Seal Sharps container and dispose of in an approved land fill
Disinfectants
• Use all disinfectants carefully
• Do not use disinfectants on needles used for fluid injectables
• Disinfectants kill Modified Live Vaccines
• Disinfectants can cause severe tissue irritation

ANTIBIOTIC STEWARDSHIP FOR BEEF PRODUCERS

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Administration of Injectables
Regardless of animal’s age, injections (All IM and routine SQ medications and
vaccines) should be given in front of the shoulders (unless directed otherwise
by a veterinarian or per label instruction); never give an injection in the rump or
back leg. In order to avoid adverse tissue reactions, whenever possible restrict
administration of drugs to SQ, IV, IN or oral use. It is against BQA guidelines to
give SQ injections along the ribs or in the elbow region. Giving injections above the
curve of the ribs could cause excessive trim in the area of the “rib-roll” or “prime
rib” cut of meat. If intramuscular medications must be used, administer them in
the neck and never exceed 10 cc per IM injection site. For example, if 24 cc is the
calculated dose, use three 8 cc injections instead of two 12 cc injections. There are
no restrictions to the volume of SQ injections other than as indicated by the product
label or as instructed by the herd veterinarian.

Recordkeeping is Essential to Document Antibiotic Use and
Monitor Withdrawal Times
• Recordkeeping is a key element of BQA, and it’s simply a good business

practice. There are many software programs on the market that are designed
for both commercial and purebred cattle operations. Pen and paper can also
be an acceptable recordkeeping system if appropriately organized.

• The important thing is to find a method that you are comfortable with, which

allows you to maintain accurate, thorough and timely documentation of your
herd health program, nutrition program and other important production factors.
It’s also essential to controlling your costs of production and keeping your eye
on other pieces of data that help you make informed management decisions.

• For example, animal health records tell the manager and veterinarian what

treatments are being used so they can make sure that recommendations are
being followed and help them decide whether treatment protocols need to be
adjusted.

• To inspire consumer confidence we must be able to document the responsible
use of products and demonstrate that we have control over risk factors that
have residue potential. Good records are also important if your operation is
inspected (for example, if one of your market cows is found to have a violative
residue) by any state or federal agency.

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ANTIBIOTIC STEWARDSHIP FOR BEEF PRODUCERS

• Should your operation get cited for a residue violation and you believe it’s a case of

mistaken identity, good records are your only evidence that the animal in question
does not belong to you. Or, if it is your animal, then your records may help prove the
animal was not given the particular drug in question by you.

• Effective documentation showing appropriate training, inventory control, product use,
animal identification, withdrawal and disposal is the only way to avoid liability from a
residue contamination. The only way to accurately determine if you are in compliance
with withdrawal times is to know exactly what was given, how much was given, where
it was given, how it was given and when it was given to the animal.

• Updated records also allow you to make well-informed decisions about marketing

cattle without worrying whether enough time has elapsed since the last treatment.
Records should also be kept on your use of pesticides, herbicides and other chemicals.

• Understand the remarks and safety restrictions with regard to withdrawal times and
animal types (pregnant, lactating, etc.) that should not be treated or exposed to
treated areas.

What to include in a record

Keep all records for at least two years from the date of transfer or sale of the cattle.
In case a problem arises later, your records will help you track the treatment history of
the animal when it was in your possession.

The treatment record should contain the following information:

• Treatment date

• Animal or group identification
• Approximate weight of animal or group average
• Product administered
• Product lot/serial number
• Earliest date the animal could clear withdrawal time
• Dose given
• Route of administration (IM, SQ, etc.)
• Location of injections
• Name of person who administered the drug

A copy of the appropriate records should be made available to the buyer of your
cattle or as they are transferred from one unit of your ranch to another. Records
should include all individual and group treatment processing history and other
information as deemed appropriate.
ANTIBIOTIC STEWARDSHIP FOR BEEF PRODUCERS

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EXTRA LABEL DRUG USE
Extra-label drug use (ELDU) is using a drug at a dose, by a route, for a condition,
indication, frequency or duration, or in a species not on the label. Extra-label drug
use is not permitted in the feedstuff for food-producing animals. ELDU is only legal
within the context of a valid VCPR.

