Correctly medicating animals is sometimes tricky. It requires a proper diagnosis and responsible veterinary treatment. Correctly medicating food-producing animals, such as cows, pigs, and chickens, is especially tricky. These animals provide us with food products like meat, milk, and eggs, and as the saying goes, “We are what we eat.”

When a food-producing animal is treated with a drug, residues of the drug may be present in or on food products made from that animal. FDA makes sure these drug residues pose little risk to people.

First, by looking at detailed information about the drug, FDA's toxicologists determine the “acceptable daily intake,” or “ADI.” The ADI is the largest amount of the drug that will not harm people even if they consume that amount every day.

Second, by using the ADI, residue chemists at FDA set the tolerance for the drug, which is the highest concentration of drug residues legally allowed to be in or on food products made from treated animals. During the approval process for a drug intended for use in food-producing animals, the drug company must provide FDA with appropriate and accurate testing methods for measuring residues in a specific edible tissue (for example, liver, kidney, tongue, or milk). These methods are used to test the tissue to make sure the drug residues aren’t above the legal tolerance. Eating food that contains even the highest legal concentration of residues (meaning, at the full tolerance) will not exceed the ADI and is safe for the consumer.

Finally, based on the tolerance, FDA's residue chemists set the withdrawal time. The withdrawal time is the time from when the animal was last treated with the drug to when the animal can be slaughtered for food or the animal’s milk or eggs can go to market. The withdrawal time allows for drug residues in the edible tissue of the treated animal to get to concentrations that are at or below the tolerance. If the withdrawal time is followed, food products made from a treated animal are safe to enter the food supply.

A drug that takes longer to be broken down or eliminated by the animal's body also takes longer to get down to concentrations that are at or below the tolerance in the meat, milk, or eggs. This results in a longer withdrawal time. Also, while there is only one tolerance for a given drug in a specific edible tissue (for example, cattle liver), the same drug may have different withdrawal times depending on how the drug is used, how it is given, or what type of food the treated animal produces. For example, the withdrawal time for a drug given to beef cattle (which provide us with meat) may be different than the withdrawal time for the same drug given to dairy cattle (which provide us with both meat and milk). Similarly, an injectable form of a drug may have a different withdrawal time than the same drug given in another form, such as orally in medicated feed.

Selling food products containing drug residues above the legal tolerance is illegal because such concentrations may harm people who eat that food. Giving either an over-the-counter or prescription animal drug to a food-producing animal can cause drug residues in the edible tissue of the treated animal to be above the legal tolerance. To avoid illegal residues and to keep food products safe, FDA reminds veterinarians and animal producers to follow the withdrawal time for every drug they use in food-producing animals. The agency also asks animal producers to “T.A.L.K. Before You Treat.”

T - Talk to your veterinarian. Always check with your veterinarian before giving any drug to your animals.

A - Ask if the drug is approved by FDA for use in your animals. FDA’s approval means the drug is safe and effective when it is used according to the label. FDA’s approval also ensures that the drug’s strength, quality, and purity are consistent from batch to batch, and that the drug’s labeling is truthful, complete, and not misleading. If a drug is used in an extra-label manner in a food-producing animal, a veterinarian must be involved and is responsible for establishing an appropriate withdrawal time. Extra-label drug use means using an approved drug in a way that isn’t listed on the drug’s labeling. Extra-label drug use is sometimes called off-label because the use is “off the label.”

L - Look at the label. Know what drug you are giving and the dosage regimen. Be aware of the withdrawal time for the dosage regimen you are using. The dosage regimen includes:

• How much of the drug to give (the dose);
• How often to give it (the frequency);
• How long to give it (the duration); and
• How to give it (the route of administration). Various routes of administration include injecting the drug under the skin, into muscle, or into a vein; giving the drug by mouth; or applying the drug topically to the skin.

K - Keep complete treatment records. Good record-keeping will help you avoid illegal drug residues because you will know:

• Which animals were treated;
• What drug they were treated with;
• How they were treated (the dosage regimen used);
• Why they were treated; and
• When it is safe for food products made from treated animals to enter the food supply.

T - Talk to your veterinarian.
A - Ask if the drug is FDA-approved.
L - Look at the label.
K - Keep complete treatment records.

Ask your veterinarian these questions each time he or she prescribes a medication for your pet.

