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ACVPM - Public Health
Admin/Education
What is the purpose of the Animal Medicinal Drug Use Clarification Act
(AMDUCA)? - CORRECT 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? - CORRECT ANSWER-ELDU regulations apply to all animal
species, not only food-producing animals.

What does AMDUCA mean to the everyday veterinary practice? - CORRECT
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;
-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.

What is extra-label drug use (ELDU)? - CORRECT 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? - CORRECT
ANSWER-use in another species
use for a different indication
use at a different dose or frequency
use via a different route of administration.


How did ELDU regulation come about and why is it necessary in veterinary
medicine? - CORRECT 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.

Who regulates ELDU and enforces the regulations? - CORRECT 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? - CORRECT 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.

How do I know what qualifies as ELDU? - CORRECT ANSWER-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: - CORRECT ANSWER--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: - CORRECT ANSWER--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? - CORRECT ANSWER-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? - CORRECT ANSWER-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? - CORRECT ANSWER-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: - CORRECT
ANSWER-1- Chloramphenicol;

, 2- Clenbuterol;
3- Diethylstilbestrol (DES);
4- Dimetridazole;
5- Ipronidazole;
6- Other nitroimidazoles;
7- Furazolidone;
8- Nitrofurazone;
9- Sulfonamide drugs in lactating dairy cattle (except approved use of
sulfadimethoxine, sulfabromomethazine, and sulfaethoxypyridazine);
10- Fluoroquinolones;
11- Glycopeptides;
12- Phenylbutazone in female dairy cattle 20 months of age or older.
13- Cephalosporin (excluding cephapirin) use in cattle, swine, chickens and
turkeys:
-Using cephalosporin drugs at unapproved dose levels, frequencies, durations or
routes of administration is prohibited
-Using cephalosporin drugs in cattle, swine, chickens or turkeys that are not
approved for use in that species (e.g., cephalosporin drugs intended for humans
or companion animals);
-Using cephalosporin drugs for disease prevention

The following drugs, or classes of drugs, approved for treating or preventing
influenza A in humans, are prohibited from ELDU in chickens, turkeys, and ducks
regardless of whether or not ELDU criteria are met: - CORRECT ANSWER-1-
Adamantanes;
2- Neuraminidase inhibitors.
Extralabel use of drugs in treating food-producing animals for improving rate of
weight gain, feed efficiency, or other production purposes is prohibited under
AMDUCA.

Some ELDU documentation requires listing a withdrawal time. What is that and
why is it necessary? - CORRECT ANSWER-If the animals treated with an
extralabel drug are food-producing animals, it is required that the veterinarian's
specified withdrawal/discard time(s) for meat, milk, eggs, or any food which might
be derived from the treated animals be listed on the label.

Where do I find information about withdrawal period information for ELDU in
food-producing animals? - CORRECT ANSWER-Withdrawal interval information
can be found on the Food Animal Residue Avoidance Databank (FARAD). FARAD
is a National Food Safety Project of the U.S. Department of Agriculture National
Institute of Food and Agriculture (NIFA). To obtain scientific information to
determine withdrawal intervals, visit the FARAD website at www.farad.org or call
(888) USFARAD. Other sources that may be used to determine a scientifically-
based withdrawal interval may include scientific literature or other academic
sources.