The AVMA has prepared the following guidelines as a resource regarding the use and distribution of veterinary prescription drugs. Veterinarians making treatment decisions must use sound clinical judgment and current medical information and must be in compliance with federal, state, and local laws and regulations.
Veterinarians should assure compliance with relevant regulations (e.g. VCPR) of their State Board of Pharmacy and State Board of Veterinary Medicine, and applicable federal regulations.
Food animal owners must also keep treatment records. Owner treatment records have been developed by several producer organizations and are available in conjunction with quality assurance programs.
All veterinary prescription drugs must be properly labeled when dispensed. A complete label should include all the information set forth under the section on Basic Information for Records, Prescriptions, and Labels.
The actual container must bear the veterinarian's name, address, name of the drug (active ingredient), identification of the animal(s) to be treated, adequate directions for proper use, and cautions/precautions including milk and meat withdrawal times. This information may be on the label applied by the manufacturer, or on a label attached to the product by the veterinarian.
If there is inadequate space on the label for any of the other required information, the veterinarian must provide the additional information on a separate sheet that accompanies the drug dispensed or prescribed.
State law and other regulations such as the Pasteurized Milk Ordinance may require more information than is stated in these guidelines. Specific label and record keeping information is required when drugs are prescribed for extralabel use (see the next section on AMDUCA).
When veterinary prescription drugs are dispensed to companion animal owners, the AVMA recommends that such drugs be placed in child-resistant containers. Such containers are mandated by law in certain states.
In the clinic, veterinary prescription drugs should be stored separately from over-the-counter drugs, and be easily distinguishable by the professional and paraprofessional staff. Drugs should be stored under conditions recommended by the manufacturer. All drugs should be examined periodically to ensure cleanliness and current dating.
Food animal clients should be advised that veterinary prescription drugs should be securely stored, with access limited to key personnel.
With passage of the AMDUCA by Congress in 1994, the extralabel use of approved animal or human drugs in animals became a codified, FDA-regulated activity. Veterinarians may utilize drugs in an extralabel manner in their regular course of practice when the health of an animal is threatened or death may result from failure to treat. Under AMDUCA regulations, extralabel use means the actual or intended use of a drug, by or on the order of a veterinarian, in a manner that is not in accordance with approved labeling. Any deviation from the label, by veterinarians or lay persons is an illegal use, unless the use meets the requirements of AMDUCA. Deviations from the label include, but are not limited to:
Extralabel use is legal only when ordered by a veterinarian and within the context of a VCPR.
This document is intended to provide a summary of the AMDUCA requirements and does not list all the regulations that may apply. Veterinarians are strongly encouraged to familiarize themselves with the complete regulations. Information is available at www.fda.gov/cvm.
AMDUCA regulations include but are not limited to the following:
1) Extralabel use is only allowed when the health of an animal is threatened, or suffering or death may result from failure to treat.
2) Record requirements-
3) Label requirements-
In addition to the requirements for extralabel use in all animals there are regulations specific for food-producing animals.
Extralabel drug use is only allowed if 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 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.
It is important to note that AMDUCA does not permit extralabel use of drugs in animal feed. AMDUCA also does not permit extralabel drug use for production purposes.
Prior to prescribing or dispensing a food-animal drug for extralabel use the veterinarian must:
Use of a human drug, or an animal drug that is only approved for use in nonfood-producing animals, has further restrictions. These drugs are not permitted if a drug that is labeled for use in a food-producing animal can be used in a labeled or extralabel manner.
The extralabel use of certain drugs is prohibited in food animals. This list may be amended by the Food and Drug Administration. Thus, the following list is accurate as of the publication date of this document.
AMDUCA also applies to medical decisions in nonfood producing animals. There is greater latitude for extralabel use in nonfood producing animals. However, the requirements stated above for "all animals" must still be followed. In addition, veterinarians should consider the following when treating nonfood-producing animals:
Compounding from FDA-approved drugs is considered extralabel drug use under FDA rules.
Compounding is the customized manipulation of an approved drug(s) by either a veterinarian, or by a pharmacist upon the prescription of a veterinarian, to meet the needs of a particular patient. For example, mixing two injectable drugs is compounding. Preparing a paste or suspension from crushed tablets is another example of compounding. Likewise, adding flavoring to a drug is compounding.
Compounding is not allowed unless there is no approved new animal or approved new human drug that, when used per label or in an extra label fashion, can appropriately treat the condition diagnosed.