1. Why are you prescribing this medication for my pet and how long do I need to give it?
2. How do I give the medication to my pet? Should it be given with food?
3. How often should the medication be given and how much should I give each time? If it's a liquid, should I shake it first?
4. How do I store the medication?
5. What should I do if my pet vomits or spits out the medication?
6. If I forget to give the medication, should I give it as soon as I remember or wait until the next scheduled dose? What if I accidently give too much?
7. Should I finish giving all the medication, even if my pet seems to be back to normal?
8. Could this medication interact with other medications my pet is taking?
9. What side effects should I watch for, and what should I do if I see any in my pet?
10. When should I bring my pet back for a recheck? Are you going to call me to check on how my pet is doing, or should I call you?

If you have any questions during your pet’s treatment, talk with your veterinarian.

If you’ve ever had to give your cat a dose of medicine, you know that it can go sideways quickly. While no cat enjoys the process, some might be more cooperative depending on how the drug is given. For example, some cats tolerate taking pills easier than liquid, while others make the pill-giving process into a battle royale.

Thankfully, your veterinarian can ask a compounding pharmacist to change that FDA-approved pill into a liquid for your finicky feline.

Some common instances where veterinarians may recommend compounding are:

• Creating an oral medication from tablets or injectable solutions
• Adding flavoring
• Mixing solutions into eardrops
• Reformulating a medication to remove a harmful ingredient (such as an allergen)

FDA’s Role in Compounded Animal Drugs

The FDA is charged with evaluating animal drugs to make sure they are safe and do what they claim to do, whether that’s treating a particular type of infection, relieving pain, or treating some other problem.

When evaluating an animal drug for FDA-approval, scientists (including veterinarians) examine the dose, what species or type of animal it’s meant for, and how that animal processes the medicine in the body. If the medicine is used in animals that produce food, like meat, milk or eggs, the FDA also checks whether it’s safe for people to eat food from an animal treated with the medicine. Compounded animal drugs, on the other hand, are not FDA-approved.

Obviously, an FDA-approved drug is the gold standard – not only has the agency found it to be safe and effective, but FDA experts have also looked at the way it’s being manufactured and inspected the facility where it’s being made. The FDA also pores over the proposed label, making sure the directions for how to use the drug are clear and account for any known side effects. This isn’t true for compounded animal drugs.

After a drug is approved, the FDA continues to monitor the drug and address any problems that come to light after it’s used in the general animal population and gather more information than could be included in a clinical study. Drug companies are also required to report to the FDA any complaints they receive about the drug, whether it’s an unexpected outcome or a packaging issue. Compounders of animal drugs don’t have the same reporting requirements, which makes it hard for the FDA to track the safety record of these products.

But at the same time, there isn’t an approved animal drug for every disease or condition in every species. For example, there aren’t many approved animal drugs for animals like chinchillas or other so-called “pocket pets,” nor for wildlife or zoo animals. And, as any veterinarian knows from trying to give a pill to a stubborn cat, no medicine will work if you can’t get it into the patient.

Some workarounds have always been legal under FDA regulations, such as using an FDA-approved drug as the starting point for a compounded drug. To help vets have the tools they need to treat all the animals in their care, the FDA has addressed veterinarians’ access to compounded drugs when starting from what’s called “bulk drug substances” – essentially making a medicine from scratch.

Your Pet and Compounded Veterinary Drugs

If your pet is using a compounded drug made from a bulk drug substance, it’s not an FDA-approved drug. But, in situations where there are no FDA-approved drugs that are appropriate for a pet’s treatment, veterinarians choose to use what’s best for the patient. That’s why your veterinarian may decide to prescribe a compounded animal drug for your pet.

Additionally, under certain circumstances, your veterinarian might keep select compounded products in inventory, meaning they aren’t developed with a particular patient in mind, but instead are medicines the veterinarian needs to keep on hand for immediate or emergency use. The drugs selected to keep in inventory should be from a list of compounded animal drugs that the FDA maintains and updates with input from the veterinary community.

The FDA, working with the veterinary community, has gathered published scientific evidence on some of the most-used bulk drug substances and initiated lists of those that are needed for emergency situations so that veterinarians won’t see any delay in using these urgently-needed drugs to treat their patients. We encourage veterinarians and compounding pharmacists to continue to work with FDA to nominate additional bulk drug substances so we can continue to expand the list of compounded drugs needed for emergency or immediate use.

