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."
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 including FDA’s Extralabel Drug Use Rules (21CFR 530) found at the Electronic Code of Federal Regulations (ecfr.gov).
Adequate written treatment records must be maintained by the veterinarian for at least two years (or as otherwise mandated by law), for all animals treated, to document that the drugs were supplied to clients in line with federal and state rules and policies, and AVMA’s Principles of Veterinary Medical Ethics. Such records must include the information set forth under Basic Information for Records, Prescriptions, and Labels.
Food animal owners should have a written treatment records system in place to decrease the risk of violative residues in meat, milk or eggs. All patient treatments should be recorded. Food animal owners must keep records when engaging in ELDU, and when milk and or meat withdrawal of a certain drug may differ from its label. 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 all the requirements of FDA's extralabel drug use rules. 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 of FDA’s VCPR found within 21 CFR 530.3 and state VCPR requirements.
Veterinarians are strongly encouraged to familiarize themselves with the complete regulations.
Veterinarians contemplating extralabel drug use should note there are additional requirements 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.
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.
When using drugs in an extralabel fashion in food animals, FDA also requires extended withdrawal intervals be established using appropriate scientific information.
It is important to note that AMDUCA does not permit extralabel use of drugs, including over-the-counter drugs and Veterinary Feed Directive drugs, in animal feed. AMDUCA also does not permit extralabel drug use for production purposes.
The extralabel use of certain drugs is prohibited in food animals. This list found at 21 CFR 530.41 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, glycopeptides, fluoroquinolones.
Prohibited therapy in lactating dairy cows: any sulfonamide except for approved uses of 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.
Prohibited cephalosporin (excluding cephapirin) use in cattle, swine, chickens and turkeys:
Using cephalosporin drugs at unapproved dose levels, frequencies, durations or routes of administration is prohibited.
Using cephalosporin drugs in cattle, swine, chickens or turkeys that are not approved for use in that species (e.g., cephaloporin drugs intended for humans or companion animals) or production class
Using cephalosporin drugs for disease prevention
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.