Extra Label Drug Use (ELDU)
*extra-label drug use is only permitted by or on
the order (written or oral) of a licensed veterinarian within
the context of a valid veterinarian-client-patient relationship;
*extra-label use of an animal drug approved for use
in food animals is permitted if there is no animal drug with the
same active ingredient and in the required dosage form and concentration
approved for that use; identity of the treated animals must be
maintained; withdrawal times must be long enough to prevent any
residues in edible tissues;
*extra-label use of an animal drug approved for use
in food animals is also permitted if an animal drug approved for
the desired use is found to be ineffective in that clinical situation;
*extra-label use is not permitted for non-therapeutic
uses such as for production purposes or for improved reproductive
performance;
*extra-label therapeutic preventive medicine is allowed
in cases where the health of the animals would be threatened if
treatment was delayed until clinical signs appeared;
*extra-label use of an animal drug not approved for
use in food animals or of a human drug is allowed unless there
is an animal drug approved for use in food animals that is approved
for the desired use or that can be used in an extra label manner;
*extra-label use of animal drug not approved for
use in food animals or of a human drug must be based on appropriate
medical rationale; in addition, the veterinarian must have "scientific
information on the human food safety aspect of the use of the
drug in food-producing animals;" such information need not
be published and could be available from FARAD, US Pharmacopeia,
manufacturers, and other sources;
*required record keeping on a group, herd, flock,
or per-client basis: identification of the drug and active ingredient(s),
condition treated, species, duration of treatment, number treated,
withdrawal time, records must be held for at least 2 years;
*proper labeling will include name and address of
the veterinarian; established name of each active ingredient,
identification of one or more of the following: class, species,
animal, herd, flock, pen, lot or other group; directions for use
including dosage, frequency, route of administration and duration,
cautionary statements; specified withdrawal time;
*the FDA has legal access to a veterinarian's records
of extra-label drug use; the main purpose of such access is for
information-gathering to determine the extent of extra-label use
of specific drugs that may pose a public health; veterinarians
will be allowed to preserve client confidentiality by copying
or reformulating records to only provide FDA with the information
required by a specific request (1).
Veterinary-Client-Patient Relationship (VCPR)
A VCPR exists when all of the following conditions
have been met:
*The veterinarian has assumed the responsibility
for making clinical judgments regarding the health of the animal(s)
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(s) to initiate at least a general or preliminary diagnosis
of the medical condition of the animal(s). This means that the
veterinarian has recently seen and is personally acquainted with
the keeping and care of the animal(s) by virtue of an examination
of the animal(s) or by medically appropriate and timely visits
to the premises where the animal(s) are kept.
*The veterinarian is readily available for follow-up
evaluation in the event of adverse reactions or failure of the
treatment regimen.