The FDA believes in both flexibility and supporting animal health, but also wants to make sure that the medicines that veterinarians have on hand are safe. In the end, it’s better for everyone, especially the animals!

Reporting Adverse Events

Manufacturers of FDA-approved drugs have to share with the FDA any complaints they receive. Compounding pharmacies are encouraged – but not required - to report problems with compounded animal drugs to the agency. The FDA encourages veterinarians and animal owners to report adverse events associated with any drugs used in animals.

• Download the fillable 1932a electronic form to your computer and email the completed form to CVM1932a@fda.hhs.gov.
• You should also report the problem to the manufacturer or distributor shown on the label and to the store where you purchased the product.

For questions about ADE reporting or to request a hard copy of the form, please contact CVM at AskCVM@fda.hhs.gov, 1-888-FDA-VETS (1-888-332-8387), or by mail:
Center for Veterinary Medicine
Food and Drug Administration
HFV-1
7500 Standish Place
Rockville, MD 20855

Your dog or cat is sick, and you head to the animal hospital. The veterinarian prescribes medications that you hope will make your pet better. But with pets, as with people, medication errors can happen.

Just as the Food and Drug Administration monitors medication errors that affect people, the agency watches out for mistakes that may harm animals. According to Linda Kim-Jung, PharmD, a safety reviewer in the Center for Veterinary Medicine’s (CVM's) Division of Veterinary Product Safety, "A number of the medication errors that occur in the treatment of people are the same as those we are seeing in the treatment of animals." For this reason, CVM collaborates with the human drug center at the FDA, the Center for Drug Evaluation and Research, Division of Medication Errors Prevention and Analysis to share, learn and disseminate outreach work on medication error prevention.

Errors Easily Made

Prescriptions for pets are sometimes filled in the same pharmacies that serve human patients. Errors can start with something as simple as an abbreviation.
"Unclear medical abbreviations are a common cause of the medication errors we review at CVM," Kim-Jung says.

Commonly used in human and veterinary medicine, abbreviations are most often used when a veterinarian is writing drug orders or documenting information in the medical record. Medical abbreviations are not universal; nor are the variations. As a result, ambiguous abbreviations and symbols can cause transcription errors. For example, a pharmacist in a human pharmacy may not be familiar with certain veterinary abbreviations for different dosage amounts. CVM has found that the abbreviation "SID" (once daily), sometimes used in veterinary prescriptions, was misinterpreted as "BID" (twice daily) and "QID" (four times daily), resulting in drug overdoses.

"If the vet has prescribed a drug where there's a strong correlation between the dose and the severity of side effects, an overdose can have serious consequences," Kim-Jung says. "Poor penmanship can add to the problem, too."

Problematic abbreviations such as "u" (units) or the Greek letter μ (mu) could be mistaken for the letter "o" or a number zero “0”. Also, the "mcg" abbreviation for microgram could be mistaken as "mg" (milligram). Additionally, when prescriptions are written without a leading zero or with a trailing zero, it can potentially lead to a dangerous overdose error. "So, a 5 mg dose written as 5.0 mg can be misread as 50 mg, potentially resulting in a 10-times overdose if the order is not clearly written," Kim-Jung explains.

In addition, drug selection errors can occur because of labels or packaging that look alike. Similarly, the pharmacy may dispense a wrong drug if the drug names look alike when written on a prescription, or if the drug names sound alike during verbal orders.

For example, one veterinarian called in a verbal order for Zeniquin (marbofloxacin) an antibiotic for a dog and asked if it was available in generic form. The pharmacist misinterpreted the order as “Sinequan” and dispensed doxepin, a generic formulation of Sinequan. Sinequan (doxepin) is used to treat depression and anxiety in humans. The dog owner called the vet 24 hours later stating that the dog was ill. Fortunately, the dog was treated and recovered.

There are numerous opportunities throughout the treatment process (from writing a prescription to administering a drug) for different people to misinterpret or misread what is written or even typed on the medication's label. "Mistakes can happen at the veterinary clinic, but also in the pharmacy which fills the prescription, and at home, when the pet owner gives the animal the meds," Kim-Jung says.

Sometimes, a pet owner is uncertain how to use a syringe or measuring device, or it doesn’t work the way it’s expected to. CVM considers human factors like this when evaluating patient safety and works on system design strategies that can prevent use errors to mitigate patient harm.

Ask Questions

There are a number of things you can do before you leave the veterinarian's office. Start by asking good questions, such as:

• What is the name of the drug? What is it supposed to do?
• If the drug comes with a device or packaged with a measuring device, ask your vet to show you how to use it properly.
• How much of the medication should I give each time?
• How many times a day should I give it?
• Should I give it before, during or after meals?
• How should I store it?
• What should I do if I forget to give a dose to my pet?
• Should I finish giving all the medication, even if my pet seems better?
• Are there reactions I should look for and call you about right away?

Help Your Veterinarian to Help You

Sharing information is a two-way street, Kim-Jung says, especially if you are getting a new prescription or seeing a new veterinarian. Be sure to:

• Keep a list of drugs that your animal is taking—including over-the-counter products, supplements and prescription drugs—and bring it with you to the veterinary office.
• Discuss any medications that your animal is allergic to or that have caused problems in the past.
• Discuss any serious or chronic health conditions that your animal may have.

Finally, there are some simple steps you can take at home to avoid medication errors:

• Keep animal drugs stored away from human drug products to prevent mix-ups. Accidental exposures to some human topical drugs and other type of human drugs can be dangerous and can cause fatalities in animals.
• Keep your animal's medications in their original labeled containers.
• Do not share the medication for one animal with another animal unless directed by the veterinarian.
• Do not give human medications to your animal unless directed by the vet.

Antibiotic resistance affects people and pets

Antibiotics save lives, but anytime they are used, they can contribute to antibiotic resistance. Antibiotic resistance can affect the health of both people and animals. Everyone can help improve antibiotic prescribing and use. Appropriate antibiotic use in people and pets helps protect the whole family––including furry, feathered, and scaly family members––from antibiotic-resistant infections.

Use antibiotics responsibly in pets

You can help prevent antibiotic resistance by asking your veterinarian about preventing common infections in pets with good hygiene, nutrition, vaccinations, and proper pet care. Use antibiotics only when needed and follow your veterinarian’s instructions.

For your pet’s health, it’s important that you safely and securely store medications. Proper storage helps prevent your pet from accidentally eating her medication, or yours, either of which could lead to potentially serious health problems.

FDA receives reports of pets accidentally eating medications as part of the agency’s overall system for monitoring drugs used in animals. Some of these reports involve pets getting into their own medications or medications for other pets in the household. There are also reports of dogs and cats getting into horse medications that have been put in horse feed or left out in the barn.

A lot of pet medications are flavored to smell and taste good—which is a positive when Princess takes her pill easily but a negative when she sniffs the pills out on her own and eats the entire supply at once. Some pets with less discriminating taste buds will eat medications that aren’t even designed to be tasty. They may even eat the entire container!

FDA also receives reports of pets accidentally getting into people medications, such as a dog eating an entire bottle of his owner’s ibuprofen. Nearly 50 percent of all phone calls to the Pet Poison Helpline are regarding pets that ingest medications intended for people—both over-the-counter and prescription. Topping the Helpline’s list of the top 10 people medications most frequently eaten by pets are nonsteroidal anti-inflammatory drugs, such as ibuprofen and naproxen.

“You may not think that bottle of medication on your kitchen counter is something that your dog would want to eat, but think again,” said Stacey Shults, a veterinarian at FDA. “Some animals chew or eat things that are not what we consider tasty. Be sure your pet can’t reach any medications—for pets or people—regardless of whether or not they’re flavored.”

In the reports that FDA receives of pets accidentally eating medications, dogs are the most common culprit, but the curious nature of cats and ferrets can get them into trouble too.

