A645
Prescription & Non-Prescription
Drug Guidelines

veterinary prescription drugs (Rx) | extra label drug use | drug storage and handling | prohibited drugs

1. The veterinarian has assumed the responsibility for making clinical judgments 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.

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.

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:

1. Careful diagnosis and evaluation of the conditions for which the drug is to be used.
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 milk, meat or other edible products from the treated animal(s).

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• Name of the drug.
• Withholding/withdrawal times.
• Active ingredients.
• Name of the manufacturer or distributor.
• Directions for use.

• Name of the drug.
• Withholding/withdrawal times.
• Active ingredients.
• Name of the manufacturer or distributor.
• Directions for use.
• 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."

• Name and address of the veterinarian dispensing the drug.
• 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: A requirement to test milk or urine for residues prior to shipment, not for use in pregnant cows, etc.)

State and Federal regulations require the correct and appropriate storage of all cleaners, sanitizers, medicines, and drugs used on dairies. These requirements are deemed to be satisfied when the following requirements are met:

1. All cleaners and sanitizers must be stored in containers according to manufacturer’s specifications for that specific product. The label on the container shall include the product name, chemical description, use directions, precautionary and warning statement, first aid instructions, container storage and maintenance instructions, as well as the name and address of the manufacturer or distributor.
2. Equipment used to administer medicines/drugs should not be cleaned in the wash vats and should not be stored where milk contamination could occur.
3. Drugs used for lactating cows must be stored separately in a cabinet, refrigerator, or other storage place on a shelf labeled "Drugs for Lactating Cows."  Drugs for non-lactating cows, calves, steers, etc., must be stored in a space labeled "Drugs for Non-lactating Cattle."
4. All drugs and medicines shall be properly labeled.
5. Unapproved and/or improperly labeled medicines or drugs are not to be used to treat dairy animals and are not to be stored in the milking barn or parlor.
6. If the drug is for lactating cows, the label must specify that it can be used in lactating cows. In addition, there must be a milk withdrawal time indicated on the label. If there is not, the drug is not approved for lactating cows.

The use of certain drugs is prohibited in food animals. This list may be amended by the Food and Drug Administration at any time.

• Prohibited therapy in food animals: Chloramphenicol; clenbuterol; diethylstilbestrol (DES); dimetridazole; ipronidazole; other nitroimidazoles; furazolidone, nitrofurazone, other nitrofurans; dipyrone; fluoroquinolones; and glycopeptides.
• Prohibited therapy in lactating dairy cows: any sulfonamide except for those specifically approved (such as Albon-Sulfadimethoxine) and phenylbutazone (bute).  A lactating diary animal is any dairy cow over 20 months of age.