Prescriptions and pharmacies: FAQs for veterinarians
Below are answers to the most common questions we receive at the AVMA about veterinary prescriptions and pharmacies.
Q: What are the requirements for writing veterinary prescriptions?
A: The AVMA's Principles of Veterinary Medical Ethics require a veterinarian-client-patient relationship (VCPR) before a veterinarian can write a prescription for an animal patient. In addition, most states have laws that specifically require a VCPR for a veterinarian to be able to write a prescription.
Each state's veterinary medical board regulates how prescriptions must be written – specifically, what information must be included on the prescription.
Although this is not a requirement, a third resource is the FDA's "A Microgram of Prevention is Worth a Milligram of Cure: Preventing Medication Errors in Animals" document, which provides additional guidance on writing prescriptions.
Q: Is it legal to dispense or write a single prescription for a drug that's to be given to multiple pets?
A: Check your state's pharmacy rules to be sure but, in general, if you are treating animals as a group, herd, or flock and you have an established veterinarian-client-patient relationship (VCPR), it would be acceptable to provide one prescription or dispensed product with directions for treating the group. For example, within a VCPR you could dispense a dewormer to a client for a litter of puppies that will be treated as a group. If the animals are to be treated as individuals, separate prescriptions would be advisable to ensure client compliance and effective treatment.
Q: What is required to be on the label of dispensed drugs?
A: The AVMA recommends that the following information be clearly included on the label. (For more information, see the AVMA's Guidelines for Veterinary Prescription Drugs and be sure to check your state's pharmacy and veterinary practice rules, as well.)
- Name, address, and telephone number of veterinarians
- Name of clients
- Identification of animal(s) treated, species and numbers of animals treated, when possible
- Date of treatment, prescribing, or dispensing of drug
- Name, active ingredient, and quantity of the drug (or drug preparation) to be prescribed or dispensed
- Drug strength (if more than one strength available)
- Dosage and duration
- Route of administration
- Number of refills
- Cautionary statements, as needed
- Expiration date if applicable
- Slaughter withdrawal and/or milk withholding times, if applicable
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.
Q: Do I have to give my client a written prescription?
A: AVMA’s Principles of Veterinary Medical Ethics require that veterinarians provide prescriptions to clients upon request in lieu of dispensing a drug when a VCPR exists and the veterinarian has determined that the drug is medically indicated. Additionally, most states have laws requiring veterinarians to provide prescriptions upon request.
Q. What is AMDUCA?
A. AMDUCA is the Animal Medicinal Drug Use Clarification Act of 1994 which permits veterinarians to prescribe extralabel uses of certain approved new animal drugs and approved human drugs for animals under certain conditions
Q. What constitutes extralablel drug use and what do I need to know about it?
A. The definition of extralablel use is the actual use or intended use of a drug in an animal in a manner that is not in accordance with the approved labeling. This includes, but is not limited to, use in species not listed in the labeling, use for indications (disease and other conditions) not listed in the labeling, use at dosage levels, frequencies, or routes of administration other than those stated in the labeling, and deviation from labeled withdrawal time based on these different uses.
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
Q: Can I develop my own clinic policy on internet pharmacies?
A: If you believe your clinic should develop a policy on the use of internet pharmacies including your clinic's protocol on filling and writing prescriptions, your clinic policy should be aligned with state and federal rules. If possible, you should try to gain input on your draft policy from your state board of veterinary medicine.
Q: Do I have to fulfill a request for a refill when I receive a fax from an internet pharmacy?
A: If you as the patient's attending veterinarian believe the drug is medically appropriate for your patient, then you can authorize (or not authorize) it at your discretion. When a veterinarian-client-patient relationship (VCPR) exists, it is your role as the veterinarian to determine a treatment plan for the animal based on your medical assessment of the animal's condition. It is at your discretion, not the pharmacy's, that prescription medications may be included in the treatment plan.
Q: I'd like to set up an online pharmacy for my clients to use. Is this legal, and what do I need to disclose to my clients?
A: Some clinics choose to enter into agreements with businesses that appear to function as online pharmacies, but dispense medications only to that practice's clients. These arrangements can be very convenient for both the practice and the pet owner, yet veterinarians should be sure they follow state and federal rules, including any requirements for disclosures to clients regarding business relationships and potential conflicts of interest. Please keep in mind that, even if you provide this online pharmacy service for your clients, your clients still have the option of filling a prescription at any pharmacy.
Q: What if my client's preferred pharmacy is located in another state?
A: As the patient's attending veterinarian, as long as you are writing an appropriate prescription in compliance with state and federal rules and regulations, generally it is acceptable to write a prescription that can be filled by a pharmacy in your state or in another state.
Q: Can my client obtain needed prescription drugs from pharmacies in Canada?