Help prevent your pet from accidentally eating medications by following these safe storage tips:

• Keep pet medications in their original containers with intact labels. It’s important that the directions for use and the pet’s name are legible.
• Keep pet medications in a secure location. What you may think is “out of reach” of your pet may, in fact, not be. Cats are good jumpers and ferrets are good climbers, so kitchen and bathroom counters, shelves, and other high places may not be secure enough. Cats can also knock a tube of medication off a counter or bedside table onto the floor, making it easier for a child or another pet to get into it. And a determined dog with a good nose can devise clever ways to reach that pill vial at the back of the cabinet, especially if the medication is flavored.
  Also, medication containers that are child safe may not be pet safe. Pets are known to chew through a variety of medication containers, including plastic pill vials, boxes, and blister packages.
• Keep pet medications away from children. Children may think a pet medication is candy, especially a chewable or liquid product. Some liquid pet medications are made to smell like banana or strawberry and may be especially attractive to children.
• Store pet medications away from people medications to prevent a mix-up. FDA sometimes receives calls from panicked owners who mistakenly took their pet’s medication or gave their personal medication to their pet. (If you accidentally ingest a pet medication, call your physician or local poison control center. If you accidentally give a medication intended for people to your pet, call your veterinarian or an animal poison control center.) To prevent mix-ups, store medications for each person and each pet in your household separately.
• If your dog goes to the barn with you, be sure to keep medications for horses and farm animals in a secure location. Many medications intended for horses contain flavoring that dogs may find attractive. Also, medicate horses and farm animals in an area that your dog can’t access. And don’t leave leftover dewormer paste or other liquid medication on the ground. Your dog may find the spot and lick it up. These precautions also apply to barn cats.
• Get rid of expired, unused, or unwanted medications properly. Pets, especially dogs, are known to go dumpster-diving and get into the garbage, so follow these guidelines for throwing out medications in your household trash:
  • Mix medications (do NOT crush tablets or capsules) with a substance that doesn’t taste good, such as kitty litter or used coffee grounds;
  • Place the mixture in a sealable container, such as a zip-top plastic bag; and
  • Throw the sealed container in your household trash.
• FDA recommends getting rid of certain potentially dangerous medications by flushing them down the toilet. This gets rid of the medication right away and helps keep both the people and pets in your family safe.
  
  Community-based drug “take-back” programs offer the best solution for disposing of expired, unused, or unwanted medications. The same take-back programs available for people medications will also take back pet medications.
  
  Here are some good resources on FDA’s website on how to safely dispose of expired, unused, or unwanted medications for both people and pets:
  • Where and How to Dispose of Unused Medicines
  • Lock it Up: Medicine Safety in Your Home
  • Disposal of Unused Medicines: What You Should Know
• Some pets need a medication that requires you to use “sharps” at home. “Sharps” are medical devices with sharp points or edges that can puncture or cut skin, such as needles and syringes. For example, insulin—a medication used to treat diabetes in dogs and cats—is injected under the skin using a small insulin syringe that has a needle.
  
  Here are some good resources on FDA’s websites on how to safely dispose of used ‘sharps’:
  • Safely Using Sharps (Needles and Syringes) at Home, at Work and on Travel
  • Sharps Disposal Containers

What to do When There’s a Problem—Reporting Problems with Pet Medications

If your pet experiences a side effect from a medication, stop giving the medication and call your veterinarian. If your pet accidentally eats his medication or a people medication, call your veterinarian or an animal poison control center.

FDA encourages pet owners to work with their veterinarian to report all problems related to a pet medication, including:

• Side effects. Side effects associated with a drug are called adverse events. This includes side effects caused by a pet accidentally eating a medication. A lack of effectiveness (the drug doesn’t do what it’s supposed to do) and reactions in people who handle the drug are also adverse events. (Call your healthcare provider if you have a reaction to your pet’s medication.)
• Product defects. These are problems such as a broken seal, the drug is off-color, or a new bottle has several crushed or broken tablets.
• Problems with a device used to give the medication. Some pet medications come with a device, such as an oral dosing syringe or other applicator, specifically designed to administer the drug. Problems with a device include dose lines that are difficult to read on the dosing syringe or a leaky applicator.
• Medication Errors. These are problems that occur if a person, such as a veterinarian or pet owner, makes a mistake and gives an animal the wrong medication or the wrong amount of medication.

To report problems with a drug that’s approved for use in animals, FDA recommends that you or your veterinarian call the drug company. Drug companies are required to submit all reports of problems with approved animal drugs to FDA. If the drug isn’t approved for use in animals, such as a drug intended for people or an unapproved animal drug, or you’re unsure if the drug is approved or not, you can report the problem directly to FDA.

When your veterinarian prescribes medication for your pet, it’s sometimes hard to remember all the information discussed during the visit. Fortunately, you can receive a Client Information Sheet from your veterinarian to answer questions and explain the medication.

