Key Points

• Veterinary prescription drugs are labeled for use only by or on the order of a licensed veterinarian. Incidents involving the sale and use of prescription drugs without a prescription should be reported to the proper state authority and the U.S. Food and Drug Administration.
• Veterinary prescription drugs are to be used or prescribed only within the context of a veterinarian-client-patient relationship (VCPR).
• Veterinary prescription drugs must be properly labeled before being dispensed.
• Appropriate dispensing and treatment records must be maintained.
• Veterinary prescription drugs should be dispensed only in quantities required for the treatment of the animal(s) for which the drugs are dispensed. Avoid unlimited refills of prescriptions or any other activity that might result in misuse of drugs.
• Any drug used in a manner not in accordance with its labeling (extralabel use) should be subjected to the same supervisory precautions that apply to veterinary prescription drugs.

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.

Veterinary Prescription Drugs
Veterinary prescription drugs are those drugs restricted by federal law to use by or on the order of a licensed veterinarian [Section 503(f) Food, Drug, and Cosmetic Act]. The law requires that the drug sponsor label such drugs with the statement: "Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian."

Veterinarian/Client/Patient Relationship
A VCPR exists when all of the following conditions have been met:

• The veterinarian has assumed the responsibility for making clinical judgments regarding the health of the animal(s) and the need for medical treatment, and the client has agreed to follow the veterinarian's instructions.
• The veterinarian has sufficient knowledge of the animal(s) to initiate at least a general or preliminary diagnosis of the medical condition of the animal(s). This means that the veterinarian has recently seen and is personally acquainted with the keeping and care of the animal(s) by virtue of an examination of the animal(s) or by medically appropriate and timely visits to the premises where the animal(s) are kept.
• The veterinarian is readily available for follow-up evaluation, or has arranged for emergency coverage, in the event of adverse reactions or failure of the treatment regimen.

Veterinary Prescription Orders
Orders issued by licensed veterinarians authorize drug distributors to deliver veterinary prescription drugs to a specific client, or authorize pharmacists to dispense such drugs to a specific client.

Veterinarians should assure compliance with relevant regulations of their State Board of Pharmacy and State Board of Veterinary Medicine.

Labeling and Record Keeping
Adequate treatment records must be maintained by the veterinarian for at least two years (or as otherwise mandated by law), for all animals treated, to show that the drugs were supplied to clients with whom a VCPR has existed. Such records must include the information set forth under Basic Information for Records, Prescriptions, and Labels.

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.

Basic Information for Records (R) Prescriptions (P), and Labels (L)

• Name, address, and telephone number of veterinarians (RPL)
• Name (L), address, and telephone number of clients (RP)
• Identification of animal(s) treated, species and numbers of animals treated, when possible (RPL)
• Date of treatment, prescribing, or dispensing of drug (RPL)
• Name, active ingredient, and quantity of the drug (or drug preparation) to be prescribed or dispensed (RPL)
• Drug strength (if more than one strength available) (RPL)
• Dosage and duration
• Route of administration (RPL)
• Number of refills (RPL)
• Cautionary statements, as needed (RPL)
• Expiration date if applicable
• Slaughter withdrawal and/or milk withholding times, if applicable (RPL)
• Signature or equivalent (P)

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.

Handling and Storage
The veterinarian should inform clients to whom prescription drugs are delivered or dispensed about appropriate drug handling and storage.

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.

Animal Medicinal Drug Use Clarification Act (AMDUCA) Compliance in Drug Use
The therapeutic administration of any approved dosage form drug in a manner that is not in accordance with the drug's labeling requires additional management. AMDUCA regulations are in force for all approved therapeutic dosage form drugs if administered in a manner not in accordance with the drug's labeling. For such usage, the FDA specifies that the following criteria must be met:

• Make a careful diagnosis and evaluation of the conditions for which the drug is to be used.
• 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.
• 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 animal(s).

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.

• Prohibited therapy in food animals: chloramphenicol, clenbuterol, diethylstilbestrol, dimetridazole, ipronidazole, other nitromidazoles, furazolidone, nitrofurazone, other nitrofurans, glycopeptides.
• Prohibited therapy in food animals except approved uses: fluoroquinolone class of antibiotics.
• Prohibited therapy in lactating dairy cows: any sulfonamide except for those specifically approved (sulfadimethoxine, sulfabromethazine and sulfaethoxypyridazine).
• Prohibited therapy in female dairy cattle 20 months of age or older: phenylbutazone.
• Prohibited therapy in chickens, turkeys, and ducks: adamantane and neuraminidase inhibitor classes of drugs that are approved for treating or preventing influenza A.

When dispensing or prescribing drugs for extralabel use one should follow the normal labeling and record keeping guidelines stated above, but also be aware AMDUCA regulations require the following:

Record requirements-

• Identify the animals, either as individuals or a group.
• Animal species treated.
• Number of animals treated.
• Condition being treated.
• The established name of the drug and active ingredient(s).
• Dosage prescribed or used.
• Duration of treatment.
• Specified withdrawal, withholding, or discard time(s), if applicable, for meat, milk, eggs or animal-derived food.
• Keep records for a minimum of 2 years.
• FDA may have access to these records to estimate risk to public health.

Label requirements-

• Name and address of the prescribing veterinarian.
• Established name of the drug.
• Any specified directions for use including the class/species or identification of the animal or herd, flock, pen, lot, or other group; the dosage frequency, and route of administration; and the duration of therapy.
• Any cautionary statements.
• Veterinarian specified withdrawal, withholding, or discard time for meat, milk, eggs, or any other food.

AMDUCA does not permit extralabel use of drugs in feed.

Compounding is defined as any manipulation to produce a dosage form drug other than that manipulation that is provided for in the directions for use on the labeling of the approved drug product. A few examples include combining drug agents for anesthesia, incorporating a tablet into reduced dosage liquid or capsule forms, or creating certain antidotes.

Guidance is found in FDA-CVM Compliance Policy Guide 608.400 "Compounding of Drugs for Use in Animals."