2
ACVPM - Public Health Admin Education Exam with verified || || || || || || || ||
detailed answers
|| ||
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 ELDU? - ✔✔use in another species
|| || || || || || || || || || || ||
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 Clarification Act (AMDUCA)? -
|| || || || || || || || || || || || || ||
✔✔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? - ✔✔ELDU regulations apply to all animal species, not only food-producing animals.
|| || || || || || || || || || || ||
What does AMDUCA mean to the everyday veterinary practice? - ✔✔Keep in mind that
|| || || || || || || || || || || || || ||
AMDUCA does not give veterinarians "carte blanche" for extralabel use of medications.
|| || || || || || || || || || || ||
,2
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 necessary in veterinary medicine? -
|| || || || || || || || || || || || || || ||
✔✔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.
|| || || || || || || || || ||
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.
|| || || ||
,2
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 ELDU in food-producing animals: -
|| || || || || || || || || || || || ||
✔✔-Such use must be accomplished in accordance with an appropriate medical rationale;
|| || || || || || || || || || || ||
and
, 2
-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. || ||
To date, the ELDU of the following drugs has been prohibited in food-producing animals,
|| || || || || || || || || || || || || ||
regardless of whether or not the criteria for ELDU are met: - ✔✔1- Chloramphenicol;
|| || || || || || || || || || || || ||
ACVPM - Public Health Admin Education Exam with verified || || || || || || || ||
detailed answers
|| ||
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 ELDU? - ✔✔use in another species
|| || || || || || || || || || || ||
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 Clarification Act (AMDUCA)? -
|| || || || || || || || || || || || || ||
✔✔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? - ✔✔ELDU regulations apply to all animal species, not only food-producing animals.
|| || || || || || || || || || || ||
What does AMDUCA mean to the everyday veterinary practice? - ✔✔Keep in mind that
|| || || || || || || || || || || || || ||
AMDUCA does not give veterinarians "carte blanche" for extralabel use of medications.
|| || || || || || || || || || || ||
,2
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 necessary in veterinary medicine? -
|| || || || || || || || || || || || || || ||
✔✔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.
|| || || || || || || || || ||
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.
|| || || ||
,2
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 ELDU in food-producing animals: -
|| || || || || || || || || || || || ||
✔✔-Such use must be accomplished in accordance with an appropriate medical rationale;
|| || || || || || || || || || || ||
and
, 2
-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. || ||
To date, the ELDU of the following drugs has been prohibited in food-producing animals,
|| || || || || || || || || || || || || ||
regardless of whether or not the criteria for ELDU are met: - ✔✔1- Chloramphenicol;
|| || || || || || || || || || || || ||