What is a Client Information Sheet?

A Client Information Sheet (CIS) is written specifically for pet owners, in a user-friendly, question-and-answer format. The handout gives you detailed information about your pet’s medication and the side effects it can cause, helping you use the medication as safely and effectively as possible for your pet. A Client Information Sheet tells you:

• what the drug’s name is and what type of drug it is,
• what you can expect the drug to do for your pet,
• what the drug’s potential side effects are, and
• what you should do if you see side effects in your pet.

A Client Information Sheet is different from the medication’s package insert. Although the package insert also explains how the drug works and what the potential side effects are, it’s written for a veterinarian.

Where can I get a Client Information Sheet?

You can get a Client Information Sheet from your veterinarian. Not all veterinary medications, however, have Client Information Sheets available. Generally, they’re written for medications where owner involvement is important for safe and effective use. Some FDA-approved veterinary medications that have Client Information Sheets include:

• Non-steroidal anti-inflammatory drugs (NSAIDs) for companion animals
• Vetoryl (trilostane)
• Felimazole (methimazole)
• Palladia (toceranib phosphate)
• Comfortis (spinosad)
• Trifexis (spinosad and milbemycin)
• ProZinc (protamine zinc human recombinant insulin)
• Recuvyra (fentanyl)

You should receive a Client Information Sheet every time you receive a prescription for any of the medications listed above; whether it’s the first time your pet is receiving it or the 15th refill. In fact, the package inserts for these medications inform the veterinarian to “Always provide a client information sheet with prescription.”

Why is a Client Information Sheet important?

A Client Information Sheet is an important, helpful reminder about your pet’s medication. If you think your pet is having a problem with the medication, you can refer to the Client Information Sheet for advice. By helping you recognize possible side effects, the handout can increase your pet’s chance for a good recovery.

What should I do if I think my pet is having side effects from a medication?

The most important thing you should do if you think your pet is having side effects from a medication is call your veterinarian immediately! Your veterinarian can determine whether your pet should be seen and whether you should stop giving your pet its medication.

My pet had a side effect from a medication. Where can I report it?

If your pet had a side effect from a medication, report the incident! Side effects, also called adverse drug experiences, should first be reported to the drug company by calling the phone number on the Client Information Sheet or on the medication’s label. Drug companies are required by law to send all reports of side effects they receive to the FDA Center for Veterinary Medicine (CVM) within certain time frames. If you tell the drug company about your pet’s side effect, the report will reach FDA.

What does CVM do with reports of side effects?

When CVM receives reports of side effects from drug companies, veterinarians, or pet owners, the center’s scientists enter the information into an online database of adverse drug experiences. CVM scientists use the ADE database to make decisions about product safety which may include changes to the label or other regulatory actions. Updated labels help veterinarians use medications more safely and effectively in their patients.

Veterinarians and pet owners aren’t required to report side effects to the drug company or CVM. However, the more complete the database, the better informed our scientists are when making product safety decisions. So please report medication side effects in your pet!

Communication is Key

All medications have risks and benefits. While your veterinarian is the most qualified source of information about your pet’s medications and care, Client Information Sheets put helpful information right in your hand. When your veterinarian prescribes medication for your pet, ask if a Client Information Sheet is available.

Remember: Being an informed owner is your pet’s best defense against serious side effects from any medication!

Pet medicines—your pet needs them, and they can be expensive. You’ve seen advertisements for online pharmacies and retail websites that promise lower prices than your veterinarian’s office, but are they trustworthy? Not all websites that sell pet medicines may be what they seem. Just as with any other Internet website, you should know what red flags to look for so you can protect yourself and your pet.

Do your homework and be website A.W.A.R.E.

A—Ask Your Veterinarian

Before you buy online, talk with your veterinarian! Your veterinarian is a reliable resource when it comes to all aspects (including cost) of your pet’s specific medication needs.

Your veterinarian:

• physically examines your pet and knows if your pet has any health issues,
• knows which medicines your pet has taken in the past and which medicines your pet is currently on,
• knows which medicines are safe for your pet,
• educates you about potential side effects of your pet’s medicines,
• shows you how to properly use the medicines prescribed for your pet,
• knows whether your pet needs a change in the dose of a medicine,
• knows whether your pet needs blood tests or a check-up, and
• obtains products from legitimate sources so you can be sure the product is authentic.

W—Watch for Red Flags

When buying your pet’s medicines from a website, watch for red flags. Be careful if…

• the website doesn’t require a veterinarian’s prescription for a prescription veterinary medicine.
  Websites that sell prescription veterinary medicines without requiring a veterinarian’s prescription are breaking the law. Under the Federal Food, Drug, and Cosmetic Act, a pharmacy or other website can’t sell you a prescription veterinary medicine without a valid prescription from a licensed veterinarian. These sites should ask you for the prescription from your veterinarian or verify it by contacting the animal hospital directly.
• the online pharmacy has no licensed pharmacist available to answer your questions.
  Can someone answer your questions about your pet’s medicines? Some online pharmacies may not be prepared to answer your questions, or they may have limited knowledge about medicines for animals.
• the pharmacy’s website does not list its physical business address, phone number, or other contact information.
  A legitimate online pharmacy lists its physical U.S. address, U.S. phone number, and other contact information on its website.
• the website does not protect your personal or financial information.
  Make sure the website is secure before you share your credit card number and other personal or financial information. Look for and read the website’s privacy and security policies. If there are none or you don’t understand them, that’s a red flag. Keep yourself safe from identity and financial theft!
• the website’s prices are much lower than your veterinarian’s or other online pharmacies’ prices.
  If it seems too good to be true, then it probably is. Suspiciously cheap medicines may be unapproved knock-offs, from another country (sometimes with the label in a language other than English), or expired.
• the website ships you medicines you didn’t order or medicines that look different from what your pet normally takes.
  Don’t give these medicines to your pet—contact your veterinarian and the website’s customer service department immediately!
• the website does not accept credit cards, only Bitcoin or payment through money transfer websites.
  If you pay with Bitcoin or a money transfer and there’s a problem with your order, you will likely have difficulty getting your money back. If you pay with a credit card and there’s a problem, the credit card company may be able to help you through the charge dispute process.

A—Always Check If and Where the Online Pharmacy Is Licensed

Do you know if the online pharmacy you’re using is licensed in the U.S.? U.S. pharmacies must be licensed by the state board of pharmacy or similar agency in the state where they are based and where they fill prescriptions. To find out whether the pharmacy is appropriately licensed, contact your state board of pharmacy or state government. You can find the contact information for the state boards of pharmacy by visiting the interactive map at Know Your Online Pharmacy and clicking on your state.

R—Report Problems

If there is a problem with your pet’s medicine that you bought from either an online pharmacy or other retail website (for example, your pet has a bad side effect, the medicine isn’t working, or it looks different than usual), contact your veterinarian first. To report problems with a veterinary medicine, you can contact the company that makes the medicine. You can also report problems directly to the Food and Drug Administration (FDA). For information on how to report problems with a veterinary medicine, visit Report a Problem.

Report suspicious online pharmacies to FDA at Reporting Unlawful Sales of Medical Products on the Internet, or to your state board of pharmacy.

If you have a problem with your order, you can contact the following organizations for help:

• Better Business Bureau (for businesses in the U.S, Canada, and Mexico)
• Federal Trade Commission (for businesses located both in the U.S. and in other countries) or by phone at (202) 326-2222
• Your credit card company, if you’ve purchased the medicines with your credit card.

If you buy your pet’s medicines from an online pharmacy or retail website based outside the U.S. and have a problem with your order, be aware that you may not be able to get your money back.

E—Educate Yourself

The best defense you have when buying your pet’s medicines online is to do your homework and be website A.W.A.R.E. Protect yourself and your pet—an informed consumer is an empowered consumer.

For more information, visit:

U.S. Food and Drug Administration
(240).402.7002

Do you have questions about the foods, drugs, and other issues involving your pet?

The Food and Drug Administration’s (FDA) Center for Veterinary Medicine (CVM) may be able to answer them. FDA regulates animal drugs, animal food (including pet food), and medical devices for animals, and conducts research that helps shape regulatory decisions, among other activities.

Below are CVM’s answers to seven questions it often receives from consumers about their pets.

Q: How do I know if a drug I am giving my pet is FDA-approved?

