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."
- Veterinary prescription drugs are labeled for use only by or on the order of a licensed veterinarian.
- Veterinary prescription drugs are to be used or prescribed only within the context of a veterinarian-client-patient relationship (VCPR).
- 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.
- 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 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, control, or prevention of disease(s) or condition(s) 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 should be subjected to the same supervisory precautions that apply to veterinary prescription drugs.
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 (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 (21 CFR Part 530) found at https://www.ecfr.gov/current/title-21/chapter-I/subchapter-E/part-530.
Animal Medicinal Drug Use Clarification Act (AMDUCA) compliance in veterinary medical practice
With passage of the AMDUCA by Congress in 1994, the extralabel use of FDA-approved animal or human drugs in animals became a codified, FDA-regulated activity. Veterinarians may utilize drugs in an extralabel manner when certain conditions are met (reference 21 CFR § 530.20). 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 requirements of FDA's extralabel drug use rules. Deviations from the label include, but are not limited to:
- Use in a species or production class not on the label
- Use of a different route of administration, indication, frequency, dose, or duration
Extralabel use is legal only when ordered by a veterinarian and within the context of the federal VCPR found within 21 CFR § 530.3 and state VCPR requirements.
Extralabel use in food animals of some drugs and drug classes is prohibited.
Veterinarians are strongly encouraged to familiarize themselves with the complete regulations.
Labeling and record keeping
Adequate written or electronic treatment records must be maintained by the veterinarian for at least two years (or as otherwise mandated by law) and for all animals treated, to document that the drugs were supplied to clients in line with federal and state rules and policies, and the AVMA's Principles of Veterinary Medical Ethics. Such records must include the information set forth under Documentation required for Records (R), Written and Electronic Prescriptions (P), and Information provided to Clients (I).
Food animal owners should have a written or electronic 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 extralabel drug use (ELDU), and when meat, milk, and or egg withdrawal of a certain drug may differ from its label. Owner treatment record templates have been developed by several producer organizations and are available in conjunction with quality assurance programs.
Documentation required for records (R) written and electronic prescriptions (P), and information provided to clients (I)
- Name, address, and telephone number of veterinarian(s) (RPI)
- Name (I), address, and telephone number of client(s) (RP)
- Identification of animal(s) treated, species and numbers of animals treated, when possible (RPI)
- Date of treatment, prescribing, or dispensing of drug (RPI)
- Name, active ingredient, and quantity of the drug (or drug preparation) to be prescribed or dispensed (RPI)
- Drug strength (if more than one strength available) (RPI)
- Dosage and duration (RPI)
- Route of administration (RPI)
- Number of refills (RPI)
- Cautionary statements, as needed (RPI)
- Expiration date if applicable (RPI)
- Slaughter withdrawal and/or eggs or milk withholding times, if applicable (RPI)
- Signature or equivalent (P)
The client must receive information on the veterinarian's name, address, name of the drug (active ingredient), identification of the animal(s) to be treated, adequate directions for proper use, date, quantity, drug strength, route of administration, number of refills and cautions/precautions including egg, milk, and meat withdrawal times in compliance with state and federal regulations. Some of this information may be applied by the manufacturer, and additional information may be attached to the product or provided by the veterinarian.
Handling, storage and disposal
The veterinarian should inform clients to whom prescription drugs are delivered or dispensed about appropriate drug handling, storage, and disposal.
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 the integrity of the product and that expired products are not dispensed.
Clients should be advised that veterinary prescription drugs should be securely stored.
Writing veterinary prescriptions
In the best interests of patient welfare, it is important for veterinarians to deliver clear and unambiguous written prescriptions to avoid medication errors. Veterinarians should be familiar with state regulations regarding the writing of prescriptions.
The AVMA encourages prescribing veterinarians to exercise initiative and establish strong collegial relationships with pharmacists in their sphere of practice. Proactively establishing open lines of communication will establish the pharmacist as part of the veterinary healthcare team, promote education and foster consultations to address issues and questions that ultimately will arise.
Client requests for prescriptions
The following recommendations are offered as a guide to client requests for prescriptions to be filled outside the veterinary practice:
- Veterinarians shall honor client requests to prescribe rather than dispense a drug (AVMA Principles of Veterinary Medical Ethics). The client has the option of filling a prescription at any pharmacy.
- Drug therapy, when medically indicated, should be initiated by the attending veterinarian in the context of a VCPR. Veterinarians asked by pharmacies to approve prescriptions they have not initiated should do so only if the prescription is appropriate and a VCPR exists.
- Clients that wish to purchase their prescription drugs from a pharmacy rather than the veterinarian should be advised to first obtain a prescription from their veterinarian before contacting a pharmacy. The veterinarian may choose to either issue the prescription in writing for the client, or contact the pharmacy electronically or by phone.
- As with any prescription, a record should be maintained.
- Prescribing veterinarians should ensure that information regarding the proper use and dosage of the prescribed drug and the risks associated with its use are communicated to the client, regardless of the drug source.
- One factor in evaluating the quality of an Internet pharmacy is accreditation by a recognized organization such as the National Association of Boards of Pharmacy (NABP). The NABP has developed a program designed to ensure that Internet pharmacies that sell veterinary drugs are properly licensed and meet other program requirements. Further information is available at www.nabp.net.
- If a client asks about obtaining drugs from a foreign country through an Internet source, they should be aware that the importation and use of drugs not approved by the FDA is illegal.