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ANTIBIOTIC STEWARDSHIP FOR BEEF PRODUCERS

Extra label Drug Use Decision Flow-Chart for Food Animals
You made a careful diagnosis in the presence of a Valid Veterinarian Client/
Patient Relationship. You are contemplating extra-label drug use. You must ask
yourself ... Are the animals to be treated food animals?

YES

s s

s s

Does a drug labeled for food animals exist which fulfills all of the following:

contains the needed ingredient
labeled for the indication

in the proper dosage form
is clinically effective?

NO

YES

You must use this drug per lable, as
extra-label drug use is unnecessary.
Observe label directions and
withdrawal time.

Is there a drug approved for food
animals which could be used in an
extra-label manner?

NO

YES
Proceed with the extra-label use of
food animal drug. Establish extended
withdrawal time. Observe label
directions and withdrawal time.

YES

Is there adequate scientific
information available to
determine withdrawal time?

YES
Proceed with extra-label drug
use of human or non-food
animal drug. Establish
extended withdrawal time.
Ensure food safety. Maintain
required records. Label drug
appropriately.

Is there a human drug or drug
approved for non-food animal
which could be used in an
extra-label manner?

NO

If compounding of approved drugs
will prevent pain and suffering,
refer to CPG 608 400 for
compounding guidance ***

NO
Drug must not be used or treated
animal must not enter the food supply.

*** Compounding of bulk drugs is generally illegal.

Adapted from Farmers Assuring Responible Management
ANTIBIOTIC STEWARDSHIP FOR BEEF PRODUCERS

21

Compounding
The use of drugs compounded from bulk ingredients in cattle is currently illegal. FDA has
exercised enforcement discretion when compounding from bulk ingredients in the case of
certain poison antidotes and euthanasia agents (refer to the Compliance Policy Guideline
on compounding and its Appendix).
Compounding from bulk ingredients to manufacture other medications for cattle under
any circumstance is inappropriate. There are circumstances, however, where minor
compounding might be considered appropriate under the AMDUCA algorithm. The AMDUCA
regulations state that compounded preparations are required to be prepared from FDAapproved animal or human drugs, and that if possible, an animal-labeled drug is to be
used for compounding rather than a human-labeled drug.
Drugs that are not approved for cattle or that are not approved for the production class of
cattle being treated should only be used after following AMDUCA regulations. Medications
that are labeled for cattle or for that production class should always be considered first
for treatment, control and prevention of disease. If the prescribing veterinarian has
determined that the labeled medication is or will be clinically ineffective for the disease
condition being treated, and extra-label use is indicated, then an extended withdrawal
period for meat and milk should be provided. The Food Animal Residue Avoidance
Databank (FARAD) may be of help in establishing these recommendations.
The labeled withdrawal period from the manufacturer does not apply if the drug is used in
an extra-label manner such as changing the dose, route, duration, frequency or production
class of animal. The FDA considers the use of medications in a production class of animal
not approved on the label to be an extra-label use. When a veterinarian prescribes this
extra-label use in an unapproved class of livestock, there is no tolerance in edible tissues
or milk. Any detectable level of the medication in such a scenario is a violative residue.
Therefore, the withdrawal time for meat and milk must be significantly extended to
ensure there is no detectable level of residue in the animal product. When an appropriate
withdrawal time cannot be established, use of the drug precludes the animal or its
products from entering the food chain.
(AABP April, 2015)

22

ANTIBIOTIC STEWARDSHIP FOR BEEF PRODUCERS

Employee Training
Employees administering animal health products should be properly trained according
to BQA guidelines and proper protocols. For employee training resources visit
www.bqa.org.

FDA Approved Drugs
For a list of drugs approved by the Food and Drug Administration, please visit bqa.org.

ANTIBIOTIC STEWARDSHIP FOR BEEF PRODUCERS

23

For more information visit:
www.bqa.org