A: Look at the drug's label. All FDA-approved animal drugs have a New Animal Drug Application (NADA) number or, for generic animal drugs, an Abbreviated New Animal Drug Application (ANADA) number. Many drug manufacturers list the six-digit NADA or ANADA number and the statement, “Approved by FDA,” on the drug’s label, although they aren’t required to do so. If you don’t see the NADA or ANADA number on the label, most FDA-approved animal drugs are listed in a searchable online database. There is more detailed information on this subject on FDA’s website.

Q: My pet had a bad reaction to a drug. How do I report this?

A: “If you suspect your animal has had a bad reaction after taking a drug, the first thing to do is to contact your veterinarian immediately,” says FDA veterinarian Carmela Stamper.

FDA also encourages both pet owners and veterinarians to report adverse drug experiences and product failures to the agency. “Data from these reports help FDA to keep tabs on product safety and look into potential drug-related problems. Every report that comes to us is important,” Stamper notes.

There are three ways you can report bad reactions, lack of effectiveness, or other product defects (like broken tablets and leaky dispensers):

1. Call the drug company to report an adverse event for an FDA-approved drug. You can usually find the company’s phone number on the product labeling. Give the reason for your call and ask to speak to a technical services veterinarian.

2. Submit FORM FDA 1932a (download PDF). The Form FDA 1932a is a pre-addressed, prepaid postage form that can be completed and dropped in the mail.

3. Call the Center for Veterinary Medicine: 1-888-FDA-VETS. Leave your name, address, phone number, and the brand name of the drug involved. Ask to have a Form FDA 1932a sent to you or ask for the phone number of the drug company you should call to report the problem. Any report you make to FDA is confidential.

Q: Why do I need a prescription from my veterinarian to purchase pet drugs from an online pet pharmacy?

A. Under the Federal Food Drug and Cosmetic Act, the law which provides much of FDA’s regulatory authority, an online pet pharmacy can’t sell you a veterinary prescription drug without a valid prescription or other type of order from a licensed veterinarian. Prescription drugs are prescription for a reason: They require professional veterinary expertise to diagnose the condition being treated, to monitor the response to treatment, and to monitor the patient for signs of adverse reactions. If the online pet pharmacy tells you that you don’t need a prescription to buy a veterinary prescription drug, it is breaking the law. In that case, you may want to find another online pet pharmacy to use.

Over-the-counter pet medicines do not require a prescription, but make sure to review the label to ensure they are FDA-approved.

Q: Which products are considered “grooming aids,” and does FDA regulate them?

A: The animal counterpart of a cosmetic is commonly called a "grooming aid" and is not regulated by FDA. These include products solely intended for cleansing or promoting attractiveness of animals, such as a dog or cat shampoo simply used for cleansing. Depending on the product’s claimed intended use, however, the product could be considered an animal drug. For example, if a product is intended for any therapeutic (medical) purpose, such as to control fungal infection or itching caused by allergies, it would be regulated by FDA as a drug.

Q: I suspect my pet had a reaction to a food. How can I report this?

A: You can report complaints about a pet food product online or by calling your state’s FDA Consumer Complaint Coordinator.

Have information ready such as:

• product name, type of package, lot number, where purchased;
• a description of the problem such as odor, color, foreign object found; and
• a description of your animal, such as weight, age, and breed.

Stamper says that pet treats are also considered pet foods and are regulated by FDA.

Q: I want to make pet treats at home. What should I know?

A: It’s okay to make pet treats at home for your own animal’s use. However, the manufacture and sale of treats—whether at a local market, a farmer’s market, a retail store, or on the internet—are subject to federal, state, and local regulation. You can learn more about requirements for selling pet treats from the Association of American Feed Control Officials (AAFCO).

If you’re making treats for your pets, be aware that certain ingredients may be harmful, Stamper says. According to the American Society of Prevention of Cruelty to Animals (ASPCA), harmful foods may include chocolate, avocado, raw bread dough, alcohol, raisins and grapes, macadamia nuts, onions and garlic.

“Most pet treats are not designed to be nutritionally complete,” Stamper says. “It’s like a person eating a cupcake.”

Q: I’m taking my pet overseas. What do I need to know?

A: Information on taking a pet overseas can be found on the U.S. Department of Agriculture’s Animal and Plant Health Inspection Service website.

If you have other questions regarding your pet, you can ask CVM’s experts by e-mail or telephone: (240) 276-9300.