A: No. Drugs from Canada are not approved by the federal government for use in the United States. If your client asks you to help them obtain veterinary drugs from Canada, you should refuse on the grounds that it is illegal to ship prescription drugs from Canada into the United States. In the past, and under very unique circumstances, the FDA has allowed the temporary importation by veterinarians of non-FDA-approved drugs under medical emergency conditions when an FDA-approved product was not available in the U.S. However, personal importation of non-FDA-approved animal drugs is not allowed.
Q: I've been asked to fill a prescription from another veterinarian, but I have not examined the animal and there is no established Veterinarian-Client-Patient Relationship. Is it legal for me to fill the prescription? Am I required to fill the prescription?
A: Most states require a veterinarian-client-patient relationship (VCPR) in order for you to fill a prescription. However, the rules on this vary by state – a few states do allow veterinarians to fill prescriptions from other veterinarians in certain scenarios. We recommend you check your own state's veterinary practice rules.
Q: Is there a way to determine the quality of a pharmacy?
A: Sometimes the best indicator of a pharmacy's quality is your past experience with the pharmacy. However, if you are not familiar with the pharmacy, veterinarians and their clients can inquire with the state board of pharmacy to determine whether a pharmacy is licensed within the state and the status of the pharmacy's license.
In addition, accreditation by independent bodies may be able to give you and your client more information about a pharmacy. Two examples of third-party accreditation include the National Association of Boards of Pharmacy Pharmacy Verified Websites Program and, for compounding pharmacies, the Pharmacy Compounding Accreditation Board.
Q: Whom should I contact to report a problem with a drug obtained from a pharmacy?
A: The state boards of pharmacy oversee the practice of pharmacy within the state and ensure state rules are followed. Contact your state board of pharmacy if you suspect that the pharmacy's dispensing practices may be in violation of the law. Also, if the pharmacy is based out of another state, call that state's board of pharmacy.
The FDA should also be contacted, especially if you suspect the pharmacy has sold prescription drugs in the absence of a prescription. Likewise, if a business seeks to purchase a large quantity of prescription drugs from you, the FDA should be made aware of the situation.
Q: What should I do if someone who isn't a client asks me to sell them prescription drugs or write a prescription for them to use to obtain drugs?
A: According to the AVMA's Principles of Veterinary Medical Ethics, it is unethical for veterinarians to sell prescription drugs outside a VCPR. Most states specifically require a VCPR, so selling prescription drugs outside the VCPR falls outside state veterinary medical practice acts that dictate how veterinarians must practice medicine. Selling prescription drugs outside a VCPR would include sales of prescription drugs to distributors or other companies. In addition, there are federal requirements for a VCPR that come into play in the case of extralabel drug use, issuing Veterinary Feed Directives, and the use of autogenous biologics.
Report fraudulent sales to the product manufacturer, and report requests for prescription drug sales to your state board of pharmacy and the Food and Drug Administration.
Q. What is the definition of compounded medications and are there legal requirements in regards to prescribing them?
A. 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.
- Compounding must be done by or under the order of a veterinarian.
- Compounded drugs must not be used for production or performance purposes.
- A compounded human drug cannot be used in a food-producing animal if a legally compounded animal drug can instead be used.
- Compounded drugs must be prepared from FDA-approved drugs
- The volume of compounded drug must be commensurate with the anticipated need for use in individual patients.
- State laws on compounding must also be followed.
- A veterinarian must be cognizant of the need to maintain a safe food supply. Specifically, veterinarians must not allow entry of a treated animal into the food chain, if there is insufficient scientific evidence indicating a proper withdrawal interval after treatment.
Please see AVMA’s Compounding Guidance for Veterinarians
Q: Is it OK if I purchase a large quantity of compounded products from a compounding pharmacy to sell at a later date?
A: Ideally when a patient needs a compounded medication, the drug should be compounded specifically for that patient's individual needs. Some states allow veterinarians to maintain compounded preparations for administration to patients within the clinic. Other states allow veterinarians to maintain compounded preparations for administration, as well as dispensing of small quantities. You should check with your state board of veterinary medicine for allowances in your state. Also, be suspicious of (and report) any pharmacy that offers to sell you large quantities of compounded drugs for a much cheaper price than what you would normally pay for an FDA-approved drug – some pharmacies illegally manufacture drugs and the FDA (and, for controlled substances, the DEA) is cracking down on these illegal activities.
Q: Sponsors of human opioid drugs are required to indicate that prescribers should provide information about naloxone to patients and caretakers and consider prescribing naloxone along with the opioid. Does this prescription labeling requirement also apply to sponsors of opioids intended for animals and therefore impose obligations on veterinarians?
A: From the perspective of legal obligations, these requirements are aimed at sponsors of human drugs. Sponsors of opioids intended for use in animals, approved under Section 512 of the FDCA, are not affected, and this action does not impose legal obligations on veterinarians when prescribing either approved human or animal opioids.
Additional resources:
Reference Guide: Pharmacy and Prescription Issues
Clinic Poster: Reduce Prescription Errors (PDF)
Client Handout: Your Pet Prescription Choices (PDF)
U.S. Food and Drug Administration: