Transcript Beef Quality Assurance - University of Nebraska–Lincoln

A Little On Drug Use
Antibiotic Use Guidelines
AMDUCA
(Animal Medicinal Drug Use Clarification Act)
ELDU
(Extra Label Drug Use)
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Rx: Basic Information for Records (R), Prescriptions (P), & Labels (L)
• Name, address, & telephone number
of veterinarians (RPL)
• Name (L), address, & telephone
number of clients (RP)
• Identification of animal(s) treated,
species & numbers of animals treated,
when possible (RPL)
• Date of treatment, prescribing, or
dispensing of drug (RPL)
• Name, active ingredient, & quantity of
the drug (or drug preparation) to be
prescribed or dispensed (RPL)
• Drug strength (if more than one
strength available) (RPL)
• Dosage & duration
• Route of administration (RPL)
• Number of refills (RPL)
• Any cautionary statements (RPL)
• Expiration date if applicable (L)
• Slaughter withdrawal &/or milk
withholding times, if applicable (RPL)
• Signature or equivalent (P)
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Producer Antibiotic Use Guidelines
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Prevent Problems:
Select and Use Antibiotics Carefully:
Avoid Abs Important In Human Medicine As First Line Therapy:
Use the Laboratory to Help You Select Antibiotics:
Avoid Using Combinations of Antibiotics:
Avoid Inappropriate Antibiotic Use:
Treatment Programs Should Reflect Best Use Principles:
Treat the Fewest Number of Animals Possible:
Treat for the Recommended Time Period:
Avoid Environmental Contamination with Antibiotics:
Keep Records of Antibiotic Use:
Follow Label Directions:
Extralabel Antibiotic Use Must follow FDA Regulations:
Subtherapeutic antibiotic use is discouraged:
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Extralabel Antibiotic Use
Must follow FDA Regulations …
• Prescriptions, including extra label use of
medications must meet the AMDUCA
(Animal Medicinal Drug Use Clarification Act)
amendments to the Food, Drug, and Cosmetic
Act and its regulations.
• Meet FDA criteria for
– ELDU (Extra Label Drug Use) &
– a valid VCPR (Veterinary Client Patient Relationship)
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FDA criteria for ELDU
1. A careful diagnosis is made by an attending veterinarian within the
context of a valid veterinarian-client-patient relationship.
2. A determination is made that 1) there is no marketable drug
specifically labeled to treat the condition diagnosed, or 2) treatment
at the dosage recommended by the labeling was found clinically
ineffective.
3. Procedures are instituted to assure that identity of the treated animal
is carefully maintained.
4. A significantly extended period is assigned for drug withdrawal prior
to marketing the treated animal and steps are taken to assure the
assigned time frames are met so that no violative residue occurs.
The Food Animal Residue Avoidance Databank (FARAD) can aid
the veterinarian in making these estimates.
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FDA criteria for VCPR
Veterinarian-Client-Patient Relationships Exist When:
A. 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.
B. 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.
C. The veterinarian is readily available for follow-up evaluation in the
event of adverse reactions or failure of the treatment regimen.
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Animal Medicinal Drug Use
Clarification Act (AMDUCA) Scope
• Applies only to approved
animal & human drugs
• Valid VCPR
• Lay ELDU not allowed
• Does not allow ELDU of feed additives
– BY ANYONE !!!
– ELDU of Water medications is OK.
AMDUCALG.doc
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AMDUCA’ Scope
• ELDU permitted only when animal’s health
is threatened or animal is suffering.
• Therapeutic only.
• No ELDU allowed for production purposes
– Implants … reproductive … etc
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ELDU in Food Animals
• No approved animal drug for such use with
same ingredient, dosage form, concentration
• VCPR
• Extended withdrawal time to ensure no illegal
residues occur
• Ensure identity of animal
• If an approved drug is shown to be ineffective,
ELDU may be used
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ELDU of Human &
Non-food Animal Drugs
• Can’t use human drug if there is
an approved animal drug available
• Scientific information on the human
food safety aspect of the use of the
drug … can obtain this info from
–FARAD or US Pharmacopeia
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AMDUCA Labeling Requirements
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Name and Address of Vet
Name of drug
Directions for use with animal ID
Cautionary Statements
Withdrawal time
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AMDUCA Records
• Identify the animals, either
as individuals or a group.
• Animal species treated.
• Number of animals treated.
• Condition being treated.
• The established name of the
drug and active
ingredient(s).
• Dosage prescribed or used.
• Duration of treatment.
• Specified withdrawal,
withholding, or discard
time(s), if applicable, for
meat, milk, eggs or animalderived food.
• Keep records for a minimum
of 2 years.
• FDA may have access to
these records to estimate
risk to public health.
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AMDUCA Records
• Records access applies only when determined
a particular use poses a risk to public health.
• Information maintained in records
– Identification of animals treated
– name of drug and active ingredient
– condition and species treated
– dosage, duration & number of animals treated
– Withdrawal time
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Prohibited Drugs
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Chloramphenicol
Clenbuterol
Diethyl stilbesterol (DES)
Dimetridazole, Ipronidazole (All Nitroimidazoles)
Furazolidones, Nitrofurazone (All Nitrofurans)
Phenylbutazone (female dairy cattle >20 months)
Sulfonamide drugs in lactating dairy cattle
(except approved use of sulfadimethoxine,
sulfabromomethazine, & sulfaethoxypyridazine)
• ELDU of Fluoroquinolones & glycopeptides
• Dipyrone
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