ACVPM: Public Health Admin/Education-
Questions with Correct Solutions
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. 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.
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
-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?
Questions with Correct Solutions
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. 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.
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
-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?
