Actual Exam Newest With Complete Questions And
100%Correct Detailed Answers| Latest Version!
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
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.
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;