CLARIFICATION ACT (AMDUCA) –HOW THEY IMPACT THE PRODUCER,
VETERINARIAN,PROCESSOR AND CONSUMER
John R. Middleton
University of Missouri
Columbia, Missouri, USA
Introduction
Therapy of animal disease has evolved significantly over the last 100 years. The introduction of
antibiotics and other therapeutic agents has allowed us to treat infection and better alleviate pain
and suffering. A wide variety of pharmaceutical agents are marketed for treatment of humans
and animals. However, only a minority of these products are specifically labeled for use in
animals with an even smaller subset being labeled for use in dairy cattle. Hence, occasions arise
where a drug must be used in an extra-label fashion, that is, in a manner other than specified on
the product label or package insert. Extra-label drug use (ELDU) is routinely employed by
veterinarians to alleviate pain and suffering in ill animals. The Animal Medicinal Drug Use
Clarification Act (AMDUCA) was enacted in 1994 and provides guidelines for ELDU in
animals.
ELDU
In general, three classifications of drugs are found on dairy farms 1) over the counter (OTC)
drugs, 2) prescription drugs, and 3) OTC or prescription drugs which are not used in according to
label directions. Over the counter products can be purchased without a veterinary prescription.
Prescription drugs are those which must be dispensed by or on the order of a veterinarian and
will carry one of the following statements on the label: “CAUTION: Federal Law restricts this
drug to use on or by the order of a licensed veterinarian” or “CAUTION: Federal Law restricts
this drug to use on or by the order of a physician”.
Extra-label drug use occurs when a product is used in a manner other than specified on the label
such as when a drug is used at a different dosage, dosing frequency, route of administration, in a
different class of animal, or the disease being treated is not specified on the label. When OTC
drugs are NOT used according to the manufacturer’s label directions they require a prescription.
Example:
Drug: Procaine Penicillin G (available OTC)
Label direction: Administer 3,000 units/lb (6,600 units/kg) intramuscularly (IM)
Commonly used dose in dairy cattle: 10,000-15,000 units/lb (22,000-33,000 units/kg)
Commonly used routes of administration: subcutaneously or intramuscularly
Comment: As commonly used this drug requires a prescription from a veterinarian even though
it is available OTC. At the prescribed higher dosage, the label milk and meat withholding times
no longer apply! 22 NMC Annual Meeting Proceedings (2008)
AMDUCA
The Animal Medicinal Drug Usage Clarification Act amended the Federal Food Drug and
Cosmetic Act to allow licensed veterinarians to prescribe extra-label uses of Food and Drug
Administration (FDA)-approved animal and human drugs in animals. Extra-label drug
usage can be prescribed for THERAPEUTIC PURPOSES ONLY (when the health of an
animal is threatened or suffering or death may result from failure to treat) and prescription must
follow the specific guidelines summarized below. Exrta-label drug use CANNOT be practiced
for enhancing production.
Requirements for ELDU (From 21 CFR 530.3 and 530.20 and AVMA Informational Outline of
AMDUCA, 2007)
The following conditions must be met for a permitted extra-label drug use in food-producing
animals.
• There is NO approved animal drug that is labeled for such use that contains the active
ingredient which is in the required dosage form and concentration, except where a
veterinarian finds, within the context of a valid veterinarian-client-patient relationship, that
the approved animal drug is clinically ineffective for its intended use.
• A valid-veterinarian-client-patient relationship exists when:
o A veterinarian has assumed responsibility for making medical judgments
regarding the health of (an) animal(s) and the need for medical treatment, and the
client (owner of animal(s) or caretaker) has agreed to follow the instructions of
the veterinarian;
o There is sufficient knowledge of the animal(s) by the veterinarian to initiate at
least a general or preliminary diagnosis of the medical condition of the animal(s);
and
o The practicing veterinarian is readily available for follow-up in case of adverse
reactions or treatment failure. Such a relationship can only exist when the
veterinarian has recently seen and is personally acquainted with the keeping and
care of the animal(s) by virtue of examination of the animal(s), and/or by
medically appropriate and timely visits to the premises where the animal(s) are
kept.
• Prior to prescribing or dispensing an FDA-approved animal or human drug for extra-label
use in a food-producing animal the veterinarian must:
o Make a careful diagnosis and evaluation of the conditions for which the drug is to
be used;
o Establish a substantially extended withdrawal period for milk, meat, or other
products supported by scientific information, if applicable;
o Institute procedures to assure that the identity of the treated animal or animals is
carefully maintained; and
o Take appropriate measures to assure that assigned timeframes for withdrawal are
met and NO ILLEGAL DRUG RESIDUES or residues which may present a risk
to human health occur in any food-producing animal or food product subjected to
extra-label treatment. NMC Annual Meeting Proceedings (2008) 23
• Use of an FDA-approved human drug or of an animal drug approved only for use in animals
not intended for human consumption must meet the following additional criteria:
o Such use must be accomplished in accordance with an appropriate medical
rationale;
o 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.
o Extra-label use of an approved human drug in a food-producing animal is not
permitted if an animal drug approved for use in food-producing animal can be
used in an extra-label manner for the particular use.
• ELDU is permitted only by or under the supervision of a veterinarian, and a valid
Veterinarian/Client/Patient relationship is a prerequisite for ALL ELDU.
• ELDU is allowed only for FDA-approved animal and human drugs.
• Rules apply to dosage form drugs and drugs administered in water. ELDU in feed is
prohibited.
• FDA prohibition of a specific ELDU precludes such use.
Recordkeeping Requirements (From AVMA Informational Outline of AMDUCA, 2007)
• Identify the treated animals either as a group or individuals.
• Record animal species, number of animals, and condition(s) being treated.
• Record the established name and active ingredient of the drug used.
• Record the dosage, dosing frequency, and duration of treatment.
• Record the specified withholding times for milk and dairy beef.
• Records must be kept for 2 years after treatment and the FDA must have access to these
records to estimate risk to public health.
Labeling Requirements (From 21 CFR 530.12)
• Name and address of the prescribing veterinarian and if dispensed by a pharmacy the name
and address of the dispensing pharmacy.
• Established name of the drug or drugs (if formulated from more than one drug).
• Directions for use including the class/species or identification of the animal herd, flock, pen,
lot or other groups of animals being treated; the dosage frequency and route of
administration; and duration of therapy.
• Any cautionary statements
• The veterinarian’s specified withdrawal, withholding, or discard time for meat, milk, eggs, or
any other food which might be derived from the treated animal or animals.
Compounding Drugs (From 21 CFR 530.13)
Compounded drugs are those which are made from multiple ingredients by a veterinarian or
pharmacist. Compounding does not include mixing, reconstituting, or other such acts that are 24 NMC Annual Meeting Proceedings (2008)
performed in accordance with directions contained in an approved labeling provided by the
product’s manufacturer, e.g., mixing sterile water with Naxcel®
to reconstitute for use.
Compounding from bulk drugs is prohibited. Extra-label drug use of product compounded from
FDA-approved animal or human drugs is permitted if:
• There is NO approved animal or human drug that, when used as labeled or in conformity
with AMDUCA in the available dosage form and concentration, will appropriately treat the
diagnosed condition. Compounding from a human drug for use in food-producing animals
will not be permitted if an approved animal drug can be used for the compounding;
• The compounding is performed by a licensed veterinarian or pharmacist within the scope of a
professional practice;
• Adequate procedures and processes are followed to ENSURE THE SAFETY AND
EFFECTIVENESS of the compounded product;
• The scale of the compounding operation is commensurate with the established need for
compounded products (e.g., similar to that of comparable practices); and
• All relevant State laws relating to compounding of drugs for use in animals are followed.
More information on compounding can be found in: Guidance for FDA Staff and Industry,
Compliance Policy Guides Manual. Sec. 608.400. Compounding of Drugs for Use in Animals.
Drugs Prohibited for use in Food-Producing Animals (From 21 CFR 530.41)
Table 1. Drugs Prohibited From Use in Food-producing Animals
Drug Name Common Examples Notes
Chloramphenicol Chloramphenicol
Clenbuterol Clenbuterol
Colloidal Silver No FDA-approved product
Diethylstilbesterol (DES)
Dimethyl Sulfoxide
(DMSO) – non-medical
grade
Industrial grade DMSO Medical-grade DMSO may be
prescribed by a veterinarian in an
extra-label manner to treat lifethreatening conditions in dairy
cattle, but under no circumstances
should the product be stored on the
operation for indiscriminant use by
dairy personnel.
Dimetridazole,
Ipronidazole, and other
Nitroimidazoles
Flagyl®
(Metronidazole)
Dipyrone Novine®
, No pain®
,
Dipyrone®
No longer marketed
Estradiol cypionate
(ECP)
No FDA-approved product Any use in food animals is
ILLEGAL
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