ACVPM - Public Health Admin/Education Exam
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Terms in this set (171)
What is extra-label drug use (ELDU)? ELDU describes the use of an approved drug in a
manner that is not in accordance with the
approved labeling, yet meets the conditions set
forth by the Animal Medicinal Drug Use
Clarification Act of 1994 (AMDUCA) and U.S. Food
and Drug Administration (FDA) regulations.
What deviations from FDA-approved use in another species
labeling make it ELDU? use for a different indication
use at a different dose or frequency
use via a different route of administration.
,What is the purpose of the Animal The Animal Medicinal Drug Use Clarification Act of
Medicinal Drug Use Clarification Act 1994 (AMDUCA) made ELDU an FDA-regulated
(AMDUCA)? veterinary medical activity, allowing veterinarians
to prescribe extra-label uses of approved animal
and human drugs when the health of an animal is
threatened, or when suffering or death may result
from failure to treat animals.
Prior to the passage of the AMDUCA, ELDU of
animal drugs was illegal. AMDUCA amended the
Federal Food, Drug, and Cosmetic Act to legalize
ELDU under a valid VCPR as well as certain other
conditions describing requirements for use, record
requirements, and label requirements according to
FDA regulations.
Isn't ELDU only for food-producing ELDU regulations apply to all animal species, not
animals? If not, to which species do only food-producing animals.
ELDU regulations apply?
,What does AMDUCA mean to the Keep in mind that AMDUCA does not give
everyday veterinary practice? veterinarians "carte blanche" for extralabel use of
medications. There are certain guidelines to follow.
To the everyday veterinary practice, this means that
the veterinarian should do the following when
considering ELDU:
-Make a careful diagnosis and evaluation of the
conditions for which the drug is to be used;
-First make certain there is no approved animal
drug that is labeled for such use in that species, or
that contains the same active ingredient in the
required dosage form and
concentration;Alternatively, if an approved animal
drug exists but a veterinarian finds, within the
context of a veterinarian-client-patient relationship,
that the approved drug is clinically ineffective for
its intended use, extralabel use of an alternative
medication is permissible.
-Assure that the identity of the treated animal(s) is
carefully maintained;
-Establish a substantially extended withdrawal
period supported by appropriate scientific
information prior to marketing milk, meat, eggs, or
other edible products from the treated animals(s);
-In non-food-producing animals, a drug labeled for
use in humans can be administered even if an
animal-label drug for that species and medical
condition exists.
, How did ELDU regulation come Prior to enactment of the AMDUCA, the Federal
about and why is it necessary in Food, Drug, and Cosmetic Act had provided that a
veterinary medicine? new animal drug was deemed unsafe unless it was
subject to the FDA's stringent approval process -
for exactly what was on the label - specific species,
disease indication, dose, duration, frequency, and
route of administration.
Created a relative disincentive for companies to
put resources toward creating new veterinary
drugs. Making it harder to treat.
Minor species have few to no drugs approved for
various indications.
Who regulates ELDU and enforces The FDA Center for Veterinary Medicine regulates
the regulations? ELDU and enforces the regulations. In cases of
AMDUCA violations, FDA regulatory actions may
include warning letters, seizure of product,
misdemeanor fines, injunction or criminal
prosecution.
Is "off-label" use the same as ELDU? "Off-label" is a term commonly used in foreign
countries, and by physicians in the United States. It
is also sometimes used in veterinary medicine in
the U.S., but the term has no legal or regulatory
definition. In the United States, extralabel drug use
is the appropriate term.
Newest 2026-2027 with Complete Questions and
Correct Detailed Answers| Graded A+
Save
Terms in this set (171)
What is extra-label drug use (ELDU)? ELDU describes the use of an approved drug in a
manner that is not in accordance with the
approved labeling, yet meets the conditions set
forth by the Animal Medicinal Drug Use
Clarification Act of 1994 (AMDUCA) and U.S. Food
and Drug Administration (FDA) regulations.
What deviations from FDA-approved use in another species
labeling make it ELDU? use for a different indication
use at a different dose or frequency
use via a different route of administration.
,What is the purpose of the Animal The Animal Medicinal Drug Use Clarification Act of
Medicinal Drug Use Clarification Act 1994 (AMDUCA) made ELDU an FDA-regulated
(AMDUCA)? veterinary medical activity, allowing veterinarians
to prescribe extra-label uses of approved animal
and human drugs when the health of an animal is
threatened, or when suffering or death may result
from failure to treat animals.
Prior to the passage of the AMDUCA, ELDU of
animal drugs was illegal. AMDUCA amended the
Federal Food, Drug, and Cosmetic Act to legalize
ELDU under a valid VCPR as well as certain other
conditions describing requirements for use, record
requirements, and label requirements according to
FDA regulations.
Isn't ELDU only for food-producing ELDU regulations apply to all animal species, not
animals? If not, to which species do only food-producing animals.
ELDU regulations apply?
,What does AMDUCA mean to the Keep in mind that AMDUCA does not give
everyday veterinary practice? veterinarians "carte blanche" for extralabel use of
medications. There are certain guidelines to follow.
To the everyday veterinary practice, this means that
the veterinarian should do the following when
considering ELDU:
-Make a careful diagnosis and evaluation of the
conditions for which the drug is to be used;
-First make certain there is no approved animal
drug that is labeled for such use in that species, or
that contains the same active ingredient in the
required dosage form and
concentration;Alternatively, if an approved animal
drug exists but a veterinarian finds, within the
context of a veterinarian-client-patient relationship,
that the approved drug is clinically ineffective for
its intended use, extralabel use of an alternative
medication is permissible.
-Assure that the identity of the treated animal(s) is
carefully maintained;
-Establish a substantially extended withdrawal
period supported by appropriate scientific
information prior to marketing milk, meat, eggs, or
other edible products from the treated animals(s);
-In non-food-producing animals, a drug labeled for
use in humans can be administered even if an
animal-label drug for that species and medical
condition exists.
, How did ELDU regulation come Prior to enactment of the AMDUCA, the Federal
about and why is it necessary in Food, Drug, and Cosmetic Act had provided that a
veterinary medicine? new animal drug was deemed unsafe unless it was
subject to the FDA's stringent approval process -
for exactly what was on the label - specific species,
disease indication, dose, duration, frequency, and
route of administration.
Created a relative disincentive for companies to
put resources toward creating new veterinary
drugs. Making it harder to treat.
Minor species have few to no drugs approved for
various indications.
Who regulates ELDU and enforces The FDA Center for Veterinary Medicine regulates
the regulations? ELDU and enforces the regulations. In cases of
AMDUCA violations, FDA regulatory actions may
include warning letters, seizure of product,
misdemeanor fines, injunction or criminal
prosecution.
Is "off-label" use the same as ELDU? "Off-label" is a term commonly used in foreign
countries, and by physicians in the United States. It
is also sometimes used in veterinary medicine in
the U.S., but the term has no legal or regulatory
definition. In the United States, extralabel drug use
is the appropriate term.
