A645
Prescription and Non-Prescription
Drug Guidelines

In order for a prescription drug to be sold, a valid veterinarian/client/patient/relationship (VCPR) must be established.

A VCPR exists when all of the following conditions have been met:
  1. The veterinarian has assumed the responsibility for making clinical judgements regarding the health of the animal(s) and the need for medical treatment.
  2. The client has agreed to follow the veterinarian’s instructions.
  3. 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.
  4. 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 Drugs

Definition: Veterinary prescription drugs are those drugs restricted by federal law for use by or on the order of a licensed veterinarian. The law requires that such drugs be labeled with the statement: "Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian."

Pharmaceuticals bearing the above label may be purchased from a veterinarian or from a non-veterinary source. If purchased from a non-veterinary source, a prescription from a licensed veterinarian is required. No prescription should be given in the absence of a valid veterinary/client/patient relationship.

Extra Label Drug Use

Animal Medicinal Drug Use Clarification Act (AMDUCA) requires additional management when using a drug in a manner that is not in accordance with the drug’s labeling. For such usage, the FDA specifies that the following criteria must be met:

  1. Make careful diagnosis and evaluation of the conditions for which the drug is to be used.
    2.
  2. 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.
  3. Alternatively, an approved animal drug exists, but a veterinarian finds, within the context of a valid veterinarian/client/patient relationship, that the approved drug is clinically ineffective for its intended use.
  4. Ensure that the identity of the treated animal(s) is carefully maintained.
  5. Establish a substantially extended withdrawal period, supported by appropriate scientific information, prior to marketing meat or other edible products from the treated animal(s).

Over the Counter Drugs (OTC) - These drugs can be sold without a prescription, but must contain the following information on the label:

Prescription (Rx) drugs must contain this information on the label:

The labels for drugs used in an "EXTRA LABEL" manner must have the following: