ACVPM - Public Health Admin/Education Exam Newest
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LAT Laboratory Animal Technician Chapter 1: Overview of Veterinary Te... Intro Vet Tech Final Exam AV
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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 labeling make it use in another species
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 Medicinal Drug Use The Animal Medicinal Drug Use Clarification Act of 1994 (AMDUCA) made
Clarification Act (AMDUCA)? 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 ELDU regulations apply to all animal species, not only food-producing animals.
which species do ELDU regulations apply?
What does AMDUCA mean to the everyday veterinary Keep in mind that AMDUCA does not give veterinarians "carte blanche" for
practice? 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 about and why is it Prior to enactment of the AMDUCA, the Federal Food, Drug, and Cosmetic Act
necessary in veterinary medicine? 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.
Who regulates ELDU and enforces the regulations? 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? "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.
How do I know what qualifies as ELDU? Specific criteria must be followed:
-A valid VCPR is a prerequisite for all ELDU;
-Only a veterinarian can determine that ELDU is needed and can administer,
prescribe or dispense a medication extralabelly. The veterinarian must direct or
supervise ELDU in an animal;
-ELDU rules only apply to FDA-approved animal and human drugs;
-ELDU is intended for prevention, treatment, and control purposes only when
an animal's health is threatened.
-ELDU is not permitted if it results in an illegal food residue, or any residue
which may present a risk to public health;
-A veterinarian must not pursue use of certain FDA-prohibited drugs in food-
producing animals
, ELDU of an FDA approved drug may be used if: -There is no approved animal drug that is labeled for such use, or that contains
the same active ingredient in the required dosage form and concentration.
-Alternatively, an approved animal drug for that species and condition exists,
but a veterinarian finds, within the context of a VCPR, that the approved drug is
clinically ineffective for its labeled use.
The following additional conditions must be met for -Such use must be accomplished in accordance with an appropriate medical
ELDU in food-producing animals: rationale; and
-If scientific information on the human food safety aspect of the use of the
drug in food producing animals is not available, the veterinarian must take
appropriate measures to assure that the animal and its food products will not
enter the human food supply.
An approved animal drug must be considered for the particular use before a
drug labeled for humans is considered. The prescribed or dispensed extralabel
drug (prescription legend or over-the-counter) must bear labeling information
which is adequate to assure the safe and proper use of the product.
What drugs qualify for ELDU? Any drug approved by the FDA qualifies for ELDU in a non-food-producing
animal given that a valid VCPR exists and FDA-delineated criteria are met. For
food-producing animals, the extralabel use of certain drugs is prohibited.
When is ELDU used/necessary? Extralabel use is limited to circumstances when the health of an animal is
threatened, or suffering or death may result from failure to treat. As we've
already stated, extralabel use to enhance production is prohibited.
What drugs are currently restricted from ELDU? FDA may prohibit the extralabel use of an approved new animal or human drug
or class of drugs in animals if FDA determines that:
1- An acceptable analytical method for residue detection needs to be
established and such method has not been established or cannot be
established, or
2- The extralabel use of the drug or class of drugs presents a risk to public
health.
A prohibition may be a general ban on the extralabel use of the drug or class
of drugs or may be limited to a specific species, indication, dosage form, route
of administration, or combination of factors.
2026-2027 with Complete Questions and Correct Detailed
Answers| Graded A+
Leave the first rating
Save
Students also studied
Flashcard sets Study guides
LAT Laboratory Animal Technician Chapter 1: Overview of Veterinary Te... Intro Vet Tech Final Exam AV
Teacher 387 terms Teacher 22 terms Teacher 79 terms Te
charles_mwangangi Preview kithomefrank Preview kithomefrank Preview
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 labeling make it use in another species
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 Medicinal Drug Use The Animal Medicinal Drug Use Clarification Act of 1994 (AMDUCA) made
Clarification Act (AMDUCA)? 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 ELDU regulations apply to all animal species, not only food-producing animals.
which species do ELDU regulations apply?
What does AMDUCA mean to the everyday veterinary Keep in mind that AMDUCA does not give veterinarians "carte blanche" for
practice? 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 about and why is it Prior to enactment of the AMDUCA, the Federal Food, Drug, and Cosmetic Act
necessary in veterinary medicine? 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.
Who regulates ELDU and enforces the regulations? 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? "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.
How do I know what qualifies as ELDU? Specific criteria must be followed:
-A valid VCPR is a prerequisite for all ELDU;
-Only a veterinarian can determine that ELDU is needed and can administer,
prescribe or dispense a medication extralabelly. The veterinarian must direct or
supervise ELDU in an animal;
-ELDU rules only apply to FDA-approved animal and human drugs;
-ELDU is intended for prevention, treatment, and control purposes only when
an animal's health is threatened.
-ELDU is not permitted if it results in an illegal food residue, or any residue
which may present a risk to public health;
-A veterinarian must not pursue use of certain FDA-prohibited drugs in food-
producing animals
, ELDU of an FDA approved drug may be used if: -There is no approved animal drug that is labeled for such use, or that contains
the same active ingredient in the required dosage form and concentration.
-Alternatively, an approved animal drug for that species and condition exists,
but a veterinarian finds, within the context of a VCPR, that the approved drug is
clinically ineffective for its labeled use.
The following additional conditions must be met for -Such use must be accomplished in accordance with an appropriate medical
ELDU in food-producing animals: rationale; and
-If scientific information on the human food safety aspect of the use of the
drug in food producing animals is not available, the veterinarian must take
appropriate measures to assure that the animal and its food products will not
enter the human food supply.
An approved animal drug must be considered for the particular use before a
drug labeled for humans is considered. The prescribed or dispensed extralabel
drug (prescription legend or over-the-counter) must bear labeling information
which is adequate to assure the safe and proper use of the product.
What drugs qualify for ELDU? Any drug approved by the FDA qualifies for ELDU in a non-food-producing
animal given that a valid VCPR exists and FDA-delineated criteria are met. For
food-producing animals, the extralabel use of certain drugs is prohibited.
When is ELDU used/necessary? Extralabel use is limited to circumstances when the health of an animal is
threatened, or suffering or death may result from failure to treat. As we've
already stated, extralabel use to enhance production is prohibited.
What drugs are currently restricted from ELDU? FDA may prohibit the extralabel use of an approved new animal or human drug
or class of drugs in animals if FDA determines that:
1- An acceptable analytical method for residue detection needs to be
established and such method has not been established or cannot be
established, or
2- The extralabel use of the drug or class of drugs presents a risk to public
health.
A prohibition may be a general ban on the extralabel use of the drug or class
of drugs or may be limited to a specific species, indication, dosage form, route
of administration, or combination of factors.
