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ACVPM - Public Health Admin/Education Exam
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Real Exam Questions And Correct Answers (Verified
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What does AMDUCA mean to the everyday veterinary
practice? - Answer-Keep in mind that AMDUCA does not
give 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;
,2|Page
-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 about and why is it
necessary in veterinary medicine? - Answer-Prior to
enactment of the AMDUCA, the Federal Food, Drug, and
Cosmetic Act had provided that a 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.
,3|Page
Who regulates ELDU and enforces the regulations? -
Answer-The FDA Center for Veterinary Medicine regulates
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? - Answer-"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.
What is extra-label drug use (ELDU)? - Answer-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 labeling make it
ELDU? - Answer-use in another species
use for a different indication
use at a different dose or frequency
, 4|Page
use via a different route of administration.
What is the purpose of the Animal Medicinal Drug Use
Clarification Act (AMDUCA)? - Answer-The Animal
Medicinal Drug Use Clarification Act of 1994 (AMDUCA)
made ELDU an FDA-regulated 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 animals? If not, to
which species do ELDU regulations apply? - Answer-
ELDU regulations apply to all animal species, not only
food-producing animals.
ACVPM - Public Health Admin/Education Exam
||Verified Exam!!|| Most Recent Exam Actual Complete
Real Exam Questions And Correct Answers (Verified
Answers) Already Graded A+ || Newest Exam!!!
What does AMDUCA mean to the everyday veterinary
practice? - Answer-Keep in mind that AMDUCA does not
give 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;
,2|Page
-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 about and why is it
necessary in veterinary medicine? - Answer-Prior to
enactment of the AMDUCA, the Federal Food, Drug, and
Cosmetic Act had provided that a 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.
,3|Page
Who regulates ELDU and enforces the regulations? -
Answer-The FDA Center for Veterinary Medicine regulates
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? - Answer-"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.
What is extra-label drug use (ELDU)? - Answer-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 labeling make it
ELDU? - Answer-use in another species
use for a different indication
use at a different dose or frequency
, 4|Page
use via a different route of administration.
What is the purpose of the Animal Medicinal Drug Use
Clarification Act (AMDUCA)? - Answer-The Animal
Medicinal Drug Use Clarification Act of 1994 (AMDUCA)
made ELDU an FDA-regulated 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 animals? If not, to
which species do ELDU regulations apply? - Answer-
ELDU regulations apply to all animal species, not only
food-producing animals.
