Prescription vs Non Prescription Drugs
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:
- The veterinarian has assumed the responsibility for making clinical judgments regarding the health of the animal(s) and the need for medical treatment. 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 animal(s) medical condition. 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 Drugs (Rx): These are 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: Extra-label drug use is defined as use or intended use of any drug in an animal in a manner that is NOT in accordance with the approved labeling. This includes use in a species not listed in the labeling, use for an indication (disease or other condition) not listed in the labeling, and use at dosage levels, frequencies, or routes of administration other than those stated in the labeling. It also includes deviation from the labeled withdrawal time. Extralabel drug use is only permitted by or on the order of a licensed veterinarian within the context of a valid veterinarian- client-patient relationship.
Due to the limited number of drugs labeled for use in sheep and goats, extra-label drug use is often necessary. Sheep and goat producers and veterinarians need to work together to ensure that all livestock drugs are used in a safe and legal manner.
The Animal Medicinal Drug Use Clarification Act (AMDUCA) requires additional management when using a drug not in accordance with the drug’s labeling. For such usage, the FDA specifies that the following criteria must be met:
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 and concentration. 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. Ensure 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 or other edible products from the treated animal(s).
Over the Counter Drugs (O-T-C) - These drugs can be sold without a prescription, but must contain the following information on the label:Name of the drug and active ingredients, Withholding/withdrawal times, Name of the manufacturer or distributor.
Directions for use. Prescription (Rx) drugs must contain this information on the label:
- Name of the drug and active ingredients.
- Withholding/withdrawal times.
- Name of the manufacturer or distributor.
- Directions for use and any special cautionary statements.
- Name and address of the dispensing veterinarian, not just the clinic.
- The statement: "CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian
The labels for drugs used in an "EXTRA LABEL" manner must have the following:
- Name and address of the veterinarian dispensing the drug.
- Name of the drug and active ingredients.
- Directions for use as specified by the veterinarian (dosage, class of animals, disease conditions, duration of therapy).
- The veterinarian’s prescribed withholding time.
- Name of the owner or farm identification numbers.
- Any special cautionary statements. (Example: Not for use in pregnant does.)
Prohibited Drugs: The use of certain drugs is prohibited in food animals. This list may be amended by the Food and Drug Administration at any time.