Sec. 608.100 Human-Labeled Drugs Distributed and Used in Animal Medicine (CPG 7125.35)
BACKGROUND:
*This Compliance Policy Guide explains how FDA will exercise its enforcement discretion
with respect to distribution and use of human-labeled drug products for use in animals. It
is FDA's
intent to:
The key regulatory elements under this policy are determination of whether or not (1)
the distribution and dispensing are practitioner driven and (2) the veterinary
practitioners limit their uses of human-labeled drug products to treating non-food
animals, with certain narrow exceptions. Since distribution and dispensing are to be
veterinary practitioner driven, and since distributors and pharmacists, after properly
distributing the drug, ordinarily cannot control end uses, this policy places primary
responsibility on the veterinarian. This policy is not intended to permit the distribution
of human-labeled drug products to veterinarians where prohibited or limited by state laws.
FDA is aware that human-labeled drug products have been promoted and distributed by manufacturers, distributors, and pharmacies for use in animals and that such drugs are being prescribed, dispensed, and administered by veterinarians for animal use.
Promotion of human-labeled drug products for veterinary use by these sources has
included acts such as advertising animal use in veterinary publications; distribution of
labeling and promotional materials suggesting or recommending use of these products in
animals; or oral statements from sales personnel describing or recommending use in
animals. Such promotion causes the drugs to be misbranded under Section 502(f)(1), or
adulterated new animal drugs under Section 501(a)(5), or both. Furthermore, such promotion
may subvert the new animal drug approval process by creating a disincentive for drug
manufacturers to seek such approvals.
Most veterinary use of human-labeled drug products occurs in non-food animal practice
(companion, sporting, exotic, etc.). Many of the maladies of pets and other non-food
animals cannot be treated in accordance with current standards of veterinary practice
without the use of human-labeled drugs since appropriate drug products bearing veterinary
labeling often do not exist. Because of this, FDA has generally refrained from taking
enforcement actions in this area because there is no expected adverse impact upon the
public health.
FDA is very concerned about the use of human-labeled drugs in food-producing animals
because of the increased potential for illegal drug residues in meat, milk, and eggs.
Human-labeled drug products have not, among other things, undergone testing for residue
depletion from edible tissues. Appropriate withdrawal times to avoid illegal residues in
food can only be estimated.
Nevertheless, there are legitimate and important veterinary needs for human-labeled
drugs in the treatment of disease or to prevent pain in food-producing animals in
instances where there simply are no animal drug products available that would avoid animal
suffering or death. Examples include, but are not necessarily limited to analgesics and
anesthetics for pain, sedation, and surgery, insulin for ketosis, and antidotes for
poisonings.
POLICY:
a. Distribution and Dispensing
Labeling, advertising, oral representations, or any other act by a manufacturer,
distributor, or pharmacy which establishes an intended use of human-labeled drugs for
animal use is subject to regulatory action. However, the simple listing of human-labeled
drug products in price sheets and catalogues distributed to veterinarians will not
ordinarily be subject to such action. Dispensing pharmacists are required by Section
503(f) to label dispensed drugs in accordance with the prescribing veterinarian's
instructions, including the name and address of the dispenser, the serial number and date
of the order or of its filing, the name of the licensed veterinarian, and directions for
use and any cautionary statements. Providing this information does not constitute
promotion against which the agency is prepared to take action.
High priority will be placed on actions against manufacturers, distributors, and
pharmacies who promote the substitution of human-labeled drug products for animal drugs
for economic reasons.
b. Use of human drugs by veterinarians in professional practice
1. Use in non-food-producing animals; e.g., dogs, cats, horses
Under usual circumstances, veterinary practitioners may consider the use of
human-labeled drug products in non-food producing animal practice without the threat of
FDA enforcement actions. In rare circumstances, for example, when the health of the
treated animals is harmed, regulatory attention by FDA would be considered or, preferably,
referred to the State veterinary licensing authority for investigation.
2. Use in food-producing animals; e.g., cattle, swine, poultry
Use of human-labeled drug products in food-producing animals should be extremely
limited, primarily because of the increased potential for illegal drug residues in meat,
milk, and eggs. For example, it is ordinarily unacceptable to use a human-labeled product
for common disease conditions in food animals because approved veterinary-labeled drug
products; e.g., antibacterials, anti-inflammatory agents, etc. are available. The food
animal veterinarian assumes greater responsibility when he or she uses a human drug rather
than a veterinary drug. Use of human-labeled drugs may be considered by food animal
veterinarians only when they have:
Regulatory action should be considered when an illegal residue occurs even if the
veterinarian followed the foregoing precautions. The enforcement discretion that might be
accorded to veterinarians will not be extended to lay persons; e.g., owners, who
administer human-labeled drugs either to food-producing or nonfood animals without the
supervision of a licensed veterinarian operating within the framework of a valid
veterinarian/client/patient relationship.
Veterinarians are expected to follow cautionary handling and disposal provisions, if any, specified in human drug labeling to protect handlers and the environment.
REGULATORY ACTION GUIDANCE:
The highest priority for regulatory attention is for follow-up on reports of illegal
tissue residues from human-labeled drugs. Follow the instructions in Compliance Program
7371.006, Illegal Drug Residues in Meat and Poultry and Compliance Program 7371.008,
National Drug Residue Milk Monitoring Program. Consultation with Case Guidance Branch for
guidance under this policy is indicated when encountering other suspected violations,
especially where there is substitution of human-labeled drugs for treatment of common
disease conditions in food animals.
The initial enforcement action of choice is ordinarily a Warning Letter. Center concurrence is required prior to issuance. Depending on the circumstances, one or more of the following charges would be appropriate.
* Material between asterisks is new or revised. *
Issued: 3/19/91
Revised: 7/20/92