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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:

• eliminate promotion by manufacturers, distributors, and pharmacies;
  
• ensure that distribution and dispensing are made only in response to requests by veterinary practitioners (practitioner driven);
  
• refrain in ordinary circumstances from enforcement actions when human drugs are used or dispensed by veterinarians in treating non-food-producing animals;
  
• take enforcement action against veterinarians who cause illegal residues in food-producing animals;
  
• limit use of human-labeled drugs in treating food-producing animals to very narrow circumstances; and
  
• prohibit use except by or on the order of a licensed veterinarian in the course of his or her practice.
  

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:

• made a careful and definitive diagnosis and evaluation of the condition for which the drug is to be used, and are otherwise operating within the confines of a veterinarian/ client/patient relationship;
• made a deliberate determination that there is no other appropriate veterinary-labeled therapy; i.e., there is no marketed veterinary labeled drug product specifically labeled for the disease condition to be treated or the veterinary drug has been found clinically ineffective by the veterinarian in the animals to be treated; and
• taken adequate steps to prevent the occurrence of illegal residues in edible animal products. This should include a review of the best available toxicological and tissue distribution and tissue residue depletion data and establishment of an extra long drug withdrawal period prior to marketing meat, milk, or eggs. The animal owner or manager should be given explicit written withdrawal instructions. The practitioner should have a high degree of confidence that the client will follow the drug withdrawal instruction.
  

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.

• 402(a)(2)(D) - food adulterated by illegal residue from a new animal drug;
  
• 402(a)(2)(A) - food adulterated by illegal residue from a human-labeled drug;
  
• 501(a)(5) - adulterated drug (labeled for human use which is accompanied by labeling indicating it for animal use which causes it to be unsafe under Section 512(a) as an unapproved new animal drug);
  
• 502(f)(1) - misbranded human drug when not used as labeled; misbranded human drug promoted for animal use in ways other than by labeling (see 21 CFR 201.128).*
  

* Material between asterisks is new or revised. *
Issued: 3/19/91
Revised: 7/20/92

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